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Arkansas cardiologist pays $900K to settle false claims allegations
in violation of the False Claims Act.
As part of the settlement, Dr. Tauth will enter into an integrity agreement with the U.S. Department of Health & Human Services, according to a news release from Henry Leventis, U.S. attorney for the Middle District of Tennessee.
“Health care fraud is a top priority of this office. We will aggressively pursue all those who are involved in fraud against government programs,” Mr. Leventis said.
Dr. Tauth formerly treated patients at National Park Medical Center (NPMC) in Hot Springs. The alleged false claims were submitted from September 2013 through August 2019.
The settlement with Dr. Tauth, aged 60, follows a November 2019 voluntary disclosure of the alleged false claims by Brentwood, Tenn.–based Lifepoint Health, which acquired NPMC and Hot Springs Cardiology Associates in November 2018.
NPMC and Hot Springs Cardiology entered into a settlement in October 2020 for the alleged violations and agreed to pay roughly $14.6 million, which includes over $9 million in restitution, according to the news release.
NPMC CEO Scott Smith said NPMC is “committed to maintaining high standards of integrity, legal compliance, and quality care for our patients. We regularly monitor our processes, procedures, and reporting and actively self-report concerns to regulators to ensure we are upholding these standards across our organization.”
“We are proud that our hospital took the appropriate steps to promptly self-report and finalize a settlement with the government for a swift resolution more than 2 years ago,” Mr. Smith said.
Dr. Tauth, however, maintains that the allegations made by NPMC are false.
“I am pleased to have reached a settlement agreement with the Department of Justice regarding allegations brought to them by my former employer, National Park Medical Center,” he said in a statement.
“The settlement agreement specifically states that it is not ‘an admission of liability’ by me, and I remain steadfast in my position that the allegations made by my former employer are false and without merit,” Dr. Tauth added.
He further stated that he has “chosen to enter into the settlement agreement because the legal process initiated by National Park’s allegations has been emotionally and financially damaging to me and my family in the extreme, and a settlement puts an end to the delays, uncertainties, inconveniences, and expenses of protracted litigation. Settlement is in the best interests of my family, my patients, and my medical practice.”
Dr. Tauth said he is “extremely grateful for the support I have received from my patients, medical staff, colleagues, friends, and family during this difficult time, and I look forward to providing high-quality cardiac care in the greater Hot Springs community for many years to come.”
A version of this article first appeared on Medscape.com.
in violation of the False Claims Act.
As part of the settlement, Dr. Tauth will enter into an integrity agreement with the U.S. Department of Health & Human Services, according to a news release from Henry Leventis, U.S. attorney for the Middle District of Tennessee.
“Health care fraud is a top priority of this office. We will aggressively pursue all those who are involved in fraud against government programs,” Mr. Leventis said.
Dr. Tauth formerly treated patients at National Park Medical Center (NPMC) in Hot Springs. The alleged false claims were submitted from September 2013 through August 2019.
The settlement with Dr. Tauth, aged 60, follows a November 2019 voluntary disclosure of the alleged false claims by Brentwood, Tenn.–based Lifepoint Health, which acquired NPMC and Hot Springs Cardiology Associates in November 2018.
NPMC and Hot Springs Cardiology entered into a settlement in October 2020 for the alleged violations and agreed to pay roughly $14.6 million, which includes over $9 million in restitution, according to the news release.
NPMC CEO Scott Smith said NPMC is “committed to maintaining high standards of integrity, legal compliance, and quality care for our patients. We regularly monitor our processes, procedures, and reporting and actively self-report concerns to regulators to ensure we are upholding these standards across our organization.”
“We are proud that our hospital took the appropriate steps to promptly self-report and finalize a settlement with the government for a swift resolution more than 2 years ago,” Mr. Smith said.
Dr. Tauth, however, maintains that the allegations made by NPMC are false.
“I am pleased to have reached a settlement agreement with the Department of Justice regarding allegations brought to them by my former employer, National Park Medical Center,” he said in a statement.
“The settlement agreement specifically states that it is not ‘an admission of liability’ by me, and I remain steadfast in my position that the allegations made by my former employer are false and without merit,” Dr. Tauth added.
He further stated that he has “chosen to enter into the settlement agreement because the legal process initiated by National Park’s allegations has been emotionally and financially damaging to me and my family in the extreme, and a settlement puts an end to the delays, uncertainties, inconveniences, and expenses of protracted litigation. Settlement is in the best interests of my family, my patients, and my medical practice.”
Dr. Tauth said he is “extremely grateful for the support I have received from my patients, medical staff, colleagues, friends, and family during this difficult time, and I look forward to providing high-quality cardiac care in the greater Hot Springs community for many years to come.”
A version of this article first appeared on Medscape.com.
in violation of the False Claims Act.
As part of the settlement, Dr. Tauth will enter into an integrity agreement with the U.S. Department of Health & Human Services, according to a news release from Henry Leventis, U.S. attorney for the Middle District of Tennessee.
“Health care fraud is a top priority of this office. We will aggressively pursue all those who are involved in fraud against government programs,” Mr. Leventis said.
Dr. Tauth formerly treated patients at National Park Medical Center (NPMC) in Hot Springs. The alleged false claims were submitted from September 2013 through August 2019.
The settlement with Dr. Tauth, aged 60, follows a November 2019 voluntary disclosure of the alleged false claims by Brentwood, Tenn.–based Lifepoint Health, which acquired NPMC and Hot Springs Cardiology Associates in November 2018.
NPMC and Hot Springs Cardiology entered into a settlement in October 2020 for the alleged violations and agreed to pay roughly $14.6 million, which includes over $9 million in restitution, according to the news release.
NPMC CEO Scott Smith said NPMC is “committed to maintaining high standards of integrity, legal compliance, and quality care for our patients. We regularly monitor our processes, procedures, and reporting and actively self-report concerns to regulators to ensure we are upholding these standards across our organization.”
“We are proud that our hospital took the appropriate steps to promptly self-report and finalize a settlement with the government for a swift resolution more than 2 years ago,” Mr. Smith said.
Dr. Tauth, however, maintains that the allegations made by NPMC are false.
“I am pleased to have reached a settlement agreement with the Department of Justice regarding allegations brought to them by my former employer, National Park Medical Center,” he said in a statement.
“The settlement agreement specifically states that it is not ‘an admission of liability’ by me, and I remain steadfast in my position that the allegations made by my former employer are false and without merit,” Dr. Tauth added.
He further stated that he has “chosen to enter into the settlement agreement because the legal process initiated by National Park’s allegations has been emotionally and financially damaging to me and my family in the extreme, and a settlement puts an end to the delays, uncertainties, inconveniences, and expenses of protracted litigation. Settlement is in the best interests of my family, my patients, and my medical practice.”
Dr. Tauth said he is “extremely grateful for the support I have received from my patients, medical staff, colleagues, friends, and family during this difficult time, and I look forward to providing high-quality cardiac care in the greater Hot Springs community for many years to come.”
A version of this article first appeared on Medscape.com.
Strong support to provide DAA therapy to all patients with HCV
, a large, real-world analysis finds.
Improved outcomes were seen among patients without cirrhosis, those with compensated cirrhosis, and those with existing liver decompensation, the authors noted.
The findings highlight a “substantial need to provide DAA therapy to all patients with HCV, regardless of disease stage or financial status,” wrote Mindie Nguyen, MD, of Stanford University Medical Center, Palo Alto, Calif., and coinvestigators.
“Additional national efforts are needed to reach and treat U.S. population groups that are underinsured or not insured, incarcerated and otherwise marginalized, such as users of illicit drugs, who are also at higher risk of disease complication and reinfection,” they said.
The study was published online in JAMA Internal Medicine.
CHC and its complications are associated with high rates of illness and death. However, large-scale data on long-term liver and nonliver effects of DAA treatment are limited.
For their study, Dr. Nguyen and colleagues analyzed administrative claims data from 2010 to 2021 for 245,596 adults with CHC, of whom 40,654 had received one or more DAA therapies (without interferon) and 204,942 had not received treatment.
DAA-treated patients were slightly older than their untreated peers (mean age, 59.9 years, vs. 58.5 years) and were more likely to be male (62% vs. 58%) and White (59% vs. 57%), and to have diabetes (26% vs. 25%) and cirrhosis (44% vs. 29%).
For liver outcomes, DAA therapy was associated with a lower incidence of decompensation (28.2 vs. 40.8 per 1,000 person-years; P < .001) and hepatocellular carcinoma (HCC) in compensated cirrhosis (20.1 vs. 41.8; P < .001).
For nonliver outcomes, DAA treatment was associated with a lower incidence of diabetes (30.2 vs. 37.2 per 1,000 person-years; P < .001) and chronic kidney disease (31.1 vs. 34.1; P < .001).
The all-cause mortality rate per 1,000 person-years was 36.5 in the DAA-treated group, vs. 64.7 in the untreated group (P < .001).
In multivariable regression analysis, DAA treatment was independently associated with a significant decrease in the risk for HCC (adjusted hazard ratio [aHR], 0.73), decompensation (aHR, 0.36), diabetes (aHR, 0.74), chronic kidney disease (aHR, 0.81), cardiovascular disease (aHR, 0.90), nonliver cancer (aHR, 0.89), and mortality (aHR, 0.43).
The 57% lower mortality rate observed among DAA-treated vs. untreated patients aligns with a large French study of adults with CHC.
“Because HCV treatment with a DAA regimen is well tolerated for nearly all patients, we believe these findings provide further support for universal HCV treatment coverage for all patients affected by HCV,” Dr. Nguyen and colleagues wrote.
The strengths of this study are its large sample of DAA-treated and untreated patients from diverse racial and ethnic groups from across the United States and from diverse practice settings (not just tertiary centers).
One limitation is that the study cohort included only patients covered by private insurance; therefore, the findings may not be generalizable to individuals who are underinsured or not insured. Miscoding and misclassification are also possible with large claims databases.
