The Hospitalist

The Resident and Student Luncheon provides future hospitalists the opportunity to meet current hospitalists and learn about various fields within hospital medicine.

“Trainees can ask hospitalists who are administrative leaders, QI gurus, medical educators, global health hospitalists, pediatricians, and researchers about their day-to-day life and what they love about their careers,” stated Darlene B. Tad-y, MD, SFHM, who is an associate professor and hospitalist at the University of Colorado Hospital, Denver. “It’s a great way for trainees to build their network in hospital medicine in addition to learning about the diverse careers available in our field.”

The luncheon is structured in such a way to maximizes attendees’ exposure and interaction with experienced hospitalists. Brian Kwan, MD, FHM, an associate professor of health science at the University of California, San Diego, and a hospitalist, elaborated on the sessions design.

“Each round table features a speaker that will highlight a different topic, including but not limited to medical education, executive leadership, global and rural health, quality improvement, advocacy, and informatics,” said Dr. Kwan.

But the session is not limited to a one-way presentation. “Conversations are facilitated by members of the SHM Physicians in Training (PIT) Committee,” he said. To maximize their exposure, “attendees will have an opportunity to select one table for the main meal and a different one for dessert, so that they have the opportunity to hear from more than one speaker.”

Dr. Kwan and Dr. Tad-y said they believe that this type of exposure is important in the professional development of medical students and residents.

“We believe it is critical for students and residents to be exposed to hospitalists working at the forefront of our field who inspire and can provide a glimpse at different HM career paths and practices. Invited speakers are selected by the PIT Committee, and the luncheon serves as a launching point for networking and potential mentorship. Engaging residents and students is critical to sustaining our pipeline for future hospitalist leaders,” Dr. Kwan said.

Dr. Tad-y stated that this could be a defining professional moment for many of the attendees. “The resident or student may even meet their next project or career mentor, as well as potential peers or project partners.”

Resident and Student Luncheon
April 9, Monday, 12-1 p.m.
New York/New Orleans Room

The Resident and Student Luncheon provides future hospitalists the opportunity to meet current hospitalists and learn about various fields within hospital medicine.

“Trainees can ask hospitalists who are administrative leaders, QI gurus, medical educators, global health hospitalists, pediatricians, and researchers about their day-to-day life and what they love about their careers,” stated Darlene B. Tad-y, MD, SFHM, who is an associate professor and hospitalist at the University of Colorado Hospital, Denver. “It’s a great way for trainees to build their network in hospital medicine in addition to learning about the diverse careers available in our field.”

The luncheon is structured in such a way to maximizes attendees’ exposure and interaction with experienced hospitalists. Brian Kwan, MD, FHM, an associate professor of health science at the University of California, San Diego, and a hospitalist, elaborated on the sessions design.

“Each round table features a speaker that will highlight a different topic, including but not limited to medical education, executive leadership, global and rural health, quality improvement, advocacy, and informatics,” said Dr. Kwan.

But the session is not limited to a one-way presentation. “Conversations are facilitated by members of the SHM Physicians in Training (PIT) Committee,” he said. To maximize their exposure, “attendees will have an opportunity to select one table for the main meal and a different one for dessert, so that they have the opportunity to hear from more than one speaker.”

Dr. Kwan and Dr. Tad-y said they believe that this type of exposure is important in the professional development of medical students and residents.

“We believe it is critical for students and residents to be exposed to hospitalists working at the forefront of our field who inspire and can provide a glimpse at different HM career paths and practices. Invited speakers are selected by the PIT Committee, and the luncheon serves as a launching point for networking and potential mentorship. Engaging residents and students is critical to sustaining our pipeline for future hospitalist leaders,” Dr. Kwan said.

Dr. Tad-y stated that this could be a defining professional moment for many of the attendees. “The resident or student may even meet their next project or career mentor, as well as potential peers or project partners.”

Resident and Student Luncheon
April 9, Monday, 12-1 p.m.
New York/New Orleans Room

The Resident and Student Luncheon provides future hospitalists the opportunity to meet current hospitalists and learn about various fields within hospital medicine.

“Trainees can ask hospitalists who are administrative leaders, QI gurus, medical educators, global health hospitalists, pediatricians, and researchers about their day-to-day life and what they love about their careers,” stated Darlene B. Tad-y, MD, SFHM, who is an associate professor and hospitalist at the University of Colorado Hospital, Denver. “It’s a great way for trainees to build their network in hospital medicine in addition to learning about the diverse careers available in our field.”

The luncheon is structured in such a way to maximizes attendees’ exposure and interaction with experienced hospitalists. Brian Kwan, MD, FHM, an associate professor of health science at the University of California, San Diego, and a hospitalist, elaborated on the sessions design.

“Each round table features a speaker that will highlight a different topic, including but not limited to medical education, executive leadership, global and rural health, quality improvement, advocacy, and informatics,” said Dr. Kwan.

But the session is not limited to a one-way presentation. “Conversations are facilitated by members of the SHM Physicians in Training (PIT) Committee,” he said. To maximize their exposure, “attendees will have an opportunity to select one table for the main meal and a different one for dessert, so that they have the opportunity to hear from more than one speaker.”

Dr. Kwan and Dr. Tad-y said they believe that this type of exposure is important in the professional development of medical students and residents.

“We believe it is critical for students and residents to be exposed to hospitalists working at the forefront of our field who inspire and can provide a glimpse at different HM career paths and practices. Invited speakers are selected by the PIT Committee, and the luncheon serves as a launching point for networking and potential mentorship. Engaging residents and students is critical to sustaining our pipeline for future hospitalist leaders,” Dr. Kwan said.

Dr. Tad-y stated that this could be a defining professional moment for many of the attendees. “The resident or student may even meet their next project or career mentor, as well as potential peers or project partners.”

Resident and Student Luncheon
April 9, Monday, 12-1 p.m.
New York/New Orleans Room

Chris Harrington knows that not all the benefits of attending the Society of Hospital Medicine’s annual meetings come from the lectures and courses; there is the formation of friendships that endure.

“I am very grateful to SHM for allowing me the opportunity to accompany Bob to their annual conferences and leadership academies over the years,” said Mrs. Harrington, spouse of former SHM president Robert Harrington Jr., MD, SFHM in an interview.

“It truly has been a rewarding experience for me both as a spouse to travel with my husband and spend time with our friends, and as a health care professional to witness the tremendous growth of SHM membership and the educational and networking opportunities it provides to its members. Watching SHM become even more innovative in universally improving patient care has been an amazing experience as well.

Chris Harrington knows that not all the benefits of attending the Society of Hospital Medicine’s annual meetings come from the lectures and courses; there is the formation of friendships that endure.

“I am very grateful to SHM for allowing me the opportunity to accompany Bob to their annual conferences and leadership academies over the years,” said Mrs. Harrington, spouse of former SHM president Robert Harrington Jr., MD, SFHM in an interview.

“It truly has been a rewarding experience for me both as a spouse to travel with my husband and spend time with our friends, and as a health care professional to witness the tremendous growth of SHM membership and the educational and networking opportunities it provides to its members. Watching SHM become even more innovative in universally improving patient care has been an amazing experience as well.

Chris Harrington knows that not all the benefits of attending the Society of Hospital Medicine’s annual meetings come from the lectures and courses; there is the formation of friendships that endure.

“I am very grateful to SHM for allowing me the opportunity to accompany Bob to their annual conferences and leadership academies over the years,” said Mrs. Harrington, spouse of former SHM president Robert Harrington Jr., MD, SFHM in an interview.

“It truly has been a rewarding experience for me both as a spouse to travel with my husband and spend time with our friends, and as a health care professional to witness the tremendous growth of SHM membership and the educational and networking opportunities it provides to its members. Watching SHM become even more innovative in universally improving patient care has been an amazing experience as well.

While every day seems to bring extraordinary new advances in science – robotic surgery, individually targeted medications, and even gene therapy – there are many people who currently approach the science of medicine with skepticism.

While it is the right of legally competent adults in a free society to chose how best to care for their own health, to explore holistic or alternative therapies, or avoid medicine altogether, it is more complex when they are skeptical of accepted medical practice in managing the health of their children. For those parents who trust you enough to bring their children to you for care but remain skeptical of vaccines or other treatments, you have an opportunity to work with that trust and engage in a discussion so that they might reconsider their position on valuable and even life-saving treatments for their children.

Wavebreakmedia/Thinkstock

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics at Harvard Medical School, Boston. Email them at [email protected].

While every day seems to bring extraordinary new advances in science – robotic surgery, individually targeted medications, and even gene therapy – there are many people who currently approach the science of medicine with skepticism.

