LAS VEGAS – Immunosuppressant thiopurine drugs are a common and often successful treatment for patients with inflammatory bowel disease (IBD), but they can cause serious side effects via myelosuppression. Now, a new study suggests that a racial gap may prevent minority patients from being promptly diagnosed with myelosuppressive side effects.

“We found that minority IBD patients – black, Hispanic, Asian/Pacific Islander – had significantly higher hospitalization rates that were due to myelosuppressive events compared to white IBD patients,” lead author Ryan Suk, MS, said in an interview. “Among those IBD patients who were hospitalized due to myelosuppression, black and Hispanic IBD patients had a significantly higher chance of getting admitted as urgent compared to white IBD patients.”

Ms. Suk, a health economics graduate student at the University of Texas, Houston, spoke in an interview prior to the presentation of her study’s findings at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

According to Ms. Suk, multiple studies have previously revealed racial and ethnic disparities in health care access and use by minority patients with IBD.

She pointed to a 2010 study that found black patients with IBD were much less likely than whites were to see a gastroenterologist or IBD specialist at least once a year. She also cited a 2009 study that found black patients with IBD were significantly less adherent than were white patients; researchers linked older age and higher trust in physicians to higher levels of adherence (Am J Gastroenterol. 2010 Oct;105[10]:2202-8; Inflamm Bowel Dis. 2009 Aug;15[8]:1233-9).

In light of these findings, she said, “we questioned what the possible results of thiopurine use could be in minority patients without proper and consistent routine IBD care.”

While thiopurine is considered a standard form of care for IBD patients, Ms. Suk said an estimated one-third of patients must stop the treatment because of side effects such as anemia, leukopenia/neutropenia, and thrombocytopenia.

For the new study, Ms. Suk and her colleagues tracked patients who were hospitalized with a primary diagnosis of IBD or IBD-related complications from 2003-2014 via the Nationwide Inpatient Sample. There were 249,253 white patients, 192,864 black patients, 28,956 Hispanic patients, 17,073 Asian/Pacific Islander patients, and 2,849 patients in the “other” category.

The researchers found higher odds of hospitalization for myelosuppression in minorities compared with non-Hispanic whites: Non-Hispanic blacks (adjusted odds ratio = 1.3; 95% confidence interval [1.2-1.4], vs. whites), Hispanics (aOR = 1.6; 95% CI [1.4-1.7], vs. whites), and Asian/Pacific Islanders (aOR = 2.3; 95% CI [1.9-2.8], vs. whites).

The researchers found that among patients diagnosed with myelosuppression, two groups – non-Hispanic blacks and Hispanics – had higher odds of being admitted urgently, compared with non-Hispanic whites (aOR = 1.7; 95% CI [1.2-2.3] and aOR = 1.6; 95% CI [1.1-2.2] vs. whites, respectively).

“Unlike Asian/Pacific Islander patients, black and Hispanic patients had a higher likelihood of getting hospitalized from myelosuppression and also higher likelihood to get admitted urgently compared to the white cohort,” Ms. Suk said. “It is possible that they have less access to thiopurine management and monitoring, leading to developing more severe adverse events and therefore having urgent myelosuppressive hospitalizations.”

As for Asian/Pacific Islander patients, she noted that they had the highest likelihood of myelosuppression hospitalization but did not have the highest chance of getting admitted as urgent. “We think that Asians have a higher risk of myelosuppression due to genetic factors, not from less access to care, and thus they had more elective hospitalizations,” she said.

The researchers also linked Medicaid, self-pay, and no-charge patients to higher levels of myelosuppression hospitalizations. “This shows that patients who have less access to care [need more] urgent admission from myelosuppressive events,” Ms. Suk said.

No funding was reported, and the study authors had no relevant disclosures.

SOURCE: Suk R et al. Crohn’s & Colitis Congress, Abstract P059.

LAS VEGAS – Immunosuppressant thiopurine drugs are a common and often successful treatment for patients with inflammatory bowel disease (IBD), but they can cause serious side effects via myelosuppression. Now, a new study suggests that a racial gap may prevent minority patients from being promptly diagnosed with myelosuppressive side effects.

“We found that minority IBD patients – black, Hispanic, Asian/Pacific Islander – had significantly higher hospitalization rates that were due to myelosuppressive events compared to white IBD patients,” lead author Ryan Suk, MS, said in an interview. “Among those IBD patients who were hospitalized due to myelosuppression, black and Hispanic IBD patients had a significantly higher chance of getting admitted as urgent compared to white IBD patients.”

Ms. Suk, a health economics graduate student at the University of Texas, Houston, spoke in an interview prior to the presentation of her study’s findings at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

According to Ms. Suk, multiple studies have previously revealed racial and ethnic disparities in health care access and use by minority patients with IBD.

She pointed to a 2010 study that found black patients with IBD were much less likely than whites were to see a gastroenterologist or IBD specialist at least once a year. She also cited a 2009 study that found black patients with IBD were significantly less adherent than were white patients; researchers linked older age and higher trust in physicians to higher levels of adherence (Am J Gastroenterol. 2010 Oct;105[10]:2202-8; Inflamm Bowel Dis. 2009 Aug;15[8]:1233-9).

In light of these findings, she said, “we questioned what the possible results of thiopurine use could be in minority patients without proper and consistent routine IBD care.”

While thiopurine is considered a standard form of care for IBD patients, Ms. Suk said an estimated one-third of patients must stop the treatment because of side effects such as anemia, leukopenia/neutropenia, and thrombocytopenia.

For the new study, Ms. Suk and her colleagues tracked patients who were hospitalized with a primary diagnosis of IBD or IBD-related complications from 2003-2014 via the Nationwide Inpatient Sample. There were 249,253 white patients, 192,864 black patients, 28,956 Hispanic patients, 17,073 Asian/Pacific Islander patients, and 2,849 patients in the “other” category.

The researchers found higher odds of hospitalization for myelosuppression in minorities compared with non-Hispanic whites: Non-Hispanic blacks (adjusted odds ratio = 1.3; 95% confidence interval [1.2-1.4], vs. whites), Hispanics (aOR = 1.6; 95% CI [1.4-1.7], vs. whites), and Asian/Pacific Islanders (aOR = 2.3; 95% CI [1.9-2.8], vs. whites).

The researchers found that among patients diagnosed with myelosuppression, two groups – non-Hispanic blacks and Hispanics – had higher odds of being admitted urgently, compared with non-Hispanic whites (aOR = 1.7; 95% CI [1.2-2.3] and aOR = 1.6; 95% CI [1.1-2.2] vs. whites, respectively).

“Unlike Asian/Pacific Islander patients, black and Hispanic patients had a higher likelihood of getting hospitalized from myelosuppression and also higher likelihood to get admitted urgently compared to the white cohort,” Ms. Suk said. “It is possible that they have less access to thiopurine management and monitoring, leading to developing more severe adverse events and therefore having urgent myelosuppressive hospitalizations.”

As for Asian/Pacific Islander patients, she noted that they had the highest likelihood of myelosuppression hospitalization but did not have the highest chance of getting admitted as urgent. “We think that Asians have a higher risk of myelosuppression due to genetic factors, not from less access to care, and thus they had more elective hospitalizations,” she said.

The researchers also linked Medicaid, self-pay, and no-charge patients to higher levels of myelosuppression hospitalizations. “This shows that patients who have less access to care [need more] urgent admission from myelosuppressive events,” Ms. Suk said.

No funding was reported, and the study authors had no relevant disclosures.

SOURCE: Suk R et al. Crohn’s & Colitis Congress, Abstract P059.

LAS VEGAS – Immunosuppressant thiopurine drugs are a common and often successful treatment for patients with inflammatory bowel disease (IBD), but they can cause serious side effects via myelosuppression. Now, a new study suggests that a racial gap may prevent minority patients from being promptly diagnosed with myelosuppressive side effects.

“We found that minority IBD patients – black, Hispanic, Asian/Pacific Islander – had significantly higher hospitalization rates that were due to myelosuppressive events compared to white IBD patients,” lead author Ryan Suk, MS, said in an interview. “Among those IBD patients who were hospitalized due to myelosuppression, black and Hispanic IBD patients had a significantly higher chance of getting admitted as urgent compared to white IBD patients.”

Ms. Suk, a health economics graduate student at the University of Texas, Houston, spoke in an interview prior to the presentation of her study’s findings at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

According to Ms. Suk, multiple studies have previously revealed racial and ethnic disparities in health care access and use by minority patients with IBD.

She pointed to a 2010 study that found black patients with IBD were much less likely than whites were to see a gastroenterologist or IBD specialist at least once a year. She also cited a 2009 study that found black patients with IBD were significantly less adherent than were white patients; researchers linked older age and higher trust in physicians to higher levels of adherence (Am J Gastroenterol. 2010 Oct;105[10]:2202-8; Inflamm Bowel Dis. 2009 Aug;15[8]:1233-9).

In light of these findings, she said, “we questioned what the possible results of thiopurine use could be in minority patients without proper and consistent routine IBD care.”

While thiopurine is considered a standard form of care for IBD patients, Ms. Suk said an estimated one-third of patients must stop the treatment because of side effects such as anemia, leukopenia/neutropenia, and thrombocytopenia.

For the new study, Ms. Suk and her colleagues tracked patients who were hospitalized with a primary diagnosis of IBD or IBD-related complications from 2003-2014 via the Nationwide Inpatient Sample. There were 249,253 white patients, 192,864 black patients, 28,956 Hispanic patients, 17,073 Asian/Pacific Islander patients, and 2,849 patients in the “other” category.

The researchers found higher odds of hospitalization for myelosuppression in minorities compared with non-Hispanic whites: Non-Hispanic blacks (adjusted odds ratio = 1.3; 95% confidence interval [1.2-1.4], vs. whites), Hispanics (aOR = 1.6; 95% CI [1.4-1.7], vs. whites), and Asian/Pacific Islanders (aOR = 2.3; 95% CI [1.9-2.8], vs. whites).