Support for the study was provided by Stanford University and the Stanford Center for Population Health Sciences. Dr. Nguyen has received institutional grants and advisory board fees from Gilead Sciences outside the submitted work.
A version of this article first appeared on Medscape.com.
, a large, real-world analysis finds.
Improved outcomes were seen among patients without cirrhosis, those with compensated cirrhosis, and those with existing liver decompensation, the authors noted.
The findings highlight a “substantial need to provide DAA therapy to all patients with HCV, regardless of disease stage or financial status,” wrote Mindie Nguyen, MD, of Stanford University Medical Center, Palo Alto, Calif., and coinvestigators.
“Additional national efforts are needed to reach and treat U.S. population groups that are underinsured or not insured, incarcerated and otherwise marginalized, such as users of illicit drugs, who are also at higher risk of disease complication and reinfection,” they said.
The study was published online in JAMA Internal Medicine.
CHC and its complications are associated with high rates of illness and death. However, large-scale data on long-term liver and nonliver effects of DAA treatment are limited.
For their study, Dr. Nguyen and colleagues analyzed administrative claims data from 2010 to 2021 for 245,596 adults with CHC, of whom 40,654 had received one or more DAA therapies (without interferon) and 204,942 had not received treatment.
DAA-treated patients were slightly older than their untreated peers (mean age, 59.9 years, vs. 58.5 years) and were more likely to be male (62% vs. 58%) and White (59% vs. 57%), and to have diabetes (26% vs. 25%) and cirrhosis (44% vs. 29%).
For liver outcomes, DAA therapy was associated with a lower incidence of decompensation (28.2 vs. 40.8 per 1,000 person-years; P < .001) and hepatocellular carcinoma (HCC) in compensated cirrhosis (20.1 vs. 41.8; P < .001).
For nonliver outcomes, DAA treatment was associated with a lower incidence of diabetes (30.2 vs. 37.2 per 1,000 person-years; P < .001) and chronic kidney disease (31.1 vs. 34.1; P < .001).
The all-cause mortality rate per 1,000 person-years was 36.5 in the DAA-treated group, vs. 64.7 in the untreated group (P < .001).
In multivariable regression analysis, DAA treatment was independently associated with a significant decrease in the risk for HCC (adjusted hazard ratio [aHR], 0.73), decompensation (aHR, 0.36), diabetes (aHR, 0.74), chronic kidney disease (aHR, 0.81), cardiovascular disease (aHR, 0.90), nonliver cancer (aHR, 0.89), and mortality (aHR, 0.43).
The 57% lower mortality rate observed among DAA-treated vs. untreated patients aligns with a large French study of adults with CHC.
“Because HCV treatment with a DAA regimen is well tolerated for nearly all patients, we believe these findings provide further support for universal HCV treatment coverage for all patients affected by HCV,” Dr. Nguyen and colleagues wrote.
The strengths of this study are its large sample of DAA-treated and untreated patients from diverse racial and ethnic groups from across the United States and from diverse practice settings (not just tertiary centers).
One limitation is that the study cohort included only patients covered by private insurance; therefore, the findings may not be generalizable to individuals who are underinsured or not insured. Miscoding and misclassification are also possible with large claims databases.
Support for the study was provided by Stanford University and the Stanford Center for Population Health Sciences. Dr. Nguyen has received institutional grants and advisory board fees from Gilead Sciences outside the submitted work.
A version of this article first appeared on Medscape.com.
, a large, real-world analysis finds.
Improved outcomes were seen among patients without cirrhosis, those with compensated cirrhosis, and those with existing liver decompensation, the authors noted.
The findings highlight a “substantial need to provide DAA therapy to all patients with HCV, regardless of disease stage or financial status,” wrote Mindie Nguyen, MD, of Stanford University Medical Center, Palo Alto, Calif., and coinvestigators.
“Additional national efforts are needed to reach and treat U.S. population groups that are underinsured or not insured, incarcerated and otherwise marginalized, such as users of illicit drugs, who are also at higher risk of disease complication and reinfection,” they said.
The study was published online in JAMA Internal Medicine.
CHC and its complications are associated with high rates of illness and death. However, large-scale data on long-term liver and nonliver effects of DAA treatment are limited.
For their study, Dr. Nguyen and colleagues analyzed administrative claims data from 2010 to 2021 for 245,596 adults with CHC, of whom 40,654 had received one or more DAA therapies (without interferon) and 204,942 had not received treatment.
DAA-treated patients were slightly older than their untreated peers (mean age, 59.9 years, vs. 58.5 years) and were more likely to be male (62% vs. 58%) and White (59% vs. 57%), and to have diabetes (26% vs. 25%) and cirrhosis (44% vs. 29%).
For liver outcomes, DAA therapy was associated with a lower incidence of decompensation (28.2 vs. 40.8 per 1,000 person-years; P < .001) and hepatocellular carcinoma (HCC) in compensated cirrhosis (20.1 vs. 41.8; P < .001).
For nonliver outcomes, DAA treatment was associated with a lower incidence of diabetes (30.2 vs. 37.2 per 1,000 person-years; P < .001) and chronic kidney disease (31.1 vs. 34.1; P < .001).
The all-cause mortality rate per 1,000 person-years was 36.5 in the DAA-treated group, vs. 64.7 in the untreated group (P < .001).
In multivariable regression analysis, DAA treatment was independently associated with a significant decrease in the risk for HCC (adjusted hazard ratio [aHR], 0.73), decompensation (aHR, 0.36), diabetes (aHR, 0.74), chronic kidney disease (aHR, 0.81), cardiovascular disease (aHR, 0.90), nonliver cancer (aHR, 0.89), and mortality (aHR, 0.43).
The 57% lower mortality rate observed among DAA-treated vs. untreated patients aligns with a large French study of adults with CHC.
“Because HCV treatment with a DAA regimen is well tolerated for nearly all patients, we believe these findings provide further support for universal HCV treatment coverage for all patients affected by HCV,” Dr. Nguyen and colleagues wrote.
The strengths of this study are its large sample of DAA-treated and untreated patients from diverse racial and ethnic groups from across the United States and from diverse practice settings (not just tertiary centers).
One limitation is that the study cohort included only patients covered by private insurance; therefore, the findings may not be generalizable to individuals who are underinsured or not insured. Miscoding and misclassification are also possible with large claims databases.
Support for the study was provided by Stanford University and the Stanford Center for Population Health Sciences. Dr. Nguyen has received institutional grants and advisory board fees from Gilead Sciences outside the submitted work.
A version of this article first appeared on Medscape.com.
FROM JAMA INTERNAL MEDICINE
FDA approves second antiamyloid for Alzheimer’s disease
Like its controversial cousin aducanumab (Aduhelm, Biogen/Eisai), lecanemab was approved under the FDA’s accelerated approval pathway, which can be used to fast-track a drug that provides a meaningful therapeutic advantage over existing treatments for a serious or life-threatening illness.
Unlike aducanumab, however, there was no formal FDA advisory committee meeting on lecanemab prior to approval.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a press release.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Dr. Dunn added.
Eisai has reported that lecanemab will cost $26,500 a year.
Modest benefit, adverse events
The FDA noted, “The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials.”
The agency approved the treatment on the basis of findings from the CLARITY AD trial, which showed modest cognitive benefit for patients with early AD – but at a cost of increased risk for amyloid-related edema and effusions.
The trial enrolled 1,795 adults with mild cognitive impairment or early Alzheimer’s disease in whom amyloid pathology in the brain had been confirmed. Treatment consisted of lecanemab 10 mg/kg biweekly or matching placebo.
After 18 months of treatment, lecanemab slowed cognitive decline by 27%, compared with placebo, as measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB). This was an absolute difference of 0.45 points (change from baseline, 1.21 for lecanemab vs. 1.66 with placebo; P < .001).
While the results are “welcome news,” a 0.45-point difference on the CDR-SB might not be clinically meaningful, authors of a recent editorial in The Lancet cautioned.
Amyloid-related imaging abnormalities that manifest as edema or microhemorrhages also occurred in one in five patients taking lecanemab.
In addition, a newly published case report in The New England Journal of Medicine describes a patient with Alzheimer’s disease who was taking lecanemab and who died after experiencing numerous intracerebral hemorrhages during treatment with tissue plasminogen activator (tPA) for acute ischemic stroke.
“The findings raise the possibility of cerebral hemorrhages and necrotizing vasculopathy associated with tPA infusion in a patient with cerebrovascular amyloid who had received lecanemab,” the authors wrote.
Alzheimer’s Association reaction
Still, in anticipation of accelerated approval of lecanemab and the antiamyloid drug donanemab (Eli Lilly), which the FDA has also fast-tracked, the Alzheimer’s Association filed a formal request last month with the Centers for Medicare & Medicaid Services asking that it provide full and unrestricted coverage for FDA-approved Alzheimer’s disease treatments.
In a letter addressed to CMS administrator Chiquita Brooks-LaSure, the association asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved antiamyloid monoclonal antibodies.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and CEO for the Alzheimer’s Association, noted in a news release at the time.
“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike added.
After news of today’s approval was released, Dr. Pike noted in a new release, “The Alzheimer’s Association welcomes and celebrates this action by the FDA. We now have a second approved treatment that changes the course of Alzheimer’s disease in a meaningful way for people in the early stages of the disease.”
Maria C. Carrillo, PhD, chief science officer at the Alzheimer’s Association, called today’s approval “a milestone achievement.”
“The progress we’ve seen in not only this class of treatments but also in the diversification of treatment types and targets over the past few years is exciting and provides real hope to those impacted by this devastating disease,” Dr. Carrillo said.
Critical issues
Commenting on the approval, Alvaro Pascual-Leone, MD, PhD, professor of neurology at Harvard Medical School, Boston, and chief medical officer at Linus Health, said FDA approval of lecanemab and its adoption in the clinic represent a “very exciting development and prospect; but arguably some critical issues need to be considered.”