While it is the right of legally competent adults in a free society to chose how best to care for their own health, to explore holistic or alternative therapies, or avoid medicine altogether, it is more complex when they are skeptical of accepted medical practice in managing the health of their children. For those parents who trust you enough to bring their children to you for care but remain skeptical of vaccines or other treatments, you have an opportunity to work with that trust and engage in a discussion so that they might reconsider their position on valuable and even life-saving treatments for their children.

Wavebreakmedia/Thinkstock

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics at Harvard Medical School, Boston. Email them at [email protected].

While every day seems to bring extraordinary new advances in science – robotic surgery, individually targeted medications, and even gene therapy – there are many people who currently approach the science of medicine with skepticism.

While it is the right of legally competent adults in a free society to chose how best to care for their own health, to explore holistic or alternative therapies, or avoid medicine altogether, it is more complex when they are skeptical of accepted medical practice in managing the health of their children. For those parents who trust you enough to bring their children to you for care but remain skeptical of vaccines or other treatments, you have an opportunity to work with that trust and engage in a discussion so that they might reconsider their position on valuable and even life-saving treatments for their children.

Wavebreakmedia/Thinkstock

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics at Harvard Medical School, Boston. Email them at [email protected].

SILVER SPRING, MD.  – Members of the Food and Drug Administration Psychopharmacologic Drugs Advisory Committee voted 11 to 1 to recommend approval of lofexidine as the first nonopioid treatment option for the symptomatic treatment of opioid withdrawal.

Opioid withdrawal symptoms are the largest barrier to discontinuing opioid use, according to Louis Baxter, MD, executive medical director of the Professional Assistance Program in Princeton, N.J., who presented on behalf of U.S. WorldMeds, which plans to market lofexidine as Lucemyra.

Lofexidine, a selective alpha2-adrenergic receptor agonist that regulates norepinephrine release has been approved for management of opioid withdrawal in the United Kingdom since 1992.

The advisory committee voted to recommend lofexidine on the strength of the results of two randomized, double-blind, and placebo controlled phase 3 studies on the safety and efficacy of lofexidine for symptomatic treatment of opioid withdrawal between days 1 through 7. One study randomized 264 patients to lofexidine (134) or placebo (130), with patients in the treatment arm received 3.2 mg of lofexidine on days 1-5, then placebo until day 7. The second study randomized 603 patients to three groups, comparing high dose (3.2 mg/day) and low dose (2.4 mg/day) regimens of lofexidine to placebo; patients in the treatment arms took four smaller doses of lofexidine throughout the day to achieve the cumulative dose.

Researchers enrolled heavy users of short-acting opioids; heroin was the predominant agent. Both studies were conducted in the scenario of abrupt withdrawal, or the most intense withdrawal situation.

Symptomatic benefit was measured using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), a patient reported outcome. Patients were asked to rank their symptoms as none, mild, moderate or severe across measures like feeling sick, stomach cramps, and heart pounding among other symptoms.  

Lofexidine increased completion of withdrawal treatment compared to placebo. Patients in the first study had a 5-day completion rate of 53%, compared to 35% for the placebo group. Researchers observed similar results in the 7-day completion rates the second study, with low and high dose completion rates of 42% and 40%, respectively, both of which were much higher than placebo (28%).

Lofexidine also reduced patient withdrawal symptoms, according to SOWS-Gossop scores during peak withdrawal. In the first study, SOWS-Gossop scores were 2-4 points lower in the lofexidine group compared to placebo. Similarly, the scores were significantly better in both lofexidine groups in the second study, compared to placebo, particularly on days 1 to 4. Decreasing withdrawal symptoms during this period is particularly important because this is the most vulnerable window for patient dropout, briefing documents from US WorldMeds.

Several notable adverse events occurred during the study, particularly at higher doses of lofexidine. The risk of bradycardia and hypotension are prominent in patients taking lofexidine, but these are risks associated with this class of drug, according to Mark Pirner, MD, senior medical director at US WorldMeds, who noted that “the lower dose, if that’s what ultimately gets approved [by the FDA], is safe and effective too.”

Development of lofexidine was conducted in collaboration with the National Institute on Drug Abuse and the FDA, according to briefing documents from US WorldMeds.

The Prescription Drug User Fee Act (PDUFA) for lofexidine is May 26; FDA actions on new drug applications often occur at near the PDUFA date.

The FDA is not obligated to follow the recommendations of its advisory committees.

[email protected]

SILVER SPRING, MD.  – Members of the Food and Drug Administration Psychopharmacologic Drugs Advisory Committee voted 11 to 1 to recommend approval of lofexidine as the first nonopioid treatment option for the symptomatic treatment of opioid withdrawal.

Opioid withdrawal symptoms are the largest barrier to discontinuing opioid use, according to Louis Baxter, MD, executive medical director of the Professional Assistance Program in Princeton, N.J., who presented on behalf of U.S. WorldMeds, which plans to market lofexidine as Lucemyra.

Lofexidine, a selective alpha2-adrenergic receptor agonist that regulates norepinephrine release has been approved for management of opioid withdrawal in the United Kingdom since 1992.

The advisory committee voted to recommend lofexidine on the strength of the results of two randomized, double-blind, and placebo controlled phase 3 studies on the safety and efficacy of lofexidine for symptomatic treatment of opioid withdrawal between days 1 through 7. One study randomized 264 patients to lofexidine (134) or placebo (130), with patients in the treatment arm received 3.2 mg of lofexidine on days 1-5, then placebo until day 7. The second study randomized 603 patients to three groups, comparing high dose (3.2 mg/day) and low dose (2.4 mg/day) regimens of lofexidine to placebo; patients in the treatment arms took four smaller doses of lofexidine throughout the day to achieve the cumulative dose.

Researchers enrolled heavy users of short-acting opioids; heroin was the predominant agent. Both studies were conducted in the scenario of abrupt withdrawal, or the most intense withdrawal situation.

Symptomatic benefit was measured using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), a patient reported outcome. Patients were asked to rank their symptoms as none, mild, moderate or severe across measures like feeling sick, stomach cramps, and heart pounding among other symptoms.  

Lofexidine increased completion of withdrawal treatment compared to placebo. Patients in the first study had a 5-day completion rate of 53%, compared to 35% for the placebo group. Researchers observed similar results in the 7-day completion rates the second study, with low and high dose completion rates of 42% and 40%, respectively, both of which were much higher than placebo (28%).

Lofexidine also reduced patient withdrawal symptoms, according to SOWS-Gossop scores during peak withdrawal. In the first study, SOWS-Gossop scores were 2-4 points lower in the lofexidine group compared to placebo. Similarly, the scores were significantly better in both lofexidine groups in the second study, compared to placebo, particularly on days 1 to 4. Decreasing withdrawal symptoms during this period is particularly important because this is the most vulnerable window for patient dropout, briefing documents from US WorldMeds.

Several notable adverse events occurred during the study, particularly at higher doses of lofexidine. The risk of bradycardia and hypotension are prominent in patients taking lofexidine, but these are risks associated with this class of drug, according to Mark Pirner, MD, senior medical director at US WorldMeds, who noted that “the lower dose, if that’s what ultimately gets approved [by the FDA], is safe and effective too.”

Development of lofexidine was conducted in collaboration with the National Institute on Drug Abuse and the FDA, according to briefing documents from US WorldMeds.

The Prescription Drug User Fee Act (PDUFA) for lofexidine is May 26; FDA actions on new drug applications often occur at near the PDUFA date.

The FDA is not obligated to follow the recommendations of its advisory committees.

[email protected]

SILVER SPRING, MD.  – Members of the Food and Drug Administration Psychopharmacologic Drugs Advisory Committee voted 11 to 1 to recommend approval of lofexidine as the first nonopioid treatment option for the symptomatic treatment of opioid withdrawal.

Opioid withdrawal symptoms are the largest barrier to discontinuing opioid use, according to Louis Baxter, MD, executive medical director of the Professional Assistance Program in Princeton, N.J., who presented on behalf of U.S. WorldMeds, which plans to market lofexidine as Lucemyra.

Lofexidine, a selective alpha2-adrenergic receptor agonist that regulates norepinephrine release has been approved for management of opioid withdrawal in the United Kingdom since 1992.

The advisory committee voted to recommend lofexidine on the strength of the results of two randomized, double-blind, and placebo controlled phase 3 studies on the safety and efficacy of lofexidine for symptomatic treatment of opioid withdrawal between days 1 through 7. One study randomized 264 patients to lofexidine (134) or placebo (130), with patients in the treatment arm received 3.2 mg of lofexidine on days 1-5, then placebo until day 7. The second study randomized 603 patients to three groups, comparing high dose (3.2 mg/day) and low dose (2.4 mg/day) regimens of lofexidine to placebo; patients in the treatment arms took four smaller doses of lofexidine throughout the day to achieve the cumulative dose.

Researchers enrolled heavy users of short-acting opioids; heroin was the predominant agent. Both studies were conducted in the scenario of abrupt withdrawal, or the most intense withdrawal situation.