The researchers found that among patients diagnosed with myelosuppression, two groups – non-Hispanic blacks and Hispanics – had higher odds of being admitted urgently, compared with non-Hispanic whites (aOR = 1.7; 95% CI [1.2-2.3] and aOR = 1.6; 95% CI [1.1-2.2] vs. whites, respectively).

“Unlike Asian/Pacific Islander patients, black and Hispanic patients had a higher likelihood of getting hospitalized from myelosuppression and also higher likelihood to get admitted urgently compared to the white cohort,” Ms. Suk said. “It is possible that they have less access to thiopurine management and monitoring, leading to developing more severe adverse events and therefore having urgent myelosuppressive hospitalizations.”

As for Asian/Pacific Islander patients, she noted that they had the highest likelihood of myelosuppression hospitalization but did not have the highest chance of getting admitted as urgent. “We think that Asians have a higher risk of myelosuppression due to genetic factors, not from less access to care, and thus they had more elective hospitalizations,” she said.

The researchers also linked Medicaid, self-pay, and no-charge patients to higher levels of myelosuppression hospitalizations. “This shows that patients who have less access to care [need more] urgent admission from myelosuppressive events,” Ms. Suk said.

No funding was reported, and the study authors had no relevant disclosures.

SOURCE: Suk R et al. Crohn’s & Colitis Congress, Abstract P059.

As new standards for access dominated recent media coverage of veterans’ health care headlines, the launch of a historically unprecedented collaboration to prevent veterans’ suicide went completely unnoticed.

On January 31, the Department of Veterans Affairs (VA) announced a partnership with the National Shooting Sports Foundation (NSSF), a firearms industry association that works to promote, protect and preserve hunting and shooting sports, and the American Foundation for Suicide Prevention (AFSP), the nation’s largest suicide prevention organization. Together, they are developing a program that empowers communities to engage in safe firearm-storage practices. The program includes information on creating community coalitions that promote and sustain firearm safety, with an emphasis on reaching service members, veterans and their families.

This partnership represents the nation’s biggest advance in forging common ground on an issue where polarization has interfered with lifesaving initiatives. It’s a game changer.

In 2016, about 69% of veteran suicides in the US (71% among male and 41% among female veterans) resulted from a firearm injury. In comparison, the proportion of suicides resulting from a firearm injury among nonveteran adults was 48%.¹ The majority of veteran suicides occur with those who do not seek care within the VA healthcare system, which has led the VA to broaden its focus to reach all veterans.

Given the frequency of firearm use as a method of suicide, VA recognizes that suicide prevention efforts must address how veterans store their firearms. The decision to take an action to kill oneself is at times made impulsively—in just a matter of minutes. Securely storing firearms creates precious time and physical space between an individual’s period of risk and the means to act. Studies have demonstrated that delaying access to deadly means can save a life.

VA is striving to be a national leader in suicide prevention, and lethal means safety is an important component of the department’s approach. VA’s lethal means safety initiatives encourage veterans to voluntarily store their firearms safely. Key to this approach is to train mental health and peer providers in veteran-centric counseling methods while promoting resources, including a national consultation call line for both VA and community providers seeking guidance for treatment practices or engaging a veteran in care.  

Because many veterans believe that firearms must remain in their homes under all circumstances, in 2018 the VA held the first of its kind open-innovation challenge for safe firearm storage. This challenge led to the creation of numerous lifesaving product designs, which are now under development in the private sector.

The latest partnership further advances VA’s effort to ensure that lethal means safety counseling is culturally relevant, comes from a trusted source and contains no anti-firearm bias. VA respects the important role firearms play in many veterans’ lives and is committed to educating veterans and their families about safe storage of firearms in a way that is consistent with each veteran’s values and priorities.

Nothing will be more effective in diminishing suicide than correcting the false belief among many veterans that the VA wants to take away veterans’ guns. When that misperception is corrected, not only would more at-risk veterans seek out VA mental health care, but it also could become commonplace for veterans, families and friends to speak up because, “Buddies talk to buddies in crisis about safely storing guns.” This is especially important for veterans in rural areas, where the rates of firearm ownership and suicide are the highest. Joining forces with NSSF could spearhead such a shift.

The VA, NSSF and AFSP should be lauded for bridging the divide and driving this far-reaching breakthrough in firearm safety conversations and community alliances. The effort will not only save countless veterans’ lives, but also forge a path to mitigate our national tragedy of suicide.

As new standards for access dominated recent media coverage of veterans’ health care headlines, the launch of a historically unprecedented collaboration to prevent veterans’ suicide went completely unnoticed.

On January 31, the Department of Veterans Affairs (VA) announced a partnership with the National Shooting Sports Foundation (NSSF), a firearms industry association that works to promote, protect and preserve hunting and shooting sports, and the American Foundation for Suicide Prevention (AFSP), the nation’s largest suicide prevention organization. Together, they are developing a program that empowers communities to engage in safe firearm-storage practices. The program includes information on creating community coalitions that promote and sustain firearm safety, with an emphasis on reaching service members, veterans and their families.

This partnership represents the nation’s biggest advance in forging common ground on an issue where polarization has interfered with lifesaving initiatives. It’s a game changer.

In 2016, about 69% of veteran suicides in the US (71% among male and 41% among female veterans) resulted from a firearm injury. In comparison, the proportion of suicides resulting from a firearm injury among nonveteran adults was 48%.¹ The majority of veteran suicides occur with those who do not seek care within the VA healthcare system, which has led the VA to broaden its focus to reach all veterans.

Given the frequency of firearm use as a method of suicide, VA recognizes that suicide prevention efforts must address how veterans store their firearms. The decision to take an action to kill oneself is at times made impulsively—in just a matter of minutes. Securely storing firearms creates precious time and physical space between an individual’s period of risk and the means to act. Studies have demonstrated that delaying access to deadly means can save a life.

VA is striving to be a national leader in suicide prevention, and lethal means safety is an important component of the department’s approach. VA’s lethal means safety initiatives encourage veterans to voluntarily store their firearms safely. Key to this approach is to train mental health and peer providers in veteran-centric counseling methods while promoting resources, including a national consultation call line for both VA and community providers seeking guidance for treatment practices or engaging a veteran in care.  

Because many veterans believe that firearms must remain in their homes under all circumstances, in 2018 the VA held the first of its kind open-innovation challenge for safe firearm storage. This challenge led to the creation of numerous lifesaving product designs, which are now under development in the private sector.

The latest partnership further advances VA’s effort to ensure that lethal means safety counseling is culturally relevant, comes from a trusted source and contains no anti-firearm bias. VA respects the important role firearms play in many veterans’ lives and is committed to educating veterans and their families about safe storage of firearms in a way that is consistent with each veteran’s values and priorities.

Nothing will be more effective in diminishing suicide than correcting the false belief among many veterans that the VA wants to take away veterans’ guns. When that misperception is corrected, not only would more at-risk veterans seek out VA mental health care, but it also could become commonplace for veterans, families and friends to speak up because, “Buddies talk to buddies in crisis about safely storing guns.” This is especially important for veterans in rural areas, where the rates of firearm ownership and suicide are the highest. Joining forces with NSSF could spearhead such a shift.

The VA, NSSF and AFSP should be lauded for bridging the divide and driving this far-reaching breakthrough in firearm safety conversations and community alliances. The effort will not only save countless veterans’ lives, but also forge a path to mitigate our national tragedy of suicide.

As new standards for access dominated recent media coverage of veterans’ health care headlines, the launch of a historically unprecedented collaboration to prevent veterans’ suicide went completely unnoticed.

On January 31, the Department of Veterans Affairs (VA) announced a partnership with the National Shooting Sports Foundation (NSSF), a firearms industry association that works to promote, protect and preserve hunting and shooting sports, and the American Foundation for Suicide Prevention (AFSP), the nation’s largest suicide prevention organization. Together, they are developing a program that empowers communities to engage in safe firearm-storage practices. The program includes information on creating community coalitions that promote and sustain firearm safety, with an emphasis on reaching service members, veterans and their families.

This partnership represents the nation’s biggest advance in forging common ground on an issue where polarization has interfered with lifesaving initiatives. It’s a game changer.

In 2016, about 69% of veteran suicides in the US (71% among male and 41% among female veterans) resulted from a firearm injury. In comparison, the proportion of suicides resulting from a firearm injury among nonveteran adults was 48%.¹ The majority of veteran suicides occur with those who do not seek care within the VA healthcare system, which has led the VA to broaden its focus to reach all veterans.

Given the frequency of firearm use as a method of suicide, VA recognizes that suicide prevention efforts must address how veterans store their firearms. The decision to take an action to kill oneself is at times made impulsively—in just a matter of minutes. Securely storing firearms creates precious time and physical space between an individual’s period of risk and the means to act. Studies have demonstrated that delaying access to deadly means can save a life.

VA is striving to be a national leader in suicide prevention, and lethal means safety is an important component of the department’s approach. VA’s lethal means safety initiatives encourage veterans to voluntarily store their firearms safely. Key to this approach is to train mental health and peer providers in veteran-centric counseling methods while promoting resources, including a national consultation call line for both VA and community providers seeking guidance for treatment practices or engaging a veteran in care.  

Because many veterans believe that firearms must remain in their homes under all circumstances, in 2018 the VA held the first of its kind open-innovation challenge for safe firearm storage. This challenge led to the creation of numerous lifesaving product designs, which are now under development in the private sector.

The latest partnership further advances VA’s effort to ensure that lethal means safety counseling is culturally relevant, comes from a trusted source and contains no anti-firearm bias. VA respects the important role firearms play in many veterans’ lives and is committed to educating veterans and their families about safe storage of firearms in a way that is consistent with each veteran’s values and priorities.

Nothing will be more effective in diminishing suicide than correcting the false belief among many veterans that the VA wants to take away veterans’ guns. When that misperception is corrected, not only would more at-risk veterans seek out VA mental health care, but it also could become commonplace for veterans, families and friends to speak up because, “Buddies talk to buddies in crisis about safely storing guns.” This is especially important for veterans in rural areas, where the rates of firearm ownership and suicide are the highest. Joining forces with NSSF could spearhead such a shift.