He noted that the health care system “is not currently prepared to cope with the challenges and demands of lecanemab,” as well as future pharmacologic agents.
“First, we need better workflows to identify suitable patients who can most benefit from this treatment,” said Dr. Pascual-Leone. He added that beyond identification of cognitive difficulties, amyloid status will need to be determined.
“Presently, this requires expensive and invasive tests,” such as positron-emission tomography scans or lumbar punctures for cerebrospinal fluid analysis. However, these are not fully covered by insurance companies and would be challenging to fully scale, he noted.
“In addition to screening, health systems will need to resolve the logistics challenges around the administration of lecanemab with twice-monthly infusions and the need for careful longitudinal evaluations for potential side effects,” said Dr. Pascual-Leone.
“While lecanemab may represent the first disease-modifying therapy widely available for early Alzheimer’s disease, the likely more promising approach is the addition of other therapies to lecanemab as part of a multi-intervention strategy combining pharmacologic and nonpharmacologic interventions,” he added.
Dr. Pascual-Leone has served as a paid member on scientific advisory boards for Neuroelectrics, Magstim, TetraNeuron, Skin2Neuron, MedRhythms, and Hearts Radiant and is a cofounder of TI Solutions and Linus Health.
A version of this article first appeared on Medscape.com.
This article was updated 1/9/23.
Like its controversial cousin aducanumab (Aduhelm, Biogen/Eisai), lecanemab was approved under the FDA’s accelerated approval pathway, which can be used to fast-track a drug that provides a meaningful therapeutic advantage over existing treatments for a serious or life-threatening illness.
Unlike aducanumab, however, there was no formal FDA advisory committee meeting on lecanemab prior to approval.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a press release.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Dr. Dunn added.
Eisai has reported that lecanemab will cost $26,500 a year.
Modest benefit, adverse events
The FDA noted, “The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials.”
The agency approved the treatment on the basis of findings from the CLARITY AD trial, which showed modest cognitive benefit for patients with early AD – but at a cost of increased risk for amyloid-related edema and effusions.
The trial enrolled 1,795 adults with mild cognitive impairment or early Alzheimer’s disease in whom amyloid pathology in the brain had been confirmed. Treatment consisted of lecanemab 10 mg/kg biweekly or matching placebo.
After 18 months of treatment, lecanemab slowed cognitive decline by 27%, compared with placebo, as measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB). This was an absolute difference of 0.45 points (change from baseline, 1.21 for lecanemab vs. 1.66 with placebo; P < .001).
While the results are “welcome news,” a 0.45-point difference on the CDR-SB might not be clinically meaningful, authors of a recent editorial in The Lancet cautioned.
Amyloid-related imaging abnormalities that manifest as edema or microhemorrhages also occurred in one in five patients taking lecanemab.
In addition, a newly published case report in The New England Journal of Medicine describes a patient with Alzheimer’s disease who was taking lecanemab and who died after experiencing numerous intracerebral hemorrhages during treatment with tissue plasminogen activator (tPA) for acute ischemic stroke.
“The findings raise the possibility of cerebral hemorrhages and necrotizing vasculopathy associated with tPA infusion in a patient with cerebrovascular amyloid who had received lecanemab,” the authors wrote.
Alzheimer’s Association reaction
Still, in anticipation of accelerated approval of lecanemab and the antiamyloid drug donanemab (Eli Lilly), which the FDA has also fast-tracked, the Alzheimer’s Association filed a formal request last month with the Centers for Medicare & Medicaid Services asking that it provide full and unrestricted coverage for FDA-approved Alzheimer’s disease treatments.
In a letter addressed to CMS administrator Chiquita Brooks-LaSure, the association asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved antiamyloid monoclonal antibodies.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and CEO for the Alzheimer’s Association, noted in a news release at the time.
“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike added.
After news of today’s approval was released, Dr. Pike noted in a new release, “The Alzheimer’s Association welcomes and celebrates this action by the FDA. We now have a second approved treatment that changes the course of Alzheimer’s disease in a meaningful way for people in the early stages of the disease.”
Maria C. Carrillo, PhD, chief science officer at the Alzheimer’s Association, called today’s approval “a milestone achievement.”
“The progress we’ve seen in not only this class of treatments but also in the diversification of treatment types and targets over the past few years is exciting and provides real hope to those impacted by this devastating disease,” Dr. Carrillo said.
Critical issues
Commenting on the approval, Alvaro Pascual-Leone, MD, PhD, professor of neurology at Harvard Medical School, Boston, and chief medical officer at Linus Health, said FDA approval of lecanemab and its adoption in the clinic represent a “very exciting development and prospect; but arguably some critical issues need to be considered.”
He noted that the health care system “is not currently prepared to cope with the challenges and demands of lecanemab,” as well as future pharmacologic agents.
“First, we need better workflows to identify suitable patients who can most benefit from this treatment,” said Dr. Pascual-Leone. He added that beyond identification of cognitive difficulties, amyloid status will need to be determined.
“Presently, this requires expensive and invasive tests,” such as positron-emission tomography scans or lumbar punctures for cerebrospinal fluid analysis. However, these are not fully covered by insurance companies and would be challenging to fully scale, he noted.
“In addition to screening, health systems will need to resolve the logistics challenges around the administration of lecanemab with twice-monthly infusions and the need for careful longitudinal evaluations for potential side effects,” said Dr. Pascual-Leone.
“While lecanemab may represent the first disease-modifying therapy widely available for early Alzheimer’s disease, the likely more promising approach is the addition of other therapies to lecanemab as part of a multi-intervention strategy combining pharmacologic and nonpharmacologic interventions,” he added.
Dr. Pascual-Leone has served as a paid member on scientific advisory boards for Neuroelectrics, Magstim, TetraNeuron, Skin2Neuron, MedRhythms, and Hearts Radiant and is a cofounder of TI Solutions and Linus Health.
A version of this article first appeared on Medscape.com.
This article was updated 1/9/23.
Like its controversial cousin aducanumab (Aduhelm, Biogen/Eisai), lecanemab was approved under the FDA’s accelerated approval pathway, which can be used to fast-track a drug that provides a meaningful therapeutic advantage over existing treatments for a serious or life-threatening illness.
Unlike aducanumab, however, there was no formal FDA advisory committee meeting on lecanemab prior to approval.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a press release.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Dr. Dunn added.
Eisai has reported that lecanemab will cost $26,500 a year.
Modest benefit, adverse events
The FDA noted, “The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials.”
The agency approved the treatment on the basis of findings from the CLARITY AD trial, which showed modest cognitive benefit for patients with early AD – but at a cost of increased risk for amyloid-related edema and effusions.
The trial enrolled 1,795 adults with mild cognitive impairment or early Alzheimer’s disease in whom amyloid pathology in the brain had been confirmed. Treatment consisted of lecanemab 10 mg/kg biweekly or matching placebo.
After 18 months of treatment, lecanemab slowed cognitive decline by 27%, compared with placebo, as measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB). This was an absolute difference of 0.45 points (change from baseline, 1.21 for lecanemab vs. 1.66 with placebo; P < .001).
While the results are “welcome news,” a 0.45-point difference on the CDR-SB might not be clinically meaningful, authors of a recent editorial in The Lancet cautioned.
Amyloid-related imaging abnormalities that manifest as edema or microhemorrhages also occurred in one in five patients taking lecanemab.
In addition, a newly published case report in The New England Journal of Medicine describes a patient with Alzheimer’s disease who was taking lecanemab and who died after experiencing numerous intracerebral hemorrhages during treatment with tissue plasminogen activator (tPA) for acute ischemic stroke.
“The findings raise the possibility of cerebral hemorrhages and necrotizing vasculopathy associated with tPA infusion in a patient with cerebrovascular amyloid who had received lecanemab,” the authors wrote.
Alzheimer’s Association reaction
Still, in anticipation of accelerated approval of lecanemab and the antiamyloid drug donanemab (Eli Lilly), which the FDA has also fast-tracked, the Alzheimer’s Association filed a formal request last month with the Centers for Medicare & Medicaid Services asking that it provide full and unrestricted coverage for FDA-approved Alzheimer’s disease treatments.
In a letter addressed to CMS administrator Chiquita Brooks-LaSure, the association asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved antiamyloid monoclonal antibodies.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and CEO for the Alzheimer’s Association, noted in a news release at the time.
“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike added.
After news of today’s approval was released, Dr. Pike noted in a new release, “The Alzheimer’s Association welcomes and celebrates this action by the FDA. We now have a second approved treatment that changes the course of Alzheimer’s disease in a meaningful way for people in the early stages of the disease.”
Maria C. Carrillo, PhD, chief science officer at the Alzheimer’s Association, called today’s approval “a milestone achievement.”
“The progress we’ve seen in not only this class of treatments but also in the diversification of treatment types and targets over the past few years is exciting and provides real hope to those impacted by this devastating disease,” Dr. Carrillo said.
Critical issues
Commenting on the approval, Alvaro Pascual-Leone, MD, PhD, professor of neurology at Harvard Medical School, Boston, and chief medical officer at Linus Health, said FDA approval of lecanemab and its adoption in the clinic represent a “very exciting development and prospect; but arguably some critical issues need to be considered.”
He noted that the health care system “is not currently prepared to cope with the challenges and demands of lecanemab,” as well as future pharmacologic agents.
“First, we need better workflows to identify suitable patients who can most benefit from this treatment,” said Dr. Pascual-Leone. He added that beyond identification of cognitive difficulties, amyloid status will need to be determined.
“Presently, this requires expensive and invasive tests,” such as positron-emission tomography scans or lumbar punctures for cerebrospinal fluid analysis. However, these are not fully covered by insurance companies and would be challenging to fully scale, he noted.
