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Most charity assistance programs do not cover prescriptions for uninsured patients
Almost all of the patient assistance programs funded by independent charities for subsidizing prescription medications exclude patients without insurance, a cross-sectional analysis has shown.
Of 274 patient assistance programs analyzed from six independent charities, 267 (97%) listed insurance coverage as an eligibility requirement for their program, according to So-Yeon Kang, MPH, MBA, a PhD student at Johns Hopkins University, Baltimore, and colleagues.
Out-of-pocket prescription costs for Medicare Part D plans can cost “thousands of dollars” because of higher coinsurance rates and no catastrophic cap on the program, the researchers noted in JAMA.
“For this reason, independent charity foundations offering patient assistance programs to these patients are entitled to receive tax-deductible donations from pharmaceutical companies,” they wrote. “However, the findings from this study suggest that several features of the programs may limit their usefulness to financially needy patients and bolster the use of expensive drugs.”
The researchers examined the 274 patient assistance programs funded by the CancerCare Co-Payment Assistance Foundation, Good Days, the HealthWell Foundation, the Patient Access Network Foundation, Patient Advocate Foundation Co-Pay Relief, and Patient Services Incorporated. Copayment assistance alone was provided by 168 programs, 90 programs offered assistance with copayments and health insurance premiums, and 9 programs provided assistance to subsidize health insurance premiums only.
Cancer or cancer-related treatments were covered by 41% of programs, and 34% provided assistance for genetic or rare diseases.
In 2017, the six charities spent an average of 86% of their revenue on patient expenditures: They had a total revenue of between $24 million and $532 million, while the expenditures for patient assistance ranged from $24 million and $353 million. With regard to eligibility, the income limit that was most common was 500% of the federal poverty level.
The researchers also studied which of 18 drugs were covered by assistance programs. They found that Of the 18 drugs studied, 12 drugs (67%) were in protected classes and therefore covered by Medicare Part D. Prescription drugs that were covered were more likely to be expensive, compared with drugs that were not covered (median annual cost of $1,157, versus $367).
The researchers noted several limitations of the study, such the inability to correlate the programs with drug spending, assuming that generic substitution was always possible. In addition, the analysis of drug use was limited to two charity foundations.
In a related editorial, Katherine L. Kraschel and Gregory D. Curfman, MD, wrote that some patient assistance programs might be violating federal law.
“Coupled with recent enforcement activity by the Department of Justice, the data reported by Kang et al. suggest that some programs may warrant continued regulatory scrutiny and enforcement,” wrote Ms. Kraschel, executive director of the Solomon Center for Health Law & Policy at Yale University Law School, New Haven, Conn., and Dr. Curfman, deputy editor of JAMA in Chicago (JAMA. 2019;322[5]:405-6).
In addition, the Office of Inspector General created a special advisory bulletin in 2014 that clarifies how pharmaceutical companies should comply with the Anti-Kickback Statute within a patient assistance program. This guidance states that pharmaceutical companies should make assistance available to all products, rather than simply high-cost or specialty drugs, which pharmaceutical companies have not consistently followed, Ms. Kraschel and Dr. Curfman explained.
To help patients and the health care system, the authors recommended the Office of the Inspector General implement stronger restrictions for pharmaceutical companies contributing to patient assistance programs and develop reporting requirements for transparency purposes.
“The extent to which patient assistance programs violate tax exemption standards that prohibit private benefit that does not further its charitable purpose and is intentionally aimed to benefit the pharmaceutical companies warrants further scrutiny,” Ms. Kraschel and Dr. Curfman wrote. “It is particularly egregious that the payments made from pharmaceutical companies to patient assistance programs may be illegal yet simultaneously tax deductible.”
The study was funded by Arnold Ventures. The authors of the study and the editorial reported no relevant conflicts of interest.
SOURCE: Kang S-Y et al. JAMA. 2019;322(5):422-9.
Almost all of the patient assistance programs funded by independent charities for subsidizing prescription medications exclude patients without insurance, a cross-sectional analysis has shown.
Of 274 patient assistance programs analyzed from six independent charities, 267 (97%) listed insurance coverage as an eligibility requirement for their program, according to So-Yeon Kang, MPH, MBA, a PhD student at Johns Hopkins University, Baltimore, and colleagues.
Out-of-pocket prescription costs for Medicare Part D plans can cost “thousands of dollars” because of higher coinsurance rates and no catastrophic cap on the program, the researchers noted in JAMA.
“For this reason, independent charity foundations offering patient assistance programs to these patients are entitled to receive tax-deductible donations from pharmaceutical companies,” they wrote. “However, the findings from this study suggest that several features of the programs may limit their usefulness to financially needy patients and bolster the use of expensive drugs.”
The researchers examined the 274 patient assistance programs funded by the CancerCare Co-Payment Assistance Foundation, Good Days, the HealthWell Foundation, the Patient Access Network Foundation, Patient Advocate Foundation Co-Pay Relief, and Patient Services Incorporated. Copayment assistance alone was provided by 168 programs, 90 programs offered assistance with copayments and health insurance premiums, and 9 programs provided assistance to subsidize health insurance premiums only.
Cancer or cancer-related treatments were covered by 41% of programs, and 34% provided assistance for genetic or rare diseases.
In 2017, the six charities spent an average of 86% of their revenue on patient expenditures: They had a total revenue of between $24 million and $532 million, while the expenditures for patient assistance ranged from $24 million and $353 million. With regard to eligibility, the income limit that was most common was 500% of the federal poverty level.
The researchers also studied which of 18 drugs were covered by assistance programs. They found that Of the 18 drugs studied, 12 drugs (67%) were in protected classes and therefore covered by Medicare Part D. Prescription drugs that were covered were more likely to be expensive, compared with drugs that were not covered (median annual cost of $1,157, versus $367).
The researchers noted several limitations of the study, such the inability to correlate the programs with drug spending, assuming that generic substitution was always possible. In addition, the analysis of drug use was limited to two charity foundations.
In a related editorial, Katherine L. Kraschel and Gregory D. Curfman, MD, wrote that some patient assistance programs might be violating federal law.
“Coupled with recent enforcement activity by the Department of Justice, the data reported by Kang et al. suggest that some programs may warrant continued regulatory scrutiny and enforcement,” wrote Ms. Kraschel, executive director of the Solomon Center for Health Law & Policy at Yale University Law School, New Haven, Conn., and Dr. Curfman, deputy editor of JAMA in Chicago (JAMA. 2019;322[5]:405-6).
In addition, the Office of Inspector General created a special advisory bulletin in 2014 that clarifies how pharmaceutical companies should comply with the Anti-Kickback Statute within a patient assistance program. This guidance states that pharmaceutical companies should make assistance available to all products, rather than simply high-cost or specialty drugs, which pharmaceutical companies have not consistently followed, Ms. Kraschel and Dr. Curfman explained.
To help patients and the health care system, the authors recommended the Office of the Inspector General implement stronger restrictions for pharmaceutical companies contributing to patient assistance programs and develop reporting requirements for transparency purposes.
“The extent to which patient assistance programs violate tax exemption standards that prohibit private benefit that does not further its charitable purpose and is intentionally aimed to benefit the pharmaceutical companies warrants further scrutiny,” Ms. Kraschel and Dr. Curfman wrote. “It is particularly egregious that the payments made from pharmaceutical companies to patient assistance programs may be illegal yet simultaneously tax deductible.”
The study was funded by Arnold Ventures. The authors of the study and the editorial reported no relevant conflicts of interest.
SOURCE: Kang S-Y et al. JAMA. 2019;322(5):422-9.
Almost all of the patient assistance programs funded by independent charities for subsidizing prescription medications exclude patients without insurance, a cross-sectional analysis has shown.
Of 274 patient assistance programs analyzed from six independent charities, 267 (97%) listed insurance coverage as an eligibility requirement for their program, according to So-Yeon Kang, MPH, MBA, a PhD student at Johns Hopkins University, Baltimore, and colleagues.
Out-of-pocket prescription costs for Medicare Part D plans can cost “thousands of dollars” because of higher coinsurance rates and no catastrophic cap on the program, the researchers noted in JAMA.
“For this reason, independent charity foundations offering patient assistance programs to these patients are entitled to receive tax-deductible donations from pharmaceutical companies,” they wrote. “However, the findings from this study suggest that several features of the programs may limit their usefulness to financially needy patients and bolster the use of expensive drugs.”
The researchers examined the 274 patient assistance programs funded by the CancerCare Co-Payment Assistance Foundation, Good Days, the HealthWell Foundation, the Patient Access Network Foundation, Patient Advocate Foundation Co-Pay Relief, and Patient Services Incorporated. Copayment assistance alone was provided by 168 programs, 90 programs offered assistance with copayments and health insurance premiums, and 9 programs provided assistance to subsidize health insurance premiums only.
Cancer or cancer-related treatments were covered by 41% of programs, and 34% provided assistance for genetic or rare diseases.
In 2017, the six charities spent an average of 86% of their revenue on patient expenditures: They had a total revenue of between $24 million and $532 million, while the expenditures for patient assistance ranged from $24 million and $353 million. With regard to eligibility, the income limit that was most common was 500% of the federal poverty level.
The researchers also studied which of 18 drugs were covered by assistance programs. They found that Of the 18 drugs studied, 12 drugs (67%) were in protected classes and therefore covered by Medicare Part D. Prescription drugs that were covered were more likely to be expensive, compared with drugs that were not covered (median annual cost of $1,157, versus $367).
The researchers noted several limitations of the study, such the inability to correlate the programs with drug spending, assuming that generic substitution was always possible. In addition, the analysis of drug use was limited to two charity foundations.
In a related editorial, Katherine L. Kraschel and Gregory D. Curfman, MD, wrote that some patient assistance programs might be violating federal law.
“Coupled with recent enforcement activity by the Department of Justice, the data reported by Kang et al. suggest that some programs may warrant continued regulatory scrutiny and enforcement,” wrote Ms. Kraschel, executive director of the Solomon Center for Health Law & Policy at Yale University Law School, New Haven, Conn., and Dr. Curfman, deputy editor of JAMA in Chicago (JAMA. 2019;322[5]:405-6).
In addition, the Office of Inspector General created a special advisory bulletin in 2014 that clarifies how pharmaceutical companies should comply with the Anti-Kickback Statute within a patient assistance program. This guidance states that pharmaceutical companies should make assistance available to all products, rather than simply high-cost or specialty drugs, which pharmaceutical companies have not consistently followed, Ms. Kraschel and Dr. Curfman explained.
To help patients and the health care system, the authors recommended the Office of the Inspector General implement stronger restrictions for pharmaceutical companies contributing to patient assistance programs and develop reporting requirements for transparency purposes.
“The extent to which patient assistance programs violate tax exemption standards that prohibit private benefit that does not further its charitable purpose and is intentionally aimed to benefit the pharmaceutical companies warrants further scrutiny,” Ms. Kraschel and Dr. Curfman wrote. “It is particularly egregious that the payments made from pharmaceutical companies to patient assistance programs may be illegal yet simultaneously tax deductible.”
The study was funded by Arnold Ventures. The authors of the study and the editorial reported no relevant conflicts of interest.
SOURCE: Kang S-Y et al. JAMA. 2019;322(5):422-9.
FROM JAMA
Key clinical point: Nearly all patient assistance programs do not provide help with prescription costs for patients without insurance.
Major finding: Of 274 assistance programs examined, 267 programs (97%) list insurance coverage as a requirement for eligibility, and those programs were more likely to cover off-patent, brand-name drugs than generic versions.
Study details: A cross-sectional study of 274 patient assistance programs funded by six independent charities in 2018.
Disclosures: This study was funded by Arnold Ventures. The authors reported no relevant conflicts of interest.
Source: Kang S-Y et al. JAMA. 2019;322(5):422-9.
ISCHEMIA trial hailed as practice changing
PHILADELPHIA – The eagerly awaited results of the ISCHEMIA trial – the largest-ever randomized trial of an initial invasive versus conservative management strategy for patients with stable ischemic heart disease – were emphatically declared practice-changing by interventional cardiologists and noninterventionalists alike at the American Heart Association scientific sessions.
At a median 3.3 years of follow-up of 5,179 participants with baseline moderate or severe ischemia at 320 sites in 37 countries in ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches), an initial invasive strategy accompanied by optimal medical therapy (OMT) didn’t reduce the risk of the primary composite endpoint of cardiovascular death, MI, hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, compared with a conservative strategy of OMT alone. The rates at 4 years were 15.5% with the conservative strategy and 13.3% with the invasive strategy, reported study chair Judith S. Hochman, MD, professor of medicine and senior associate dean for clinical sciences at New York University.
Nor was there a significant between-group difference in the major secondary endpoint of cardiovascular death or MI: 13.9% with the conservative strategy, 11.7% with invasive management.
“The probability of at least a 10% benefit of the invasive strategy on all-cause mortality was less than 10%, based on a prespecified Bayesian analysis,” she added.
Prior to enrollment and randomization, CT angiography was routinely performed to rule out left main coronary artery disease.
Fifty-four percent of participants in the National Heart, Lung, and Blood Institute–funded trial had severe ischemia on a baseline noninvasive stress test. To the investigators’ surprise, patients with more severe ischemia or more extensive multivessel involvement didn’t do better with the invasive approach.
Almost a quarter (23%) of patients in the conservative management group crossed over to revascularization within 4 years.
Quality-of-life results
An invasive strategy did result in significantly greater improvement in angina control and quality of life, as measured using the Seattle Angina Questionnaire, than OMT alone in patients who had angina at least once a month at baseline.
“We have 100% confidence that there is a treatment benefit associated with an invasive approach early as well as late after randomization,” said John A. Spertus, MD, coprincipal investigator for the ISCHEMIA quality of life analysis.
Indeed, he calculated that, for patients with weekly angina, the number needed to treat with revascularization instead of OMT alone for one to be angina-free at 3 months was three.
However, in the 35% of ISCHEMIA participants who reported no angina within the past month at baseline, the invasive strategy offered no quality of life advantage, he added.
“I really think we need to hit ‘pause’ on asymptomatic revascularization. I just don’t see any benefit in patients without symptoms, left main disease excluded,” commented Dr. Spertus, director of health outcomes research at St. Luke’s Mid-America Heart Institute and professor of medicine at the University of Missouri, Kansas City.
The reaction
ISCHEMIA addressed a key clinical issue that’s long been surrounded by equipoise because of a paucity of high-quality data. As such, it was deemed worthy of its own AHA Late-Breaking Science session. The assembled discussants agreed the results will change their clinical practice.
“Based on the trial results to date in the patient population studied in the trial, I as a clinician would feel comfortable advising my patients not to undergo the invasive strategy if their angina was absent or controlled or tolerated. I don’t think we should feel obligated to take them to the cath lab,” said Alice K. Jacobs, MD, an AHA past-president and professor of medicine and director of the cardiac catheterization laboratory and interventional cardiology at Boston Medical Center.
The ISCHEMIA trial has been the target of criticism because of its cost, prolonged duration, and shifting endpoints, but Glenn L. Levine, MD, praised the ISCHEMIA investigators for achieving “as well-designed and -executed a trial as one could practically do in the real world.” ISCHEMIA will undoubtedly be incorporated into AHA/American College of Cardiology guidelines on chest pain and on revascularization that are now in the process of being updated, predicted the cardiologist, who has chaired writing panels for numerous AHA/ACC guidelines.