The VA, NSSF and AFSP should be lauded for bridging the divide and driving this far-reaching breakthrough in firearm safety conversations and community alliances. The effort will not only save countless veterans’ lives, but also forge a path to mitigate our national tragedy of suicide.

In the presence of mild levels of depression or significant fatigue in persons with multiple sclerosis (MS), subjective cognitive measures are unlikely to provide accurate estimates of objective cognitive functioning. This according to a recent study that aimed to examine the degree to which depressive symptoms and fatigue in individuals with MS are associated with discrepancies between subjective and objective cognitive impairment. 99 adults with MS completed the Patient Health Questionnaire–8 (PHQ-8), Fatigue Severity Scale (FSS), MS Neuropsychological Screening Questionnaire (MSNQ), and Brief International Cognitive Assessment for MS (BICAMS). Participants were classified as “Accurates,” “Underestimators,” or “Overestimators” based on discrepancies between their MSNQ (subjective) and BICAMS (objective) scores. Researchers found:

• The PHQ-8 (r=.58) and FSS (r=.48) significantly correlated with the MSNQ, but not with the
  BICAMS (rs<.07).
• Underestimators (ie, participants who underestimated their objective cognitive functioning) exhibited higher PHQ-8 and FSS scores compared to Accurates and Overestimators.
• Optimal cut-scores of ≥6 on the PHQ-8 and ≥36 on the FSS provided fair accuracy (78% and 74%) for identifying Underestimators.
• Identification of Underestimators based on PHQ-8 and FSS scores was not moderated by any demographic or MS clinical variables.

Hughes AJ. Depressive symptoms and fatigue as predictors of objective-subjective discrepancies in cognitive function in multiple sclerosis. [Published online ahead of print January 31, 2019]. Mult Scler Relat Disord. doi:10.1016/j.msard.2019.01.055.

In the presence of mild levels of depression or significant fatigue in persons with multiple sclerosis (MS), subjective cognitive measures are unlikely to provide accurate estimates of objective cognitive functioning. This according to a recent study that aimed to examine the degree to which depressive symptoms and fatigue in individuals with MS are associated with discrepancies between subjective and objective cognitive impairment. 99 adults with MS completed the Patient Health Questionnaire–8 (PHQ-8), Fatigue Severity Scale (FSS), MS Neuropsychological Screening Questionnaire (MSNQ), and Brief International Cognitive Assessment for MS (BICAMS). Participants were classified as “Accurates,” “Underestimators,” or “Overestimators” based on discrepancies between their MSNQ (subjective) and BICAMS (objective) scores. Researchers found:

• The PHQ-8 (r=.58) and FSS (r=.48) significantly correlated with the MSNQ, but not with the
  BICAMS (rs<.07).
• Underestimators (ie, participants who underestimated their objective cognitive functioning) exhibited higher PHQ-8 and FSS scores compared to Accurates and Overestimators.
• Optimal cut-scores of ≥6 on the PHQ-8 and ≥36 on the FSS provided fair accuracy (78% and 74%) for identifying Underestimators.
• Identification of Underestimators based on PHQ-8 and FSS scores was not moderated by any demographic or MS clinical variables.

Hughes AJ. Depressive symptoms and fatigue as predictors of objective-subjective discrepancies in cognitive function in multiple sclerosis. [Published online ahead of print January 31, 2019]. Mult Scler Relat Disord. doi:10.1016/j.msard.2019.01.055.

In the presence of mild levels of depression or significant fatigue in persons with multiple sclerosis (MS), subjective cognitive measures are unlikely to provide accurate estimates of objective cognitive functioning. This according to a recent study that aimed to examine the degree to which depressive symptoms and fatigue in individuals with MS are associated with discrepancies between subjective and objective cognitive impairment. 99 adults with MS completed the Patient Health Questionnaire–8 (PHQ-8), Fatigue Severity Scale (FSS), MS Neuropsychological Screening Questionnaire (MSNQ), and Brief International Cognitive Assessment for MS (BICAMS). Participants were classified as “Accurates,” “Underestimators,” or “Overestimators” based on discrepancies between their MSNQ (subjective) and BICAMS (objective) scores. Researchers found:

• The PHQ-8 (r=.58) and FSS (r=.48) significantly correlated with the MSNQ, but not with the
  BICAMS (rs<.07).
• Underestimators (ie, participants who underestimated their objective cognitive functioning) exhibited higher PHQ-8 and FSS scores compared to Accurates and Overestimators.
• Optimal cut-scores of ≥6 on the PHQ-8 and ≥36 on the FSS provided fair accuracy (78% and 74%) for identifying Underestimators.
• Identification of Underestimators based on PHQ-8 and FSS scores was not moderated by any demographic or MS clinical variables.

Hughes AJ. Depressive symptoms and fatigue as predictors of objective-subjective discrepancies in cognitive function in multiple sclerosis. [Published online ahead of print January 31, 2019]. Mult Scler Relat Disord. doi:10.1016/j.msard.2019.01.055.

SNOWMASS, COLO. – Electrophysiologist N.A. Mark Estes III, MD, has a piece of advice for his general cardiology colleagues regarding arrhythmogenic right ventricular cardiomyopathy (ARVC), an inherited arrhythmia syndrome that’s one of the most common causes of sudden death in athletes under the age of 40 years.

“When you have a patient with syncope and an ECG abnormality that suggests ARVC, you immediately restrict activity and immediately go on to imaging. And then it’s time to get that patient off to somebody who deals with these patients all the time,” he said at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

ARVC is thought to affect 1 in 5,000 people. It’s the cause of sudden death in roughly 5% of young athletes in the United States and 25% in Italy, with the disparity believed to be largely caused by underrecognition of the disease.

Dr. Estes was a coauthor of a 2015 international task force consensus statement on the treatment of ARVC (Eur Heart J. 2015 Dec 7;36[46]:3227-37). An updated report that incorporates much new information is due to be released in May 2019.

“The new guidelines are going to put some very clear limits on physical activity: Less than 7 METs [metabolic equivalents], which is about a brisk walk. Exercise is not good with ARVC,” said Dr. Estes, professor of medicine at the University of Pittsburgh.

Patients with ARVC absolutely must be restricted from participation in competitive sports, a step whose importance was demonstrated in the North American Multidisciplinary Study of ARVC, for which Dr. Estes was a coauthor. That study, too recent for inclusion in the 2015 task force consensus statement, showed that competitive sport was associated with a 100% increased risk of ventricular tachyarrhythmias and death, as well as earlier presentation with symptoms, compared with patients with ARVC who engaged in much less intense recreational athletic activity, who in turn didn’t have a risk level any different from inactive patients. That being said, however, the investigators also noted that the absolute risk of ventricular tachyarrhythmias or death remained high even in the inactive and recreational sports participants, at 23% by 2 years post diagnosis (Eur Heart J. 2015 Jul 14;36[27]:1735-43).

ARVC has three phases: An early concealed phase, with an associated high rate of syncope or sudden cardiac death; an intermediate phase marked by frequent arrhythmias; and a late phase involving cardiomyopathy and heart failure. Pathologically, the disease involves progressive loss of myocytes caused by abnormalities of plakoglobin and plakophilin, which Dr. Estes described as “essentially the glue that holds the sarcomeres together.” As myocytes are lost they are replaced by fibrofatty deposits, mostly in the right ventricle, creating a substrate for ventricular arrhythmias.

When to suspect ARVC?

“Anyone who has syncope with exertion automatically has a red flag because there is almost certainly something causing that event that’s potentially malignant,” according to the cardiologist.

An early, sensitive, and reasonably specific hallmark of ARVC on the 12-lead ECG is T wave inversion in right precordial leads V1, V2, and V3 or beyond. An epsilon wave – a small positive deflection at the end of the QRS complex – is present in about one in five patients with ARVC and is diagnostic of the condition.

“It’s an ECG you want to commit to memory. And when you see it, think ARVC,” Dr. Estes advised.

Abnormalities on MRI and 2D echocardiography include right ventricular enlargement and wall motion abnormalities, with left ventricular involvement becoming common in more advanced disease.

The detailed structural, electrographic, functional imaging, histologic, and clinical diagnostic criteria for ARVC, known as the 2010 Task Force Criteria, are readily available (Circulation. 2010 Apr 6;121[13]:1533-41). So are guidelines on genetic testing, which practitioners need to understand is now the standard of care for patients with ARVC and, in the event they are found to have a pathogenic mutation, in first-degree family members as well (Europace. 2011 Aug;13(8):1077-109).

“These days all you need to do is simply Google ‘syncope’ and ‘ARVC’ and you will get to the guidelines,” Dr. Estes advised. “It’s virtually impossible to keep up with all this information, but you should know how to access it and apply it in an individual patient. And learn the role of genetic testing. It’s very much an evolving area, quite mature for the long QT syndromes, but not a robust database for ARVC now. Yet there’s no doubt it’s going to be used more and more for diagnosis, risk stratification, and therapy of ARVC in the future.”

Once the diagnosis of ARVC is made in accordance with the 2010 Task Force Criteria, risk stratification and decision making about definitive therapy become paramount. The international task force consensus statement gives a Class I recommendation to implantable cardioverter defibrillator (ICD) therapy in high-risk ARVC patients, defined as those who’ve had a cardiac arrest, sustained ventricular tachycardia, or have severe right and/or left ventricular dysfunction. ICD therapy gets a Class IIa recommendation in those with at least one of the major risk factors: syncope, nonsustained ventricular tachycardia, and moderate ventricular dysfunction. For ARVC patients with one or more minor risk factors, which include frequent premature ventricular contractions and inducible ventricular tachycardia upon electrophysiological testing, the strength of the recommendation for ICD therapy drops to Class IIb, or “may be considered.” And for low-risk patients, those with confirmed ARVC but no phenotypic expressions of the disorder, the ICD recommendation is Class III, meaning nonindicated.

“There’s a very low threshold for putting in an ICD in patients with ARVC because if you eliminate the arrhythmic mortality, progression to heart failure needing advanced therapies or transplant is extremely rare as long as they’re restricted from athletics,” Dr. Estes said.