“In addition to screening, health systems will need to resolve the logistics challenges around the administration of lecanemab with twice-monthly infusions and the need for careful longitudinal evaluations for potential side effects,” said Dr. Pascual-Leone.
“While lecanemab may represent the first disease-modifying therapy widely available for early Alzheimer’s disease, the likely more promising approach is the addition of other therapies to lecanemab as part of a multi-intervention strategy combining pharmacologic and nonpharmacologic interventions,” he added.
Dr. Pascual-Leone has served as a paid member on scientific advisory boards for Neuroelectrics, Magstim, TetraNeuron, Skin2Neuron, MedRhythms, and Hearts Radiant and is a cofounder of TI Solutions and Linus Health.
A version of this article first appeared on Medscape.com.
This article was updated 1/9/23.
Heart benefits begin at well under 10,000 daily steps
– and the benefits accrue at well below the widely promoted threshold of 10,000 steps per day, new research shows.
Among adults aged 60 and older, those who took roughly 6,000 to 9,000 steps per day had a 40% to 50% lower risk of CVD, compared with peers logging just 2,000 steps per day.
“We hope this study will contribute evidence to future public health and clinical guidance on how many steps we need for health,” Amanda Paluch, PhD, with University of Massachusetts Amherst, told this news organization.
Getting in more steps per day can lower an individual’s risk for heart disease – but it’s not an “all or nothing” situation, Dr. Paluch said.
“The heart health benefits begin at lower than 10,000 steps per day. So, for the many adults that may find 10,000 steps a bit out of reach, it is important to promote that even small increases in steps can be beneficial for health,” Dr. Paluch said.
The study was published online in Circulation.
Attainable step goals
As part of the Steps for Health Collaborative, Dr. Paluch and colleagues examined the dose-response relationship between steps per day and CVD in a meta-analysis of eight prospective studies involving 20,152 adults (mean age 63, 52% women).
Steps were measured in each study using one of five different commercially available step-measuring devices. Adults aged 60 years and older took a median of 4,323 steps per day (interquartile range, 2,760-6,924), while younger adults walked a bit more (median 6,911 daily steps; IQR, 4,783-9,794).
During follow-up lasting an average of 6.2 years, a total of 1,523 CVD events were reported.
In the final adjusted model, for older adults, compared with those in quartile 1 who got the fewest steps per day (median 1,811), the risk of CVD was 20% lower in those in quartile 2, who got a median of 3,823 steps per day (hazard ratio, 0.80; 95% confidence interval, 0.69-0.93).
CVD risk was 38% lower in older adults in quartile 3 who got a median of 5,520 steps per day (HR, 0.62; 95% CI, 0.52-0.74) and 49% lower in those in quartile 4 who walked the most (a median of 9,259 steps per day; HR, 0.51; 95% CI, 0.41-0.63).
Restricting the analysis to individuals without known CVD at baseline showed similar results.
Among six studies that excluded adults with a history of CVD at baseline, compared with the lowest quartile, the HR for incident CVD events was 0.74 (95% CI, 0.60-0.91) in the second quartile, 0.60 (95% CI, 0.47-0.77) in the third quartile, and 0.55 (95% CI, 0.40-0.76) in the fourth quartile.
Despite the inverse association of steps with CVD in older adults, there was no association in younger adults. The researchers caution, however, that CVD is a disease of aging, and the follow-up period in these studies may not have been long enough to capture CVD incidence in younger adults.
Stepping rate (pace or cadence) was not associated with CVD risk beyond that of total steps per day. However, only four of the eight studies reported data on stepping rate, so this finding should be viewed as preliminary, Dr. Paluch and colleagues say.
Start small and go from there
Dr. Paluch said the take-home message from this study and numerous others is simple.
“Move more and sit less! Being physically active, by getting in your steps, is an important part of keeping your heart healthy,” she said in an interview.
For adults who are currently inactive, Dr. Paluch suggests finding small ways to get in a few more steps per day. “It does not need to be drastic changes. Consider a brief 5- to 10-minute walking break at lunch, taking the stairs, or playing a game of hide and seek with the grandchildren,” Dr. Paluch advised.
“For adults starting at 3,000 steps a day, set a goal of 4,000, and then 5,000. Each improvement can lead to better heart health,” Dr. Paluch said. “And for those who are already active, keep it up, as there are benefits with higher volumes of steps per day as well.”
Support for this research was provided by the Intergovernmental Personnel Act Agreement through the Centers for Disease Control and Prevention. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
– and the benefits accrue at well below the widely promoted threshold of 10,000 steps per day, new research shows.
Among adults aged 60 and older, those who took roughly 6,000 to 9,000 steps per day had a 40% to 50% lower risk of CVD, compared with peers logging just 2,000 steps per day.
“We hope this study will contribute evidence to future public health and clinical guidance on how many steps we need for health,” Amanda Paluch, PhD, with University of Massachusetts Amherst, told this news organization.
Getting in more steps per day can lower an individual’s risk for heart disease – but it’s not an “all or nothing” situation, Dr. Paluch said.
“The heart health benefits begin at lower than 10,000 steps per day. So, for the many adults that may find 10,000 steps a bit out of reach, it is important to promote that even small increases in steps can be beneficial for health,” Dr. Paluch said.
The study was published online in Circulation.
Attainable step goals
As part of the Steps for Health Collaborative, Dr. Paluch and colleagues examined the dose-response relationship between steps per day and CVD in a meta-analysis of eight prospective studies involving 20,152 adults (mean age 63, 52% women).
Steps were measured in each study using one of five different commercially available step-measuring devices. Adults aged 60 years and older took a median of 4,323 steps per day (interquartile range, 2,760-6,924), while younger adults walked a bit more (median 6,911 daily steps; IQR, 4,783-9,794).
During follow-up lasting an average of 6.2 years, a total of 1,523 CVD events were reported.
In the final adjusted model, for older adults, compared with those in quartile 1 who got the fewest steps per day (median 1,811), the risk of CVD was 20% lower in those in quartile 2, who got a median of 3,823 steps per day (hazard ratio, 0.80; 95% confidence interval, 0.69-0.93).
CVD risk was 38% lower in older adults in quartile 3 who got a median of 5,520 steps per day (HR, 0.62; 95% CI, 0.52-0.74) and 49% lower in those in quartile 4 who walked the most (a median of 9,259 steps per day; HR, 0.51; 95% CI, 0.41-0.63).
Restricting the analysis to individuals without known CVD at baseline showed similar results.
Among six studies that excluded adults with a history of CVD at baseline, compared with the lowest quartile, the HR for incident CVD events was 0.74 (95% CI, 0.60-0.91) in the second quartile, 0.60 (95% CI, 0.47-0.77) in the third quartile, and 0.55 (95% CI, 0.40-0.76) in the fourth quartile.
Despite the inverse association of steps with CVD in older adults, there was no association in younger adults. The researchers caution, however, that CVD is a disease of aging, and the follow-up period in these studies may not have been long enough to capture CVD incidence in younger adults.
Stepping rate (pace or cadence) was not associated with CVD risk beyond that of total steps per day. However, only four of the eight studies reported data on stepping rate, so this finding should be viewed as preliminary, Dr. Paluch and colleagues say.
Start small and go from there
Dr. Paluch said the take-home message from this study and numerous others is simple.
“Move more and sit less! Being physically active, by getting in your steps, is an important part of keeping your heart healthy,” she said in an interview.
For adults who are currently inactive, Dr. Paluch suggests finding small ways to get in a few more steps per day. “It does not need to be drastic changes. Consider a brief 5- to 10-minute walking break at lunch, taking the stairs, or playing a game of hide and seek with the grandchildren,” Dr. Paluch advised.
“For adults starting at 3,000 steps a day, set a goal of 4,000, and then 5,000. Each improvement can lead to better heart health,” Dr. Paluch said. “And for those who are already active, keep it up, as there are benefits with higher volumes of steps per day as well.”
Support for this research was provided by the Intergovernmental Personnel Act Agreement through the Centers for Disease Control and Prevention. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
– and the benefits accrue at well below the widely promoted threshold of 10,000 steps per day, new research shows.
Among adults aged 60 and older, those who took roughly 6,000 to 9,000 steps per day had a 40% to 50% lower risk of CVD, compared with peers logging just 2,000 steps per day.
“We hope this study will contribute evidence to future public health and clinical guidance on how many steps we need for health,” Amanda Paluch, PhD, with University of Massachusetts Amherst, told this news organization.
Getting in more steps per day can lower an individual’s risk for heart disease – but it’s not an “all or nothing” situation, Dr. Paluch said.
“The heart health benefits begin at lower than 10,000 steps per day. So, for the many adults that may find 10,000 steps a bit out of reach, it is important to promote that even small increases in steps can be beneficial for health,” Dr. Paluch said.
The study was published online in Circulation.
Attainable step goals
As part of the Steps for Health Collaborative, Dr. Paluch and colleagues examined the dose-response relationship between steps per day and CVD in a meta-analysis of eight prospective studies involving 20,152 adults (mean age 63, 52% women).
Steps were measured in each study using one of five different commercially available step-measuring devices. Adults aged 60 years and older took a median of 4,323 steps per day (interquartile range, 2,760-6,924), while younger adults walked a bit more (median 6,911 daily steps; IQR, 4,783-9,794).
During follow-up lasting an average of 6.2 years, a total of 1,523 CVD events were reported.
In the final adjusted model, for older adults, compared with those in quartile 1 who got the fewest steps per day (median 1,811), the risk of CVD was 20% lower in those in quartile 2, who got a median of 3,823 steps per day (hazard ratio, 0.80; 95% confidence interval, 0.69-0.93).
CVD risk was 38% lower in older adults in quartile 3 who got a median of 5,520 steps per day (HR, 0.62; 95% CI, 0.52-0.74) and 49% lower in those in quartile 4 who walked the most (a median of 9,259 steps per day; HR, 0.51; 95% CI, 0.41-0.63).