Symptomatic benefit was measured using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), a patient reported outcome. Patients were asked to rank their symptoms as none, mild, moderate or severe across measures like feeling sick, stomach cramps, and heart pounding among other symptoms.  

Lofexidine increased completion of withdrawal treatment compared to placebo. Patients in the first study had a 5-day completion rate of 53%, compared to 35% for the placebo group. Researchers observed similar results in the 7-day completion rates the second study, with low and high dose completion rates of 42% and 40%, respectively, both of which were much higher than placebo (28%).

Lofexidine also reduced patient withdrawal symptoms, according to SOWS-Gossop scores during peak withdrawal. In the first study, SOWS-Gossop scores were 2-4 points lower in the lofexidine group compared to placebo. Similarly, the scores were significantly better in both lofexidine groups in the second study, compared to placebo, particularly on days 1 to 4. Decreasing withdrawal symptoms during this period is particularly important because this is the most vulnerable window for patient dropout, briefing documents from US WorldMeds.

Several notable adverse events occurred during the study, particularly at higher doses of lofexidine. The risk of bradycardia and hypotension are prominent in patients taking lofexidine, but these are risks associated with this class of drug, according to Mark Pirner, MD, senior medical director at US WorldMeds, who noted that “the lower dose, if that’s what ultimately gets approved [by the FDA], is safe and effective too.”

Development of lofexidine was conducted in collaboration with the National Institute on Drug Abuse and the FDA, according to briefing documents from US WorldMeds.

The Prescription Drug User Fee Act (PDUFA) for lofexidine is May 26; FDA actions on new drug applications often occur at near the PDUFA date.

The FDA is not obligated to follow the recommendations of its advisory committees.

[email protected]

SNOWMASS, COLO. – More than 960,000 new cases of heart failure will occur in the United States this year – and most of them could have been prevented, Gregg C. Fonarow, MD, asserted at the Annual Cardiovascular Conference at Snowmass.

Preventing heart failure doesn’t require heroic measures. It entails identifying high-risk individuals while they are still asymptomatic and free of structural heart disease – that is, patients who are stage A, pre–heart failure, in the American College of Cardiology/American Heart Association classification system for heart failure – and then addressing their modifiable risk factors via evidence-based, guideline-directed medical therapy, said Dr. Fonarow, professor of cardiovascular medicine and cochief of cardiology at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center.

Bruce Jancin/MDedge News

Antihypertensive therapy

More than a quarter century ago, the landmark SHEP trial (Systolic Hypertension in the Elderly Program) in more than 4,700 hypertensive seniors showed that treatment with diuretics and beta-blockers resulted in a 49% reduction in heart failure events, compared with placebo. And this has been a consistent finding in other studies: A meta-analysis of all 12 major randomized trials of antihypertensive therapy conducted over a 20-year period showed that treatment resulted in a whopping 52% reduction in the risk of heart failure (J Am Coll Cardiol. 1995 Apr; 27[5]:1214-8).

“If you ask most people why they’re on antihypertensive medication, they say, ‘Oh, to prevent heart attacks and stroke.’ But in fact the greatest relative risk reduction that we see is this remarkable reduction in the risk of developing heart failure with blood pressure treatment,” Dr. Fonarow said.

There has been some argument within medicine as to whether aggressive blood pressure lowering is appropriate in individuals over age 80. But in the HYVET trial (Hypertension in the Very Elderly Trial) conducted in that age group, the use of diuretics and/or ACE inhibitors to lower systolic blood pressure from roughly 155 mm Hg to 145 mm Hg resulted in a dramatic 64% reduction in the rate of new-onset heart failure (N Engl J Med. 2008 May 1;358[18]:1887-98).

How low to go with blood pressure reduction in order to maximize the heart failure risk reduction benefit? In the SPRINT trial (Systolic Blood Pressure Intervention Trial) of 9,361 hypertensive patients with a history of cardiovascular disease or multiple risk factors, participants randomized to a goal of less than 120 mm Hg enjoyed a 38% lower risk of heart failure events, compared with those whose target was less than 140 mm Hg (N Engl J Med. 2015 Nov 26;373[22]:2103-16).

A secondary analysis from SPRINT showed that the risk of acute decompensated heart failure was 37% lower in patients treated to the target of less than 120 mm Hg. That finding takes on particular importance because SPRINT participants who developed acute decompensated heart failure had a 27-fold increase in cardiovascular death (Circ Heart Fail. 2017 Apr; doi: 10.1161/CIRCHEARTFAILURE.116.003613).

Lipid lowering

A meta-analysis of four major, randomized clinical trials of intensive versus moderate statin therapy in 27,546 patients with stable coronary artery disease or acute coronary syndrome concluded that intensive therapy resulted in a 27% reduction in the risk of hospitalization for heart failure (J Am Coll Cardiol. 2006 Jun 6;47[11]:2326-31).
 

SGLT-2 inhibition

Until the randomized EMPA-REG OUTCOME trial of the sodium-glucose transporter 2 (SGLT-2) inhibitor empagliflozin(Jardiance), no glucose-lowering drug available for treatment of type 2 diabetes had shown any benefit in terms of reducing diabetic patients’ elevated risk of heart failure. Neither had weight loss. Abundant evidence showed that glycemic control had no impact on the risk of heart failure events. So EMPA-REG OUTCOME was cause for celebration among heart failure specialists, with its demonstration of a 35% reduction in the risk of hospitalization for heart failure, compared with placebo in more than 7,000 randomized patients. The risk of death because of heart failure was chopped by 68%. Sharp reductions in other cardiovascular events were also seen with empagliflozin (N Engl J Med. 2015 Nov 26;373[22]:2117-28).

Similar benefits were subsequently documented with another SGLT-2 inhibitor, canagliflozin(Invokana), in the CANVAS study program (N Engl J Med. 2017 Aug 17;377:644-57).

The reduction in cardiovascular mortality achieved with empagliflozin in EMPA-REG OUTCOME was actually bigger than seen with ACE inhibitors and angiotensin-receptor blockers (ARBs) in earlier landmark heart failure trials (Eur J Heart Fail. 2017 Jan;19[1]:43-53).

Dr. Fonarow views these data as “compelling.” These trials mark a huge step forward in the prevention of heart failure.

“We now for the first time in patients with diabetes have the ability to markedly prevent heart failure as well as cardiovascular death,” the cardiologist commented. “It is critical for cardiologists and heart failure specialists to play an active role in this [pharmacologic diabetes] management, as choice of therapy is a key determinant of outcomes, including survival.”

ACE inhibitors and ARBs

The ACC/AHA heart failure guidelines give a Class I recommendation to the routine use of ACE inhibitors or ARBs in patients at high risk for developing heart failure because of a history of diabetes, hypertension with associated cardiovascular risk factors, or any form of atherosclerotic vascular disease.

Lifestyle modification

Heavy drinking is known to raise the risk of heart failure. However, moderate alcohol consumption may be protective. In a classic prospective cohort study, individuals who reported consuming 1.5-4 drinks per day in the previous month had a 47% reduction in subsequent new-onset heart failure, compared with teetotalers in a multivariate analysis adjusted for conventional cardiovascular risk factors. Those who drank less than 1.5 drinks per day had a 21% reduction in heart failure risk, compared with the nondrinkers (JAMA. 2001 Apr 18;285[15]:1971-7).

In the prospective observational Physicians’ Health Study of nearly 21,000 men, adherence to six modifiable healthy lifestyle factors was associated with an incremental stepwise reduction in lifetime risk of developing heart failure. The six lifestyle factors – a forerunner of the AHA’s Life’s Simple 7 – were maintaining a normal body weight, stopping smoking, getting exercise, drinking alcohol in moderation, consuming breakfast cereals, and eating fruits and vegetables. Male physicians who shunned all six had a 21.2% lifetime risk of heart failure; those who followed at least four of the healthy lifestyle factors had a 10.1% risk (JAMA 2009 Jul 22;302[4]:394-400).

In a separate analysis from the Physicians’ Health Study, men who engaged in vigorous exercise to the point of breaking a sweat as little as one to three times per month had an 18% lower risk of developing heart failure during follow-up, compared with inactive men (Circulation 2009 Jan 6;119[1]:44-52).

What’s next in prevention of heart failure

Heart failure is one of the most expensive health care problems in the United States, and one of the deadliest. Today an estimated 6.5 million Americans have symptomatic heart failure. But that’s just the tip of the iceberg.

“Countless millions more are likely to manifest heart failure in the future,” Dr. Fonarow warned, noting the vast prevalence of identifiable risk factors.

It’s time for a high-visibility public health campaign designed to foster community education and engagement regarding heart failure prevention, he added.