He reported serving as a consultant to Boston Scientific, Medtronic, and St. Jude Medical.bjancin@mdedge.com

SNOWMASS, COLO. – Electrophysiologist N.A. Mark Estes III, MD, has a piece of advice for his general cardiology colleagues regarding arrhythmogenic right ventricular cardiomyopathy (ARVC), an inherited arrhythmia syndrome that’s one of the most common causes of sudden death in athletes under the age of 40 years.

“When you have a patient with syncope and an ECG abnormality that suggests ARVC, you immediately restrict activity and immediately go on to imaging. And then it’s time to get that patient off to somebody who deals with these patients all the time,” he said at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

ARVC is thought to affect 1 in 5,000 people. It’s the cause of sudden death in roughly 5% of young athletes in the United States and 25% in Italy, with the disparity believed to be largely caused by underrecognition of the disease.

Dr. Estes was a coauthor of a 2015 international task force consensus statement on the treatment of ARVC (Eur Heart J. 2015 Dec 7;36[46]:3227-37). An updated report that incorporates much new information is due to be released in May 2019.

“The new guidelines are going to put some very clear limits on physical activity: Less than 7 METs [metabolic equivalents], which is about a brisk walk. Exercise is not good with ARVC,” said Dr. Estes, professor of medicine at the University of Pittsburgh.

Patients with ARVC absolutely must be restricted from participation in competitive sports, a step whose importance was demonstrated in the North American Multidisciplinary Study of ARVC, for which Dr. Estes was a coauthor. That study, too recent for inclusion in the 2015 task force consensus statement, showed that competitive sport was associated with a 100% increased risk of ventricular tachyarrhythmias and death, as well as earlier presentation with symptoms, compared with patients with ARVC who engaged in much less intense recreational athletic activity, who in turn didn’t have a risk level any different from inactive patients. That being said, however, the investigators also noted that the absolute risk of ventricular tachyarrhythmias or death remained high even in the inactive and recreational sports participants, at 23% by 2 years post diagnosis (Eur Heart J. 2015 Jul 14;36[27]:1735-43).

ARVC has three phases: An early concealed phase, with an associated high rate of syncope or sudden cardiac death; an intermediate phase marked by frequent arrhythmias; and a late phase involving cardiomyopathy and heart failure. Pathologically, the disease involves progressive loss of myocytes caused by abnormalities of plakoglobin and plakophilin, which Dr. Estes described as “essentially the glue that holds the sarcomeres together.” As myocytes are lost they are replaced by fibrofatty deposits, mostly in the right ventricle, creating a substrate for ventricular arrhythmias.

When to suspect ARVC?

“Anyone who has syncope with exertion automatically has a red flag because there is almost certainly something causing that event that’s potentially malignant,” according to the cardiologist.

An early, sensitive, and reasonably specific hallmark of ARVC on the 12-lead ECG is T wave inversion in right precordial leads V1, V2, and V3 or beyond. An epsilon wave – a small positive deflection at the end of the QRS complex – is present in about one in five patients with ARVC and is diagnostic of the condition.

“It’s an ECG you want to commit to memory. And when you see it, think ARVC,” Dr. Estes advised.

Abnormalities on MRI and 2D echocardiography include right ventricular enlargement and wall motion abnormalities, with left ventricular involvement becoming common in more advanced disease.

The detailed structural, electrographic, functional imaging, histologic, and clinical diagnostic criteria for ARVC, known as the 2010 Task Force Criteria, are readily available (Circulation. 2010 Apr 6;121[13]:1533-41). So are guidelines on genetic testing, which practitioners need to understand is now the standard of care for patients with ARVC and, in the event they are found to have a pathogenic mutation, in first-degree family members as well (Europace. 2011 Aug;13(8):1077-109).

“These days all you need to do is simply Google ‘syncope’ and ‘ARVC’ and you will get to the guidelines,” Dr. Estes advised. “It’s virtually impossible to keep up with all this information, but you should know how to access it and apply it in an individual patient. And learn the role of genetic testing. It’s very much an evolving area, quite mature for the long QT syndromes, but not a robust database for ARVC now. Yet there’s no doubt it’s going to be used more and more for diagnosis, risk stratification, and therapy of ARVC in the future.”

Once the diagnosis of ARVC is made in accordance with the 2010 Task Force Criteria, risk stratification and decision making about definitive therapy become paramount. The international task force consensus statement gives a Class I recommendation to implantable cardioverter defibrillator (ICD) therapy in high-risk ARVC patients, defined as those who’ve had a cardiac arrest, sustained ventricular tachycardia, or have severe right and/or left ventricular dysfunction. ICD therapy gets a Class IIa recommendation in those with at least one of the major risk factors: syncope, nonsustained ventricular tachycardia, and moderate ventricular dysfunction. For ARVC patients with one or more minor risk factors, which include frequent premature ventricular contractions and inducible ventricular tachycardia upon electrophysiological testing, the strength of the recommendation for ICD therapy drops to Class IIb, or “may be considered.” And for low-risk patients, those with confirmed ARVC but no phenotypic expressions of the disorder, the ICD recommendation is Class III, meaning nonindicated.

“There’s a very low threshold for putting in an ICD in patients with ARVC because if you eliminate the arrhythmic mortality, progression to heart failure needing advanced therapies or transplant is extremely rare as long as they’re restricted from athletics,” Dr. Estes said.

He reported serving as a consultant to Boston Scientific, Medtronic, and St. Jude Medical.bjancin@mdedge.com

SNOWMASS, COLO. – Electrophysiologist N.A. Mark Estes III, MD, has a piece of advice for his general cardiology colleagues regarding arrhythmogenic right ventricular cardiomyopathy (ARVC), an inherited arrhythmia syndrome that’s one of the most common causes of sudden death in athletes under the age of 40 years.

“When you have a patient with syncope and an ECG abnormality that suggests ARVC, you immediately restrict activity and immediately go on to imaging. And then it’s time to get that patient off to somebody who deals with these patients all the time,” he said at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

ARVC is thought to affect 1 in 5,000 people. It’s the cause of sudden death in roughly 5% of young athletes in the United States and 25% in Italy, with the disparity believed to be largely caused by underrecognition of the disease.

Dr. Estes was a coauthor of a 2015 international task force consensus statement on the treatment of ARVC (Eur Heart J. 2015 Dec 7;36[46]:3227-37). An updated report that incorporates much new information is due to be released in May 2019.

“The new guidelines are going to put some very clear limits on physical activity: Less than 7 METs [metabolic equivalents], which is about a brisk walk. Exercise is not good with ARVC,” said Dr. Estes, professor of medicine at the University of Pittsburgh.

Patients with ARVC absolutely must be restricted from participation in competitive sports, a step whose importance was demonstrated in the North American Multidisciplinary Study of ARVC, for which Dr. Estes was a coauthor. That study, too recent for inclusion in the 2015 task force consensus statement, showed that competitive sport was associated with a 100% increased risk of ventricular tachyarrhythmias and death, as well as earlier presentation with symptoms, compared with patients with ARVC who engaged in much less intense recreational athletic activity, who in turn didn’t have a risk level any different from inactive patients. That being said, however, the investigators also noted that the absolute risk of ventricular tachyarrhythmias or death remained high even in the inactive and recreational sports participants, at 23% by 2 years post diagnosis (Eur Heart J. 2015 Jul 14;36[27]:1735-43).

ARVC has three phases: An early concealed phase, with an associated high rate of syncope or sudden cardiac death; an intermediate phase marked by frequent arrhythmias; and a late phase involving cardiomyopathy and heart failure. Pathologically, the disease involves progressive loss of myocytes caused by abnormalities of plakoglobin and plakophilin, which Dr. Estes described as “essentially the glue that holds the sarcomeres together.” As myocytes are lost they are replaced by fibrofatty deposits, mostly in the right ventricle, creating a substrate for ventricular arrhythmias.

When to suspect ARVC?

“Anyone who has syncope with exertion automatically has a red flag because there is almost certainly something causing that event that’s potentially malignant,” according to the cardiologist.

An early, sensitive, and reasonably specific hallmark of ARVC on the 12-lead ECG is T wave inversion in right precordial leads V1, V2, and V3 or beyond. An epsilon wave – a small positive deflection at the end of the QRS complex – is present in about one in five patients with ARVC and is diagnostic of the condition.

“It’s an ECG you want to commit to memory. And when you see it, think ARVC,” Dr. Estes advised.

Abnormalities on MRI and 2D echocardiography include right ventricular enlargement and wall motion abnormalities, with left ventricular involvement becoming common in more advanced disease.

The detailed structural, electrographic, functional imaging, histologic, and clinical diagnostic criteria for ARVC, known as the 2010 Task Force Criteria, are readily available (Circulation. 2010 Apr 6;121[13]:1533-41). So are guidelines on genetic testing, which practitioners need to understand is now the standard of care for patients with ARVC and, in the event they are found to have a pathogenic mutation, in first-degree family members as well (Europace. 2011 Aug;13(8):1077-109).

“These days all you need to do is simply Google ‘syncope’ and ‘ARVC’ and you will get to the guidelines,” Dr. Estes advised. “It’s virtually impossible to keep up with all this information, but you should know how to access it and apply it in an individual patient. And learn the role of genetic testing. It’s very much an evolving area, quite mature for the long QT syndromes, but not a robust database for ARVC now. Yet there’s no doubt it’s going to be used more and more for diagnosis, risk stratification, and therapy of ARVC in the future.”

Once the diagnosis of ARVC is made in accordance with the 2010 Task Force Criteria, risk stratification and decision making about definitive therapy become paramount. The international task force consensus statement gives a Class I recommendation to implantable cardioverter defibrillator (ICD) therapy in high-risk ARVC patients, defined as those who’ve had a cardiac arrest, sustained ventricular tachycardia, or have severe right and/or left ventricular dysfunction. ICD therapy gets a Class IIa recommendation in those with at least one of the major risk factors: syncope, nonsustained ventricular tachycardia, and moderate ventricular dysfunction. For ARVC patients with one or more minor risk factors, which include frequent premature ventricular contractions and inducible ventricular tachycardia upon electrophysiological testing, the strength of the recommendation for ICD therapy drops to Class IIb, or “may be considered.” And for low-risk patients, those with confirmed ARVC but no phenotypic expressions of the disorder, the ICD recommendation is Class III, meaning nonindicated.