Restricting the analysis to individuals without known CVD at baseline showed similar results.
Among six studies that excluded adults with a history of CVD at baseline, compared with the lowest quartile, the HR for incident CVD events was 0.74 (95% CI, 0.60-0.91) in the second quartile, 0.60 (95% CI, 0.47-0.77) in the third quartile, and 0.55 (95% CI, 0.40-0.76) in the fourth quartile.
Despite the inverse association of steps with CVD in older adults, there was no association in younger adults. The researchers caution, however, that CVD is a disease of aging, and the follow-up period in these studies may not have been long enough to capture CVD incidence in younger adults.
Stepping rate (pace or cadence) was not associated with CVD risk beyond that of total steps per day. However, only four of the eight studies reported data on stepping rate, so this finding should be viewed as preliminary, Dr. Paluch and colleagues say.
Start small and go from there
Dr. Paluch said the take-home message from this study and numerous others is simple.
“Move more and sit less! Being physically active, by getting in your steps, is an important part of keeping your heart healthy,” she said in an interview.
For adults who are currently inactive, Dr. Paluch suggests finding small ways to get in a few more steps per day. “It does not need to be drastic changes. Consider a brief 5- to 10-minute walking break at lunch, taking the stairs, or playing a game of hide and seek with the grandchildren,” Dr. Paluch advised.
“For adults starting at 3,000 steps a day, set a goal of 4,000, and then 5,000. Each improvement can lead to better heart health,” Dr. Paluch said. “And for those who are already active, keep it up, as there are benefits with higher volumes of steps per day as well.”
Support for this research was provided by the Intergovernmental Personnel Act Agreement through the Centers for Disease Control and Prevention. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION
Top cardiology societies call for revamp of clinical trials
Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.
“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, England, told this news organization. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”
The joint opinion is from the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation. It was simultaneously published online in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.
The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Prof. Bowman said.
Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).
But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinders the ability to conduct trials swiftly and affordably, the authors point out.
The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.
“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Prof. Bowman told this news organization.
A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.
“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Prof. Bowman said.
“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Prof. Bowman acknowledged.
“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.
No commercial funding was received. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.
“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, England, told this news organization. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”
The joint opinion is from the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation. It was simultaneously published online in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.
The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Prof. Bowman said.
Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).
But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinders the ability to conduct trials swiftly and affordably, the authors point out.
The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.
“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Prof. Bowman told this news organization.
A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.
“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Prof. Bowman said.
“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Prof. Bowman acknowledged.
“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.
No commercial funding was received. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.
“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, England, told this news organization. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”
The joint opinion is from the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation. It was simultaneously published online in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.
The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Prof. Bowman said.
Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).
But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinders the ability to conduct trials swiftly and affordably, the authors point out.
The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.
“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Prof. Bowman told this news organization.
A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.
“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Prof. Bowman said.
“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Prof. Bowman acknowledged.
“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.
No commercial funding was received. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Vonoprazan triple therapy most cost-effective for H. pylori: Study
A new analysis finds that vonoprazan triple therapy (Voquezna) is the most cost-effective first-line regimen to eradicate Helicobacter pylori infection in the United States.
Rifabutin triple therapy (Talicia) is the second most cost-effective strategy for H. pylori eradication, followed in order of decreasing cost-effectiveness by vonoprazan dual therapy, bismuth quadruple therapy, and clarithromycin triple therapy.
The analysis is believed to be the first to report on the cost-effectiveness of vonoprazan- and rifabutin-based regimens as first-line treatments for H. pylori infection from the perspective of U.S. health care payers.
for U.S. payers, reported Ismaeel Yunusa, PharmD, PhD, of the University of South Carolina College of Pharmacy in Columbia, and colleagues.
The study was published online in the American Journal of Gastroenterology.
It’s estimated that more than 114 million people in the United States have H. pylori infection. Clinical practice guidelines recommend H. pylori eradication in all patients with a positive test of active infection.
Using a Markov model, Dr. Yunusa and colleagues estimated the cost-effectiveness of five prepackaged or co-formulated H. pylori eradication regimens: clarithromycin triple therapy, bismuth quadruple therapy, vonoprazan dual therapy, vonoprazan triple therapy, and rifabutin triple therapy.
The model estimated the expected costs in 2022 U.S. dollars, expected quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICERs), and expected net monetary benefit over 20 years.
Among their key findings and conclusions:
- Bismuth quadruple therapy had the highest expected cost ($1,439) and rifabutin triple regimen had the lowest expected cost ($1,048).
- Because rifabutin triple therapy was predicted to cost less and was more effective than clarithromycin triple therapy, bismuth quadruple therapy, and vonoprazan dual therapy, it dominated all treatment strategies – except for vonoprazan triple therapy.
- Compared with rifabutin triple therapy, vonoprazan triple therapy had a higher expected cost ($1,172 vs. $1,048) and expected QALY (14.262 vs. 14.256), yielding an ICER of $22,573 per QALY.
- Vonoprazan triple therapy had the highest expected net monetary benefit and was the most cost-effective at willingness to pay thresholds between $50,000 and $150,000 per QALY, followed by rifabutin triple therapy.
- Vonoprazan triple therapy would result on average in an incremental net benefit of $1,655 per patient than clarithromycin triple therapy.
- Because the rifabutin-based regimen was more cost-effective than all but vonoprazan triple therapy, it has a potential role as an alternative first-line treatment.
- Rifabutin triple therapy and vonoprazan dual therapy would need to be considerably discounted (by 15%-43% and by 44%-85%, respectively), to be cost-effective at commonly used cost-effectiveness thresholds.
- Vonoprazan dual therapy demonstrated limited value relative to other available options; thus, its widespread adoption as a first-line strategy seems unlikely.
- Based on the results, it would be hard to justify the use of bismuth quadruple therapy or clarithromycin triple therapy since they provide the lowest net monetary benefit and have lower eradication rates.
The investigators noted that their analysis considered only direct costs of therapy, not other costs such as appointments, travel, and time away from work.
They also assumed medical costs, including endoscopy and H. pylori testing, would not change regardless of treatment regimen. Therefore, total health care costs may be underestimated.
The study did not receive any funding. The authors have declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new analysis finds that vonoprazan triple therapy (Voquezna) is the most cost-effective first-line regimen to eradicate Helicobacter pylori infection in the United States.
Rifabutin triple therapy (Talicia) is the second most cost-effective strategy for H. pylori eradication, followed in order of decreasing cost-effectiveness by vonoprazan dual therapy, bismuth quadruple therapy, and clarithromycin triple therapy.
The analysis is believed to be the first to report on the cost-effectiveness of vonoprazan- and rifabutin-based regimens as first-line treatments for H. pylori infection from the perspective of U.S. health care payers.
for U.S. payers, reported Ismaeel Yunusa, PharmD, PhD, of the University of South Carolina College of Pharmacy in Columbia, and colleagues.
The study was published online in the American Journal of Gastroenterology.
It’s estimated that more than 114 million people in the United States have H. pylori infection. Clinical practice guidelines recommend H. pylori eradication in all patients with a positive test of active infection.
Using a Markov model, Dr. Yunusa and colleagues estimated the cost-effectiveness of five prepackaged or co-formulated H. pylori eradication regimens: clarithromycin triple therapy, bismuth quadruple therapy, vonoprazan dual therapy, vonoprazan triple therapy, and rifabutin triple therapy.
The model estimated the expected costs in 2022 U.S. dollars, expected quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICERs), and expected net monetary benefit over 20 years.
Among their key findings and conclusions:
- Bismuth quadruple therapy had the highest expected cost ($1,439) and rifabutin triple regimen had the lowest expected cost ($1,048).
- Because rifabutin triple therapy was predicted to cost less and was more effective than clarithromycin triple therapy, bismuth quadruple therapy, and vonoprazan dual therapy, it dominated all treatment strategies – except for vonoprazan triple therapy.
- Compared with rifabutin triple therapy, vonoprazan triple therapy had a higher expected cost ($1,172 vs. $1,048) and expected QALY (14.262 vs. 14.256), yielding an ICER of $22,573 per QALY.
- Vonoprazan triple therapy had the highest expected net monetary benefit and was the most cost-effective at willingness to pay thresholds between $50,000 and $150,000 per QALY, followed by rifabutin triple therapy.
- Vonoprazan triple therapy would result on average in an incremental net benefit of $1,655 per patient than clarithromycin triple therapy.
- Because the rifabutin-based regimen was more cost-effective than all but vonoprazan triple therapy, it has a potential role as an alternative first-line treatment.
- Rifabutin triple therapy and vonoprazan dual therapy would need to be considerably discounted (by 15%-43% and by 44%-85%, respectively), to be cost-effective at commonly used cost-effectiveness thresholds.
- Vonoprazan dual therapy demonstrated limited value relative to other available options; thus, its widespread adoption as a first-line strategy seems unlikely.
- Based on the results, it would be hard to justify the use of bismuth quadruple therapy or clarithromycin triple therapy since they provide the lowest net monetary benefit and have lower eradication rates.
The investigators noted that their analysis considered only direct costs of therapy, not other costs such as appointments, travel, and time away from work.
They also assumed medical costs, including endoscopy and H. pylori testing, would not change regardless of treatment regimen. Therefore, total health care costs may be underestimated.
The study did not receive any funding. The authors have declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new analysis finds that vonoprazan triple therapy (Voquezna) is the most cost-effective first-line regimen to eradicate Helicobacter pylori infection in the United States.
Rifabutin triple therapy (Talicia) is the second most cost-effective strategy for H. pylori eradication, followed in order of decreasing cost-effectiveness by vonoprazan dual therapy, bismuth quadruple therapy, and clarithromycin triple therapy.
The analysis is believed to be the first to report on the cost-effectiveness of vonoprazan- and rifabutin-based regimens as first-line treatments for H. pylori infection from the perspective of U.S. health care payers.
for U.S. payers, reported Ismaeel Yunusa, PharmD, PhD, of the University of South Carolina College of Pharmacy in Columbia, and colleagues.