“We have a lot of action and events around preventing atherosclerotic cardiovascular disease. But can you think of any campaign you’ve seen focusing specifically on heart failure? Heart failure isn’t one of the endpoints in the ACC/AHA Atherosclerotic Cardiovascular Disease Risk Calculator or even the new hypertension risk calculator, so we need to take this a whole lot more seriously,” the cardiologist said.

The 2017 focused update of the ACC/AHA heart failure guidelines endorsed a novel strategy of primary care–centered, biomarker-based screening of patients with cardiovascular risk factors as a means of triggering early intervention to prevent heart failure (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803). This strategy, which received a Class IIa recommendation, involves screening measurement of a natriuretic peptide biomarker.

The recommendation was based on evidence including the STOP-HF randomized trial (St. Vincent’s Screening to Prevent Heart Failure Study), in which 1,374 asymptomatic Irish patients with cardiovascular risk factors were randomized to routine primary care or primary care plus screening with brain-type natriuretic peptide testing. Patients with a brain-type natriuretic peptide level of 50 pg/mL or more were directed to team-based care involving a collaboration between their primary care physician and a specialist cardiovascular service focused on optimizing guideline-directed medical therapy. During a mean follow-up of 4.2 years, the primary endpoint of new-onset left ventricular dysfunction occurred in 5.3% of the intervention group and 8.7% of controls, for a 45% relative risk reduction (JAMA 2013 Jul 3;310[1]:66-74).

Dr. Fonarow reported receiving research grants from and serving as a consultant to the National Heart, Lung, and Blood Institute and a handful of medical companies.

[email protected]

SNOWMASS, COLO. – More than 960,000 new cases of heart failure will occur in the United States this year – and most of them could have been prevented, Gregg C. Fonarow, MD, asserted at the Annual Cardiovascular Conference at Snowmass.

Preventing heart failure doesn’t require heroic measures. It entails identifying high-risk individuals while they are still asymptomatic and free of structural heart disease – that is, patients who are stage A, pre–heart failure, in the American College of Cardiology/American Heart Association classification system for heart failure – and then addressing their modifiable risk factors via evidence-based, guideline-directed medical therapy, said Dr. Fonarow, professor of cardiovascular medicine and cochief of cardiology at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center.

Bruce Jancin/MDedge News

Antihypertensive therapy

More than a quarter century ago, the landmark SHEP trial (Systolic Hypertension in the Elderly Program) in more than 4,700 hypertensive seniors showed that treatment with diuretics and beta-blockers resulted in a 49% reduction in heart failure events, compared with placebo. And this has been a consistent finding in other studies: A meta-analysis of all 12 major randomized trials of antihypertensive therapy conducted over a 20-year period showed that treatment resulted in a whopping 52% reduction in the risk of heart failure (J Am Coll Cardiol. 1995 Apr; 27[5]:1214-8).

“If you ask most people why they’re on antihypertensive medication, they say, ‘Oh, to prevent heart attacks and stroke.’ But in fact the greatest relative risk reduction that we see is this remarkable reduction in the risk of developing heart failure with blood pressure treatment,” Dr. Fonarow said.

There has been some argument within medicine as to whether aggressive blood pressure lowering is appropriate in individuals over age 80. But in the HYVET trial (Hypertension in the Very Elderly Trial) conducted in that age group, the use of diuretics and/or ACE inhibitors to lower systolic blood pressure from roughly 155 mm Hg to 145 mm Hg resulted in a dramatic 64% reduction in the rate of new-onset heart failure (N Engl J Med. 2008 May 1;358[18]:1887-98).

How low to go with blood pressure reduction in order to maximize the heart failure risk reduction benefit? In the SPRINT trial (Systolic Blood Pressure Intervention Trial) of 9,361 hypertensive patients with a history of cardiovascular disease or multiple risk factors, participants randomized to a goal of less than 120 mm Hg enjoyed a 38% lower risk of heart failure events, compared with those whose target was less than 140 mm Hg (N Engl J Med. 2015 Nov 26;373[22]:2103-16).

A secondary analysis from SPRINT showed that the risk of acute decompensated heart failure was 37% lower in patients treated to the target of less than 120 mm Hg. That finding takes on particular importance because SPRINT participants who developed acute decompensated heart failure had a 27-fold increase in cardiovascular death (Circ Heart Fail. 2017 Apr; doi: 10.1161/CIRCHEARTFAILURE.116.003613).

Lipid lowering

A meta-analysis of four major, randomized clinical trials of intensive versus moderate statin therapy in 27,546 patients with stable coronary artery disease or acute coronary syndrome concluded that intensive therapy resulted in a 27% reduction in the risk of hospitalization for heart failure (J Am Coll Cardiol. 2006 Jun 6;47[11]:2326-31).
 

SGLT-2 inhibition

Until the randomized EMPA-REG OUTCOME trial of the sodium-glucose transporter 2 (SGLT-2) inhibitor empagliflozin(Jardiance), no glucose-lowering drug available for treatment of type 2 diabetes had shown any benefit in terms of reducing diabetic patients’ elevated risk of heart failure. Neither had weight loss. Abundant evidence showed that glycemic control had no impact on the risk of heart failure events. So EMPA-REG OUTCOME was cause for celebration among heart failure specialists, with its demonstration of a 35% reduction in the risk of hospitalization for heart failure, compared with placebo in more than 7,000 randomized patients. The risk of death because of heart failure was chopped by 68%. Sharp reductions in other cardiovascular events were also seen with empagliflozin (N Engl J Med. 2015 Nov 26;373[22]:2117-28).

Similar benefits were subsequently documented with another SGLT-2 inhibitor, canagliflozin(Invokana), in the CANVAS study program (N Engl J Med. 2017 Aug 17;377:644-57).

The reduction in cardiovascular mortality achieved with empagliflozin in EMPA-REG OUTCOME was actually bigger than seen with ACE inhibitors and angiotensin-receptor blockers (ARBs) in earlier landmark heart failure trials (Eur J Heart Fail. 2017 Jan;19[1]:43-53).

Dr. Fonarow views these data as “compelling.” These trials mark a huge step forward in the prevention of heart failure.

“We now for the first time in patients with diabetes have the ability to markedly prevent heart failure as well as cardiovascular death,” the cardiologist commented. “It is critical for cardiologists and heart failure specialists to play an active role in this [pharmacologic diabetes] management, as choice of therapy is a key determinant of outcomes, including survival.”

ACE inhibitors and ARBs

The ACC/AHA heart failure guidelines give a Class I recommendation to the routine use of ACE inhibitors or ARBs in patients at high risk for developing heart failure because of a history of diabetes, hypertension with associated cardiovascular risk factors, or any form of atherosclerotic vascular disease.

Lifestyle modification

Heavy drinking is known to raise the risk of heart failure. However, moderate alcohol consumption may be protective. In a classic prospective cohort study, individuals who reported consuming 1.5-4 drinks per day in the previous month had a 47% reduction in subsequent new-onset heart failure, compared with teetotalers in a multivariate analysis adjusted for conventional cardiovascular risk factors. Those who drank less than 1.5 drinks per day had a 21% reduction in heart failure risk, compared with the nondrinkers (JAMA. 2001 Apr 18;285[15]:1971-7).

In the prospective observational Physicians’ Health Study of nearly 21,000 men, adherence to six modifiable healthy lifestyle factors was associated with an incremental stepwise reduction in lifetime risk of developing heart failure. The six lifestyle factors – a forerunner of the AHA’s Life’s Simple 7 – were maintaining a normal body weight, stopping smoking, getting exercise, drinking alcohol in moderation, consuming breakfast cereals, and eating fruits and vegetables. Male physicians who shunned all six had a 21.2% lifetime risk of heart failure; those who followed at least four of the healthy lifestyle factors had a 10.1% risk (JAMA 2009 Jul 22;302[4]:394-400).

In a separate analysis from the Physicians’ Health Study, men who engaged in vigorous exercise to the point of breaking a sweat as little as one to three times per month had an 18% lower risk of developing heart failure during follow-up, compared with inactive men (Circulation 2009 Jan 6;119[1]:44-52).

What’s next in prevention of heart failure

Heart failure is one of the most expensive health care problems in the United States, and one of the deadliest. Today an estimated 6.5 million Americans have symptomatic heart failure. But that’s just the tip of the iceberg.

“Countless millions more are likely to manifest heart failure in the future,” Dr. Fonarow warned, noting the vast prevalence of identifiable risk factors.

It’s time for a high-visibility public health campaign designed to foster community education and engagement regarding heart failure prevention, he added.

“We have a lot of action and events around preventing atherosclerotic cardiovascular disease. But can you think of any campaign you’ve seen focusing specifically on heart failure? Heart failure isn’t one of the endpoints in the ACC/AHA Atherosclerotic Cardiovascular Disease Risk Calculator or even the new hypertension risk calculator, so we need to take this a whole lot more seriously,” the cardiologist said.