“As someone who has been intimately involved with our national guidelines for the last 6 years, I say thank you to all the investigators and participants,” added Dr. Levine, professor of medicine at Baylor College of Medicine and director of the cardiac care unit at the Michael E. Debakey Medical Center, Houston.
“I’ll just say that this definitely will change my practice,” commented Brahmajee K. Nallamothu, MD, an interventional cardiologist and professor of medicine at the University of Michigan, Ann Arbor. “Just like the COURAGE trial taught me that not every blockage needs to have a stent in it right away, I think this is teaching me that not every patient with moderate-to-severe ischemia needs to go right away to the cath lab.”
Session cochair James de Lemos, MD, declared, “My take home is this is a remarkable finding. It’s medical proof that revascularization does not appear to have a marked effect.”
“I think the downstream implications of ISCHEMIA with regard to noninvasive testing are massive. I think that’s where will see more of an impact in our practice,” according to Dr. de Lemos, professor of medicine at the University of Texas Southwestern Medical Center and chief of the cardiology service at Parklawn Hospital in Dallas.
Numerous panelists expressed hope that the National Institutes of Health will fund a long-term extension of ISCHEMIA to learn if the results hold up.
The ISCHEMIA trial was funded by the National Heart, Lung, and Blood Institute. Dr. Spertus holds the copyright for the Seattle Angina Questionnaire.
SOURCE: Hochman JS. AHA late breaker.
PHILADELPHIA – The eagerly awaited results of the ISCHEMIA trial – the largest-ever randomized trial of an initial invasive versus conservative management strategy for patients with stable ischemic heart disease – were emphatically declared practice-changing by interventional cardiologists and noninterventionalists alike at the American Heart Association scientific sessions.
At a median 3.3 years of follow-up of 5,179 participants with baseline moderate or severe ischemia at 320 sites in 37 countries in ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches), an initial invasive strategy accompanied by optimal medical therapy (OMT) didn’t reduce the risk of the primary composite endpoint of cardiovascular death, MI, hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, compared with a conservative strategy of OMT alone. The rates at 4 years were 15.5% with the conservative strategy and 13.3% with the invasive strategy, reported study chair Judith S. Hochman, MD, professor of medicine and senior associate dean for clinical sciences at New York University.
Nor was there a significant between-group difference in the major secondary endpoint of cardiovascular death or MI: 13.9% with the conservative strategy, 11.7% with invasive management.
“The probability of at least a 10% benefit of the invasive strategy on all-cause mortality was less than 10%, based on a prespecified Bayesian analysis,” she added.
Prior to enrollment and randomization, CT angiography was routinely performed to rule out left main coronary artery disease.
Fifty-four percent of participants in the National Heart, Lung, and Blood Institute–funded trial had severe ischemia on a baseline noninvasive stress test. To the investigators’ surprise, patients with more severe ischemia or more extensive multivessel involvement didn’t do better with the invasive approach.
Almost a quarter (23%) of patients in the conservative management group crossed over to revascularization within 4 years.
Quality-of-life results
An invasive strategy did result in significantly greater improvement in angina control and quality of life, as measured using the Seattle Angina Questionnaire, than OMT alone in patients who had angina at least once a month at baseline.
“We have 100% confidence that there is a treatment benefit associated with an invasive approach early as well as late after randomization,” said John A. Spertus, MD, coprincipal investigator for the ISCHEMIA quality of life analysis.
Indeed, he calculated that, for patients with weekly angina, the number needed to treat with revascularization instead of OMT alone for one to be angina-free at 3 months was three.
However, in the 35% of ISCHEMIA participants who reported no angina within the past month at baseline, the invasive strategy offered no quality of life advantage, he added.
“I really think we need to hit ‘pause’ on asymptomatic revascularization. I just don’t see any benefit in patients without symptoms, left main disease excluded,” commented Dr. Spertus, director of health outcomes research at St. Luke’s Mid-America Heart Institute and professor of medicine at the University of Missouri, Kansas City.
The reaction
ISCHEMIA addressed a key clinical issue that’s long been surrounded by equipoise because of a paucity of high-quality data. As such, it was deemed worthy of its own AHA Late-Breaking Science session. The assembled discussants agreed the results will change their clinical practice.
“Based on the trial results to date in the patient population studied in the trial, I as a clinician would feel comfortable advising my patients not to undergo the invasive strategy if their angina was absent or controlled or tolerated. I don’t think we should feel obligated to take them to the cath lab,” said Alice K. Jacobs, MD, an AHA past-president and professor of medicine and director of the cardiac catheterization laboratory and interventional cardiology at Boston Medical Center.
The ISCHEMIA trial has been the target of criticism because of its cost, prolonged duration, and shifting endpoints, but Glenn L. Levine, MD, praised the ISCHEMIA investigators for achieving “as well-designed and -executed a trial as one could practically do in the real world.” ISCHEMIA will undoubtedly be incorporated into AHA/American College of Cardiology guidelines on chest pain and on revascularization that are now in the process of being updated, predicted the cardiologist, who has chaired writing panels for numerous AHA/ACC guidelines.
“As someone who has been intimately involved with our national guidelines for the last 6 years, I say thank you to all the investigators and participants,” added Dr. Levine, professor of medicine at Baylor College of Medicine and director of the cardiac care unit at the Michael E. Debakey Medical Center, Houston.
“I’ll just say that this definitely will change my practice,” commented Brahmajee K. Nallamothu, MD, an interventional cardiologist and professor of medicine at the University of Michigan, Ann Arbor. “Just like the COURAGE trial taught me that not every blockage needs to have a stent in it right away, I think this is teaching me that not every patient with moderate-to-severe ischemia needs to go right away to the cath lab.”
Session cochair James de Lemos, MD, declared, “My take home is this is a remarkable finding. It’s medical proof that revascularization does not appear to have a marked effect.”
“I think the downstream implications of ISCHEMIA with regard to noninvasive testing are massive. I think that’s where will see more of an impact in our practice,” according to Dr. de Lemos, professor of medicine at the University of Texas Southwestern Medical Center and chief of the cardiology service at Parklawn Hospital in Dallas.
Numerous panelists expressed hope that the National Institutes of Health will fund a long-term extension of ISCHEMIA to learn if the results hold up.
The ISCHEMIA trial was funded by the National Heart, Lung, and Blood Institute. Dr. Spertus holds the copyright for the Seattle Angina Questionnaire.
SOURCE: Hochman JS. AHA late breaker.
PHILADELPHIA – The eagerly awaited results of the ISCHEMIA trial – the largest-ever randomized trial of an initial invasive versus conservative management strategy for patients with stable ischemic heart disease – were emphatically declared practice-changing by interventional cardiologists and noninterventionalists alike at the American Heart Association scientific sessions.
At a median 3.3 years of follow-up of 5,179 participants with baseline moderate or severe ischemia at 320 sites in 37 countries in ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches), an initial invasive strategy accompanied by optimal medical therapy (OMT) didn’t reduce the risk of the primary composite endpoint of cardiovascular death, MI, hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, compared with a conservative strategy of OMT alone. The rates at 4 years were 15.5% with the conservative strategy and 13.3% with the invasive strategy, reported study chair Judith S. Hochman, MD, professor of medicine and senior associate dean for clinical sciences at New York University.
Nor was there a significant between-group difference in the major secondary endpoint of cardiovascular death or MI: 13.9% with the conservative strategy, 11.7% with invasive management.
“The probability of at least a 10% benefit of the invasive strategy on all-cause mortality was less than 10%, based on a prespecified Bayesian analysis,” she added.
Prior to enrollment and randomization, CT angiography was routinely performed to rule out left main coronary artery disease.
Fifty-four percent of participants in the National Heart, Lung, and Blood Institute–funded trial had severe ischemia on a baseline noninvasive stress test. To the investigators’ surprise, patients with more severe ischemia or more extensive multivessel involvement didn’t do better with the invasive approach.
Almost a quarter (23%) of patients in the conservative management group crossed over to revascularization within 4 years.
Quality-of-life results
An invasive strategy did result in significantly greater improvement in angina control and quality of life, as measured using the Seattle Angina Questionnaire, than OMT alone in patients who had angina at least once a month at baseline.
“We have 100% confidence that there is a treatment benefit associated with an invasive approach early as well as late after randomization,” said John A. Spertus, MD, coprincipal investigator for the ISCHEMIA quality of life analysis.
Indeed, he calculated that, for patients with weekly angina, the number needed to treat with revascularization instead of OMT alone for one to be angina-free at 3 months was three.
However, in the 35% of ISCHEMIA participants who reported no angina within the past month at baseline, the invasive strategy offered no quality of life advantage, he added.
“I really think we need to hit ‘pause’ on asymptomatic revascularization. I just don’t see any benefit in patients without symptoms, left main disease excluded,” commented Dr. Spertus, director of health outcomes research at St. Luke’s Mid-America Heart Institute and professor of medicine at the University of Missouri, Kansas City.
The reaction
ISCHEMIA addressed a key clinical issue that’s long been surrounded by equipoise because of a paucity of high-quality data. As such, it was deemed worthy of its own AHA Late-Breaking Science session. The assembled discussants agreed the results will change their clinical practice.
“Based on the trial results to date in the patient population studied in the trial, I as a clinician would feel comfortable advising my patients not to undergo the invasive strategy if their angina was absent or controlled or tolerated. I don’t think we should feel obligated to take them to the cath lab,” said Alice K. Jacobs, MD, an AHA past-president and professor of medicine and director of the cardiac catheterization laboratory and interventional cardiology at Boston Medical Center.
The ISCHEMIA trial has been the target of criticism because of its cost, prolonged duration, and shifting endpoints, but Glenn L. Levine, MD, praised the ISCHEMIA investigators for achieving “as well-designed and -executed a trial as one could practically do in the real world.” ISCHEMIA will undoubtedly be incorporated into AHA/American College of Cardiology guidelines on chest pain and on revascularization that are now in the process of being updated, predicted the cardiologist, who has chaired writing panels for numerous AHA/ACC guidelines.
“As someone who has been intimately involved with our national guidelines for the last 6 years, I say thank you to all the investigators and participants,” added Dr. Levine, professor of medicine at Baylor College of Medicine and director of the cardiac care unit at the Michael E. Debakey Medical Center, Houston.
“I’ll just say that this definitely will change my practice,” commented Brahmajee K. Nallamothu, MD, an interventional cardiologist and professor of medicine at the University of Michigan, Ann Arbor. “Just like the COURAGE trial taught me that not every blockage needs to have a stent in it right away, I think this is teaching me that not every patient with moderate-to-severe ischemia needs to go right away to the cath lab.”
Session cochair James de Lemos, MD, declared, “My take home is this is a remarkable finding. It’s medical proof that revascularization does not appear to have a marked effect.”
“I think the downstream implications of ISCHEMIA with regard to noninvasive testing are massive. I think that’s where will see more of an impact in our practice,” according to Dr. de Lemos, professor of medicine at the University of Texas Southwestern Medical Center and chief of the cardiology service at Parklawn Hospital in Dallas.
Numerous panelists expressed hope that the National Institutes of Health will fund a long-term extension of ISCHEMIA to learn if the results hold up.
The ISCHEMIA trial was funded by the National Heart, Lung, and Blood Institute. Dr. Spertus holds the copyright for the Seattle Angina Questionnaire.
SOURCE: Hochman JS. AHA late breaker.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point: .
Major finding: Immediate revascularization in patients with stable ischemic heart disease provided no reduction in cardiovascular endpoints through 4 years of follow-up, compared with initial optimal medical therapy alone.
Study details: This international randomized trial included 5,129 patients with at least moderate ischemia who were assigned to initial invasive or conservative management and followed for a median of 3.3 years.
Disclosures: The ISCHEMIA trial was funded by the National Heart, Lung, and Blood Institute.
Source: Hochman JS. AHA 2019 late breaker.
DAPA-HF: Dapagliflozin’s HFrEF efficacy confirmed in nondiabetics
PHILADELPHIA – The primary outcome results from the practice-changing DAPA-HF trial gave clinicians strong evidence that the diabetes drug dapagliflozin was equally effective at reducing cardiovascular death and acute exacerbations in patients with heart failure with reduced ejection fraction, whether or not they also had type 2 diabetes. More detailed findings from the 2,605 enrolled patients in DAPA-HF who lacked diabetes (55% of the total study population) have now sealed the deal.
“The relative and absolute reductions in cardiovascular death and hospitalizations or urgent visits for heart failure were substantial, clinically important, and consistent in patients with or without type 2 diabetes,” John McMurray, MD, declared at the American Heart Association scientific sessions as he summarized new trial results that confirmed the initial finding he reported previously.
While the initial report of the DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) by the study’s lead investigator, Dr. McMurray, was limited to the finding that the relative risk reduction for the study’s primary endpoint was a highly statistically significant 25% in heart failure patients with diabetes and an equally strongly significant 27% relative cut among patients without diabetes (N Engl J Med. 2019 Sep 19;doi: 10.1056/NEJMoa1911303), the new data showed that same consistency across the range of outcomes studied in the trial as well as across the range of glycosylated hemoglobin levels that patients had at study entry.
In an analysis that divided the entire study population of 4,744 patients with heart failure with reduced ejection fraction (HFrEF) into tertiles based on their entry blood level of hemoglobin A1c, patients with a normal level at or below 5.6% had a 26% relative reduction in the study’s primary endpoint, essentially the same response as the 29% relative cut in adverse events in the tertile of patients with a glycosylated hemoglobin level of 5.7%-5.9% and the relative 28% relative reduction in events in patients diagnosed with type 2 diabetes and having a hemoglobin A1c of 6.0% or greater, reported Dr. McMurray, professor of cardiology at the University of Glasgow. The results also showed a very benign safety profile in the patients without diabetes, similar to patients with diabetes and to placebo, and with no episodes of major hypoglycemia or diabetic ketoacidosis.
“It’s quite impressive that the result was consistent regardless of the level of hemoglobin A1c,” commented Larry A. Allen, MD, professor of medicine at the University of Colorado in Aurora and designated discussant for the report. Even though the patients without diabetes constituted just over half of the full DAPA-HF enrollment, the comparison of the effect of dapagliflozin in patients with or without diabetes was prespecified in a trial that enrolled a relatively large number of patients into each of the two subgroups by diabetes status. “I think there a good chance dapagliflozin will get an indication” for treating HFrEF patients without diabetes, Dr. Allen suggested in a video interview.
If the DAPA-HF results persuade the U.S. Food and Drug Administration to grant a supplemental indication to dapagliflozin for use in cutting cardiovascular deaths and acute heart failure exacerbations in patients without diabetes, it would pave the way for health insurers to pay for the drug. Right now, even though Dr. Allen and other heart failure physicians have been impressed by the DAPA-HF findings and are eager to add the drug to the list of agents that HFrEF patients routinely receive, he’s been stymied so far by patients’ out-of pocket cost for using dapagliflozin off-label, roughly $500 a month.
“The DAPA-HF results suggest there is strong reason to consider dapagliflozin for patients without diabetes, and for payers to pay for it. I’m not prescribing dapagliflozin to HFrEF patients without diabetes right now; not because of the data, but because of noncoverage. Payers have not yet caught up with the data,” he said, and they likely will continue to not pay for the drug when used by patients without diabetes until a new labeled indication appears for those patients.