“There’s a very low threshold for putting in an ICD in patients with ARVC because if you eliminate the arrhythmic mortality, progression to heart failure needing advanced therapies or transplant is extremely rare as long as they’re restricted from athletics,” Dr. Estes said.

He reported serving as a consultant to Boston Scientific, Medtronic, and St. Jude Medical.bjancin@mdedge.com

Higher baseline trait conscientiousness predicts slower rates of longitudinal cognitive decline in multiple sclerosis (MS), according to a recent study. Researchers conducted a retrospective analysis of 531 patients with MS whose data were gleaned from a multi-study database, aggregated over 16 years. Linear mixed effects modeling was applied to estimate the average rate of decline on Symbol Digit Modalities Test (SDMT) performance and to predict rates of decline using baseline clinical variables. They found:

• Participants exhibited an average estimated decline of 0.22 SDMT raw-score points/year.
• There was a significant main effect of time from baseline (t = −2.78), test form (t = 2.13), disease course (t = 2.91), age (t = −2.76), sex (t = −2.71), subjective cognitive impairment (t = −2.00), premorbid verbal intelligence (t = 5.14), and trait Conscientiousness (t = 2.69).
• A significant interaction emerged for Conscientiousness and time from baseline (t = 2.57).

Fuchs TA, Wojcik C, Wilding GE, et al. Trait Conscientiousness predicts rate of longitudinal SDMT decline in multiple sclerosis. [Published online ahead of print January 7, 2019]. Mult Scler. doi:10.1177%2F1352458518820272.

Higher baseline trait conscientiousness predicts slower rates of longitudinal cognitive decline in multiple sclerosis (MS), according to a recent study. Researchers conducted a retrospective analysis of 531 patients with MS whose data were gleaned from a multi-study database, aggregated over 16 years. Linear mixed effects modeling was applied to estimate the average rate of decline on Symbol Digit Modalities Test (SDMT) performance and to predict rates of decline using baseline clinical variables. They found:

• Participants exhibited an average estimated decline of 0.22 SDMT raw-score points/year.
• There was a significant main effect of time from baseline (t = −2.78), test form (t = 2.13), disease course (t = 2.91), age (t = −2.76), sex (t = −2.71), subjective cognitive impairment (t = −2.00), premorbid verbal intelligence (t = 5.14), and trait Conscientiousness (t = 2.69).
• A significant interaction emerged for Conscientiousness and time from baseline (t = 2.57).

Fuchs TA, Wojcik C, Wilding GE, et al. Trait Conscientiousness predicts rate of longitudinal SDMT decline in multiple sclerosis. [Published online ahead of print January 7, 2019]. Mult Scler. doi:10.1177%2F1352458518820272.

Higher baseline trait conscientiousness predicts slower rates of longitudinal cognitive decline in multiple sclerosis (MS), according to a recent study. Researchers conducted a retrospective analysis of 531 patients with MS whose data were gleaned from a multi-study database, aggregated over 16 years. Linear mixed effects modeling was applied to estimate the average rate of decline on Symbol Digit Modalities Test (SDMT) performance and to predict rates of decline using baseline clinical variables. They found:

• Participants exhibited an average estimated decline of 0.22 SDMT raw-score points/year.
• There was a significant main effect of time from baseline (t = −2.78), test form (t = 2.13), disease course (t = 2.91), age (t = −2.76), sex (t = −2.71), subjective cognitive impairment (t = −2.00), premorbid verbal intelligence (t = 5.14), and trait Conscientiousness (t = 2.69).
• A significant interaction emerged for Conscientiousness and time from baseline (t = 2.57).

Fuchs TA, Wojcik C, Wilding GE, et al. Trait Conscientiousness predicts rate of longitudinal SDMT decline in multiple sclerosis. [Published online ahead of print January 7, 2019]. Mult Scler. doi:10.1177%2F1352458518820272.

HONOLULU – A minimally invasive approach to lysing an intracerebral hemorrhage clot was safe but failed to produce a statistically significant improvement in long-term functional outcome when compared with usual medical management in a phase 3 randomized trial of 499 patients. However, the results also showed that when the procedure met its acute goal of cutting residual clot to a volume of 15 mL or less, it significantly boosted the percentage of patients with a modified Rankin Scale score of 0-3 when assessed a year after treatment, Daniel F. Hanley Jr., MD, said at the International Stroke Conference, sponsored by the American Heart Association.

“Improved function and increased survival was produced by surgical [clot] reduction to 15 mL or less,” said Dr. Hanley, professor of neurology at Johns Hopkins University, Baltimore, and one of the organizers of the MISTIE III trial.

When assessed by another measure, treated patients showed significant, long-term functional improvement compared with controls when their clot burden dropped by at least 70% following the lytic procedure.

“This is the first description of specific thresholds of hematoma evacuation that impact functional outcomes in intracerebral hemorrhage surgery trials,” said Issam A. Awad, MD, professor of surgery and director of neurovascular surgery at the University of Chicago and coprincipal investigator of the trial.

The problem in the trial was that the surgeons who performed the interventions did not treat many patients aggressively enough to reach these thresholds. They achieved the prespecified goal of residual clot of 15 mL or less in 59% of patients, Dr. Hanley reported, even though the study protocol called for serial infusions of 1 mg of tissue plasminogen activator (Alteplase) into the clot via a placed catheter as many as nine times, administered at 8 hour intervals, with treatment to continue until patients reached the goal residual volume or until they had received all nine doses. In actual practice during the study, operators administered a median of four lytic doses.

“We showed that this goal was important, but not all sites embraced the goal,” Dr. Hanley said. Even though the participating clinicians had a specific interest in intracerebral hemorrhage patients and in this procedure, several nonetheless “had a poor understanding of the goal,” he said in an interview. He attributed the less-than-aggressive approach many operators took to the safety concern that further doses of the lytic drug could trigger recurrent hemorrhage.

“We showed that the goal was important. I think they will embrace the [hematoma evacuation] goal when they see these data,” Dr. Hanley predicted.

An as-treated analysis of the data that focused on the 145 of 246 patients who were treated with minimally invasive lysis and reached the target residual volume and who were then functionally assessed a year later, showed that the rate of patients with a modified Rankin Scale score of 0-3 was 53%, compared with 42% among the controls, an 11% difference.

This shows “a large treatment effect. This is a big, transformative treatment,” Dr. Hanley said. “Our data clearly show that more than half the patients had a positive outcome when their surgeons were more aggressive about clot removal.” He cautioned that the trial was not just about the volume of clot removed but was also about doing it in a gentle way, with a minimum of tissue trauma. Other approaches to reducing hematoma volume may be faster or more complete but they cannot now match the record of safety and efficacy documented in MISTIE III for minimally invasive clot lysis, Dr. Hanley noted.

MISTIE III (Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III) enrolled patients at 78 centers in the United States and several other countries during 2013-2017. Patients had to enroll 12-72 hours after onset and present with a hematoma volume of at least 30 mL. Participating neurosurgeons used image-guided neuronavigation to place a 4- to 6-mm cannula through the clot, ideally straight through the hematoma’s long axis and with the tip placed within the largest clot segment. Among the 110 surgeons who performed this procedure during the study, 88% had never done it before, and operator and site experience linked with better performance. No surgeon who had already performed four minimally invasive lytic cases, and no center that had already performed seven cases, had a subsequent patient with a residual volume that exceeded 30 mL, Dr. Awad said. The surgical experience during the trial showed that catheter repositioning and using a second catheter were both safe ways to maximize evacuation of the hematoma, he added.

The trial’s primary endpoint, the rate of patients with a modified Rankin Scale score of 0-3 at 1 year after treatment in a modified intention-to-treat analysis that included all patients regardless of the amount of hematoma evacuation they received, showed a 45% rate among the patients who underwent minimally invasive lysis and a 41% rate among those in the control arm, a difference that was not statistically significant. Safety assessments showed that patients treated with the investigational approach had significantly lower mortality 7 days after treatment: 0.8% compared with 4.0%. By 1 year after treatment, mortality was cut by one-third in the minimally invasive patients, compared with the control patients, also a statistically significant difference. The rates of symptomatic bleeds and brain infections were similar in the two treatment groups, Dr. Hanley reported. Concurrently with his talk at the conference, a paper with the primary study results appeared online (Lancet. 2019 Feb 7. doi: 10.1016/S0140-6736[19]30195-3).

MISTIE III was supported by the National Institute of Neurological Disorders and Stroke. The trial received no commercial support aside from free tissue plasminogen activator (Alteplase) supplied by Genentech. Dr. Hanley has been a consultant to BrainScope, Neurotrope, Portola, and Op2Lysis, and he has served as an expert witness on behalf of Medtronic. Dr. Awad had no disclosures.

mzoler@mdedge.com

SOURCE: Hanley DF et al. ISC 2019, Abstract LB4; Awad IS et al. ISC 2019, Abstract LB5.

HONOLULU – A minimally invasive approach to lysing an intracerebral hemorrhage clot was safe but failed to produce a statistically significant improvement in long-term functional outcome when compared with usual medical management in a phase 3 randomized trial of 499 patients. However, the results also showed that when the procedure met its acute goal of cutting residual clot to a volume of 15 mL or less, it significantly boosted the percentage of patients with a modified Rankin Scale score of 0-3 when assessed a year after treatment, Daniel F. Hanley Jr., MD, said at the International Stroke Conference, sponsored by the American Heart Association.

“Improved function and increased survival was produced by surgical [clot] reduction to 15 mL or less,” said Dr. Hanley, professor of neurology at Johns Hopkins University, Baltimore, and one of the organizers of the MISTIE III trial.

When assessed by another measure, treated patients showed significant, long-term functional improvement compared with controls when their clot burden dropped by at least 70% following the lytic procedure.