The 2017 focused update of the ACC/AHA heart failure guidelines endorsed a novel strategy of primary care–centered, biomarker-based screening of patients with cardiovascular risk factors as a means of triggering early intervention to prevent heart failure (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803). This strategy, which received a Class IIa recommendation, involves screening measurement of a natriuretic peptide biomarker.

The recommendation was based on evidence including the STOP-HF randomized trial (St. Vincent’s Screening to Prevent Heart Failure Study), in which 1,374 asymptomatic Irish patients with cardiovascular risk factors were randomized to routine primary care or primary care plus screening with brain-type natriuretic peptide testing. Patients with a brain-type natriuretic peptide level of 50 pg/mL or more were directed to team-based care involving a collaboration between their primary care physician and a specialist cardiovascular service focused on optimizing guideline-directed medical therapy. During a mean follow-up of 4.2 years, the primary endpoint of new-onset left ventricular dysfunction occurred in 5.3% of the intervention group and 8.7% of controls, for a 45% relative risk reduction (JAMA 2013 Jul 3;310[1]:66-74).

Dr. Fonarow reported receiving research grants from and serving as a consultant to the National Heart, Lung, and Blood Institute and a handful of medical companies.

[email protected]

SNOWMASS, COLO. – More than 960,000 new cases of heart failure will occur in the United States this year – and most of them could have been prevented, Gregg C. Fonarow, MD, asserted at the Annual Cardiovascular Conference at Snowmass.

Preventing heart failure doesn’t require heroic measures. It entails identifying high-risk individuals while they are still asymptomatic and free of structural heart disease – that is, patients who are stage A, pre–heart failure, in the American College of Cardiology/American Heart Association classification system for heart failure – and then addressing their modifiable risk factors via evidence-based, guideline-directed medical therapy, said Dr. Fonarow, professor of cardiovascular medicine and cochief of cardiology at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center.

Bruce Jancin/MDedge News

Antihypertensive therapy

More than a quarter century ago, the landmark SHEP trial (Systolic Hypertension in the Elderly Program) in more than 4,700 hypertensive seniors showed that treatment with diuretics and beta-blockers resulted in a 49% reduction in heart failure events, compared with placebo. And this has been a consistent finding in other studies: A meta-analysis of all 12 major randomized trials of antihypertensive therapy conducted over a 20-year period showed that treatment resulted in a whopping 52% reduction in the risk of heart failure (J Am Coll Cardiol. 1995 Apr; 27[5]:1214-8).

“If you ask most people why they’re on antihypertensive medication, they say, ‘Oh, to prevent heart attacks and stroke.’ But in fact the greatest relative risk reduction that we see is this remarkable reduction in the risk of developing heart failure with blood pressure treatment,” Dr. Fonarow said.

There has been some argument within medicine as to whether aggressive blood pressure lowering is appropriate in individuals over age 80. But in the HYVET trial (Hypertension in the Very Elderly Trial) conducted in that age group, the use of diuretics and/or ACE inhibitors to lower systolic blood pressure from roughly 155 mm Hg to 145 mm Hg resulted in a dramatic 64% reduction in the rate of new-onset heart failure (N Engl J Med. 2008 May 1;358[18]:1887-98).

How low to go with blood pressure reduction in order to maximize the heart failure risk reduction benefit? In the SPRINT trial (Systolic Blood Pressure Intervention Trial) of 9,361 hypertensive patients with a history of cardiovascular disease or multiple risk factors, participants randomized to a goal of less than 120 mm Hg enjoyed a 38% lower risk of heart failure events, compared with those whose target was less than 140 mm Hg (N Engl J Med. 2015 Nov 26;373[22]:2103-16).

A secondary analysis from SPRINT showed that the risk of acute decompensated heart failure was 37% lower in patients treated to the target of less than 120 mm Hg. That finding takes on particular importance because SPRINT participants who developed acute decompensated heart failure had a 27-fold increase in cardiovascular death (Circ Heart Fail. 2017 Apr; doi: 10.1161/CIRCHEARTFAILURE.116.003613).

Lipid lowering

A meta-analysis of four major, randomized clinical trials of intensive versus moderate statin therapy in 27,546 patients with stable coronary artery disease or acute coronary syndrome concluded that intensive therapy resulted in a 27% reduction in the risk of hospitalization for heart failure (J Am Coll Cardiol. 2006 Jun 6;47[11]:2326-31).
 

SGLT-2 inhibition

Until the randomized EMPA-REG OUTCOME trial of the sodium-glucose transporter 2 (SGLT-2) inhibitor empagliflozin(Jardiance), no glucose-lowering drug available for treatment of type 2 diabetes had shown any benefit in terms of reducing diabetic patients’ elevated risk of heart failure. Neither had weight loss. Abundant evidence showed that glycemic control had no impact on the risk of heart failure events. So EMPA-REG OUTCOME was cause for celebration among heart failure specialists, with its demonstration of a 35% reduction in the risk of hospitalization for heart failure, compared with placebo in more than 7,000 randomized patients. The risk of death because of heart failure was chopped by 68%. Sharp reductions in other cardiovascular events were also seen with empagliflozin (N Engl J Med. 2015 Nov 26;373[22]:2117-28).

Similar benefits were subsequently documented with another SGLT-2 inhibitor, canagliflozin(Invokana), in the CANVAS study program (N Engl J Med. 2017 Aug 17;377:644-57).

The reduction in cardiovascular mortality achieved with empagliflozin in EMPA-REG OUTCOME was actually bigger than seen with ACE inhibitors and angiotensin-receptor blockers (ARBs) in earlier landmark heart failure trials (Eur J Heart Fail. 2017 Jan;19[1]:43-53).

Dr. Fonarow views these data as “compelling.” These trials mark a huge step forward in the prevention of heart failure.

“We now for the first time in patients with diabetes have the ability to markedly prevent heart failure as well as cardiovascular death,” the cardiologist commented. “It is critical for cardiologists and heart failure specialists to play an active role in this [pharmacologic diabetes] management, as choice of therapy is a key determinant of outcomes, including survival.”

ACE inhibitors and ARBs

The ACC/AHA heart failure guidelines give a Class I recommendation to the routine use of ACE inhibitors or ARBs in patients at high risk for developing heart failure because of a history of diabetes, hypertension with associated cardiovascular risk factors, or any form of atherosclerotic vascular disease.

Lifestyle modification

Heavy drinking is known to raise the risk of heart failure. However, moderate alcohol consumption may be protective. In a classic prospective cohort study, individuals who reported consuming 1.5-4 drinks per day in the previous month had a 47% reduction in subsequent new-onset heart failure, compared with teetotalers in a multivariate analysis adjusted for conventional cardiovascular risk factors. Those who drank less than 1.5 drinks per day had a 21% reduction in heart failure risk, compared with the nondrinkers (JAMA. 2001 Apr 18;285[15]:1971-7).

In the prospective observational Physicians’ Health Study of nearly 21,000 men, adherence to six modifiable healthy lifestyle factors was associated with an incremental stepwise reduction in lifetime risk of developing heart failure. The six lifestyle factors – a forerunner of the AHA’s Life’s Simple 7 – were maintaining a normal body weight, stopping smoking, getting exercise, drinking alcohol in moderation, consuming breakfast cereals, and eating fruits and vegetables. Male physicians who shunned all six had a 21.2% lifetime risk of heart failure; those who followed at least four of the healthy lifestyle factors had a 10.1% risk (JAMA 2009 Jul 22;302[4]:394-400).

In a separate analysis from the Physicians’ Health Study, men who engaged in vigorous exercise to the point of breaking a sweat as little as one to three times per month had an 18% lower risk of developing heart failure during follow-up, compared with inactive men (Circulation 2009 Jan 6;119[1]:44-52).

What’s next in prevention of heart failure

Heart failure is one of the most expensive health care problems in the United States, and one of the deadliest. Today an estimated 6.5 million Americans have symptomatic heart failure. But that’s just the tip of the iceberg.

“Countless millions more are likely to manifest heart failure in the future,” Dr. Fonarow warned, noting the vast prevalence of identifiable risk factors.

It’s time for a high-visibility public health campaign designed to foster community education and engagement regarding heart failure prevention, he added.

“We have a lot of action and events around preventing atherosclerotic cardiovascular disease. But can you think of any campaign you’ve seen focusing specifically on heart failure? Heart failure isn’t one of the endpoints in the ACC/AHA Atherosclerotic Cardiovascular Disease Risk Calculator or even the new hypertension risk calculator, so we need to take this a whole lot more seriously,” the cardiologist said.

The 2017 focused update of the ACC/AHA heart failure guidelines endorsed a novel strategy of primary care–centered, biomarker-based screening of patients with cardiovascular risk factors as a means of triggering early intervention to prevent heart failure (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803). This strategy, which received a Class IIa recommendation, involves screening measurement of a natriuretic peptide biomarker.