The immediate availability of dapagliflozin (Farxiga) and the two other approved members of the sodium-glucose co-transporter 2 inhibitor class of drugs, empagliflozin (Jardiance) and canagliflozin (Invokana), to treat patients with HFrEF, and the prospect of soon having dapagliflozin and possibly the other drugs in this class to treat patients with HFrEF but without diabetes also raises issues of drug sequencing in these patients and the overall number of drugs that HFrEF patients must now take to be on optimized medical therapy, Dr. Allen noted.
The already-existing lineup of medications for HFrEF patients includes starting on an ACE inhibitor or angiotensin receptor blocker and adding a beta-blocker, a mineralocorticoid receptor antagonist, then swapping out the initial renin-angiotensin system inhibitor for sacubitril/valsartan, and then, on top of all this, adding dapagliflozin or another drug in the same class. It raises questions of what is objectively the best way to introduce all these drugs into patients, and how to do it without subjecting patients to “financial toxicity,” Dr. Allen said during his discussion of the trial’s results.
DAPA-HF was sponsored by AstraZeneca, which markets dapagliflozin (Farxiga). The University of Glasgow received payment from AstraZeneca to compensate for the time Dr. McMurray spent running the study. Dr. Allen has been a consultant to ACI Clinical, Boston Scientific, and Janssen.
SOURCE: McMurray JJV. AHA 19, Late-Breaking Science 1.
A labeling change for dapagliflozin that says the drug is approved for use in patients with heart failure with reduced ejection fraction (HFrEF) and without diabetes is critical so that payers will get on board with this new and important treatment. The evidence for efficacy and safety in patients without diabetes was so strong in the DAPA-HF trial that I don’t think a second trial will be needed for the Food and Drug Administration to add this indication to dapagliflozin’s label.
For patients with type 2 diabetes as well as HFrEF, it’s already full steam ahead to use dapagliflozin or another drug from the class of sodium glucose co-transporter 2 (SGLT2) inhibitors, empagliflozin and canagliflozin. However, so far these drugs are not being widely prescribed by clinicians to patients with HFrEF but without diabetes. We need to build up the familiarity of clinicians with the SGLT2 inhibitor drugs so that primary care physicians will feel comfortable starting HFrEF patients on them. It’s relatively easy to start patients on the drugs in this class because of their good safety and no signal of problems when using them with other HFrEF medications.
The growing list of key drugs to use on patients with HFrEF means that we need to become smarter on how we start patients on these agents. Currently it’s done without evidence for which order of introduction works best. We also need to confirm that all five types of drugs that now appear indicated for HFrEF patients are all truly additive: an angiotensin receptor blocker coupled with the angiotensin receptor neprilysin inhibitor sacubitril, a beta-blocker, a mineralocorticoid receptor antagonist, and now an SGLT2 inhibitor. I propose that researchers run studies that systematically stop one of these drugs to see whether the overall benefit to HFrEF patients remains unchanged, thereby identifying an agent that could be dropped from what is a growing list of drug classes, with possibly more classes to follow depending on results from studies now underway.
Christopher M. O’Connor, MD, is a heart failure physician and president of the Inova Heart and Vascular Institute in Falls Church, Va. He has been a consultant to Arena, Bayer, Bristol-Meyers Squibb, Merck, and Windtree Therapeutics. He made these comments in an interview.
A labeling change for dapagliflozin that says the drug is approved for use in patients with heart failure with reduced ejection fraction (HFrEF) and without diabetes is critical so that payers will get on board with this new and important treatment. The evidence for efficacy and safety in patients without diabetes was so strong in the DAPA-HF trial that I don’t think a second trial will be needed for the Food and Drug Administration to add this indication to dapagliflozin’s label.
For patients with type 2 diabetes as well as HFrEF, it’s already full steam ahead to use dapagliflozin or another drug from the class of sodium glucose co-transporter 2 (SGLT2) inhibitors, empagliflozin and canagliflozin. However, so far these drugs are not being widely prescribed by clinicians to patients with HFrEF but without diabetes. We need to build up the familiarity of clinicians with the SGLT2 inhibitor drugs so that primary care physicians will feel comfortable starting HFrEF patients on them. It’s relatively easy to start patients on the drugs in this class because of their good safety and no signal of problems when using them with other HFrEF medications.
The growing list of key drugs to use on patients with HFrEF means that we need to become smarter on how we start patients on these agents. Currently it’s done without evidence for which order of introduction works best. We also need to confirm that all five types of drugs that now appear indicated for HFrEF patients are all truly additive: an angiotensin receptor blocker coupled with the angiotensin receptor neprilysin inhibitor sacubitril, a beta-blocker, a mineralocorticoid receptor antagonist, and now an SGLT2 inhibitor. I propose that researchers run studies that systematically stop one of these drugs to see whether the overall benefit to HFrEF patients remains unchanged, thereby identifying an agent that could be dropped from what is a growing list of drug classes, with possibly more classes to follow depending on results from studies now underway.
Christopher M. O’Connor, MD, is a heart failure physician and president of the Inova Heart and Vascular Institute in Falls Church, Va. He has been a consultant to Arena, Bayer, Bristol-Meyers Squibb, Merck, and Windtree Therapeutics. He made these comments in an interview.
A labeling change for dapagliflozin that says the drug is approved for use in patients with heart failure with reduced ejection fraction (HFrEF) and without diabetes is critical so that payers will get on board with this new and important treatment. The evidence for efficacy and safety in patients without diabetes was so strong in the DAPA-HF trial that I don’t think a second trial will be needed for the Food and Drug Administration to add this indication to dapagliflozin’s label.
For patients with type 2 diabetes as well as HFrEF, it’s already full steam ahead to use dapagliflozin or another drug from the class of sodium glucose co-transporter 2 (SGLT2) inhibitors, empagliflozin and canagliflozin. However, so far these drugs are not being widely prescribed by clinicians to patients with HFrEF but without diabetes. We need to build up the familiarity of clinicians with the SGLT2 inhibitor drugs so that primary care physicians will feel comfortable starting HFrEF patients on them. It’s relatively easy to start patients on the drugs in this class because of their good safety and no signal of problems when using them with other HFrEF medications.
The growing list of key drugs to use on patients with HFrEF means that we need to become smarter on how we start patients on these agents. Currently it’s done without evidence for which order of introduction works best. We also need to confirm that all five types of drugs that now appear indicated for HFrEF patients are all truly additive: an angiotensin receptor blocker coupled with the angiotensin receptor neprilysin inhibitor sacubitril, a beta-blocker, a mineralocorticoid receptor antagonist, and now an SGLT2 inhibitor. I propose that researchers run studies that systematically stop one of these drugs to see whether the overall benefit to HFrEF patients remains unchanged, thereby identifying an agent that could be dropped from what is a growing list of drug classes, with possibly more classes to follow depending on results from studies now underway.
Christopher M. O’Connor, MD, is a heart failure physician and president of the Inova Heart and Vascular Institute in Falls Church, Va. He has been a consultant to Arena, Bayer, Bristol-Meyers Squibb, Merck, and Windtree Therapeutics. He made these comments in an interview.
PHILADELPHIA – The primary outcome results from the practice-changing DAPA-HF trial gave clinicians strong evidence that the diabetes drug dapagliflozin was equally effective at reducing cardiovascular death and acute exacerbations in patients with heart failure with reduced ejection fraction, whether or not they also had type 2 diabetes. More detailed findings from the 2,605 enrolled patients in DAPA-HF who lacked diabetes (55% of the total study population) have now sealed the deal.
“The relative and absolute reductions in cardiovascular death and hospitalizations or urgent visits for heart failure were substantial, clinically important, and consistent in patients with or without type 2 diabetes,” John McMurray, MD, declared at the American Heart Association scientific sessions as he summarized new trial results that confirmed the initial finding he reported previously.
While the initial report of the DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) by the study’s lead investigator, Dr. McMurray, was limited to the finding that the relative risk reduction for the study’s primary endpoint was a highly statistically significant 25% in heart failure patients with diabetes and an equally strongly significant 27% relative cut among patients without diabetes (N Engl J Med. 2019 Sep 19;doi: 10.1056/NEJMoa1911303), the new data showed that same consistency across the range of outcomes studied in the trial as well as across the range of glycosylated hemoglobin levels that patients had at study entry.
In an analysis that divided the entire study population of 4,744 patients with heart failure with reduced ejection fraction (HFrEF) into tertiles based on their entry blood level of hemoglobin A1c, patients with a normal level at or below 5.6% had a 26% relative reduction in the study’s primary endpoint, essentially the same response as the 29% relative cut in adverse events in the tertile of patients with a glycosylated hemoglobin level of 5.7%-5.9% and the relative 28% relative reduction in events in patients diagnosed with type 2 diabetes and having a hemoglobin A1c of 6.0% or greater, reported Dr. McMurray, professor of cardiology at the University of Glasgow. The results also showed a very benign safety profile in the patients without diabetes, similar to patients with diabetes and to placebo, and with no episodes of major hypoglycemia or diabetic ketoacidosis.
“It’s quite impressive that the result was consistent regardless of the level of hemoglobin A1c,” commented Larry A. Allen, MD, professor of medicine at the University of Colorado in Aurora and designated discussant for the report. Even though the patients without diabetes constituted just over half of the full DAPA-HF enrollment, the comparison of the effect of dapagliflozin in patients with or without diabetes was prespecified in a trial that enrolled a relatively large number of patients into each of the two subgroups by diabetes status. “I think there a good chance dapagliflozin will get an indication” for treating HFrEF patients without diabetes, Dr. Allen suggested in a video interview.
If the DAPA-HF results persuade the U.S. Food and Drug Administration to grant a supplemental indication to dapagliflozin for use in cutting cardiovascular deaths and acute heart failure exacerbations in patients without diabetes, it would pave the way for health insurers to pay for the drug. Right now, even though Dr. Allen and other heart failure physicians have been impressed by the DAPA-HF findings and are eager to add the drug to the list of agents that HFrEF patients routinely receive, he’s been stymied so far by patients’ out-of pocket cost for using dapagliflozin off-label, roughly $500 a month.
“The DAPA-HF results suggest there is strong reason to consider dapagliflozin for patients without diabetes, and for payers to pay for it. I’m not prescribing dapagliflozin to HFrEF patients without diabetes right now; not because of the data, but because of noncoverage. Payers have not yet caught up with the data,” he said, and they likely will continue to not pay for the drug when used by patients without diabetes until a new labeled indication appears for those patients.
The immediate availability of dapagliflozin (Farxiga) and the two other approved members of the sodium-glucose co-transporter 2 inhibitor class of drugs, empagliflozin (Jardiance) and canagliflozin (Invokana), to treat patients with HFrEF, and the prospect of soon having dapagliflozin and possibly the other drugs in this class to treat patients with HFrEF but without diabetes also raises issues of drug sequencing in these patients and the overall number of drugs that HFrEF patients must now take to be on optimized medical therapy, Dr. Allen noted.
The already-existing lineup of medications for HFrEF patients includes starting on an ACE inhibitor or angiotensin receptor blocker and adding a beta-blocker, a mineralocorticoid receptor antagonist, then swapping out the initial renin-angiotensin system inhibitor for sacubitril/valsartan, and then, on top of all this, adding dapagliflozin or another drug in the same class. It raises questions of what is objectively the best way to introduce all these drugs into patients, and how to do it without subjecting patients to “financial toxicity,” Dr. Allen said during his discussion of the trial’s results.
DAPA-HF was sponsored by AstraZeneca, which markets dapagliflozin (Farxiga). The University of Glasgow received payment from AstraZeneca to compensate for the time Dr. McMurray spent running the study. Dr. Allen has been a consultant to ACI Clinical, Boston Scientific, and Janssen.
SOURCE: McMurray JJV. AHA 19, Late-Breaking Science 1.
PHILADELPHIA – The primary outcome results from the practice-changing DAPA-HF trial gave clinicians strong evidence that the diabetes drug dapagliflozin was equally effective at reducing cardiovascular death and acute exacerbations in patients with heart failure with reduced ejection fraction, whether or not they also had type 2 diabetes. More detailed findings from the 2,605 enrolled patients in DAPA-HF who lacked diabetes (55% of the total study population) have now sealed the deal.
“The relative and absolute reductions in cardiovascular death and hospitalizations or urgent visits for heart failure were substantial, clinically important, and consistent in patients with or without type 2 diabetes,” John McMurray, MD, declared at the American Heart Association scientific sessions as he summarized new trial results that confirmed the initial finding he reported previously.
While the initial report of the DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) by the study’s lead investigator, Dr. McMurray, was limited to the finding that the relative risk reduction for the study’s primary endpoint was a highly statistically significant 25% in heart failure patients with diabetes and an equally strongly significant 27% relative cut among patients without diabetes (N Engl J Med. 2019 Sep 19;doi: 10.1056/NEJMoa1911303), the new data showed that same consistency across the range of outcomes studied in the trial as well as across the range of glycosylated hemoglobin levels that patients had at study entry.
In an analysis that divided the entire study population of 4,744 patients with heart failure with reduced ejection fraction (HFrEF) into tertiles based on their entry blood level of hemoglobin A1c, patients with a normal level at or below 5.6% had a 26% relative reduction in the study’s primary endpoint, essentially the same response as the 29% relative cut in adverse events in the tertile of patients with a glycosylated hemoglobin level of 5.7%-5.9% and the relative 28% relative reduction in events in patients diagnosed with type 2 diabetes and having a hemoglobin A1c of 6.0% or greater, reported Dr. McMurray, professor of cardiology at the University of Glasgow. The results also showed a very benign safety profile in the patients without diabetes, similar to patients with diabetes and to placebo, and with no episodes of major hypoglycemia or diabetic ketoacidosis.
“It’s quite impressive that the result was consistent regardless of the level of hemoglobin A1c,” commented Larry A. Allen, MD, professor of medicine at the University of Colorado in Aurora and designated discussant for the report. Even though the patients without diabetes constituted just over half of the full DAPA-HF enrollment, the comparison of the effect of dapagliflozin in patients with or without diabetes was prespecified in a trial that enrolled a relatively large number of patients into each of the two subgroups by diabetes status. “I think there a good chance dapagliflozin will get an indication” for treating HFrEF patients without diabetes, Dr. Allen suggested in a video interview.
If the DAPA-HF results persuade the U.S. Food and Drug Administration to grant a supplemental indication to dapagliflozin for use in cutting cardiovascular deaths and acute heart failure exacerbations in patients without diabetes, it would pave the way for health insurers to pay for the drug. Right now, even though Dr. Allen and other heart failure physicians have been impressed by the DAPA-HF findings and are eager to add the drug to the list of agents that HFrEF patients routinely receive, he’s been stymied so far by patients’ out-of pocket cost for using dapagliflozin off-label, roughly $500 a month.
“The DAPA-HF results suggest there is strong reason to consider dapagliflozin for patients without diabetes, and for payers to pay for it. I’m not prescribing dapagliflozin to HFrEF patients without diabetes right now; not because of the data, but because of noncoverage. Payers have not yet caught up with the data,” he said, and they likely will continue to not pay for the drug when used by patients without diabetes until a new labeled indication appears for those patients.