The study was published online in the American Journal of Gastroenterology.
It’s estimated that more than 114 million people in the United States have H. pylori infection. Clinical practice guidelines recommend H. pylori eradication in all patients with a positive test of active infection.
Using a Markov model, Dr. Yunusa and colleagues estimated the cost-effectiveness of five prepackaged or co-formulated H. pylori eradication regimens: clarithromycin triple therapy, bismuth quadruple therapy, vonoprazan dual therapy, vonoprazan triple therapy, and rifabutin triple therapy.
The model estimated the expected costs in 2022 U.S. dollars, expected quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICERs), and expected net monetary benefit over 20 years.
Among their key findings and conclusions:
- Bismuth quadruple therapy had the highest expected cost ($1,439) and rifabutin triple regimen had the lowest expected cost ($1,048).
- Because rifabutin triple therapy was predicted to cost less and was more effective than clarithromycin triple therapy, bismuth quadruple therapy, and vonoprazan dual therapy, it dominated all treatment strategies – except for vonoprazan triple therapy.
- Compared with rifabutin triple therapy, vonoprazan triple therapy had a higher expected cost ($1,172 vs. $1,048) and expected QALY (14.262 vs. 14.256), yielding an ICER of $22,573 per QALY.
- Vonoprazan triple therapy had the highest expected net monetary benefit and was the most cost-effective at willingness to pay thresholds between $50,000 and $150,000 per QALY, followed by rifabutin triple therapy.
- Vonoprazan triple therapy would result on average in an incremental net benefit of $1,655 per patient than clarithromycin triple therapy.
- Because the rifabutin-based regimen was more cost-effective than all but vonoprazan triple therapy, it has a potential role as an alternative first-line treatment.
- Rifabutin triple therapy and vonoprazan dual therapy would need to be considerably discounted (by 15%-43% and by 44%-85%, respectively), to be cost-effective at commonly used cost-effectiveness thresholds.
- Vonoprazan dual therapy demonstrated limited value relative to other available options; thus, its widespread adoption as a first-line strategy seems unlikely.
- Based on the results, it would be hard to justify the use of bismuth quadruple therapy or clarithromycin triple therapy since they provide the lowest net monetary benefit and have lower eradication rates.
The investigators noted that their analysis considered only direct costs of therapy, not other costs such as appointments, travel, and time away from work.
They also assumed medical costs, including endoscopy and H. pylori testing, would not change regardless of treatment regimen. Therefore, total health care costs may be underestimated.
The study did not receive any funding. The authors have declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Strong link between muscle strength, mobility, and brain health
A new study shows a strong correlation between muscle strength, mobility, and brain volume, including in the hippocampus that underlies memory function, in adults with Alzheimer’s disease (AD).
Investigators found statistically significant relationships between better handgrip strength and mobility and hippocampal and lobar brain volumes in 38 cognitively impaired adults with biomarker evidence of AD.
study investigator Cyrus Raji, MD, PhD, Mallinckrodt Institute of Radiology, Washington University, St. Louis, told this news organization.
The study was published online in the Journal of Alzheimer’s Disease.
Brain-body connection
The researchers measured handgrip strength in patients’ dominant and nondominant hands using a hand dynamometer and calculated handgrip asymmetry. Mobility was measured via the 2-minute walk test. Together, the test results were used to categorize patients as “frail” or “not frail.”
They measured regional brain volumes using Neuroreader (Brainreader), a U.S. Food and Drug Administration–approved software application that measures brain volumes on MRI scans.
The investigators found higher nondominant handgrip strength was significantly associated with larger volumes in the hippocampal volume (P = .02). In addition, higher dominant handgrip strength correlated with higher frontal lobe volume (P = .02).
Results also showed higher scores on the 2-minute walk test were associated with larger hippocampal (P = .04), frontal (P = .01), temporal (P = .03), parietal (P = .009), and occipital lobe (P = .005) volumes. Frailty was associated with reduced frontal, temporal, and parietal lobe volumes.
“In this study we combined objective evaluations of frailty with measurable determinants of brain structure on MRI to demonstrate a link between frailty and brain health in patients with both biomarker evidence of AD and cognitive impairment,” study investigator Somayeh Meysami, MD, with Pacific Brain Health Center, Pacific Neuroscience Institute Foundation (PNI), Santa Monica, Calif., told this news organization.
The researchers noted that it’s possible that interventions specifically focused on improving ambulatory mobility and handgrip strength could be beneficial in improving dementia trajectories.
‘Use it or lose it’
The chief limitation of the study is the cross-sectional design that precludes drawing firm conclusions about the causal relationships between handgrip strength and changes in brain structure.
In addition, the study used a relatively small convenience sample of outpatients from a specialty memory clinic.
The researchers say future longitudinal analyses with a larger sample size will be important to better understand the possible directions of causality between handgrip strength and progression of atrophy in AD.
However, despite these limitations, the findings emphasize the importance of “body-brain connections,” added David A. Merrill, MD, PhD, director of the Pacific Brain Health Center at PNI.
“Training our muscles helps sustain our brains and vice versa. It’s ‘use it or lose it’ for both body and mind. Exercise remains among the best strategies for maintaining a healthy body and mind with aging,” Dr. Merrill said in an interview.
“While it’s long been appreciated that aerobic training helps the brain, these findings add to the importance of strength training in supporting successful aging,” he added.
This work was supported by Providence St. Joseph Health, Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute Foundation; and the National Institutes of Health. Dr. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution. Dr. Merrill and Dr. Meysami reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
A new study shows a strong correlation between muscle strength, mobility, and brain volume, including in the hippocampus that underlies memory function, in adults with Alzheimer’s disease (AD).
Investigators found statistically significant relationships between better handgrip strength and mobility and hippocampal and lobar brain volumes in 38 cognitively impaired adults with biomarker evidence of AD.
study investigator Cyrus Raji, MD, PhD, Mallinckrodt Institute of Radiology, Washington University, St. Louis, told this news organization.
The study was published online in the Journal of Alzheimer’s Disease.
Brain-body connection
The researchers measured handgrip strength in patients’ dominant and nondominant hands using a hand dynamometer and calculated handgrip asymmetry. Mobility was measured via the 2-minute walk test. Together, the test results were used to categorize patients as “frail” or “not frail.”
They measured regional brain volumes using Neuroreader (Brainreader), a U.S. Food and Drug Administration–approved software application that measures brain volumes on MRI scans.
The investigators found higher nondominant handgrip strength was significantly associated with larger volumes in the hippocampal volume (P = .02). In addition, higher dominant handgrip strength correlated with higher frontal lobe volume (P = .02).
Results also showed higher scores on the 2-minute walk test were associated with larger hippocampal (P = .04), frontal (P = .01), temporal (P = .03), parietal (P = .009), and occipital lobe (P = .005) volumes. Frailty was associated with reduced frontal, temporal, and parietal lobe volumes.
“In this study we combined objective evaluations of frailty with measurable determinants of brain structure on MRI to demonstrate a link between frailty and brain health in patients with both biomarker evidence of AD and cognitive impairment,” study investigator Somayeh Meysami, MD, with Pacific Brain Health Center, Pacific Neuroscience Institute Foundation (PNI), Santa Monica, Calif., told this news organization.
The researchers noted that it’s possible that interventions specifically focused on improving ambulatory mobility and handgrip strength could be beneficial in improving dementia trajectories.
‘Use it or lose it’
The chief limitation of the study is the cross-sectional design that precludes drawing firm conclusions about the causal relationships between handgrip strength and changes in brain structure.
In addition, the study used a relatively small convenience sample of outpatients from a specialty memory clinic.
The researchers say future longitudinal analyses with a larger sample size will be important to better understand the possible directions of causality between handgrip strength and progression of atrophy in AD.
However, despite these limitations, the findings emphasize the importance of “body-brain connections,” added David A. Merrill, MD, PhD, director of the Pacific Brain Health Center at PNI.
“Training our muscles helps sustain our brains and vice versa. It’s ‘use it or lose it’ for both body and mind. Exercise remains among the best strategies for maintaining a healthy body and mind with aging,” Dr. Merrill said in an interview.
“While it’s long been appreciated that aerobic training helps the brain, these findings add to the importance of strength training in supporting successful aging,” he added.
This work was supported by Providence St. Joseph Health, Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute Foundation; and the National Institutes of Health. Dr. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution. Dr. Merrill and Dr. Meysami reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
A new study shows a strong correlation between muscle strength, mobility, and brain volume, including in the hippocampus that underlies memory function, in adults with Alzheimer’s disease (AD).
Investigators found statistically significant relationships between better handgrip strength and mobility and hippocampal and lobar brain volumes in 38 cognitively impaired adults with biomarker evidence of AD.
study investigator Cyrus Raji, MD, PhD, Mallinckrodt Institute of Radiology, Washington University, St. Louis, told this news organization.
The study was published online in the Journal of Alzheimer’s Disease.
Brain-body connection
The researchers measured handgrip strength in patients’ dominant and nondominant hands using a hand dynamometer and calculated handgrip asymmetry. Mobility was measured via the 2-minute walk test. Together, the test results were used to categorize patients as “frail” or “not frail.”
They measured regional brain volumes using Neuroreader (Brainreader), a U.S. Food and Drug Administration–approved software application that measures brain volumes on MRI scans.
The investigators found higher nondominant handgrip strength was significantly associated with larger volumes in the hippocampal volume (P = .02). In addition, higher dominant handgrip strength correlated with higher frontal lobe volume (P = .02).
Results also showed higher scores on the 2-minute walk test were associated with larger hippocampal (P = .04), frontal (P = .01), temporal (P = .03), parietal (P = .009), and occipital lobe (P = .005) volumes. Frailty was associated with reduced frontal, temporal, and parietal lobe volumes.