The recommendation was based on evidence including the STOP-HF randomized trial (St. Vincent’s Screening to Prevent Heart Failure Study), in which 1,374 asymptomatic Irish patients with cardiovascular risk factors were randomized to routine primary care or primary care plus screening with brain-type natriuretic peptide testing. Patients with a brain-type natriuretic peptide level of 50 pg/mL or more were directed to team-based care involving a collaboration between their primary care physician and a specialist cardiovascular service focused on optimizing guideline-directed medical therapy. During a mean follow-up of 4.2 years, the primary endpoint of new-onset left ventricular dysfunction occurred in 5.3% of the intervention group and 8.7% of controls, for a 45% relative risk reduction (JAMA 2013 Jul 3;310[1]:66-74).

Dr. Fonarow reported receiving research grants from and serving as a consultant to the National Heart, Lung, and Blood Institute and a handful of medical companies.

[email protected]

Jason Blair, DO, recently was named an honorary Fellow by the American College of Osteopathic Internists (ACOI) for excellence in the practice of internal medicine. Dr. Blair currently is a hospitalist at Lake Regional Health System in Osage Beach, Mo.

The degree of Fellow is given to physicians who demonstrate continuing professional accomplishments, scholarship, and professional activities, including teaching, research, and community service. The ACOI represents more than 5,000 osteopathic internists and subspecialists nationwide. Dr. Blair joined Lake Regional in 2017.
 

Dr. Howell is the division director of the Collaborative Inpatient Medicine Service (CIMS) and a professor of medicine at the Johns Hopkins Bayview Medical Center in Baltimore. He received the award for his work with project EQUIP (Excellence in Quality, Utilization Integration, and Patient-Centered Care) to improve quality and efficiency and to reduce mortality, emergency department boarding, and patient lengths of stay.
 

David Svec, MD, MBA, has been named the new chief medical officer at Stanford Health Care – ValleyCare in Pleasanton, Calif. Dr. Svec has served as a hospitalist and internal medicine specialist at ValleyCare for the past 6 years. Previously, he was ValleyCare’s medical director of the hospitalist team and a clinical assistant professor of medicine. Dr. Svec helped develop the hospitalist program at ValleyCare and will continue to work in that capacity while advancing into his new role.

As CMO, Dr. Svec will carry on the mission of Stanford Health Care, including increasing innovative programs, monitoring outcome measures, and developing and implementing improvement plans.

Dr. Svec earned Stanford Health Care’s 2016 David A. Rytand Clinical Teaching Award, the 2016 Lawrence Mathers Award: Exceptional Commitment to Teaching/Active Involvement in Medical Student Education, and the 2014 Arthur L. Bloomfield Award for Excellence in Clinical Teaching.
 

Brent Baboolal, MD, recently was selected by the International Association of HealthCare Professionals to be part of the Leading Physicians of the World. Dr. Baboolal is an internist and a hospitalist serving the Texas Health Presbyterian Hospital in Dallas.

Trained in Grenada, Dr. Baboolal came to the United States in 2009 and began work at Stamford (Conn.) Hospital. He is board certified by the American Board of Internal Medicine and is renowned as a leading internist and hospitalist. He is a former associate professor at the University of Texas School of Nursing.

BUSINESS MOVES

Sound Physicians in Tacoma, Wash., recently announced that it will take over providing hospitalist services for SSM Health DePaul Hospital and SSM Health St. Mary’s Hospital in St. Louis. Sound Physicians already had been running critical care at SSM Health St. Clare Hospital, Fenton, Mo.

SSM Health is a Catholic, faith-based, nonprofit health system serving communities in Illinois, Missouri, Oklahoma, and Wisconsin.

“We have been impressed with their efficiency and professionalism of establishing Sound Physicians’ infrastructure that supports providers and implementing processes to drive improved outcomes,” said Rajiv Patel, MD, vice president of medical affairs for SSM Health DePaul Hospital.

Sound Physicians prides itself on improving quality and lowering costs of acute care for health organizations and facilities. Sound provides emergency medicine, hospital medicine, critical care, transitional care, and advisory services for its partners nationwide.
 

Pittsburgh-based health leaders Highmark Health and Allegheny Health Network, and Erie, Pa.–based Lecom Health have agreed to establish an affiliation with Warren (Pa.) General Hospital, a full-service, 87-bed facility about an hour from Erie. The agreement will provide Warren General with capital to make improvements to its maternity unit and radiation oncology equipment, among other services.

The partnership includes Warren General agreeing to use Allegheny Health Network (AHN) affiliates for clinical, emergency, and hospitalist services, and Warren General physicians will join the AHN integrated network. AHN, Highmark, and Lecom will assist Warren General with capital investments and community health reinvestment projects.
 

Hospitalist group Adfinitas Health in Hanover, Md., announced it has acquired a majority interest in Advanced Inpatient Medicine in Lakeville, Pa. Advanced Inpatient Medicine (AIM) provides hospitalist services for four hospitals and several acute care and skilled nursing facilities in Northeastern Pennsylvania.

AIM and its 40 employees join Adfinitas, which has partnership agreements with 14 hospitals and 40 postacute facilities in Maryland, Virginia, and Michigan. AIM and Adfinitas share the theory of integrating advanced practice providers, such as nurse practitioners and physician assistants, into their physician-led care teams.

Jason Blair, DO, recently was named an honorary Fellow by the American College of Osteopathic Internists (ACOI) for excellence in the practice of internal medicine. Dr. Blair currently is a hospitalist at Lake Regional Health System in Osage Beach, Mo.

The degree of Fellow is given to physicians who demonstrate continuing professional accomplishments, scholarship, and professional activities, including teaching, research, and community service. The ACOI represents more than 5,000 osteopathic internists and subspecialists nationwide. Dr. Blair joined Lake Regional in 2017.
 

Dr. Howell is the division director of the Collaborative Inpatient Medicine Service (CIMS) and a professor of medicine at the Johns Hopkins Bayview Medical Center in Baltimore. He received the award for his work with project EQUIP (Excellence in Quality, Utilization Integration, and Patient-Centered Care) to improve quality and efficiency and to reduce mortality, emergency department boarding, and patient lengths of stay.
 

David Svec, MD, MBA, has been named the new chief medical officer at Stanford Health Care – ValleyCare in Pleasanton, Calif. Dr. Svec has served as a hospitalist and internal medicine specialist at ValleyCare for the past 6 years. Previously, he was ValleyCare’s medical director of the hospitalist team and a clinical assistant professor of medicine. Dr. Svec helped develop the hospitalist program at ValleyCare and will continue to work in that capacity while advancing into his new role.

As CMO, Dr. Svec will carry on the mission of Stanford Health Care, including increasing innovative programs, monitoring outcome measures, and developing and implementing improvement plans.

Dr. Svec earned Stanford Health Care’s 2016 David A. Rytand Clinical Teaching Award, the 2016 Lawrence Mathers Award: Exceptional Commitment to Teaching/Active Involvement in Medical Student Education, and the 2014 Arthur L. Bloomfield Award for Excellence in Clinical Teaching.
 

Brent Baboolal, MD, recently was selected by the International Association of HealthCare Professionals to be part of the Leading Physicians of the World. Dr. Baboolal is an internist and a hospitalist serving the Texas Health Presbyterian Hospital in Dallas.

Trained in Grenada, Dr. Baboolal came to the United States in 2009 and began work at Stamford (Conn.) Hospital. He is board certified by the American Board of Internal Medicine and is renowned as a leading internist and hospitalist. He is a former associate professor at the University of Texas School of Nursing.

BUSINESS MOVES

Sound Physicians in Tacoma, Wash., recently announced that it will take over providing hospitalist services for SSM Health DePaul Hospital and SSM Health St. Mary’s Hospital in St. Louis. Sound Physicians already had been running critical care at SSM Health St. Clare Hospital, Fenton, Mo.

SSM Health is a Catholic, faith-based, nonprofit health system serving communities in Illinois, Missouri, Oklahoma, and Wisconsin.

“We have been impressed with their efficiency and professionalism of establishing Sound Physicians’ infrastructure that supports providers and implementing processes to drive improved outcomes,” said Rajiv Patel, MD, vice president of medical affairs for SSM Health DePaul Hospital.

Sound Physicians prides itself on improving quality and lowering costs of acute care for health organizations and facilities. Sound provides emergency medicine, hospital medicine, critical care, transitional care, and advisory services for its partners nationwide.
 

Pittsburgh-based health leaders Highmark Health and Allegheny Health Network, and Erie, Pa.–based Lecom Health have agreed to establish an affiliation with Warren (Pa.) General Hospital, a full-service, 87-bed facility about an hour from Erie. The agreement will provide Warren General with capital to make improvements to its maternity unit and radiation oncology equipment, among other services.