“This is the first description of specific thresholds of hematoma evacuation that impact functional outcomes in intracerebral hemorrhage surgery trials,” said Issam A. Awad, MD, professor of surgery and director of neurovascular surgery at the University of Chicago and coprincipal investigator of the trial.

The problem in the trial was that the surgeons who performed the interventions did not treat many patients aggressively enough to reach these thresholds. They achieved the prespecified goal of residual clot of 15 mL or less in 59% of patients, Dr. Hanley reported, even though the study protocol called for serial infusions of 1 mg of tissue plasminogen activator (Alteplase) into the clot via a placed catheter as many as nine times, administered at 8 hour intervals, with treatment to continue until patients reached the goal residual volume or until they had received all nine doses. In actual practice during the study, operators administered a median of four lytic doses.

“We showed that this goal was important, but not all sites embraced the goal,” Dr. Hanley said. Even though the participating clinicians had a specific interest in intracerebral hemorrhage patients and in this procedure, several nonetheless “had a poor understanding of the goal,” he said in an interview. He attributed the less-than-aggressive approach many operators took to the safety concern that further doses of the lytic drug could trigger recurrent hemorrhage.

“We showed that the goal was important. I think they will embrace the [hematoma evacuation] goal when they see these data,” Dr. Hanley predicted.

An as-treated analysis of the data that focused on the 145 of 246 patients who were treated with minimally invasive lysis and reached the target residual volume and who were then functionally assessed a year later, showed that the rate of patients with a modified Rankin Scale score of 0-3 was 53%, compared with 42% among the controls, an 11% difference.

This shows “a large treatment effect. This is a big, transformative treatment,” Dr. Hanley said. “Our data clearly show that more than half the patients had a positive outcome when their surgeons were more aggressive about clot removal.” He cautioned that the trial was not just about the volume of clot removed but was also about doing it in a gentle way, with a minimum of tissue trauma. Other approaches to reducing hematoma volume may be faster or more complete but they cannot now match the record of safety and efficacy documented in MISTIE III for minimally invasive clot lysis, Dr. Hanley noted.

MISTIE III (Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III) enrolled patients at 78 centers in the United States and several other countries during 2013-2017. Patients had to enroll 12-72 hours after onset and present with a hematoma volume of at least 30 mL. Participating neurosurgeons used image-guided neuronavigation to place a 4- to 6-mm cannula through the clot, ideally straight through the hematoma’s long axis and with the tip placed within the largest clot segment. Among the 110 surgeons who performed this procedure during the study, 88% had never done it before, and operator and site experience linked with better performance. No surgeon who had already performed four minimally invasive lytic cases, and no center that had already performed seven cases, had a subsequent patient with a residual volume that exceeded 30 mL, Dr. Awad said. The surgical experience during the trial showed that catheter repositioning and using a second catheter were both safe ways to maximize evacuation of the hematoma, he added.

The trial’s primary endpoint, the rate of patients with a modified Rankin Scale score of 0-3 at 1 year after treatment in a modified intention-to-treat analysis that included all patients regardless of the amount of hematoma evacuation they received, showed a 45% rate among the patients who underwent minimally invasive lysis and a 41% rate among those in the control arm, a difference that was not statistically significant. Safety assessments showed that patients treated with the investigational approach had significantly lower mortality 7 days after treatment: 0.8% compared with 4.0%. By 1 year after treatment, mortality was cut by one-third in the minimally invasive patients, compared with the control patients, also a statistically significant difference. The rates of symptomatic bleeds and brain infections were similar in the two treatment groups, Dr. Hanley reported. Concurrently with his talk at the conference, a paper with the primary study results appeared online (Lancet. 2019 Feb 7. doi: 10.1016/S0140-6736[19]30195-3).

MISTIE III was supported by the National Institute of Neurological Disorders and Stroke. The trial received no commercial support aside from free tissue plasminogen activator (Alteplase) supplied by Genentech. Dr. Hanley has been a consultant to BrainScope, Neurotrope, Portola, and Op2Lysis, and he has served as an expert witness on behalf of Medtronic. Dr. Awad had no disclosures.

mzoler@mdedge.com

SOURCE: Hanley DF et al. ISC 2019, Abstract LB4; Awad IS et al. ISC 2019, Abstract LB5.

HONOLULU – A minimally invasive approach to lysing an intracerebral hemorrhage clot was safe but failed to produce a statistically significant improvement in long-term functional outcome when compared with usual medical management in a phase 3 randomized trial of 499 patients. However, the results also showed that when the procedure met its acute goal of cutting residual clot to a volume of 15 mL or less, it significantly boosted the percentage of patients with a modified Rankin Scale score of 0-3 when assessed a year after treatment, Daniel F. Hanley Jr., MD, said at the International Stroke Conference, sponsored by the American Heart Association.

“Improved function and increased survival was produced by surgical [clot] reduction to 15 mL or less,” said Dr. Hanley, professor of neurology at Johns Hopkins University, Baltimore, and one of the organizers of the MISTIE III trial.

When assessed by another measure, treated patients showed significant, long-term functional improvement compared with controls when their clot burden dropped by at least 70% following the lytic procedure.

“This is the first description of specific thresholds of hematoma evacuation that impact functional outcomes in intracerebral hemorrhage surgery trials,” said Issam A. Awad, MD, professor of surgery and director of neurovascular surgery at the University of Chicago and coprincipal investigator of the trial.

The problem in the trial was that the surgeons who performed the interventions did not treat many patients aggressively enough to reach these thresholds. They achieved the prespecified goal of residual clot of 15 mL or less in 59% of patients, Dr. Hanley reported, even though the study protocol called for serial infusions of 1 mg of tissue plasminogen activator (Alteplase) into the clot via a placed catheter as many as nine times, administered at 8 hour intervals, with treatment to continue until patients reached the goal residual volume or until they had received all nine doses. In actual practice during the study, operators administered a median of four lytic doses.

“We showed that this goal was important, but not all sites embraced the goal,” Dr. Hanley said. Even though the participating clinicians had a specific interest in intracerebral hemorrhage patients and in this procedure, several nonetheless “had a poor understanding of the goal,” he said in an interview. He attributed the less-than-aggressive approach many operators took to the safety concern that further doses of the lytic drug could trigger recurrent hemorrhage.

“We showed that the goal was important. I think they will embrace the [hematoma evacuation] goal when they see these data,” Dr. Hanley predicted.

An as-treated analysis of the data that focused on the 145 of 246 patients who were treated with minimally invasive lysis and reached the target residual volume and who were then functionally assessed a year later, showed that the rate of patients with a modified Rankin Scale score of 0-3 was 53%, compared with 42% among the controls, an 11% difference.

This shows “a large treatment effect. This is a big, transformative treatment,” Dr. Hanley said. “Our data clearly show that more than half the patients had a positive outcome when their surgeons were more aggressive about clot removal.” He cautioned that the trial was not just about the volume of clot removed but was also about doing it in a gentle way, with a minimum of tissue trauma. Other approaches to reducing hematoma volume may be faster or more complete but they cannot now match the record of safety and efficacy documented in MISTIE III for minimally invasive clot lysis, Dr. Hanley noted.

MISTIE III (Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III) enrolled patients at 78 centers in the United States and several other countries during 2013-2017. Patients had to enroll 12-72 hours after onset and present with a hematoma volume of at least 30 mL. Participating neurosurgeons used image-guided neuronavigation to place a 4- to 6-mm cannula through the clot, ideally straight through the hematoma’s long axis and with the tip placed within the largest clot segment. Among the 110 surgeons who performed this procedure during the study, 88% had never done it before, and operator and site experience linked with better performance. No surgeon who had already performed four minimally invasive lytic cases, and no center that had already performed seven cases, had a subsequent patient with a residual volume that exceeded 30 mL, Dr. Awad said. The surgical experience during the trial showed that catheter repositioning and using a second catheter were both safe ways to maximize evacuation of the hematoma, he added.

The trial’s primary endpoint, the rate of patients with a modified Rankin Scale score of 0-3 at 1 year after treatment in a modified intention-to-treat analysis that included all patients regardless of the amount of hematoma evacuation they received, showed a 45% rate among the patients who underwent minimally invasive lysis and a 41% rate among those in the control arm, a difference that was not statistically significant. Safety assessments showed that patients treated with the investigational approach had significantly lower mortality 7 days after treatment: 0.8% compared with 4.0%. By 1 year after treatment, mortality was cut by one-third in the minimally invasive patients, compared with the control patients, also a statistically significant difference. The rates of symptomatic bleeds and brain infections were similar in the two treatment groups, Dr. Hanley reported. Concurrently with his talk at the conference, a paper with the primary study results appeared online (Lancet. 2019 Feb 7. doi: 10.1016/S0140-6736[19]30195-3).

MISTIE III was supported by the National Institute of Neurological Disorders and Stroke. The trial received no commercial support aside from free tissue plasminogen activator (Alteplase) supplied by Genentech. Dr. Hanley has been a consultant to BrainScope, Neurotrope, Portola, and Op2Lysis, and he has served as an expert witness on behalf of Medtronic. Dr. Awad had no disclosures.

mzoler@mdedge.com

SOURCE: Hanley DF et al. ISC 2019, Abstract LB4; Awad IS et al. ISC 2019, Abstract LB5.

The prevalence of multiple sclerosis (MS) has increased substantially in many regions around the world since 1990, according to The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD). These recent findings will be useful for resource allocation and planning in health services. Researchers assessed the epidemiology of MS from 1990 to 2016. Data on prevalence and deaths are summarized in the indicator, disability-adjusted life-years (DALYs), which was calculated as the sum of years of life lost (YLLs) and years of life lived with a disability. They found:

• In 2016, there were 2,221,188 prevalent cases of MS globally, which corresponded to a 10.4% increase in the age-standardized prevalence since 1990.
• The highest age-standardized MS prevalence estimates per 100,000 persons were in high-income North America (164.6), western Europe (127.0), and Australasia (91.1), and the lowest were in eastern sub-Saharan Africa (3.3), central sub-Saharan African (2.8), and Oceania (2.0).
• There were 18,932 deaths due to MS and 1,151,478 DALYs due to MS in 2016.
• Globally, age-standardized death rates decreased significantly (change −11.5%), whereas the change in age-standardized DALYs was not significant (−4.2%,).