The immediate availability of dapagliflozin (Farxiga) and the two other approved members of the sodium-glucose co-transporter 2 inhibitor class of drugs, empagliflozin (Jardiance) and canagliflozin (Invokana), to treat patients with HFrEF, and the prospect of soon having dapagliflozin and possibly the other drugs in this class to treat patients with HFrEF but without diabetes also raises issues of drug sequencing in these patients and the overall number of drugs that HFrEF patients must now take to be on optimized medical therapy, Dr. Allen noted.
The already-existing lineup of medications for HFrEF patients includes starting on an ACE inhibitor or angiotensin receptor blocker and adding a beta-blocker, a mineralocorticoid receptor antagonist, then swapping out the initial renin-angiotensin system inhibitor for sacubitril/valsartan, and then, on top of all this, adding dapagliflozin or another drug in the same class. It raises questions of what is objectively the best way to introduce all these drugs into patients, and how to do it without subjecting patients to “financial toxicity,” Dr. Allen said during his discussion of the trial’s results.
DAPA-HF was sponsored by AstraZeneca, which markets dapagliflozin (Farxiga). The University of Glasgow received payment from AstraZeneca to compensate for the time Dr. McMurray spent running the study. Dr. Allen has been a consultant to ACI Clinical, Boston Scientific, and Janssen.
SOURCE: McMurray JJV. AHA 19, Late-Breaking Science 1.
REPORTING FROM AHA 2019
Key clinical point: Dapaglifozin produced as much benefit in HFrEF patients without diabetes as it did in those with type 2 diabetes.
Major finding: The relative risk reduction with dapagliflozin was 26% in patients with a hemoglobin A1c of 5.6% or less.
Study details: DAPA-HF is a multicenter, randomized trial involving 4,744 patients with heart failure with reduced ejection fraction.
Disclosures: DAPA-HF was sponsored by AstraZeneca, which markets dapagliflozin (Farxiga). The University of Glasgow received payment from AstraZeneca to compensate for the time Dr. McMurray spent running the study. Dr. Allen has been a consultant to ACI Clinical, Boston Scientific, and Janssen.
Source: McMurray JJV et al. AHA 19, Late-Breaking Science 1.
Finding the right job
. There is some useful material pertaining to this topic on the American Academy of Dermatology website, which I helped develop. This should help you decide whether you want to go solo, small group, large group, VA, or academic practice. These options all have certain advantages and drawbacks.
Your first decision should be where you want to practice geographically, which will determine many of the details of any practice situation. For instance, if you go where there is a shortage of dermatologists, you will be more welcome and more sought after. I will never forget sitting in a hospital break room in New York City after giving grand rounds with a large group of residents, who asked me about practice opportunities. I asked them where they wanted to practice. Every resident – first, second, and third year – indicated they wanted to stay in New York City. I had to laugh to myself. If there are any cities with a surplus of dermatologists, it’s the hip ones: New York, San Francisco, Los Angeles, Miami, and so on. If you can find a job there, it will be a “this is what everyone signs” contract situation, and a large part of your pay is the privilege of living in an urban “paradise.”
If you are willing to look further afield, I suggest you start with an old classic, the “Places Rated Almanac: The Classic Guide for Finding Your Best Places to Live in America” (Washington: Places Rated Books, 2007). This is a resource (that needs a new edition) that provides all kinds of details on different areas of the country that you may not have considered, including median income, schools, climate, and livability.
When you know the general area where you would like to settle – and after considering the parents, the in-laws, and the outlaws – remember that the best jobs are not advertised. You should contact all the dermatology, multispeciality, and hospital groups in the area (yes, write them a nice snail mail letter) indicating you are interested, and ask them if they are hiring. Practices are usually interested in a general dermatologist, or perhaps a Mohs surgeon or dermatopathologist, willing to practice general dermatology half time. For example, I know a very nice general dermatology practice in the Midwest that has been looking for the right derm-path/general derm for years. The days of strolling in and setting up an all-Mohs or all-dermpath practice are over, unless you buy out, or become employed by one of the older established specialist groups.
Ask the staff (and former physician employees if you can find them) lots of questions. See if their style of medicine suits you. See if their electronic health record system is fast or a major hindrance. Find out how many extenders you will be responsible for supervising.
And find out if they are considering selling out (selling you) to private equity. Private equity groups are a major new influence on the specialty, run a lot of ads, and hire a lot of graduating dermatologists. They offer more benefits and higher initial salaries. There is no free lunch, however, and these perks must be paid back with future earnings. The private equity groups take 20%-30% of profits “off the top” and your earnings will hit a ceiling at a level that is significantly lower than it would be in a solo practice or dermatology group. They also have long, detailed, ferocious contracts with penalty clauses and noncompetes from all outlets. More numerous advertisements are a negative tip off, but will give you an idea of which markets they think are promising with regard to need and payer mix. See what the private equity group’s private health insurance rates are. If they are significantly greater than Medicare rates, they deserve a second look, though few are. Remember that the senior physician who pitches for them in the lounge doesn’t work for free, but receives a significant bonus for getting you to sign.
If you find a great location, it is time for contract review. The first rule is that no contract is better than who you sign it with. If they are determined to mistreat you, they will – no matter the contract. I advise always having a graceful exit written into the contract specifying severance terms (if any), even if you never need this.
If you are ready to work hard and make more income, you should forgo the perks and go on a percentage of collections basis. If you are considering a place where they very much need dermatologists (sorry, not New York City), you may have some negotiating room and it is worth spending a few thousand dollars to ask a medical contract attorney to go over the contract for you, or even negotiate for you. Don’t overestimate your value, however, because you might negotiate your way right out of a job. The expanding scope of nurse practitioners and physician assistants have taken away much of your indispensability. While there is a shortage of dermatologists in most of the United States, there generally is no shortage of dermatology appointments.
When you start a new job you are not certain about, resist the urge to buy a big house and put down roots right away. You may need to move on if it doesn’t work out. You may want to work a few years, pay down school loans, save a little, and set up your own practice somewhere.
All things considered, these are exciting times and being a board-certified dermatologist is a wonderful place to be in the medical world. I am not at all sure if any of the proposed end-of-the-world health care plans will come true. And let me know if you are one of those New York City residents who struck out for the western frontier. Us fly-over-country folk have got to stick together!
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.
. There is some useful material pertaining to this topic on the American Academy of Dermatology website, which I helped develop. This should help you decide whether you want to go solo, small group, large group, VA, or academic practice. These options all have certain advantages and drawbacks.
Your first decision should be where you want to practice geographically, which will determine many of the details of any practice situation. For instance, if you go where there is a shortage of dermatologists, you will be more welcome and more sought after. I will never forget sitting in a hospital break room in New York City after giving grand rounds with a large group of residents, who asked me about practice opportunities. I asked them where they wanted to practice. Every resident – first, second, and third year – indicated they wanted to stay in New York City. I had to laugh to myself. If there are any cities with a surplus of dermatologists, it’s the hip ones: New York, San Francisco, Los Angeles, Miami, and so on. If you can find a job there, it will be a “this is what everyone signs” contract situation, and a large part of your pay is the privilege of living in an urban “paradise.”
If you are willing to look further afield, I suggest you start with an old classic, the “Places Rated Almanac: The Classic Guide for Finding Your Best Places to Live in America” (Washington: Places Rated Books, 2007). This is a resource (that needs a new edition) that provides all kinds of details on different areas of the country that you may not have considered, including median income, schools, climate, and livability.
When you know the general area where you would like to settle – and after considering the parents, the in-laws, and the outlaws – remember that the best jobs are not advertised. You should contact all the dermatology, multispeciality, and hospital groups in the area (yes, write them a nice snail mail letter) indicating you are interested, and ask them if they are hiring. Practices are usually interested in a general dermatologist, or perhaps a Mohs surgeon or dermatopathologist, willing to practice general dermatology half time. For example, I know a very nice general dermatology practice in the Midwest that has been looking for the right derm-path/general derm for years. The days of strolling in and setting up an all-Mohs or all-dermpath practice are over, unless you buy out, or become employed by one of the older established specialist groups.
Ask the staff (and former physician employees if you can find them) lots of questions. See if their style of medicine suits you. See if their electronic health record system is fast or a major hindrance. Find out how many extenders you will be responsible for supervising.
And find out if they are considering selling out (selling you) to private equity. Private equity groups are a major new influence on the specialty, run a lot of ads, and hire a lot of graduating dermatologists. They offer more benefits and higher initial salaries. There is no free lunch, however, and these perks must be paid back with future earnings. The private equity groups take 20%-30% of profits “off the top” and your earnings will hit a ceiling at a level that is significantly lower than it would be in a solo practice or dermatology group. They also have long, detailed, ferocious contracts with penalty clauses and noncompetes from all outlets. More numerous advertisements are a negative tip off, but will give you an idea of which markets they think are promising with regard to need and payer mix. See what the private equity group’s private health insurance rates are. If they are significantly greater than Medicare rates, they deserve a second look, though few are. Remember that the senior physician who pitches for them in the lounge doesn’t work for free, but receives a significant bonus for getting you to sign.
If you find a great location, it is time for contract review. The first rule is that no contract is better than who you sign it with. If they are determined to mistreat you, they will – no matter the contract. I advise always having a graceful exit written into the contract specifying severance terms (if any), even if you never need this.
If you are ready to work hard and make more income, you should forgo the perks and go on a percentage of collections basis. If you are considering a place where they very much need dermatologists (sorry, not New York City), you may have some negotiating room and it is worth spending a few thousand dollars to ask a medical contract attorney to go over the contract for you, or even negotiate for you. Don’t overestimate your value, however, because you might negotiate your way right out of a job. The expanding scope of nurse practitioners and physician assistants have taken away much of your indispensability. While there is a shortage of dermatologists in most of the United States, there generally is no shortage of dermatology appointments.
When you start a new job you are not certain about, resist the urge to buy a big house and put down roots right away. You may need to move on if it doesn’t work out. You may want to work a few years, pay down school loans, save a little, and set up your own practice somewhere.
All things considered, these are exciting times and being a board-certified dermatologist is a wonderful place to be in the medical world. I am not at all sure if any of the proposed end-of-the-world health care plans will come true. And let me know if you are one of those New York City residents who struck out for the western frontier. Us fly-over-country folk have got to stick together!
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.
. There is some useful material pertaining to this topic on the American Academy of Dermatology website, which I helped develop. This should help you decide whether you want to go solo, small group, large group, VA, or academic practice. These options all have certain advantages and drawbacks.
Your first decision should be where you want to practice geographically, which will determine many of the details of any practice situation. For instance, if you go where there is a shortage of dermatologists, you will be more welcome and more sought after. I will never forget sitting in a hospital break room in New York City after giving grand rounds with a large group of residents, who asked me about practice opportunities. I asked them where they wanted to practice. Every resident – first, second, and third year – indicated they wanted to stay in New York City. I had to laugh to myself. If there are any cities with a surplus of dermatologists, it’s the hip ones: New York, San Francisco, Los Angeles, Miami, and so on. If you can find a job there, it will be a “this is what everyone signs” contract situation, and a large part of your pay is the privilege of living in an urban “paradise.”
If you are willing to look further afield, I suggest you start with an old classic, the “Places Rated Almanac: The Classic Guide for Finding Your Best Places to Live in America” (Washington: Places Rated Books, 2007). This is a resource (that needs a new edition) that provides all kinds of details on different areas of the country that you may not have considered, including median income, schools, climate, and livability.
When you know the general area where you would like to settle – and after considering the parents, the in-laws, and the outlaws – remember that the best jobs are not advertised. You should contact all the dermatology, multispeciality, and hospital groups in the area (yes, write them a nice snail mail letter) indicating you are interested, and ask them if they are hiring. Practices are usually interested in a general dermatologist, or perhaps a Mohs surgeon or dermatopathologist, willing to practice general dermatology half time. For example, I know a very nice general dermatology practice in the Midwest that has been looking for the right derm-path/general derm for years. The days of strolling in and setting up an all-Mohs or all-dermpath practice are over, unless you buy out, or become employed by one of the older established specialist groups.
Ask the staff (and former physician employees if you can find them) lots of questions. See if their style of medicine suits you. See if their electronic health record system is fast or a major hindrance. Find out how many extenders you will be responsible for supervising.
And find out if they are considering selling out (selling you) to private equity. Private equity groups are a major new influence on the specialty, run a lot of ads, and hire a lot of graduating dermatologists. They offer more benefits and higher initial salaries. There is no free lunch, however, and these perks must be paid back with future earnings. The private equity groups take 20%-30% of profits “off the top” and your earnings will hit a ceiling at a level that is significantly lower than it would be in a solo practice or dermatology group. They also have long, detailed, ferocious contracts with penalty clauses and noncompetes from all outlets. More numerous advertisements are a negative tip off, but will give you an idea of which markets they think are promising with regard to need and payer mix. See what the private equity group’s private health insurance rates are. If they are significantly greater than Medicare rates, they deserve a second look, though few are. Remember that the senior physician who pitches for them in the lounge doesn’t work for free, but receives a significant bonus for getting you to sign.
If you find a great location, it is time for contract review. The first rule is that no contract is better than who you sign it with. If they are determined to mistreat you, they will – no matter the contract. I advise always having a graceful exit written into the contract specifying severance terms (if any), even if you never need this.
If you are ready to work hard and make more income, you should forgo the perks and go on a percentage of collections basis. If you are considering a place where they very much need dermatologists (sorry, not New York City), you may have some negotiating room and it is worth spending a few thousand dollars to ask a medical contract attorney to go over the contract for you, or even negotiate for you. Don’t overestimate your value, however, because you might negotiate your way right out of a job. The expanding scope of nurse practitioners and physician assistants have taken away much of your indispensability. While there is a shortage of dermatologists in most of the United States, there generally is no shortage of dermatology appointments.
When you start a new job you are not certain about, resist the urge to buy a big house and put down roots right away. You may need to move on if it doesn’t work out. You may want to work a few years, pay down school loans, save a little, and set up your own practice somewhere.
All things considered, these are exciting times and being a board-certified dermatologist is a wonderful place to be in the medical world. I am not at all sure if any of the proposed end-of-the-world health care plans will come true. And let me know if you are one of those New York City residents who struck out for the western frontier. Us fly-over-country folk have got to stick together!
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.
Weaknesses exposed in valsartan recall
ED visits for hypertension in month after the 2018 recall spiked 55%
PHILADELPHIA – The 2018 recall of generic forms of the antihypertensive valsartan exposed weaknesses in the recall systems for generic drugs in both the United States and Canada that caused many patients on the drug to fall through the cracks, according to a study of prescribing patterns in Ontario before and after the recall reported at the American Heart Association scientific sessions.
The results also have been published online in the journal Circulation (2019 Nov 11. doi: 10.1161/CIRCULATIONAHA.119.044494).
Cynthia Jackevicius, PharmD, of the Western University of Health Sciences in Pomona, Calif., reported that 90% of patients on recalled generic valsartan products switched to another antihypertension drug, but called the 10% for whom the study had no data “concerning.” She also said that ED visits for hypertension (HTN) in the month after the recall spiked 55%, from a rate of 0.11% to 0.17% (P = .02). While small, that increase was statistically significant, she said.
The Food and Drug Administration and Health Canada issued voluntary recalls of generic forms of valsartan in July 2018 following reports of N-nitrosodimethylamine (NDMA), a suspected carcinogen, being found in the products. Eventually, the recalls expanded to include valsartan products containing the contaminants N-nitrosodiethylamine (NDEA) and N-nitroso-N-methyl-4-aminobutyric acid (NMBA), as well as losartan and irbesartan products.