The partnership includes Warren General agreeing to use Allegheny Health Network (AHN) affiliates for clinical, emergency, and hospitalist services, and Warren General physicians will join the AHN integrated network. AHN, Highmark, and Lecom will assist Warren General with capital investments and community health reinvestment projects.
 

Hospitalist group Adfinitas Health in Hanover, Md., announced it has acquired a majority interest in Advanced Inpatient Medicine in Lakeville, Pa. Advanced Inpatient Medicine (AIM) provides hospitalist services for four hospitals and several acute care and skilled nursing facilities in Northeastern Pennsylvania.

AIM and its 40 employees join Adfinitas, which has partnership agreements with 14 hospitals and 40 postacute facilities in Maryland, Virginia, and Michigan. AIM and Adfinitas share the theory of integrating advanced practice providers, such as nurse practitioners and physician assistants, into their physician-led care teams.

Jason Blair, DO, recently was named an honorary Fellow by the American College of Osteopathic Internists (ACOI) for excellence in the practice of internal medicine. Dr. Blair currently is a hospitalist at Lake Regional Health System in Osage Beach, Mo.

The degree of Fellow is given to physicians who demonstrate continuing professional accomplishments, scholarship, and professional activities, including teaching, research, and community service. The ACOI represents more than 5,000 osteopathic internists and subspecialists nationwide. Dr. Blair joined Lake Regional in 2017.
 

Dr. Howell is the division director of the Collaborative Inpatient Medicine Service (CIMS) and a professor of medicine at the Johns Hopkins Bayview Medical Center in Baltimore. He received the award for his work with project EQUIP (Excellence in Quality, Utilization Integration, and Patient-Centered Care) to improve quality and efficiency and to reduce mortality, emergency department boarding, and patient lengths of stay.
 

David Svec, MD, MBA, has been named the new chief medical officer at Stanford Health Care – ValleyCare in Pleasanton, Calif. Dr. Svec has served as a hospitalist and internal medicine specialist at ValleyCare for the past 6 years. Previously, he was ValleyCare’s medical director of the hospitalist team and a clinical assistant professor of medicine. Dr. Svec helped develop the hospitalist program at ValleyCare and will continue to work in that capacity while advancing into his new role.

As CMO, Dr. Svec will carry on the mission of Stanford Health Care, including increasing innovative programs, monitoring outcome measures, and developing and implementing improvement plans.

Dr. Svec earned Stanford Health Care’s 2016 David A. Rytand Clinical Teaching Award, the 2016 Lawrence Mathers Award: Exceptional Commitment to Teaching/Active Involvement in Medical Student Education, and the 2014 Arthur L. Bloomfield Award for Excellence in Clinical Teaching.
 

Brent Baboolal, MD, recently was selected by the International Association of HealthCare Professionals to be part of the Leading Physicians of the World. Dr. Baboolal is an internist and a hospitalist serving the Texas Health Presbyterian Hospital in Dallas.

Trained in Grenada, Dr. Baboolal came to the United States in 2009 and began work at Stamford (Conn.) Hospital. He is board certified by the American Board of Internal Medicine and is renowned as a leading internist and hospitalist. He is a former associate professor at the University of Texas School of Nursing.

BUSINESS MOVES

Sound Physicians in Tacoma, Wash., recently announced that it will take over providing hospitalist services for SSM Health DePaul Hospital and SSM Health St. Mary’s Hospital in St. Louis. Sound Physicians already had been running critical care at SSM Health St. Clare Hospital, Fenton, Mo.

SSM Health is a Catholic, faith-based, nonprofit health system serving communities in Illinois, Missouri, Oklahoma, and Wisconsin.

“We have been impressed with their efficiency and professionalism of establishing Sound Physicians’ infrastructure that supports providers and implementing processes to drive improved outcomes,” said Rajiv Patel, MD, vice president of medical affairs for SSM Health DePaul Hospital.

Sound Physicians prides itself on improving quality and lowering costs of acute care for health organizations and facilities. Sound provides emergency medicine, hospital medicine, critical care, transitional care, and advisory services for its partners nationwide.
 

Pittsburgh-based health leaders Highmark Health and Allegheny Health Network, and Erie, Pa.–based Lecom Health have agreed to establish an affiliation with Warren (Pa.) General Hospital, a full-service, 87-bed facility about an hour from Erie. The agreement will provide Warren General with capital to make improvements to its maternity unit and radiation oncology equipment, among other services.

The partnership includes Warren General agreeing to use Allegheny Health Network (AHN) affiliates for clinical, emergency, and hospitalist services, and Warren General physicians will join the AHN integrated network. AHN, Highmark, and Lecom will assist Warren General with capital investments and community health reinvestment projects.
 

Hospitalist group Adfinitas Health in Hanover, Md., announced it has acquired a majority interest in Advanced Inpatient Medicine in Lakeville, Pa. Advanced Inpatient Medicine (AIM) provides hospitalist services for four hospitals and several acute care and skilled nursing facilities in Northeastern Pennsylvania.

AIM and its 40 employees join Adfinitas, which has partnership agreements with 14 hospitals and 40 postacute facilities in Maryland, Virginia, and Michigan. AIM and Adfinitas share the theory of integrating advanced practice providers, such as nurse practitioners and physician assistants, into their physician-led care teams.

ORLANDO – Hospitals in the first quartile of short-term performance in treating heart failure patients had higher long-term survival rates for those patients, based on data from 317 hospitals that participated in a voluntary quality improvement program.

The burden of heart failure remains substantial in the United States, and health policies are increasingly focused on improving care for heart failure patients, said Ambarish Pandey, MD, of the University of Texas, Dallas, in a presentation at the annual meeting of the American College of Cardiology.

Heidi Splete/Frontline Medical News

SOURCE: Pandy A. ACC 2018.

ORLANDO – Hospitals in the first quartile of short-term performance in treating heart failure patients had higher long-term survival rates for those patients, based on data from 317 hospitals that participated in a voluntary quality improvement program.

The burden of heart failure remains substantial in the United States, and health policies are increasingly focused on improving care for heart failure patients, said Ambarish Pandey, MD, of the University of Texas, Dallas, in a presentation at the annual meeting of the American College of Cardiology.

Heidi Splete/Frontline Medical News

SOURCE: Pandy A. ACC 2018.

ORLANDO – Hospitals in the first quartile of short-term performance in treating heart failure patients had higher long-term survival rates for those patients, based on data from 317 hospitals that participated in a voluntary quality improvement program.

The burden of heart failure remains substantial in the United States, and health policies are increasingly focused on improving care for heart failure patients, said Ambarish Pandey, MD, of the University of Texas, Dallas, in a presentation at the annual meeting of the American College of Cardiology.

Heidi Splete/Frontline Medical News

SOURCE: Pandy A. ACC 2018.

Federal programs can be enormously complicated, and the Medicare value-based payment programs, such as the Physician Quality Reporting System, the physician value-based payment modifier, and the new Merit-Based Incentive Payment System, are no exception.

It can be a challenge to navigate the rules, to identify how and which measures to report, and to determine how to integrate those requirements into your practice. Furthermore, the feedback from these programs to providers can be difficult to read and interpret.

Part of the value of being a member of the Society of Hospital Medicine (SHM) is having another set of eyes – particularly those that spend a significant amount of time immersed in federal regulations – to parse the policy-practice nexus. SHM hears from members all over the country, many in different practice types and with different policy needs. This knowledge can be shared, both with other members and with policymakers. A recent example highlights the power of this relationship.

Your membership contributes directly to the advocacy efforts of SHM, and the engagement of members with SHM staff on policy issues is a force multiplier for the effect SHM can have on policy decisions. There is a lot of value for belonging to SHM, and sometimes, we can put an exact number on it.

A solo-practicing hospitalist called seeking perspective on why he received a letter indicating he would be receiving a penalty in 2018 for failing the requirements of Physician Quality Reporting System reporting. This hospitalist had successfully reported on as many measures as he possibly could, so he could not understand why he would be receiving a penalty.

All told, a different read of the feedback reports, and some strategic questions from SHM staff, helped this hospitalist understand why he was being penalized and how, in this case, he could ask Centers for Medicare & Medicaid Services for reconsideration. Upon second review by CMS, the penalties were overturned, and this provider should save nearly $30,000 in Medicare payments in 2018.

SHM helped the provider by being a sounding board and by sharing information learned from experiences other members had had with these programs. In turn, the knowledge gained from this interaction will be used to fine-tune SHM’s educational materials and outreach efforts about these programs. It has also already contributed to advocacy efforts with CMS policymakers regarding how they can improve the programs to be more transparent and equitable. The learning is shared in both directions.

Mr. Lapps is the government relations manager at the Society of Hospital Medicine.

Federal programs can be enormously complicated, and the Medicare value-based payment programs, such as the Physician Quality Reporting System, the physician value-based payment modifier, and the new Merit-Based Incentive Payment System, are no exception.