GBD 2016 Multiple Sclerosis Collaborators. Global, regional, and national burden of multiple sclerosis 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;18(3):269-285. doi:10.1016/S1474-4422(18)30443-5.

The prevalence of multiple sclerosis (MS) has increased substantially in many regions around the world since 1990, according to The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD). These recent findings will be useful for resource allocation and planning in health services. Researchers assessed the epidemiology of MS from 1990 to 2016. Data on prevalence and deaths are summarized in the indicator, disability-adjusted life-years (DALYs), which was calculated as the sum of years of life lost (YLLs) and years of life lived with a disability. They found:

• In 2016, there were 2,221,188 prevalent cases of MS globally, which corresponded to a 10.4% increase in the age-standardized prevalence since 1990.
• The highest age-standardized MS prevalence estimates per 100,000 persons were in high-income North America (164.6), western Europe (127.0), and Australasia (91.1), and the lowest were in eastern sub-Saharan Africa (3.3), central sub-Saharan African (2.8), and Oceania (2.0).
• There were 18,932 deaths due to MS and 1,151,478 DALYs due to MS in 2016.
• Globally, age-standardized death rates decreased significantly (change −11.5%), whereas the change in age-standardized DALYs was not significant (−4.2%,).

GBD 2016 Multiple Sclerosis Collaborators. Global, regional, and national burden of multiple sclerosis 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;18(3):269-285. doi:10.1016/S1474-4422(18)30443-5.

The prevalence of multiple sclerosis (MS) has increased substantially in many regions around the world since 1990, according to The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD). These recent findings will be useful for resource allocation and planning in health services. Researchers assessed the epidemiology of MS from 1990 to 2016. Data on prevalence and deaths are summarized in the indicator, disability-adjusted life-years (DALYs), which was calculated as the sum of years of life lost (YLLs) and years of life lived with a disability. They found:

• In 2016, there were 2,221,188 prevalent cases of MS globally, which corresponded to a 10.4% increase in the age-standardized prevalence since 1990.
• The highest age-standardized MS prevalence estimates per 100,000 persons were in high-income North America (164.6), western Europe (127.0), and Australasia (91.1), and the lowest were in eastern sub-Saharan Africa (3.3), central sub-Saharan African (2.8), and Oceania (2.0).
• There were 18,932 deaths due to MS and 1,151,478 DALYs due to MS in 2016.
• Globally, age-standardized death rates decreased significantly (change −11.5%), whereas the change in age-standardized DALYs was not significant (−4.2%,).

GBD 2016 Multiple Sclerosis Collaborators. Global, regional, and national burden of multiple sclerosis 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;18(3):269-285. doi:10.1016/S1474-4422(18)30443-5.

An early study adding palbociclib to ibrutinib in previously treated patients with mantle cell lymphoma (MCL) showed a higher complete response rate than what has previously been reported for single-agent ibrutinib, according to investigators.

Results from the phase 1 trial (NCT02159755) support preclinical models, suggesting that the CDK4/6 inhibitor palbociclib may be able to help overcome resistance to ibrutinib, an inhibitor of Bruton’s tyrosine kinase (BTK).

These findings set the stage for an ongoing phase 2 multicenter study, reported lead author Peter Martin, MD, of Weill Cornell Medicine in New York and his colleagues.

The present study involved 27 patients with previously treated MCL, the investigators wrote in Blood. Of these, 21 were men and 6 were women, all of whom had adequate organ and bone marrow function, good performance status, and no previous treatment with CDK4/6 or BTK inhibitors.

Patients were randomly grouped into five dose levels of each drug: Ibrutinib doses ranged from 280-560 mg, and palbociclib from 75-125 mg. Ibrutinib was given daily and palbociclib was administered for 21 out of 28 days per cycle. Therapy continued until withdrawal, unacceptable toxicity, or disease progression.

The primary objective was to determine phase 2 dose. Secondarily, the investigators sought to determine activity and toxicity profiles. The maximum tolerated doses were ibrutinib 560 mg daily plus palbociclib 100 mg on days 1-21 of each 28-day cycle.

Across all patients, the complete response rate was 37%, compared with 21% for ibrutinib monotherapy in a previous trial. About two-thirds of patients had a response of any kind, which aligns closely with the overall response rate previously reported for ibrutinib alone (67% vs. 68%). After a median follow-up of 25.6 months in survivors, the 2-year progression free survival was 59.4%. The two-year overall survival rate was 60.6%.

The dose-limiting toxicity was grade 3 rash, which occurred in two out of five patients treated at the highest doses. The most common grade 3 or higher toxicities were neutropenia (41%) and thrombocytopenia (30%), followed by hypertension (15%), febrile neutropenia (15%), lung infection (11%), fatigue (7%), upper respiratory tract infection (7%), hyperglycemia (7%), rash (7%), myalgia (7%), and increased alanine transaminase/aspartate aminotransferase (7%).

“Although BTK-inhibitor-based combinations appear promising, the degree to which they improve upon single-agent ibrutinib is unclear,” the investigators wrote, noting that a phase 2 trial (NCT03478514) is currently underway and uses the maximum tolerated doses.

The phase 1 trial was sponsored by the National Cancer Institute. Study funding was provided by the Sarah Cannon Fund at the HCA Foundation. The investigators reported financial relationships with Janssen, Gilead, AstraZeneca, Celgene, Karyopharm, and others.

SOURCE: Martin P et al. Blood. 2019 Jan 28. doi: 10.1182/blood-2018-11-886457.

An early study adding palbociclib to ibrutinib in previously treated patients with mantle cell lymphoma (MCL) showed a higher complete response rate than what has previously been reported for single-agent ibrutinib, according to investigators.

Results from the phase 1 trial (NCT02159755) support preclinical models, suggesting that the CDK4/6 inhibitor palbociclib may be able to help overcome resistance to ibrutinib, an inhibitor of Bruton’s tyrosine kinase (BTK).

These findings set the stage for an ongoing phase 2 multicenter study, reported lead author Peter Martin, MD, of Weill Cornell Medicine in New York and his colleagues.

The present study involved 27 patients with previously treated MCL, the investigators wrote in Blood. Of these, 21 were men and 6 were women, all of whom had adequate organ and bone marrow function, good performance status, and no previous treatment with CDK4/6 or BTK inhibitors.

Patients were randomly grouped into five dose levels of each drug: Ibrutinib doses ranged from 280-560 mg, and palbociclib from 75-125 mg. Ibrutinib was given daily and palbociclib was administered for 21 out of 28 days per cycle. Therapy continued until withdrawal, unacceptable toxicity, or disease progression.

The primary objective was to determine phase 2 dose. Secondarily, the investigators sought to determine activity and toxicity profiles. The maximum tolerated doses were ibrutinib 560 mg daily plus palbociclib 100 mg on days 1-21 of each 28-day cycle.

Across all patients, the complete response rate was 37%, compared with 21% for ibrutinib monotherapy in a previous trial. About two-thirds of patients had a response of any kind, which aligns closely with the overall response rate previously reported for ibrutinib alone (67% vs. 68%). After a median follow-up of 25.6 months in survivors, the 2-year progression free survival was 59.4%. The two-year overall survival rate was 60.6%.

The dose-limiting toxicity was grade 3 rash, which occurred in two out of five patients treated at the highest doses. The most common grade 3 or higher toxicities were neutropenia (41%) and thrombocytopenia (30%), followed by hypertension (15%), febrile neutropenia (15%), lung infection (11%), fatigue (7%), upper respiratory tract infection (7%), hyperglycemia (7%), rash (7%), myalgia (7%), and increased alanine transaminase/aspartate aminotransferase (7%).

“Although BTK-inhibitor-based combinations appear promising, the degree to which they improve upon single-agent ibrutinib is unclear,” the investigators wrote, noting that a phase 2 trial (NCT03478514) is currently underway and uses the maximum tolerated doses.

The phase 1 trial was sponsored by the National Cancer Institute. Study funding was provided by the Sarah Cannon Fund at the HCA Foundation. The investigators reported financial relationships with Janssen, Gilead, AstraZeneca, Celgene, Karyopharm, and others.

SOURCE: Martin P et al. Blood. 2019 Jan 28. doi: 10.1182/blood-2018-11-886457.

An early study adding palbociclib to ibrutinib in previously treated patients with mantle cell lymphoma (MCL) showed a higher complete response rate than what has previously been reported for single-agent ibrutinib, according to investigators.

Results from the phase 1 trial (NCT02159755) support preclinical models, suggesting that the CDK4/6 inhibitor palbociclib may be able to help overcome resistance to ibrutinib, an inhibitor of Bruton’s tyrosine kinase (BTK).

These findings set the stage for an ongoing phase 2 multicenter study, reported lead author Peter Martin, MD, of Weill Cornell Medicine in New York and his colleagues.

The present study involved 27 patients with previously treated MCL, the investigators wrote in Blood. Of these, 21 were men and 6 were women, all of whom had adequate organ and bone marrow function, good performance status, and no previous treatment with CDK4/6 or BTK inhibitors.

Patients were randomly grouped into five dose levels of each drug: Ibrutinib doses ranged from 280-560 mg, and palbociclib from 75-125 mg. Ibrutinib was given daily and palbociclib was administered for 21 out of 28 days per cycle. Therapy continued until withdrawal, unacceptable toxicity, or disease progression.

The primary objective was to determine phase 2 dose. Secondarily, the investigators sought to determine activity and toxicity profiles. The maximum tolerated doses were ibrutinib 560 mg daily plus palbociclib 100 mg on days 1-21 of each 28-day cycle.

Across all patients, the complete response rate was 37%, compared with 21% for ibrutinib monotherapy in a previous trial. About two-thirds of patients had a response of any kind, which aligns closely with the overall response rate previously reported for ibrutinib alone (67% vs. 68%). After a median follow-up of 25.6 months in survivors, the 2-year progression free survival was 59.4%. The two-year overall survival rate was 60.6%.