The Ontario study evaluated prescribing patterns and health system utilization in four different provincewide health databases and involved 55,461 patients, all of whom were on recalled generic valsartan when Health Canada issued the recall. The study also computed monthly rates of ED visits and hospitalizations for HTN, congestive heart failure, stroke/transit ischemic attack, and MI as primary diagnoses for 18 months before and 6 months after the recall. Rates of utilization for CHF and MI remained relatively flat through the study period, Dr. Jackevicius said, but rates of ED visits for stroke/TIA showed “a very small relative increase: 6% and 8% in ED visits and hospitalizations, respectively.” Respective P values were .020 and .037.
As for the nature of the ED visits after the recall, Dr. Jackevicius said the study did not tease that out. Many visits could have been for uncontrolled HTN or to get expired prescriptions refilled.
“But either way, even if it is just getting a new prescription, this isn’t the best response,” she said. We need to have a better system where patients can more easily or with less burden deal with a recall.”
Session moderator Seth S. Martin, MD, MHS, of Johns Hopkins University in Baltimore, echoed Dr. Jackevicius’s concerns about the handling of drug recalls. “Recalls are increasing,” he said. “Is this just the tip of the iceberg on the quality of generics and we’re going to see these floodgates open? Is this going to be chaos or is this more isolated to this class of medication, the ARBs? This is becoming a little concerning.”
Dr. Jackevicius made note of the recalls that followed the original valsartan recall.
“This really opened a lot of questions in terms of the quality of generic products,” she said. Drug manufacturers are putting safeguards into place to detect these potential contaminants, she said, “but a lot more work needs to be done to ensure the supply. All of these recalls and the prominence of this will be increased.”
The response to the recalls also must undergo revision, she said, citing the experiences of the United States and Canada. “There isn’t really a good system or strategy for recalls in either country,” Dr. Jackevicius said, noting that regulatory bodies notify prescribers and physicians, but “they don’t know which patients are on it.”
A better strategy would be to involve pharmacies more in the process. “The pharmacies have the lot numbers, and they will know what patients are on the recalled drug,” she said. “The pharmacists are the ones who are making the changes in the drugs, and giving them the responsibility so patients don’t have to go into the ED is important. If it’s a basic interchange of a drug, the pharmacists can do that to help raise compliance.”
Dr. Jackevicius had no relevant relationships to disclose.
SOURCE: Jackevicius J. AHA 2019. Session FS.AOS.F1.
ED visits for hypertension in month after the 2018 recall spiked 55%
ED visits for hypertension in month after the 2018 recall spiked 55%
PHILADELPHIA – The 2018 recall of generic forms of the antihypertensive valsartan exposed weaknesses in the recall systems for generic drugs in both the United States and Canada that caused many patients on the drug to fall through the cracks, according to a study of prescribing patterns in Ontario before and after the recall reported at the American Heart Association scientific sessions.
The results also have been published online in the journal Circulation (2019 Nov 11. doi: 10.1161/CIRCULATIONAHA.119.044494).
Cynthia Jackevicius, PharmD, of the Western University of Health Sciences in Pomona, Calif., reported that 90% of patients on recalled generic valsartan products switched to another antihypertension drug, but called the 10% for whom the study had no data “concerning.” She also said that ED visits for hypertension (HTN) in the month after the recall spiked 55%, from a rate of 0.11% to 0.17% (P = .02). While small, that increase was statistically significant, she said.
The Food and Drug Administration and Health Canada issued voluntary recalls of generic forms of valsartan in July 2018 following reports of N-nitrosodimethylamine (NDMA), a suspected carcinogen, being found in the products. Eventually, the recalls expanded to include valsartan products containing the contaminants N-nitrosodiethylamine (NDEA) and N-nitroso-N-methyl-4-aminobutyric acid (NMBA), as well as losartan and irbesartan products.
The Ontario study evaluated prescribing patterns and health system utilization in four different provincewide health databases and involved 55,461 patients, all of whom were on recalled generic valsartan when Health Canada issued the recall. The study also computed monthly rates of ED visits and hospitalizations for HTN, congestive heart failure, stroke/transit ischemic attack, and MI as primary diagnoses for 18 months before and 6 months after the recall. Rates of utilization for CHF and MI remained relatively flat through the study period, Dr. Jackevicius said, but rates of ED visits for stroke/TIA showed “a very small relative increase: 6% and 8% in ED visits and hospitalizations, respectively.” Respective P values were .020 and .037.
As for the nature of the ED visits after the recall, Dr. Jackevicius said the study did not tease that out. Many visits could have been for uncontrolled HTN or to get expired prescriptions refilled.
“But either way, even if it is just getting a new prescription, this isn’t the best response,” she said. We need to have a better system where patients can more easily or with less burden deal with a recall.”
Session moderator Seth S. Martin, MD, MHS, of Johns Hopkins University in Baltimore, echoed Dr. Jackevicius’s concerns about the handling of drug recalls. “Recalls are increasing,” he said. “Is this just the tip of the iceberg on the quality of generics and we’re going to see these floodgates open? Is this going to be chaos or is this more isolated to this class of medication, the ARBs? This is becoming a little concerning.”
Dr. Jackevicius made note of the recalls that followed the original valsartan recall.
“This really opened a lot of questions in terms of the quality of generic products,” she said. Drug manufacturers are putting safeguards into place to detect these potential contaminants, she said, “but a lot more work needs to be done to ensure the supply. All of these recalls and the prominence of this will be increased.”
The response to the recalls also must undergo revision, she said, citing the experiences of the United States and Canada. “There isn’t really a good system or strategy for recalls in either country,” Dr. Jackevicius said, noting that regulatory bodies notify prescribers and physicians, but “they don’t know which patients are on it.”
A better strategy would be to involve pharmacies more in the process. “The pharmacies have the lot numbers, and they will know what patients are on the recalled drug,” she said. “The pharmacists are the ones who are making the changes in the drugs, and giving them the responsibility so patients don’t have to go into the ED is important. If it’s a basic interchange of a drug, the pharmacists can do that to help raise compliance.”
Dr. Jackevicius had no relevant relationships to disclose.
SOURCE: Jackevicius J. AHA 2019. Session FS.AOS.F1.
PHILADELPHIA – The 2018 recall of generic forms of the antihypertensive valsartan exposed weaknesses in the recall systems for generic drugs in both the United States and Canada that caused many patients on the drug to fall through the cracks, according to a study of prescribing patterns in Ontario before and after the recall reported at the American Heart Association scientific sessions.
The results also have been published online in the journal Circulation (2019 Nov 11. doi: 10.1161/CIRCULATIONAHA.119.044494).
Cynthia Jackevicius, PharmD, of the Western University of Health Sciences in Pomona, Calif., reported that 90% of patients on recalled generic valsartan products switched to another antihypertension drug, but called the 10% for whom the study had no data “concerning.” She also said that ED visits for hypertension (HTN) in the month after the recall spiked 55%, from a rate of 0.11% to 0.17% (P = .02). While small, that increase was statistically significant, she said.
The Food and Drug Administration and Health Canada issued voluntary recalls of generic forms of valsartan in July 2018 following reports of N-nitrosodimethylamine (NDMA), a suspected carcinogen, being found in the products. Eventually, the recalls expanded to include valsartan products containing the contaminants N-nitrosodiethylamine (NDEA) and N-nitroso-N-methyl-4-aminobutyric acid (NMBA), as well as losartan and irbesartan products.
The Ontario study evaluated prescribing patterns and health system utilization in four different provincewide health databases and involved 55,461 patients, all of whom were on recalled generic valsartan when Health Canada issued the recall. The study also computed monthly rates of ED visits and hospitalizations for HTN, congestive heart failure, stroke/transit ischemic attack, and MI as primary diagnoses for 18 months before and 6 months after the recall. Rates of utilization for CHF and MI remained relatively flat through the study period, Dr. Jackevicius said, but rates of ED visits for stroke/TIA showed “a very small relative increase: 6% and 8% in ED visits and hospitalizations, respectively.” Respective P values were .020 and .037.
As for the nature of the ED visits after the recall, Dr. Jackevicius said the study did not tease that out. Many visits could have been for uncontrolled HTN or to get expired prescriptions refilled.
“But either way, even if it is just getting a new prescription, this isn’t the best response,” she said. We need to have a better system where patients can more easily or with less burden deal with a recall.”
Session moderator Seth S. Martin, MD, MHS, of Johns Hopkins University in Baltimore, echoed Dr. Jackevicius’s concerns about the handling of drug recalls. “Recalls are increasing,” he said. “Is this just the tip of the iceberg on the quality of generics and we’re going to see these floodgates open? Is this going to be chaos or is this more isolated to this class of medication, the ARBs? This is becoming a little concerning.”
Dr. Jackevicius made note of the recalls that followed the original valsartan recall.
“This really opened a lot of questions in terms of the quality of generic products,” she said. Drug manufacturers are putting safeguards into place to detect these potential contaminants, she said, “but a lot more work needs to be done to ensure the supply. All of these recalls and the prominence of this will be increased.”
The response to the recalls also must undergo revision, she said, citing the experiences of the United States and Canada. “There isn’t really a good system or strategy for recalls in either country,” Dr. Jackevicius said, noting that regulatory bodies notify prescribers and physicians, but “they don’t know which patients are on it.”
A better strategy would be to involve pharmacies more in the process. “The pharmacies have the lot numbers, and they will know what patients are on the recalled drug,” she said. “The pharmacists are the ones who are making the changes in the drugs, and giving them the responsibility so patients don’t have to go into the ED is important. If it’s a basic interchange of a drug, the pharmacists can do that to help raise compliance.”
Dr. Jackevicius had no relevant relationships to disclose.
SOURCE: Jackevicius J. AHA 2019. Session FS.AOS.F1.
REPORTING FROM AHA 2019
Key clinical point: Neither Canada nor the United States has a good system or strategy for recalling generic drugs.
Major finding: One in 10 patients may have discontinued therapy after the recall.
Study details: Population study of prescribing patterns and health utilization rates of 55,461 patients on valsartan before and after the July 2018 recall.
Disclosures: Dr. Jackevicius has no relevant financial relationships to report.
Source: Jackevicius C. AHA 2019. Session FS.AOS.F1.
Stress echo could predict PCI efficacy in stable CAD
Dobutamine stress echocardiography could be used to predict which patients with single-vessel stable coronary artery disease are most likely to benefit from percutaneous coronary intervention, according to secondary analysis of data from the ORBITA trial.
In a study to be presented at the American Heart Association scientific sessions on Nov. 16, researchers outline the results of a stress-echo stratification of patients who participated in the Objective Randomized Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina (ORBITA) trial.
The original double-blind randomized controlled trial, comparing percutaneous coronary intervention (PCI) to a placebo procedure in 200 patients with stable angina and angiographically severe single-vessel coronary artery disease, found a smaller-than-expected effect size.
“While there was no significant difference between PCI and placebo groups in the patient-reported and physician-assessed symptom and quality of life endpoints, ischemia as assessed by dobutamine stress echocardiography (DSE) wall motion score index showed a clear reduction with PCI,” wrote Rasha K. Al-Lamee, MD, from the National Heart and Lung Institute at Imperial College London, and coauthors.
In their paper, published in Circulation, the researchers analyzed data from 183 patients who underwent prerandomization dobutamine stress echocardiography to see the impact of their stress echo score on the placebo-controlled effect of PCI.
The stress echo score reflects the number of segments that are abnormal at peak stress; akinetic segments count as double and dyskinetic segments count as triple.
The researchers found a significant interaction between the prerandomization stress echo score and the effect of PCI on angina frequency, with the largest placebo-controlled effects of PCI seen in patients with the highest stress echo scores.
Patients with a prerandomization stress echo score at or above 1 were three times more likely to have a lower angina frequency score with PCI than with placebo (odds ratio, 3.18; 95% confidence interval, 1.38, 7.34; P = .007). They were also more than four times more likely to be free from angina with PCI compared to placebo (OR, 4.62; 95% CI, 1.70, 12.60; P = .003).
“We have previously found that there is a clear relationship between invasive physiology and stress echo score but no relationship between invasive physiology and placebo-controlled symptom improvement,” the authors wrote. “The present analysis shows that there is clear evidence of a relationship between ischemia on stress echo and the placebo-controlled efficacy of PCI on frequency of angina.”
The analysis, however, found no detectable interaction between prerandomization stress echo score and the effect of PCI on physical limitation score, quality of life, Canadian Cardiovascular Society angina class score, or treadmill time.
The mean prerandomization stress echo score was 1.56 in the PCI arm and 1.61 in the placebo arm.
The study also looked at the relationship between prerandomization stress echo score and fractional flow reserve. This revealed that, as the stress echo score increased with a greater number of ischemia myocardial segments, the fractional flow reserve value decreased, pointing to a greater degree of ischemia. Researchers also noted that as the stress echo score became larger, the instantaneous wave-free ratio also decreased significantly.
“This stress echo-stratified analysis shows the link between stress-induced myocardial wall motion abnormalities and patient-reported angina frequency,” the authors wrote. “The greater the ischemia on [dobutamine stress echocardiography], the greater the placebo-controlled angina relief from PCI.”
The study was funded by grants from the National Institute for Health Research Imperial Biomedical Research Centre, Foundation for Circulatory Health, Imperial College Healthcare Charity, and in-kind support from Philips Volcano. Two authors declared patents relating to technology used in the study and three declared consultancies, speakers’ fees, and research grants from Philips Volcano. No other conflicts of interest were declared.
SOURCE: Al-Lamee R et al. Circulation. 2019 Nov 11. doi: doi.org/10.1161/CIRCULATIONAHA.119.042918.
Current evidence about the relationship between stress-induced ischemia and the benefits of percutaneous coronary intervention is unclear, and the only sham-controlled trial prior to this one found no effect of PCI on exercise time or angina frequency.
This secondary analysis of data from the ORBITA trial, which finds a reduced frequency of angina in PCI-treated patients with an echocardiographic score at or above 1, is consistent with other studies finding a prompt improvement in angina symptoms above medical therapy alone.
The finding of greater symptom improvement with greater ischemia is intriguing, but what is unclear is whether improvement in symptoms is only likely to be realized above a certain threshold of ischemic severity.
While there remains a question about how effective noninvasive ischemia testing is in guiding decision-making about revascularization, the important take-home message of this study is that ischemia is an important, but not the only, mediator of improvement in patient symptoms after PCI.
Leslee J. Shaw, PhD, is from the Weill Cornell Medical College, New York; Harmony R. Reynolds, MD, is from New York University; and Michael H. Picard, MD, is from Harvard Medical School, Boston. These comments are adapted from an accompanying editorial (Circulation. 2019 Nov 11.). The three authors reported having no conflicts of interest.
Current evidence about the relationship between stress-induced ischemia and the benefits of percutaneous coronary intervention is unclear, and the only sham-controlled trial prior to this one found no effect of PCI on exercise time or angina frequency.
This secondary analysis of data from the ORBITA trial, which finds a reduced frequency of angina in PCI-treated patients with an echocardiographic score at or above 1, is consistent with other studies finding a prompt improvement in angina symptoms above medical therapy alone.
The finding of greater symptom improvement with greater ischemia is intriguing, but what is unclear is whether improvement in symptoms is only likely to be realized above a certain threshold of ischemic severity.