“In this study we combined objective evaluations of frailty with measurable determinants of brain structure on MRI to demonstrate a link between frailty and brain health in patients with both biomarker evidence of AD and cognitive impairment,” study investigator Somayeh Meysami, MD, with Pacific Brain Health Center, Pacific Neuroscience Institute Foundation (PNI), Santa Monica, Calif., told this news organization.
The researchers noted that it’s possible that interventions specifically focused on improving ambulatory mobility and handgrip strength could be beneficial in improving dementia trajectories.
‘Use it or lose it’
The chief limitation of the study is the cross-sectional design that precludes drawing firm conclusions about the causal relationships between handgrip strength and changes in brain structure.
In addition, the study used a relatively small convenience sample of outpatients from a specialty memory clinic.
The researchers say future longitudinal analyses with a larger sample size will be important to better understand the possible directions of causality between handgrip strength and progression of atrophy in AD.
However, despite these limitations, the findings emphasize the importance of “body-brain connections,” added David A. Merrill, MD, PhD, director of the Pacific Brain Health Center at PNI.
“Training our muscles helps sustain our brains and vice versa. It’s ‘use it or lose it’ for both body and mind. Exercise remains among the best strategies for maintaining a healthy body and mind with aging,” Dr. Merrill said in an interview.
“While it’s long been appreciated that aerobic training helps the brain, these findings add to the importance of strength training in supporting successful aging,” he added.
This work was supported by Providence St. Joseph Health, Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute Foundation; and the National Institutes of Health. Dr. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution. Dr. Merrill and Dr. Meysami reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF ALZHEIMER’S DISEASE
Two exercise interventions may ease acute, subacute spine pain
Two conservative interventions are effective for treating acute and subacute spine pain, new research suggests.
Results from the SPINE CARE randomized controlled trial showed that 6-8 weeks of an individualized postural therapy (IPT) or a multidisciplinary biopsychosocial intervention known as ICE (identify, coordinate, and enhance) that includes physical therapy were associated with small but statistically significant reductions in pain-related disability at 3 months compared with usual care.
In addition, spine-related health care spending did not differ significantly between ICE and usual care. However, IPT significantly increased spending compared with usual care.
– long after the interventions were over,” lead author Niteesh K. Choudhry, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, told this news organization.
The findings were published online in JAMA.
Common complaint
Spine pain is defined as pain that occurs in the neck or back, the investigators noted. It “accounted for more health spending than any other health condition in the U.S. in 2016,” they added.
“Spine pain is an exceptionally common reason for patients to visit their primary care providers,” Dr. Choudhry said.
The SPINE CARE trial enrolled 2,971 adults (60% were women; mean age was 51 years) with back or neck pain that had lasted less than 12 weeks. All were randomly allocated to usual care (no intervention, n = 992) or to the ICE (n = 829) or IPT (n = 1150) interventions.
The ICE care model stratifies patients on the basis of their risk of progression from acute to chronic pain and addresses biopsychosocial contributors to pain. Low-risk patients received one physical therapy (PT) visit and one coaching call, while higher-risk patients received three PT visits, three coaching calls, and one e-consultation.
The IPT intervention, which was delivered in 8 weekly sessions, focuses on postural realignment. IPT also emphasizes self-efficacy and self-management, including daily exercises to improve postural control, coordination, and muscle balance.
Results at 3 months showed that both the ICE and IPT groups improved significantly more in Oswestry Disability Index (ODI) scores than in the usual care group (ICE, 31.2 to 15.4; IPT, 29.3 to 15.4; usual care, 28.9 to 19.5).
At 3 months, the absolute difference in ODI score vs. usual care was −5.8 for ICE (95% confidence interval [CI], −7.7 to −3.9; P < .001) and −4.3 for IPT (95% CI, −5.9 to −2.6; P < .001) for IPT.
Both interventions reduced resource utilization, such as diagnostic imaging, procedures, and specialist visits, Dr. Choudhry reported. “Because of this, both reduced spending unrelated to the interventions themselves,” he added.
When the intervention costs were included, ICE resulted in lower costs overall than those of usual care ($139 less), while overall spending for IPT was higher than for usual care (by $941).
“We tested the interventions in a way that was integrated into primary care, so implementing them in other practice settings should be quite straightforward,” Dr. Choudhry said.
He noted that the ICE model does not currently exist as a complete program – but its components, such as physical therapy or specialist e-consults, do. “And we think that our results justify exploring how to set this up more broadly,” he said.
Dr. Choudhry added that IPT was tested using a specific provider (Egoscue), “which has locations in a variety of places in the U.S. and internationally, and so should also be straightforward to integrate into routine practice.”
However, other important factors, such as insurance coverage, will need to be explored in the future, he said.
Confirmatory evidence?
In an accompanying editorial, Erin Krebs, MD, Minneapolis VA Health Care System, and colleagues, noted that past systematic reviews have concluded that exercise therapies are “generally effective” for chronic back and neck pain, which is usually defined as pain lasting more than 12 weeks, but not for acute pain, defined as pain lasting less than 4-6 weeks.
“The present trial contributes evidence for effectiveness of exercise therapy among patients with a current episode of less than 12 weeks, meaning not yet chronic, but not necessarily acute,” the editorialists wrote.
“Clinicians should more often recommend structured exercise programs for subacute back or neck pain, especially when the pain is recurrent,” they added.
The study was funded by unrestricted philanthropic gifts to Stanford (Calif.) University. Dr. Choudhry received grants from Stanford University during the conduct of the study.
A version of this article first appeared on Medscape.com.
Two conservative interventions are effective for treating acute and subacute spine pain, new research suggests.
Results from the SPINE CARE randomized controlled trial showed that 6-8 weeks of an individualized postural therapy (IPT) or a multidisciplinary biopsychosocial intervention known as ICE (identify, coordinate, and enhance) that includes physical therapy were associated with small but statistically significant reductions in pain-related disability at 3 months compared with usual care.
In addition, spine-related health care spending did not differ significantly between ICE and usual care. However, IPT significantly increased spending compared with usual care.
– long after the interventions were over,” lead author Niteesh K. Choudhry, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, told this news organization.
The findings were published online in JAMA.
Common complaint
Spine pain is defined as pain that occurs in the neck or back, the investigators noted. It “accounted for more health spending than any other health condition in the U.S. in 2016,” they added.
“Spine pain is an exceptionally common reason for patients to visit their primary care providers,” Dr. Choudhry said.
The SPINE CARE trial enrolled 2,971 adults (60% were women; mean age was 51 years) with back or neck pain that had lasted less than 12 weeks. All were randomly allocated to usual care (no intervention, n = 992) or to the ICE (n = 829) or IPT (n = 1150) interventions.
The ICE care model stratifies patients on the basis of their risk of progression from acute to chronic pain and addresses biopsychosocial contributors to pain. Low-risk patients received one physical therapy (PT) visit and one coaching call, while higher-risk patients received three PT visits, three coaching calls, and one e-consultation.
The IPT intervention, which was delivered in 8 weekly sessions, focuses on postural realignment. IPT also emphasizes self-efficacy and self-management, including daily exercises to improve postural control, coordination, and muscle balance.
Results at 3 months showed that both the ICE and IPT groups improved significantly more in Oswestry Disability Index (ODI) scores than in the usual care group (ICE, 31.2 to 15.4; IPT, 29.3 to 15.4; usual care, 28.9 to 19.5).
At 3 months, the absolute difference in ODI score vs. usual care was −5.8 for ICE (95% confidence interval [CI], −7.7 to −3.9; P < .001) and −4.3 for IPT (95% CI, −5.9 to −2.6; P < .001) for IPT.
Both interventions reduced resource utilization, such as diagnostic imaging, procedures, and specialist visits, Dr. Choudhry reported. “Because of this, both reduced spending unrelated to the interventions themselves,” he added.
When the intervention costs were included, ICE resulted in lower costs overall than those of usual care ($139 less), while overall spending for IPT was higher than for usual care (by $941).
“We tested the interventions in a way that was integrated into primary care, so implementing them in other practice settings should be quite straightforward,” Dr. Choudhry said.
He noted that the ICE model does not currently exist as a complete program – but its components, such as physical therapy or specialist e-consults, do. “And we think that our results justify exploring how to set this up more broadly,” he said.
Dr. Choudhry added that IPT was tested using a specific provider (Egoscue), “which has locations in a variety of places in the U.S. and internationally, and so should also be straightforward to integrate into routine practice.”
However, other important factors, such as insurance coverage, will need to be explored in the future, he said.
Confirmatory evidence?
In an accompanying editorial, Erin Krebs, MD, Minneapolis VA Health Care System, and colleagues, noted that past systematic reviews have concluded that exercise therapies are “generally effective” for chronic back and neck pain, which is usually defined as pain lasting more than 12 weeks, but not for acute pain, defined as pain lasting less than 4-6 weeks.
“The present trial contributes evidence for effectiveness of exercise therapy among patients with a current episode of less than 12 weeks, meaning not yet chronic, but not necessarily acute,” the editorialists wrote.
“Clinicians should more often recommend structured exercise programs for subacute back or neck pain, especially when the pain is recurrent,” they added.
The study was funded by unrestricted philanthropic gifts to Stanford (Calif.) University. Dr. Choudhry received grants from Stanford University during the conduct of the study.
A version of this article first appeared on Medscape.com.
Two conservative interventions are effective for treating acute and subacute spine pain, new research suggests.
Results from the SPINE CARE randomized controlled trial showed that 6-8 weeks of an individualized postural therapy (IPT) or a multidisciplinary biopsychosocial intervention known as ICE (identify, coordinate, and enhance) that includes physical therapy were associated with small but statistically significant reductions in pain-related disability at 3 months compared with usual care.
In addition, spine-related health care spending did not differ significantly between ICE and usual care. However, IPT significantly increased spending compared with usual care.