The dose-limiting toxicity was grade 3 rash, which occurred in two out of five patients treated at the highest doses. The most common grade 3 or higher toxicities were neutropenia (41%) and thrombocytopenia (30%), followed by hypertension (15%), febrile neutropenia (15%), lung infection (11%), fatigue (7%), upper respiratory tract infection (7%), hyperglycemia (7%), rash (7%), myalgia (7%), and increased alanine transaminase/aspartate aminotransferase (7%).

“Although BTK-inhibitor-based combinations appear promising, the degree to which they improve upon single-agent ibrutinib is unclear,” the investigators wrote, noting that a phase 2 trial (NCT03478514) is currently underway and uses the maximum tolerated doses.

The phase 1 trial was sponsored by the National Cancer Institute. Study funding was provided by the Sarah Cannon Fund at the HCA Foundation. The investigators reported financial relationships with Janssen, Gilead, AstraZeneca, Celgene, Karyopharm, and others.

SOURCE: Martin P et al. Blood. 2019 Jan 28. doi: 10.1182/blood-2018-11-886457.

Kate Gerull and Maren Loe founded the non-profit 500 Women in Medicine. Ms. Gerull and Ms. Loe are third-year medical students at Washington University School of Medicine in St. Louis. According to Gerull and Loe, the aim is to create a network of support and advancement for women in medicine. 500 Women in Medicine is a pod of the organization 500 Women Scientists.
Apple Podcasts
Google Podcasts
Spotify
 

Kate Gerull and Maren Loe founded the non-profit 500 Women in Medicine. Ms. Gerull and Ms. Loe are third-year medical students at Washington University School of Medicine in St. Louis. According to Gerull and Loe, the aim is to create a network of support and advancement for women in medicine. 500 Women in Medicine is a pod of the organization 500 Women Scientists.
Apple Podcasts
Google Podcasts
Spotify
 

Kate Gerull and Maren Loe founded the non-profit 500 Women in Medicine. Ms. Gerull and Ms. Loe are third-year medical students at Washington University School of Medicine in St. Louis. According to Gerull and Loe, the aim is to create a network of support and advancement for women in medicine. 500 Women in Medicine is a pod of the organization 500 Women Scientists.
Apple Podcasts
Google Podcasts
Spotify
 

Women, younger patients, and individuals from minority groups are significantly less likely to be adherent with their statins, and are at greater risk of hospitalization and death, a study has found.

Louise Koenig/MDedge News

In JAMA Cardiology, researchers report the outcomes of a retrospective cohort analysis involving 347,104 adults with atherosclerotic cardiovascular disease and stable statin prescriptions, who were treated within the Veterans Affairs Health System.

Statin adherence – defined as a medication possession ratio of 80% or above – was 87.7%. Patients on a moderate intensity of statin therapy were slightly more adherent than were patients on low- or high-intensity therapy.

The lowest levels of adherence were seen in the youngest patients. Those aged under 35 years had a 60% lower likelihood of adherence compared with the reference group aged 65-74 years, and those aged 35-44 years had a 47% lower likelihood of adherence. From age 55 on, adherence improved.

Women were 11% less likely to be adherent to statin therapy than were men. Adherence was significantly different among persons of different racial backgrounds and ethnicities: black patients were 42% less likely to be adherent compared with non-Hispanic whites, Asian patients were 18% less likely to be adherent, and Hispanic patients were 27% less likely to be adherent.

Lower adherence was significantly associated with an increased risk of hospitalization for cardiovascular disease. Among patients with a medication possession ratio less than 50%, 13.4% were hospitalized for ischemic heart disease or ischemic stroke, compared with 11.5% of patients who had a medication possession ratio of 90% or above, even after adjustment for baseline characteristics.

Researchers saw a dose-response association between lower adherence and higher mortality. The incidence of death in the first year was 8.8% in patients with a medication possession ration below 50%, 7.5% for those with a ratio of 50%-69%, 6.3% for those with a ratio between 70% and 89%, and 5.7% among those with a medication possession ratio at or above 90%.

This effect was slightly attenuated by adjustment for adherence to other cardiac medications, but the association remained significant.

“Although statins are among the most effective drugs for the secondary prevention of [atherosclerotic cardiovascular disease], low adherence is a common problem,” wrote Dr. Fatima Rodriguez of Stanford (Calif.) University’s Division of Cardiovascular Medicine, and her coauthors. “Minorities have not been well represented in statin-related trials and more work is needed to implement strategies to improve guideline adherence in these populations.”

Stanford’s Division of Cardiovascular Medicine supported the study. The investigators have received funding from the Doris Duke Charitable Trust, the Department of Veterans Affairs Health Services Research and Development Service, the National Lipid Association, and Duke Clinical Research Institute.

SOURCE: Rodriguez F et al. JAMA Cardiol. 2019 Feb 13. doi: 10.1001/jamacardio.2018.4936.

Women, younger patients, and individuals from minority groups are significantly less likely to be adherent with their statins, and are at greater risk of hospitalization and death, a study has found.

Louise Koenig/MDedge News

In JAMA Cardiology, researchers report the outcomes of a retrospective cohort analysis involving 347,104 adults with atherosclerotic cardiovascular disease and stable statin prescriptions, who were treated within the Veterans Affairs Health System.

Statin adherence – defined as a medication possession ratio of 80% or above – was 87.7%. Patients on a moderate intensity of statin therapy were slightly more adherent than were patients on low- or high-intensity therapy.

The lowest levels of adherence were seen in the youngest patients. Those aged under 35 years had a 60% lower likelihood of adherence compared with the reference group aged 65-74 years, and those aged 35-44 years had a 47% lower likelihood of adherence. From age 55 on, adherence improved.

Women were 11% less likely to be adherent to statin therapy than were men. Adherence was significantly different among persons of different racial backgrounds and ethnicities: black patients were 42% less likely to be adherent compared with non-Hispanic whites, Asian patients were 18% less likely to be adherent, and Hispanic patients were 27% less likely to be adherent.

Lower adherence was significantly associated with an increased risk of hospitalization for cardiovascular disease. Among patients with a medication possession ratio less than 50%, 13.4% were hospitalized for ischemic heart disease or ischemic stroke, compared with 11.5% of patients who had a medication possession ratio of 90% or above, even after adjustment for baseline characteristics.

Researchers saw a dose-response association between lower adherence and higher mortality. The incidence of death in the first year was 8.8% in patients with a medication possession ration below 50%, 7.5% for those with a ratio of 50%-69%, 6.3% for those with a ratio between 70% and 89%, and 5.7% among those with a medication possession ratio at or above 90%.

This effect was slightly attenuated by adjustment for adherence to other cardiac medications, but the association remained significant.

“Although statins are among the most effective drugs for the secondary prevention of [atherosclerotic cardiovascular disease], low adherence is a common problem,” wrote Dr. Fatima Rodriguez of Stanford (Calif.) University’s Division of Cardiovascular Medicine, and her coauthors. “Minorities have not been well represented in statin-related trials and more work is needed to implement strategies to improve guideline adherence in these populations.”

Stanford’s Division of Cardiovascular Medicine supported the study. The investigators have received funding from the Doris Duke Charitable Trust, the Department of Veterans Affairs Health Services Research and Development Service, the National Lipid Association, and Duke Clinical Research Institute.

SOURCE: Rodriguez F et al. JAMA Cardiol. 2019 Feb 13. doi: 10.1001/jamacardio.2018.4936.

Women, younger patients, and individuals from minority groups are significantly less likely to be adherent with their statins, and are at greater risk of hospitalization and death, a study has found.

Louise Koenig/MDedge News

In JAMA Cardiology, researchers report the outcomes of a retrospective cohort analysis involving 347,104 adults with atherosclerotic cardiovascular disease and stable statin prescriptions, who were treated within the Veterans Affairs Health System.

Statin adherence – defined as a medication possession ratio of 80% or above – was 87.7%. Patients on a moderate intensity of statin therapy were slightly more adherent than were patients on low- or high-intensity therapy.

The lowest levels of adherence were seen in the youngest patients. Those aged under 35 years had a 60% lower likelihood of adherence compared with the reference group aged 65-74 years, and those aged 35-44 years had a 47% lower likelihood of adherence. From age 55 on, adherence improved.

Women were 11% less likely to be adherent to statin therapy than were men. Adherence was significantly different among persons of different racial backgrounds and ethnicities: black patients were 42% less likely to be adherent compared with non-Hispanic whites, Asian patients were 18% less likely to be adherent, and Hispanic patients were 27% less likely to be adherent.

Lower adherence was significantly associated with an increased risk of hospitalization for cardiovascular disease. Among patients with a medication possession ratio less than 50%, 13.4% were hospitalized for ischemic heart disease or ischemic stroke, compared with 11.5% of patients who had a medication possession ratio of 90% or above, even after adjustment for baseline characteristics.

Researchers saw a dose-response association between lower adherence and higher mortality. The incidence of death in the first year was 8.8% in patients with a medication possession ration below 50%, 7.5% for those with a ratio of 50%-69%, 6.3% for those with a ratio between 70% and 89%, and 5.7% among those with a medication possession ratio at or above 90%.

This effect was slightly attenuated by adjustment for adherence to other cardiac medications, but the association remained significant.

“Although statins are among the most effective drugs for the secondary prevention of [atherosclerotic cardiovascular disease], low adherence is a common problem,” wrote Dr. Fatima Rodriguez of Stanford (Calif.) University’s Division of Cardiovascular Medicine, and her coauthors. “Minorities have not been well represented in statin-related trials and more work is needed to implement strategies to improve guideline adherence in these populations.”

Stanford’s Division of Cardiovascular Medicine supported the study. The investigators have received funding from the Doris Duke Charitable Trust, the Department of Veterans Affairs Health Services Research and Development Service, the National Lipid Association, and Duke Clinical Research Institute.

SOURCE: Rodriguez F et al. JAMA Cardiol. 2019 Feb 13. doi: 10.1001/jamacardio.2018.4936.