While there remains a question about how effective noninvasive ischemia testing is in guiding decision-making about revascularization, the important take-home message of this study is that ischemia is an important, but not the only, mediator of improvement in patient symptoms after PCI.
Leslee J. Shaw, PhD, is from the Weill Cornell Medical College, New York; Harmony R. Reynolds, MD, is from New York University; and Michael H. Picard, MD, is from Harvard Medical School, Boston. These comments are adapted from an accompanying editorial (Circulation. 2019 Nov 11.). The three authors reported having no conflicts of interest.
Current evidence about the relationship between stress-induced ischemia and the benefits of percutaneous coronary intervention is unclear, and the only sham-controlled trial prior to this one found no effect of PCI on exercise time or angina frequency.
This secondary analysis of data from the ORBITA trial, which finds a reduced frequency of angina in PCI-treated patients with an echocardiographic score at or above 1, is consistent with other studies finding a prompt improvement in angina symptoms above medical therapy alone.
The finding of greater symptom improvement with greater ischemia is intriguing, but what is unclear is whether improvement in symptoms is only likely to be realized above a certain threshold of ischemic severity.
While there remains a question about how effective noninvasive ischemia testing is in guiding decision-making about revascularization, the important take-home message of this study is that ischemia is an important, but not the only, mediator of improvement in patient symptoms after PCI.
Leslee J. Shaw, PhD, is from the Weill Cornell Medical College, New York; Harmony R. Reynolds, MD, is from New York University; and Michael H. Picard, MD, is from Harvard Medical School, Boston. These comments are adapted from an accompanying editorial (Circulation. 2019 Nov 11.). The three authors reported having no conflicts of interest.
Dobutamine stress echocardiography could be used to predict which patients with single-vessel stable coronary artery disease are most likely to benefit from percutaneous coronary intervention, according to secondary analysis of data from the ORBITA trial.
In a study to be presented at the American Heart Association scientific sessions on Nov. 16, researchers outline the results of a stress-echo stratification of patients who participated in the Objective Randomized Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina (ORBITA) trial.
The original double-blind randomized controlled trial, comparing percutaneous coronary intervention (PCI) to a placebo procedure in 200 patients with stable angina and angiographically severe single-vessel coronary artery disease, found a smaller-than-expected effect size.
“While there was no significant difference between PCI and placebo groups in the patient-reported and physician-assessed symptom and quality of life endpoints, ischemia as assessed by dobutamine stress echocardiography (DSE) wall motion score index showed a clear reduction with PCI,” wrote Rasha K. Al-Lamee, MD, from the National Heart and Lung Institute at Imperial College London, and coauthors.
In their paper, published in Circulation, the researchers analyzed data from 183 patients who underwent prerandomization dobutamine stress echocardiography to see the impact of their stress echo score on the placebo-controlled effect of PCI.
The stress echo score reflects the number of segments that are abnormal at peak stress; akinetic segments count as double and dyskinetic segments count as triple.
The researchers found a significant interaction between the prerandomization stress echo score and the effect of PCI on angina frequency, with the largest placebo-controlled effects of PCI seen in patients with the highest stress echo scores.
Patients with a prerandomization stress echo score at or above 1 were three times more likely to have a lower angina frequency score with PCI than with placebo (odds ratio, 3.18; 95% confidence interval, 1.38, 7.34; P = .007). They were also more than four times more likely to be free from angina with PCI compared to placebo (OR, 4.62; 95% CI, 1.70, 12.60; P = .003).
“We have previously found that there is a clear relationship between invasive physiology and stress echo score but no relationship between invasive physiology and placebo-controlled symptom improvement,” the authors wrote. “The present analysis shows that there is clear evidence of a relationship between ischemia on stress echo and the placebo-controlled efficacy of PCI on frequency of angina.”
The analysis, however, found no detectable interaction between prerandomization stress echo score and the effect of PCI on physical limitation score, quality of life, Canadian Cardiovascular Society angina class score, or treadmill time.
The mean prerandomization stress echo score was 1.56 in the PCI arm and 1.61 in the placebo arm.
The study also looked at the relationship between prerandomization stress echo score and fractional flow reserve. This revealed that, as the stress echo score increased with a greater number of ischemia myocardial segments, the fractional flow reserve value decreased, pointing to a greater degree of ischemia. Researchers also noted that as the stress echo score became larger, the instantaneous wave-free ratio also decreased significantly.
“This stress echo-stratified analysis shows the link between stress-induced myocardial wall motion abnormalities and patient-reported angina frequency,” the authors wrote. “The greater the ischemia on [dobutamine stress echocardiography], the greater the placebo-controlled angina relief from PCI.”
The study was funded by grants from the National Institute for Health Research Imperial Biomedical Research Centre, Foundation for Circulatory Health, Imperial College Healthcare Charity, and in-kind support from Philips Volcano. Two authors declared patents relating to technology used in the study and three declared consultancies, speakers’ fees, and research grants from Philips Volcano. No other conflicts of interest were declared.
SOURCE: Al-Lamee R et al. Circulation. 2019 Nov 11. doi: doi.org/10.1161/CIRCULATIONAHA.119.042918.
Dobutamine stress echocardiography could be used to predict which patients with single-vessel stable coronary artery disease are most likely to benefit from percutaneous coronary intervention, according to secondary analysis of data from the ORBITA trial.
In a study to be presented at the American Heart Association scientific sessions on Nov. 16, researchers outline the results of a stress-echo stratification of patients who participated in the Objective Randomized Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina (ORBITA) trial.
The original double-blind randomized controlled trial, comparing percutaneous coronary intervention (PCI) to a placebo procedure in 200 patients with stable angina and angiographically severe single-vessel coronary artery disease, found a smaller-than-expected effect size.
“While there was no significant difference between PCI and placebo groups in the patient-reported and physician-assessed symptom and quality of life endpoints, ischemia as assessed by dobutamine stress echocardiography (DSE) wall motion score index showed a clear reduction with PCI,” wrote Rasha K. Al-Lamee, MD, from the National Heart and Lung Institute at Imperial College London, and coauthors.
In their paper, published in Circulation, the researchers analyzed data from 183 patients who underwent prerandomization dobutamine stress echocardiography to see the impact of their stress echo score on the placebo-controlled effect of PCI.
The stress echo score reflects the number of segments that are abnormal at peak stress; akinetic segments count as double and dyskinetic segments count as triple.
The researchers found a significant interaction between the prerandomization stress echo score and the effect of PCI on angina frequency, with the largest placebo-controlled effects of PCI seen in patients with the highest stress echo scores.
Patients with a prerandomization stress echo score at or above 1 were three times more likely to have a lower angina frequency score with PCI than with placebo (odds ratio, 3.18; 95% confidence interval, 1.38, 7.34; P = .007). They were also more than four times more likely to be free from angina with PCI compared to placebo (OR, 4.62; 95% CI, 1.70, 12.60; P = .003).
“We have previously found that there is a clear relationship between invasive physiology and stress echo score but no relationship between invasive physiology and placebo-controlled symptom improvement,” the authors wrote. “The present analysis shows that there is clear evidence of a relationship between ischemia on stress echo and the placebo-controlled efficacy of PCI on frequency of angina.”
The analysis, however, found no detectable interaction between prerandomization stress echo score and the effect of PCI on physical limitation score, quality of life, Canadian Cardiovascular Society angina class score, or treadmill time.
The mean prerandomization stress echo score was 1.56 in the PCI arm and 1.61 in the placebo arm.
The study also looked at the relationship between prerandomization stress echo score and fractional flow reserve. This revealed that, as the stress echo score increased with a greater number of ischemia myocardial segments, the fractional flow reserve value decreased, pointing to a greater degree of ischemia. Researchers also noted that as the stress echo score became larger, the instantaneous wave-free ratio also decreased significantly.
“This stress echo-stratified analysis shows the link between stress-induced myocardial wall motion abnormalities and patient-reported angina frequency,” the authors wrote. “The greater the ischemia on [dobutamine stress echocardiography], the greater the placebo-controlled angina relief from PCI.”
The study was funded by grants from the National Institute for Health Research Imperial Biomedical Research Centre, Foundation for Circulatory Health, Imperial College Healthcare Charity, and in-kind support from Philips Volcano. Two authors declared patents relating to technology used in the study and three declared consultancies, speakers’ fees, and research grants from Philips Volcano. No other conflicts of interest were declared.
SOURCE: Al-Lamee R et al. Circulation. 2019 Nov 11. doi: doi.org/10.1161/CIRCULATIONAHA.119.042918.
REPORTING FROM AHA 2019
Key clinical point: Dobutamine stress echo scores are linked to outcomes from PCI in stable coronary artery disease.
Major finding: A prerandomization stress echo score of 1 or greater was associated with significantly higher odds of a lower angina frequency score after PCI.
Study details: Secondary analysis of data from 183 patients enrolled in the ORBITA study.
Disclosures: The study was funded by grants from the National Institute for Health Research Imperial Biomedical Research Centre, Foundation for Circulatory Health, Imperial College Healthcare Charity, and in-kind support from Philips Volcano. Two authors declared patents relating to technology used in the study and three declared consultancies, speakers’ fees, and research grants from Philips Volcano. No other conflicts of interest were declared.
Source: Al-Lamee R et al. Circulation. 2019 Nov 11. doi: doi.org/10.1161/CIRCULATIONAHA.119.042918.
Adding polatuzumab extends survival in relapsed/refractory DLBCL
For patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), adding polatuzumab vedotin to bendamustine and rituximab can improve complete response rates and extend overall survival, according to findings from a phase 1b/2 trial.
Adding polatuzumab decreased mortality risk by 58%, reported lead author Laurie H. Sehn, MD, of the University of British Columbia, Vancouver, and colleagues.
“Patients with transplantation-ineligible [relapsed/refractory] DLBCL, including those who experienced treatment failure with [autologous stem cell transplant], have dismal outcomes with limited therapeutic options,” the investigators wrote in the Journal of Clinical Oncology. “To our knowledge, this is the first randomized trial demonstrating an [overall survival] benefit in patients with transplantation-ineligible [relapsed/refractory] DLBCL.”
In the first part of the study, 27 patients were treated with polatuzumab vedotin, bendamustine, and obinutuzumab. After a median follow-up of 27 months, this regimen returned a complete response rate of 29.6%, median progression-free survival of 6.3 months, and median overall survival of 10.8 months.
In the primary analysis, 80 patients were randomized to receive bendamustine and rituximab, with or without polatuzumab. Adding polatuzumab had a significant benefit, as 40.0% of these patients achieved a complete response, compared with 17.5% of patients who did not receive polatuzumab. After a median follow-up of 22.3 months, outcomes also were significantly improved with the addition of polatuzumab for both median progression-free survival (9.5 vs. 3.7 months) and overall survival (12.4 vs. 4.7 months).
Adding polatuzumab did come with some safety trade-offs. Rates of certain grade 3 or 4 adverse events were higher, including thrombocytopenia (41% vs. 23.1%), neutropenia (46.2% vs. 33.3%), and anemia (28.2% vs. 17.9%), while infection rates were comparable. Almost half of the patients treated with polatuzumab (43.6%) developed grade 1 or 2 peripheral neuropathy, but most cases resolved.
Combination therapy with polatuzumab, bendamustine, and rituximab “represents a novel, effective therapeutic regimen to address the unmet need of patients with transplantation-ineligible [relapsed/refractory] DLBCL,” the investigators wrote. Since just 25% of polatuzumab combination–treated patients had received prior autologous stem cell transplant, the investigators said they could not make definitive conclusions on this combination’s efficacy in the post-ASCT setting.
Additional trials involving polatuzumab in the relapsed/refractory setting are ongoing. For patients with treatment-naive DLBCL, a phase 3 trial (NCT03274492) is evaluating substitution of polatuzumab for vincristine in the R-CHOP regimen.
The study was funded by F. Hoffmann-La Roche and Genentech. The investigators reported additional relationships with AbbVie, Kite Pharma, Lundbeck, and others.
SOURCE: Sehn LH et al. J Clin Oncol. 2019 Nov 6. doi: 10.1200/JCO.19.00172.
For patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), adding polatuzumab vedotin to bendamustine and rituximab can improve complete response rates and extend overall survival, according to findings from a phase 1b/2 trial.
Adding polatuzumab decreased mortality risk by 58%, reported lead author Laurie H. Sehn, MD, of the University of British Columbia, Vancouver, and colleagues.
“Patients with transplantation-ineligible [relapsed/refractory] DLBCL, including those who experienced treatment failure with [autologous stem cell transplant], have dismal outcomes with limited therapeutic options,” the investigators wrote in the Journal of Clinical Oncology. “To our knowledge, this is the first randomized trial demonstrating an [overall survival] benefit in patients with transplantation-ineligible [relapsed/refractory] DLBCL.”
In the first part of the study, 27 patients were treated with polatuzumab vedotin, bendamustine, and obinutuzumab. After a median follow-up of 27 months, this regimen returned a complete response rate of 29.6%, median progression-free survival of 6.3 months, and median overall survival of 10.8 months.
In the primary analysis, 80 patients were randomized to receive bendamustine and rituximab, with or without polatuzumab. Adding polatuzumab had a significant benefit, as 40.0% of these patients achieved a complete response, compared with 17.5% of patients who did not receive polatuzumab. After a median follow-up of 22.3 months, outcomes also were significantly improved with the addition of polatuzumab for both median progression-free survival (9.5 vs. 3.7 months) and overall survival (12.4 vs. 4.7 months).
Adding polatuzumab did come with some safety trade-offs. Rates of certain grade 3 or 4 adverse events were higher, including thrombocytopenia (41% vs. 23.1%), neutropenia (46.2% vs. 33.3%), and anemia (28.2% vs. 17.9%), while infection rates were comparable. Almost half of the patients treated with polatuzumab (43.6%) developed grade 1 or 2 peripheral neuropathy, but most cases resolved.
Combination therapy with polatuzumab, bendamustine, and rituximab “represents a novel, effective therapeutic regimen to address the unmet need of patients with transplantation-ineligible [relapsed/refractory] DLBCL,” the investigators wrote. Since just 25% of polatuzumab combination–treated patients had received prior autologous stem cell transplant, the investigators said they could not make definitive conclusions on this combination’s efficacy in the post-ASCT setting.
Additional trials involving polatuzumab in the relapsed/refractory setting are ongoing. For patients with treatment-naive DLBCL, a phase 3 trial (NCT03274492) is evaluating substitution of polatuzumab for vincristine in the R-CHOP regimen.
The study was funded by F. Hoffmann-La Roche and Genentech. The investigators reported additional relationships with AbbVie, Kite Pharma, Lundbeck, and others.
SOURCE: Sehn LH et al. J Clin Oncol. 2019 Nov 6. doi: 10.1200/JCO.19.00172.
For patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), adding polatuzumab vedotin to bendamustine and rituximab can improve complete response rates and extend overall survival, according to findings from a phase 1b/2 trial.
Adding polatuzumab decreased mortality risk by 58%, reported lead author Laurie H. Sehn, MD, of the University of British Columbia, Vancouver, and colleagues.
“Patients with transplantation-ineligible [relapsed/refractory] DLBCL, including those who experienced treatment failure with [autologous stem cell transplant], have dismal outcomes with limited therapeutic options,” the investigators wrote in the Journal of Clinical Oncology. “To our knowledge, this is the first randomized trial demonstrating an [overall survival] benefit in patients with transplantation-ineligible [relapsed/refractory] DLBCL.”