– long after the interventions were over,” lead author Niteesh K. Choudhry, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, told this news organization.
The findings were published online in JAMA.
Common complaint
Spine pain is defined as pain that occurs in the neck or back, the investigators noted. It “accounted for more health spending than any other health condition in the U.S. in 2016,” they added.
“Spine pain is an exceptionally common reason for patients to visit their primary care providers,” Dr. Choudhry said.
The SPINE CARE trial enrolled 2,971 adults (60% were women; mean age was 51 years) with back or neck pain that had lasted less than 12 weeks. All were randomly allocated to usual care (no intervention, n = 992) or to the ICE (n = 829) or IPT (n = 1150) interventions.
The ICE care model stratifies patients on the basis of their risk of progression from acute to chronic pain and addresses biopsychosocial contributors to pain. Low-risk patients received one physical therapy (PT) visit and one coaching call, while higher-risk patients received three PT visits, three coaching calls, and one e-consultation.
The IPT intervention, which was delivered in 8 weekly sessions, focuses on postural realignment. IPT also emphasizes self-efficacy and self-management, including daily exercises to improve postural control, coordination, and muscle balance.
Results at 3 months showed that both the ICE and IPT groups improved significantly more in Oswestry Disability Index (ODI) scores than in the usual care group (ICE, 31.2 to 15.4; IPT, 29.3 to 15.4; usual care, 28.9 to 19.5).
At 3 months, the absolute difference in ODI score vs. usual care was −5.8 for ICE (95% confidence interval [CI], −7.7 to −3.9; P < .001) and −4.3 for IPT (95% CI, −5.9 to −2.6; P < .001) for IPT.
Both interventions reduced resource utilization, such as diagnostic imaging, procedures, and specialist visits, Dr. Choudhry reported. “Because of this, both reduced spending unrelated to the interventions themselves,” he added.
When the intervention costs were included, ICE resulted in lower costs overall than those of usual care ($139 less), while overall spending for IPT was higher than for usual care (by $941).
“We tested the interventions in a way that was integrated into primary care, so implementing them in other practice settings should be quite straightforward,” Dr. Choudhry said.
He noted that the ICE model does not currently exist as a complete program – but its components, such as physical therapy or specialist e-consults, do. “And we think that our results justify exploring how to set this up more broadly,” he said.
Dr. Choudhry added that IPT was tested using a specific provider (Egoscue), “which has locations in a variety of places in the U.S. and internationally, and so should also be straightforward to integrate into routine practice.”
However, other important factors, such as insurance coverage, will need to be explored in the future, he said.
Confirmatory evidence?
In an accompanying editorial, Erin Krebs, MD, Minneapolis VA Health Care System, and colleagues, noted that past systematic reviews have concluded that exercise therapies are “generally effective” for chronic back and neck pain, which is usually defined as pain lasting more than 12 weeks, but not for acute pain, defined as pain lasting less than 4-6 weeks.
“The present trial contributes evidence for effectiveness of exercise therapy among patients with a current episode of less than 12 weeks, meaning not yet chronic, but not necessarily acute,” the editorialists wrote.
“Clinicians should more often recommend structured exercise programs for subacute back or neck pain, especially when the pain is recurrent,” they added.
The study was funded by unrestricted philanthropic gifts to Stanford (Calif.) University. Dr. Choudhry received grants from Stanford University during the conduct of the study.
A version of this article first appeared on Medscape.com.
FROM JAMA
Lupin recalls quinapril tablets because of potential carcinogen
Lupin Pharmaceuticals is recalling four lots of quinapril tablets because of unacceptable levels of the nitrosamine impurity, N-nitroso-quinapril, a potential carcinogen.
Nitrosamines “may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” the company says in a recall notice posted on the Food and Drug Administration website.
Lupin says it “has received no reports of illness that appear to relate to this issue.”
Quinapril is an ACE inhibitor used to treat hypertension. Lupin stopped marketing quinapril tablets in September 2022.
The recalled product – quinapril tablets USP 20 mg and 40 mg – are packaged in 90-count bottles and were distributed nationwide to U.S. wholesalers, drug chains, mail order pharmacies, and supermarkets between March 15, 2021, and Sept. 1, 2022.
Lupin is notifying customers to immediately stop distribution of the recalled product and is arranging for the affected product lots to be returned to the company.
Questions regarding this recall should be directed to Inmar Rx Solutions at (877) 538-8445 Monday to Friday between 9:00 a.m. to 5:00 p.m. EST.
Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting program.
Pfizer recalled several lots of quinapril owing to the presence of the same impurity in March 2022and again in April.
A version of this article first appeared on Medscape.com.
Lupin Pharmaceuticals is recalling four lots of quinapril tablets because of unacceptable levels of the nitrosamine impurity, N-nitroso-quinapril, a potential carcinogen.
Nitrosamines “may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” the company says in a recall notice posted on the Food and Drug Administration website.
Lupin says it “has received no reports of illness that appear to relate to this issue.”
Quinapril is an ACE inhibitor used to treat hypertension. Lupin stopped marketing quinapril tablets in September 2022.
The recalled product – quinapril tablets USP 20 mg and 40 mg – are packaged in 90-count bottles and were distributed nationwide to U.S. wholesalers, drug chains, mail order pharmacies, and supermarkets between March 15, 2021, and Sept. 1, 2022.
Lupin is notifying customers to immediately stop distribution of the recalled product and is arranging for the affected product lots to be returned to the company.
Questions regarding this recall should be directed to Inmar Rx Solutions at (877) 538-8445 Monday to Friday between 9:00 a.m. to 5:00 p.m. EST.
Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting program.
Pfizer recalled several lots of quinapril owing to the presence of the same impurity in March 2022and again in April.
A version of this article first appeared on Medscape.com.
Lupin Pharmaceuticals is recalling four lots of quinapril tablets because of unacceptable levels of the nitrosamine impurity, N-nitroso-quinapril, a potential carcinogen.
Nitrosamines “may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” the company says in a recall notice posted on the Food and Drug Administration website.
Lupin says it “has received no reports of illness that appear to relate to this issue.”
Quinapril is an ACE inhibitor used to treat hypertension. Lupin stopped marketing quinapril tablets in September 2022.
The recalled product – quinapril tablets USP 20 mg and 40 mg – are packaged in 90-count bottles and were distributed nationwide to U.S. wholesalers, drug chains, mail order pharmacies, and supermarkets between March 15, 2021, and Sept. 1, 2022.
Lupin is notifying customers to immediately stop distribution of the recalled product and is arranging for the affected product lots to be returned to the company.
Questions regarding this recall should be directed to Inmar Rx Solutions at (877) 538-8445 Monday to Friday between 9:00 a.m. to 5:00 p.m. EST.
Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting program.
Pfizer recalled several lots of quinapril owing to the presence of the same impurity in March 2022and again in April.
A version of this article first appeared on Medscape.com.
Sexual assault allegations lead to arrest of Ohio gastroenterologist
According to Cleveland Municipal Court records, Omar Massoud, MD, PhD, of Westlake, Ohio, has been charged with three counts of kidnapping, all first-degree felonies, and three counts of gross sexual imposition, all third-degree felonies.
The assaults are alleged to have happened during liver examinations on March 25, Nov. 11, and Nov. 28, 2022 at Cleveland Clinic’s main campus located at 9500 Euclid Avenue.
No further details were provided.
Dr. Massoud is the former chief of hepatology at the Cleveland Clinic.
In a statement, the Cleveland Clinic said it “immediately reported the accusations to the appropriate law enforcement agencies and are fully cooperating with the investigations.”
“Following a thorough internal investigation,” Dr. Massoud was fired, the Cleveland Clinic said.
“Cleveland Clinic is strongly committed to protecting the rights and safety of our patients, visitors, and caregivers from any type of inappropriate behavior. We care deeply about patient safety and any form of misconduct is not tolerated,” the statement said.
A version of this article first appeared on Medscape.com.
According to Cleveland Municipal Court records, Omar Massoud, MD, PhD, of Westlake, Ohio, has been charged with three counts of kidnapping, all first-degree felonies, and three counts of gross sexual imposition, all third-degree felonies.
The assaults are alleged to have happened during liver examinations on March 25, Nov. 11, and Nov. 28, 2022 at Cleveland Clinic’s main campus located at 9500 Euclid Avenue.
No further details were provided.
Dr. Massoud is the former chief of hepatology at the Cleveland Clinic.
In a statement, the Cleveland Clinic said it “immediately reported the accusations to the appropriate law enforcement agencies and are fully cooperating with the investigations.”
“Following a thorough internal investigation,” Dr. Massoud was fired, the Cleveland Clinic said.
“Cleveland Clinic is strongly committed to protecting the rights and safety of our patients, visitors, and caregivers from any type of inappropriate behavior. We care deeply about patient safety and any form of misconduct is not tolerated,” the statement said.
A version of this article first appeared on Medscape.com.
According to Cleveland Municipal Court records, Omar Massoud, MD, PhD, of Westlake, Ohio, has been charged with three counts of kidnapping, all first-degree felonies, and three counts of gross sexual imposition, all third-degree felonies.
The assaults are alleged to have happened during liver examinations on March 25, Nov. 11, and Nov. 28, 2022 at Cleveland Clinic’s main campus located at 9500 Euclid Avenue.
No further details were provided.
Dr. Massoud is the former chief of hepatology at the Cleveland Clinic.
In a statement, the Cleveland Clinic said it “immediately reported the accusations to the appropriate law enforcement agencies and are fully cooperating with the investigations.”
“Following a thorough internal investigation,” Dr. Massoud was fired, the Cleveland Clinic said.
“Cleveland Clinic is strongly committed to protecting the rights and safety of our patients, visitors, and caregivers from any type of inappropriate behavior. We care deeply about patient safety and any form of misconduct is not tolerated,” the statement said.
A version of this article first appeared on Medscape.com.