In the first part of the study, 27 patients were treated with polatuzumab vedotin, bendamustine, and obinutuzumab. After a median follow-up of 27 months, this regimen returned a complete response rate of 29.6%, median progression-free survival of 6.3 months, and median overall survival of 10.8 months.
In the primary analysis, 80 patients were randomized to receive bendamustine and rituximab, with or without polatuzumab. Adding polatuzumab had a significant benefit, as 40.0% of these patients achieved a complete response, compared with 17.5% of patients who did not receive polatuzumab. After a median follow-up of 22.3 months, outcomes also were significantly improved with the addition of polatuzumab for both median progression-free survival (9.5 vs. 3.7 months) and overall survival (12.4 vs. 4.7 months).
Adding polatuzumab did come with some safety trade-offs. Rates of certain grade 3 or 4 adverse events were higher, including thrombocytopenia (41% vs. 23.1%), neutropenia (46.2% vs. 33.3%), and anemia (28.2% vs. 17.9%), while infection rates were comparable. Almost half of the patients treated with polatuzumab (43.6%) developed grade 1 or 2 peripheral neuropathy, but most cases resolved.
Combination therapy with polatuzumab, bendamustine, and rituximab “represents a novel, effective therapeutic regimen to address the unmet need of patients with transplantation-ineligible [relapsed/refractory] DLBCL,” the investigators wrote. Since just 25% of polatuzumab combination–treated patients had received prior autologous stem cell transplant, the investigators said they could not make definitive conclusions on this combination’s efficacy in the post-ASCT setting.
Additional trials involving polatuzumab in the relapsed/refractory setting are ongoing. For patients with treatment-naive DLBCL, a phase 3 trial (NCT03274492) is evaluating substitution of polatuzumab for vincristine in the R-CHOP regimen.
The study was funded by F. Hoffmann-La Roche and Genentech. The investigators reported additional relationships with AbbVie, Kite Pharma, Lundbeck, and others.
SOURCE: Sehn LH et al. J Clin Oncol. 2019 Nov 6. doi: 10.1200/JCO.19.00172.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Bezafibrate beats placebo in pruritus of chronic cholestasis: The FITCH trial
BOSTON – Bezafibrate was superior to placebo for ameliorating pruritus in patients with chronic cholestatic liver diseases, investigators reported at the annual meeting of the American Association for the Study of Liver Diseases.
Improvements in itch were reported by four times as many patients treated with the peroxisome proliferator-activated receptor (PPAR) agonist, compared with those treated with placebo, according to results of the FITCH (Fibrates for cholestatic ITCH) trial.
That finding from FITCH is very encouraging for patients with this “vexing” clinical issue, which can be highly distressing and is a common feature of cholestatic liver diseases, said Michael R. Charlton, MBBS, FRCP, director of the Transplant Institute and hepatology chief at the University of Chicago.
“It’s generally a misery-making condition,” Dr. Charlton said in a podium discussion of the FITCH study results at the Liver Meeting 2019. “I had a patient tell me that they felt like the subject of Edvard Munch’s ‘Scream’ painting.”
As of this meeting, bezafibrate should be considered superior to placebo for treatment of pruritus in cholangiopathies and should be “considered as first-line treatment” for pruritus in primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), added Dr. Charlton, who was not involved in the study.
Investigators in FITCH recruited a total of 74 patients – all enrolled in the Netherlands or Spain – with cholestasis-induced pruritus who reported itch with an intensity of least 5 out of 10 on a visual analogue scale (VAS). Of the 70 patients who completed the trial, 44 had PSC, 24 had PBC, and 2 had secondary sclerosing cholangitis. Patients were randomly allocated to receive bezafibrate 400 mg once daily or placebo for 21 days.
The hypothesis was that PPAR agonist treatment would relieve itch by alleviating hepatobiliary inflammation and reducing formation of a biliary itch factor, according to the investigators, led by Elsemieke de Vries, MD, of the department of gastroenterology and hepatology, Amsterdam University Medical Centers.
“Guideline-approved pharmacological strategies show limited efficacy and can provoke serious side effects,” Dr. de Vries and coauthors said in the published abstract on the study.
The primary study endpoint, a 50% reduction in pruritus VAS score, was achieved in 45% of patients in the bezafibrate treatment arm (17 of 38 patients) versus just 11% in the placebo arm (4 of 36 patients; P = .003), according to updated results presented at the meeting.
The mean VAS score, comparable at baseline, was significantly lower in the bezafibrate group vs. the placebo group at day 21 (P < .001), the results showed.
Authors of the FITCH study reported disclosures related to Intercept Pharmaceuticals, Gilead, Takeda, Tillotts, Pliant, and Dr. Falk GmbH.
SOURCE: de Vries E et al. The Liver Meeting 2019. Abstract 13.
BOSTON – Bezafibrate was superior to placebo for ameliorating pruritus in patients with chronic cholestatic liver diseases, investigators reported at the annual meeting of the American Association for the Study of Liver Diseases.
Improvements in itch were reported by four times as many patients treated with the peroxisome proliferator-activated receptor (PPAR) agonist, compared with those treated with placebo, according to results of the FITCH (Fibrates for cholestatic ITCH) trial.
That finding from FITCH is very encouraging for patients with this “vexing” clinical issue, which can be highly distressing and is a common feature of cholestatic liver diseases, said Michael R. Charlton, MBBS, FRCP, director of the Transplant Institute and hepatology chief at the University of Chicago.
“It’s generally a misery-making condition,” Dr. Charlton said in a podium discussion of the FITCH study results at the Liver Meeting 2019. “I had a patient tell me that they felt like the subject of Edvard Munch’s ‘Scream’ painting.”
As of this meeting, bezafibrate should be considered superior to placebo for treatment of pruritus in cholangiopathies and should be “considered as first-line treatment” for pruritus in primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), added Dr. Charlton, who was not involved in the study.
Investigators in FITCH recruited a total of 74 patients – all enrolled in the Netherlands or Spain – with cholestasis-induced pruritus who reported itch with an intensity of least 5 out of 10 on a visual analogue scale (VAS). Of the 70 patients who completed the trial, 44 had PSC, 24 had PBC, and 2 had secondary sclerosing cholangitis. Patients were randomly allocated to receive bezafibrate 400 mg once daily or placebo for 21 days.
The hypothesis was that PPAR agonist treatment would relieve itch by alleviating hepatobiliary inflammation and reducing formation of a biliary itch factor, according to the investigators, led by Elsemieke de Vries, MD, of the department of gastroenterology and hepatology, Amsterdam University Medical Centers.
“Guideline-approved pharmacological strategies show limited efficacy and can provoke serious side effects,” Dr. de Vries and coauthors said in the published abstract on the study.
The primary study endpoint, a 50% reduction in pruritus VAS score, was achieved in 45% of patients in the bezafibrate treatment arm (17 of 38 patients) versus just 11% in the placebo arm (4 of 36 patients; P = .003), according to updated results presented at the meeting.
The mean VAS score, comparable at baseline, was significantly lower in the bezafibrate group vs. the placebo group at day 21 (P < .001), the results showed.
Authors of the FITCH study reported disclosures related to Intercept Pharmaceuticals, Gilead, Takeda, Tillotts, Pliant, and Dr. Falk GmbH.
SOURCE: de Vries E et al. The Liver Meeting 2019. Abstract 13.
BOSTON – Bezafibrate was superior to placebo for ameliorating pruritus in patients with chronic cholestatic liver diseases, investigators reported at the annual meeting of the American Association for the Study of Liver Diseases.
Improvements in itch were reported by four times as many patients treated with the peroxisome proliferator-activated receptor (PPAR) agonist, compared with those treated with placebo, according to results of the FITCH (Fibrates for cholestatic ITCH) trial.
That finding from FITCH is very encouraging for patients with this “vexing” clinical issue, which can be highly distressing and is a common feature of cholestatic liver diseases, said Michael R. Charlton, MBBS, FRCP, director of the Transplant Institute and hepatology chief at the University of Chicago.
“It’s generally a misery-making condition,” Dr. Charlton said in a podium discussion of the FITCH study results at the Liver Meeting 2019. “I had a patient tell me that they felt like the subject of Edvard Munch’s ‘Scream’ painting.”
As of this meeting, bezafibrate should be considered superior to placebo for treatment of pruritus in cholangiopathies and should be “considered as first-line treatment” for pruritus in primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), added Dr. Charlton, who was not involved in the study.
Investigators in FITCH recruited a total of 74 patients – all enrolled in the Netherlands or Spain – with cholestasis-induced pruritus who reported itch with an intensity of least 5 out of 10 on a visual analogue scale (VAS). Of the 70 patients who completed the trial, 44 had PSC, 24 had PBC, and 2 had secondary sclerosing cholangitis. Patients were randomly allocated to receive bezafibrate 400 mg once daily or placebo for 21 days.
The hypothesis was that PPAR agonist treatment would relieve itch by alleviating hepatobiliary inflammation and reducing formation of a biliary itch factor, according to the investigators, led by Elsemieke de Vries, MD, of the department of gastroenterology and hepatology, Amsterdam University Medical Centers.
“Guideline-approved pharmacological strategies show limited efficacy and can provoke serious side effects,” Dr. de Vries and coauthors said in the published abstract on the study.
The primary study endpoint, a 50% reduction in pruritus VAS score, was achieved in 45% of patients in the bezafibrate treatment arm (17 of 38 patients) versus just 11% in the placebo arm (4 of 36 patients; P = .003), according to updated results presented at the meeting.
The mean VAS score, comparable at baseline, was significantly lower in the bezafibrate group vs. the placebo group at day 21 (P < .001), the results showed.
Authors of the FITCH study reported disclosures related to Intercept Pharmaceuticals, Gilead, Takeda, Tillotts, Pliant, and Dr. Falk GmbH.
SOURCE: de Vries E et al. The Liver Meeting 2019. Abstract 13.
REPORTING FROM THE LIVER MEETING 2019
Key clinical point: Bezafibrate was superior to placebo for improving pruritus in chronic cholestatic liver diseases.
Major finding: A 50% reduction in pruritus visual analogue scale (VAS) score was achieved in 45% of patients in the bezafibrate treatment arm versus 11% in the placebo arm (P = .003).
Study details: Report on the randomized, placebo-controlled FITCH trial including 74 patients with cholestasis-induced pruritus.
Disclosures: Authors of the FITCH study reported disclosures related to Intercept Pharmaceuticals, Gilead, Takeda, Tillotts, Pliant, and Dr. Falk GmbH.
Source: de Vries E et al. The Liver Meeting 2019. Abstract 13.
Addressing the Suicide Crisis: ‘More Can Be Done’
More than 6,000 veterans die by suicide every year—more than the total number of combat deaths in Iraq and Afghanistan combined.
In recently released Improving the Quality of Mental Health Care for Veterans: Lessons from Rand Research, RAND researchers say the overwhelming message from 10 years of research, including a comprehensive evaluation of the US Department of Veterans Affairs (VA) mental health system and a congressionally mandated analysis of VA health care vs other health care systems, is, We could do more to save the lives of veterans.
RAND research has found that the VA outperforms other health systems on most measures of health care, including mental health care. The report also acknowledges that the VA and US Department of Defense (DoD) have both invested heavily in public-awareness campaigns and efforts to better identify those at risk of suicide, but “the research shows it’s not enough.”
Improving the Quality of Mental Health Care for Veterans has 6 recommendations:
1. Increase the number of highly trained mental health providers within the VA and in private practice. The VA has continued to hire more providers, integrate mental health into primary care settings, and expand the use of telemental health. However, quality varies “considerably” across facilities, the report says, with best practices not universally delivered.
Moreover, fewer than half of all veterans get their care at the VA. Most use local hospitals and health clinics. RAND research has shown those community health providers are often not prepared to address the needs of veterans. Few community providers even ask their patients if they ever served, the researchers say. Recently, the report notes, the VA has taken steps to help private providers serve veterans more effectively, by providing toolkits, training programs, and other resources.
2. Reduce barriers to care by educating veterans about treatment and expanding access to high-quality treatment. The report notes that patients may believe that admitting a mental health problem is a “sign of weakness,” or that they may be skeptical about the effectiveness of treatment.
3. Adopt and enforce appropriate, consistent quality-of-care standards by creating incentives and disincentives that support best practices.
4. Improve monitoring and performance measurement for VA community care programs. According to the report, “Little is known about the timeliness or quality of care that veterans receive through these programs as mandated.”
5. Continue to develop and test new models of care, particularly as new interventions become available and show promise. The report lists examples of evidence-based practices that have proven effective, including narrative exposure therapy for PTSD, mindfulness-based therapies for depression, and behavioral couples therapy for alcohol use disorder.
6. Strengthen the evidence base for understanding the effectiveness of complementary and alternative therapies for mental health conditions.
The research also supports the concept that policies that change the environment and attitudes can reduce and prevent suicides. For instance, a RAND essay advocates policies that promote better sleep and address a “culture of stress.” Policies that promote safe gun storage, encourage health care providers to ask their patients about guns, and remove guns from those at highest risk could help: Nearly 70% of veterans who die by suicide use a firearm. And because sexual assault within the military is a major risk factor for suicide among female veterans, a zero-tolerance policy on sexual assault could make a difference for thousands of service members.
In 2011, RAND researchers published The War Within, a comprehensive look at suicide in the military. One of the driving forces behind the research was senior behavioral scientist Terri Tanielian, whose father, a veteran, committed suicide. Evidence-based treatment not only improves recovery rates but saves money, Tanielian says. In 2008, she and other researchers estimated the 2-year societal costs of postdeployment mental health problems among veterans who had served since the September 11, 2001, attacks at approximately $6.2 billion (in 2007 dollars). If all veterans received high-quality care for depression, posttraumatic stress disorder, and other conditions, those costs could be reduced by $1.2 billion, they found.
The RAND report emphasizes that suicide and mental health issues are a national problem, not just a VA problem. “We can’t think about addressing these issues in the veteran population without thinking about them for the larger American population,” Tanielian says. “We can’t keep pointing a finger at the DoD and the VA. We have to think about this as the national public health crisis that it is.”
More than 6,000 veterans die by suicide every year—more than the total number of combat deaths in Iraq and Afghanistan combined.
In recently released Improving the Quality of Mental Health Care for Veterans: Lessons from Rand Research, RAND researchers say the overwhelming message from 10 years of research, including a comprehensive evaluation of the US Department of Veterans Affairs (VA) mental health system and a congressionally mandated analysis of VA health care vs other health care systems, is, We could do more to save the lives of veterans.
RAND research has found that the VA outperforms other health systems on most measures of health care, including mental health care. The report also acknowledges that the VA and US Department of Defense (DoD) have both invested heavily in public-awareness campaigns and efforts to better identify those at risk of suicide, but “the research shows it’s not enough.”
Improving the Quality of Mental Health Care for Veterans has 6 recommendations:
1. Increase the number of highly trained mental health providers within the VA and in private practice. The VA has continued to hire more providers, integrate mental health into primary care settings, and expand the use of telemental health. However, quality varies “considerably” across facilities, the report says, with best practices not universally delivered.
Moreover, fewer than half of all veterans get their care at the VA. Most use local hospitals and health clinics. RAND research has shown those community health providers are often not prepared to address the needs of veterans. Few community providers even ask their patients if they ever served, the researchers say. Recently, the report notes, the VA has taken steps to help private providers serve veterans more effectively, by providing toolkits, training programs, and other resources.
2. Reduce barriers to care by educating veterans about treatment and expanding access to high-quality treatment. The report notes that patients may believe that admitting a mental health problem is a “sign of weakness,” or that they may be skeptical about the effectiveness of treatment.
3. Adopt and enforce appropriate, consistent quality-of-care standards by creating incentives and disincentives that support best practices.
4. Improve monitoring and performance measurement for VA community care programs. According to the report, “Little is known about the timeliness or quality of care that veterans receive through these programs as mandated.”
5. Continue to develop and test new models of care, particularly as new interventions become available and show promise. The report lists examples of evidence-based practices that have proven effective, including narrative exposure therapy for PTSD, mindfulness-based therapies for depression, and behavioral couples therapy for alcohol use disorder.
6. Strengthen the evidence base for understanding the effectiveness of complementary and alternative therapies for mental health conditions.
The research also supports the concept that policies that change the environment and attitudes can reduce and prevent suicides. For instance, a RAND essay advocates policies that promote better sleep and address a “culture of stress.” Policies that promote safe gun storage, encourage health care providers to ask their patients about guns, and remove guns from those at highest risk could help: Nearly 70% of veterans who die by suicide use a firearm. And because sexual assault within the military is a major risk factor for suicide among female veterans, a zero-tolerance policy on sexual assault could make a difference for thousands of service members.
In 2011, RAND researchers published The War Within, a comprehensive look at suicide in the military. One of the driving forces behind the research was senior behavioral scientist Terri Tanielian, whose father, a veteran, committed suicide. Evidence-based treatment not only improves recovery rates but saves money, Tanielian says. In 2008, she and other researchers estimated the 2-year societal costs of postdeployment mental health problems among veterans who had served since the September 11, 2001, attacks at approximately $6.2 billion (in 2007 dollars). If all veterans received high-quality care for depression, posttraumatic stress disorder, and other conditions, those costs could be reduced by $1.2 billion, they found.
The RAND report emphasizes that suicide and mental health issues are a national problem, not just a VA problem. “We can’t think about addressing these issues in the veteran population without thinking about them for the larger American population,” Tanielian says. “We can’t keep pointing a finger at the DoD and the VA. We have to think about this as the national public health crisis that it is.”
More than 6,000 veterans die by suicide every year—more than the total number of combat deaths in Iraq and Afghanistan combined.
In recently released Improving the Quality of Mental Health Care for Veterans: Lessons from Rand Research, RAND researchers say the overwhelming message from 10 years of research, including a comprehensive evaluation of the US Department of Veterans Affairs (VA) mental health system and a congressionally mandated analysis of VA health care vs other health care systems, is, We could do more to save the lives of veterans.
RAND research has found that the VA outperforms other health systems on most measures of health care, including mental health care. The report also acknowledges that the VA and US Department of Defense (DoD) have both invested heavily in public-awareness campaigns and efforts to better identify those at risk of suicide, but “the research shows it’s not enough.”
Improving the Quality of Mental Health Care for Veterans has 6 recommendations:
1. Increase the number of highly trained mental health providers within the VA and in private practice. The VA has continued to hire more providers, integrate mental health into primary care settings, and expand the use of telemental health. However, quality varies “considerably” across facilities, the report says, with best practices not universally delivered.
Moreover, fewer than half of all veterans get their care at the VA. Most use local hospitals and health clinics. RAND research has shown those community health providers are often not prepared to address the needs of veterans. Few community providers even ask their patients if they ever served, the researchers say. Recently, the report notes, the VA has taken steps to help private providers serve veterans more effectively, by providing toolkits, training programs, and other resources.
2. Reduce barriers to care by educating veterans about treatment and expanding access to high-quality treatment. The report notes that patients may believe that admitting a mental health problem is a “sign of weakness,” or that they may be skeptical about the effectiveness of treatment.
3. Adopt and enforce appropriate, consistent quality-of-care standards by creating incentives and disincentives that support best practices.
4. Improve monitoring and performance measurement for VA community care programs. According to the report, “Little is known about the timeliness or quality of care that veterans receive through these programs as mandated.”
5. Continue to develop and test new models of care, particularly as new interventions become available and show promise. The report lists examples of evidence-based practices that have proven effective, including narrative exposure therapy for PTSD, mindfulness-based therapies for depression, and behavioral couples therapy for alcohol use disorder.
6. Strengthen the evidence base for understanding the effectiveness of complementary and alternative therapies for mental health conditions.
The research also supports the concept that policies that change the environment and attitudes can reduce and prevent suicides. For instance, a RAND essay advocates policies that promote better sleep and address a “culture of stress.” Policies that promote safe gun storage, encourage health care providers to ask their patients about guns, and remove guns from those at highest risk could help: Nearly 70% of veterans who die by suicide use a firearm. And because sexual assault within the military is a major risk factor for suicide among female veterans, a zero-tolerance policy on sexual assault could make a difference for thousands of service members.
In 2011, RAND researchers published The War Within, a comprehensive look at suicide in the military. One of the driving forces behind the research was senior behavioral scientist Terri Tanielian, whose father, a veteran, committed suicide. Evidence-based treatment not only improves recovery rates but saves money, Tanielian says. In 2008, she and other researchers estimated the 2-year societal costs of postdeployment mental health problems among veterans who had served since the September 11, 2001, attacks at approximately $6.2 billion (in 2007 dollars). If all veterans received high-quality care for depression, posttraumatic stress disorder, and other conditions, those costs could be reduced by $1.2 billion, they found.
The RAND report emphasizes that suicide and mental health issues are a national problem, not just a VA problem. “We can’t think about addressing these issues in the veteran population without thinking about them for the larger American population,” Tanielian says. “We can’t keep pointing a finger at the DoD and the VA. We have to think about this as the national public health crisis that it is.”
Feds propose new price transparency rules in health care
Three federal agencies have jointly issued a price transparency proposal that would require most employer-based health plans and health insurance issuers to disclose price and cost-sharing information up front.
The goal behind the proposal is to give consumers accurate estimates about the out-of-pocket costs they may incur for medical services, giving them the opportunity to shop around for medical treatment.
“Under the status quo, health care prices are about as clear as mud to patients,” Seema Verma, administrator of the Centers for Medicare & Medicaid Services said in a statement, adding that “we are throwing open the shutters and bringing to light the price of care for American consumers. Kept secret, these prices are simply dollar amounts on a ledger; disclosed, they deliver fuel to the engines of competition among hospitals and insurers.”
The “Transparency in Coverage” proposed rule, was released online on Nov. 15 jointly by the Department of Health & Human Services, the Department of Labor, and the Department of the Treasury. If finalized, it would give consumers “real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability for all covered health care items and services through an online tool that most group health plans and health insurance issuers would be required to make available to all of their members, and in paper form, at the consumer’s request,” a fact sheet outlining the features of the proposed rule states.
Health plans would also “be required to disclose on a public website their negotiated rates for in-network providers and allowed amounts paid for out-of-network providers,” the fact sheet continues.
The proposal comes as the CMS finalized transparency-related rules in the 2020 update to the hospital outpatient prospective payment system (OPPS). The price transparency portion of the OPPS is scheduled to go into effect on Jan. 1, 2021.
A fact sheet on the OPPS states that each hospital in the United States will be required to “establish (and update) and make public a yearly list of the hospital’s standard charges for items and services provided by the hospital.”
That list must include all standard charges, including gross charges, discounted cash prices, payer-specific negotiated charges, and deidentified minimum and maximum negotiated charges for all hospital items and services, as well as cash prices, payer-specific negotiated charges, and deidentified minimum and maximum negotiated charges for 300 shoppable services (70 identified by CMS and 230 selected by the hospital). A shoppable service is a service that can be scheduled in advance.
“This final rule and the proposed rule will bring forward the transparency we need to finally begin reducing the overall health care costs,” Ms. Verma said. “Today’s rules usher in a new era that upends the status quo to empower patients and put them first.”
America’s Health Insurance Plans said in a statement that it is evaluating the proposal and the final OPPS rule through a lens of three core principles: that consumers deserve transparency about out-of-pocket costs to help them make informed decisions; that transparency should be achieved in a way that encourages, not undermines, competitive negotiations to lower costs; and that public programs and the free market work together to deliver on our commitments to affordable, quality, and value.
“Neither of these rules, together or separately, satisfies these principles,” AHIP stated.
The Federation of American Hospitals is already anticipating a legal challenge to the rules.
“Patients should have readily available and easy-to-understand cost-sharing information when they need to make health care decisions,” FAH President and CEO Chip Kahn said in a statement. “Health care pricing transparency ought to be defined by the right information at the right time. This final regulation on hospital transparency fails to meet the definition of price transparency useful for patients. Instead, it will only result in patient overload of useless information while distorting the competitive market for purchasing hospital care.”
Mr. Kahn said FAH plans “on joining with hospitals to file a legal challenge,” asserting that CMS has exceeded it’s authority with these rules.
Three federal agencies have jointly issued a price transparency proposal that would require most employer-based health plans and health insurance issuers to disclose price and cost-sharing information up front.
The goal behind the proposal is to give consumers accurate estimates about the out-of-pocket costs they may incur for medical services, giving them the opportunity to shop around for medical treatment.
“Under the status quo, health care prices are about as clear as mud to patients,” Seema Verma, administrator of the Centers for Medicare & Medicaid Services said in a statement, adding that “we are throwing open the shutters and bringing to light the price of care for American consumers. Kept secret, these prices are simply dollar amounts on a ledger; disclosed, they deliver fuel to the engines of competition among hospitals and insurers.”
The “Transparency in Coverage” proposed rule, was released online on Nov. 15 jointly by the Department of Health & Human Services, the Department of Labor, and the Department of the Treasury. If finalized, it would give consumers “real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability for all covered health care items and services through an online tool that most group health plans and health insurance issuers would be required to make available to all of their members, and in paper form, at the consumer’s request,” a fact sheet outlining the features of the proposed rule states.
Health plans would also “be required to disclose on a public website their negotiated rates for in-network providers and allowed amounts paid for out-of-network providers,” the fact sheet continues.
The proposal comes as the CMS finalized transparency-related rules in the 2020 update to the hospital outpatient prospective payment system (OPPS). The price transparency portion of the OPPS is scheduled to go into effect on Jan. 1, 2021.
A fact sheet on the OPPS states that each hospital in the United States will be required to “establish (and update) and make public a yearly list of the hospital’s standard charges for items and services provided by the hospital.”
That list must include all standard charges, including gross charges, discounted cash prices, payer-specific negotiated charges, and deidentified minimum and maximum negotiated charges for all hospital items and services, as well as cash prices, payer-specific negotiated charges, and deidentified minimum and maximum negotiated charges for 300 shoppable services (70 identified by CMS and 230 selected by the hospital). A shoppable service is a service that can be scheduled in advance.
“This final rule and the proposed rule will bring forward the transparency we need to finally begin reducing the overall health care costs,” Ms. Verma said. “Today’s rules usher in a new era that upends the status quo to empower patients and put them first.”
America’s Health Insurance Plans said in a statement that it is evaluating the proposal and the final OPPS rule through a lens of three core principles: that consumers deserve transparency about out-of-pocket costs to help them make informed decisions; that transparency should be achieved in a way that encourages, not undermines, competitive negotiations to lower costs; and that public programs and the free market work together to deliver on our commitments to affordable, quality, and value.
“Neither of these rules, together or separately, satisfies these principles,” AHIP stated.
The Federation of American Hospitals is already anticipating a legal challenge to the rules.
“Patients should have readily available and easy-to-understand cost-sharing information when they need to make health care decisions,” FAH President and CEO Chip Kahn said in a statement. “Health care pricing transparency ought to be defined by the right information at the right time. This final regulation on hospital transparency fails to meet the definition of price transparency useful for patients. Instead, it will only result in patient overload of useless information while distorting the competitive market for purchasing hospital care.”
Mr. Kahn said FAH plans “on joining with hospitals to file a legal challenge,” asserting that CMS has exceeded it’s authority with these rules.
Three federal agencies have jointly issued a price transparency proposal that would require most employer-based health plans and health insurance issuers to disclose price and cost-sharing information up front.
The goal behind the proposal is to give consumers accurate estimates about the out-of-pocket costs they may incur for medical services, giving them the opportunity to shop around for medical treatment.
“Under the status quo, health care prices are about as clear as mud to patients,” Seema Verma, administrator of the Centers for Medicare & Medicaid Services said in a statement, adding that “we are throwing open the shutters and bringing to light the price of care for American consumers. Kept secret, these prices are simply dollar amounts on a ledger; disclosed, they deliver fuel to the engines of competition among hospitals and insurers.”
The “Transparency in Coverage” proposed rule, was released online on Nov. 15 jointly by the Department of Health & Human Services, the Department of Labor, and the Department of the Treasury. If finalized, it would give consumers “real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability for all covered health care items and services through an online tool that most group health plans and health insurance issuers would be required to make available to all of their members, and in paper form, at the consumer’s request,” a fact sheet outlining the features of the proposed rule states.
Health plans would also “be required to disclose on a public website their negotiated rates for in-network providers and allowed amounts paid for out-of-network providers,” the fact sheet continues.
The proposal comes as the CMS finalized transparency-related rules in the 2020 update to the hospital outpatient prospective payment system (OPPS). The price transparency portion of the OPPS is scheduled to go into effect on Jan. 1, 2021.
A fact sheet on the OPPS states that each hospital in the United States will be required to “establish (and update) and make public a yearly list of the hospital’s standard charges for items and services provided by the hospital.”
That list must include all standard charges, including gross charges, discounted cash prices, payer-specific negotiated charges, and deidentified minimum and maximum negotiated charges for all hospital items and services, as well as cash prices, payer-specific negotiated charges, and deidentified minimum and maximum negotiated charges for 300 shoppable services (70 identified by CMS and 230 selected by the hospital). A shoppable service is a service that can be scheduled in advance.
“This final rule and the proposed rule will bring forward the transparency we need to finally begin reducing the overall health care costs,” Ms. Verma said. “Today’s rules usher in a new era that upends the status quo to empower patients and put them first.”
America’s Health Insurance Plans said in a statement that it is evaluating the proposal and the final OPPS rule through a lens of three core principles: that consumers deserve transparency about out-of-pocket costs to help them make informed decisions; that transparency should be achieved in a way that encourages, not undermines, competitive negotiations to lower costs; and that public programs and the free market work together to deliver on our commitments to affordable, quality, and value.
“Neither of these rules, together or separately, satisfies these principles,” AHIP stated.
The Federation of American Hospitals is already anticipating a legal challenge to the rules.
“Patients should have readily available and easy-to-understand cost-sharing information when they need to make health care decisions,” FAH President and CEO Chip Kahn said in a statement. “Health care pricing transparency ought to be defined by the right information at the right time. This final regulation on hospital transparency fails to meet the definition of price transparency useful for patients. Instead, it will only result in patient overload of useless information while distorting the competitive market for purchasing hospital care.”
Mr. Kahn said FAH plans “on joining with hospitals to file a legal challenge,” asserting that CMS has exceeded it’s authority with these rules.