It can be a challenge to navigate the rules, to identify how and which measures to report, and to determine how to integrate those requirements into your practice. Furthermore, the feedback from these programs to providers can be difficult to read and interpret.

Part of the value of being a member of the Society of Hospital Medicine (SHM) is having another set of eyes – particularly those that spend a significant amount of time immersed in federal regulations – to parse the policy-practice nexus. SHM hears from members all over the country, many in different practice types and with different policy needs. This knowledge can be shared, both with other members and with policymakers. A recent example highlights the power of this relationship.

Your membership contributes directly to the advocacy efforts of SHM, and the engagement of members with SHM staff on policy issues is a force multiplier for the effect SHM can have on policy decisions. There is a lot of value for belonging to SHM, and sometimes, we can put an exact number on it.

A solo-practicing hospitalist called seeking perspective on why he received a letter indicating he would be receiving a penalty in 2018 for failing the requirements of Physician Quality Reporting System reporting. This hospitalist had successfully reported on as many measures as he possibly could, so he could not understand why he would be receiving a penalty.

All told, a different read of the feedback reports, and some strategic questions from SHM staff, helped this hospitalist understand why he was being penalized and how, in this case, he could ask Centers for Medicare & Medicaid Services for reconsideration. Upon second review by CMS, the penalties were overturned, and this provider should save nearly $30,000 in Medicare payments in 2018.

SHM helped the provider by being a sounding board and by sharing information learned from experiences other members had had with these programs. In turn, the knowledge gained from this interaction will be used to fine-tune SHM’s educational materials and outreach efforts about these programs. It has also already contributed to advocacy efforts with CMS policymakers regarding how they can improve the programs to be more transparent and equitable. The learning is shared in both directions.

Mr. Lapps is the government relations manager at the Society of Hospital Medicine.

Federal programs can be enormously complicated, and the Medicare value-based payment programs, such as the Physician Quality Reporting System, the physician value-based payment modifier, and the new Merit-Based Incentive Payment System, are no exception.

It can be a challenge to navigate the rules, to identify how and which measures to report, and to determine how to integrate those requirements into your practice. Furthermore, the feedback from these programs to providers can be difficult to read and interpret.

Part of the value of being a member of the Society of Hospital Medicine (SHM) is having another set of eyes – particularly those that spend a significant amount of time immersed in federal regulations – to parse the policy-practice nexus. SHM hears from members all over the country, many in different practice types and with different policy needs. This knowledge can be shared, both with other members and with policymakers. A recent example highlights the power of this relationship.

Your membership contributes directly to the advocacy efforts of SHM, and the engagement of members with SHM staff on policy issues is a force multiplier for the effect SHM can have on policy decisions. There is a lot of value for belonging to SHM, and sometimes, we can put an exact number on it.

A solo-practicing hospitalist called seeking perspective on why he received a letter indicating he would be receiving a penalty in 2018 for failing the requirements of Physician Quality Reporting System reporting. This hospitalist had successfully reported on as many measures as he possibly could, so he could not understand why he would be receiving a penalty.

All told, a different read of the feedback reports, and some strategic questions from SHM staff, helped this hospitalist understand why he was being penalized and how, in this case, he could ask Centers for Medicare & Medicaid Services for reconsideration. Upon second review by CMS, the penalties were overturned, and this provider should save nearly $30,000 in Medicare payments in 2018.

SHM helped the provider by being a sounding board and by sharing information learned from experiences other members had had with these programs. In turn, the knowledge gained from this interaction will be used to fine-tune SHM’s educational materials and outreach efforts about these programs. It has also already contributed to advocacy efforts with CMS policymakers regarding how they can improve the programs to be more transparent and equitable. The learning is shared in both directions.

Mr. Lapps is the government relations manager at the Society of Hospital Medicine.

Hospital boards play an important role in quality improvement (QI), and now researchers in England have developed a framework they can use to help develop their QI capability by comparing 15 health care organizations.

“We already know that certain board practices are associated with higher quality care,” said lead researcher Lorelei Jones, PhD. “For example, hospital boards that regularly review quality performance have better patient outcomes. But we don’t know a lot about what boards actually do, or what ‘good’ looks like in relation to quality governance. There is a lot of guidance for boards on what they should be doing, but very little research evidence.”

In their study, researchers developed an evidence-based measure of QI “maturity” – how developed boards were in how they led and oversaw quality improvement. They applied this measure to various organizations and then looked at the characteristics of organizations that showed a highly developed approach to QI.

“Organizations with higher levels of QI maturity prioritized QI; balanced attention to short-term (external) priorities with a long-term (internal) investment in QI; used data for quality improvement, not just quality assurance; engaged staff and patients in QI; and had a culture of continuous improvement,” Dr. Jones said. These characteristics often seemed to be facilitated by clinical leaders; the study also highlighted the importance of board-level clinical leaders in hospitals, she said.

Researchers found that organizations with a highly developed approach to QI did the following:

• Brought in-depth knowledge and understanding of quality issues and provided the board with meaningful analyses of data.
• Contributed knowledge of relevant developments in national policy and links to external networks.
• Played an important role as “boundary spanners,” providing a link between “the board and the ward,” making connections between sources of data and aligning external demands with internal priorities.

“Boards can use our framework to help develop their QI capability,” Dr. Jones said. “For example, boards can use it to do a gap analysis to explore areas that might need strengthening and for ideas on how they could do this.”

Reference

Jones L et al. How do hospital boards govern for quality improvement? A mixed methods study of 15 organisations in England. BMJ Qual Saf. 2017 Dec;26(12):978-86.

Hospital boards play an important role in quality improvement (QI), and now researchers in England have developed a framework they can use to help develop their QI capability by comparing 15 health care organizations.

“We already know that certain board practices are associated with higher quality care,” said lead researcher Lorelei Jones, PhD. “For example, hospital boards that regularly review quality performance have better patient outcomes. But we don’t know a lot about what boards actually do, or what ‘good’ looks like in relation to quality governance. There is a lot of guidance for boards on what they should be doing, but very little research evidence.”

In their study, researchers developed an evidence-based measure of QI “maturity” – how developed boards were in how they led and oversaw quality improvement. They applied this measure to various organizations and then looked at the characteristics of organizations that showed a highly developed approach to QI.

“Organizations with higher levels of QI maturity prioritized QI; balanced attention to short-term (external) priorities with a long-term (internal) investment in QI; used data for quality improvement, not just quality assurance; engaged staff and patients in QI; and had a culture of continuous improvement,” Dr. Jones said. These characteristics often seemed to be facilitated by clinical leaders; the study also highlighted the importance of board-level clinical leaders in hospitals, she said.

Researchers found that organizations with a highly developed approach to QI did the following:

• Brought in-depth knowledge and understanding of quality issues and provided the board with meaningful analyses of data.
• Contributed knowledge of relevant developments in national policy and links to external networks.
• Played an important role as “boundary spanners,” providing a link between “the board and the ward,” making connections between sources of data and aligning external demands with internal priorities.

“Boards can use our framework to help develop their QI capability,” Dr. Jones said. “For example, boards can use it to do a gap analysis to explore areas that might need strengthening and for ideas on how they could do this.”

Reference

Jones L et al. How do hospital boards govern for quality improvement? A mixed methods study of 15 organisations in England. BMJ Qual Saf. 2017 Dec;26(12):978-86.

Hospital boards play an important role in quality improvement (QI), and now researchers in England have developed a framework they can use to help develop their QI capability by comparing 15 health care organizations.

“We already know that certain board practices are associated with higher quality care,” said lead researcher Lorelei Jones, PhD. “For example, hospital boards that regularly review quality performance have better patient outcomes. But we don’t know a lot about what boards actually do, or what ‘good’ looks like in relation to quality governance. There is a lot of guidance for boards on what they should be doing, but very little research evidence.”

In their study, researchers developed an evidence-based measure of QI “maturity” – how developed boards were in how they led and oversaw quality improvement. They applied this measure to various organizations and then looked at the characteristics of organizations that showed a highly developed approach to QI.

“Organizations with higher levels of QI maturity prioritized QI; balanced attention to short-term (external) priorities with a long-term (internal) investment in QI; used data for quality improvement, not just quality assurance; engaged staff and patients in QI; and had a culture of continuous improvement,” Dr. Jones said. These characteristics often seemed to be facilitated by clinical leaders; the study also highlighted the importance of board-level clinical leaders in hospitals, she said.

Researchers found that organizations with a highly developed approach to QI did the following:

• Brought in-depth knowledge and understanding of quality issues and provided the board with meaningful analyses of data.
• Contributed knowledge of relevant developments in national policy and links to external networks.
• Played an important role as “boundary spanners,” providing a link between “the board and the ward,” making connections between sources of data and aligning external demands with internal priorities.

“Boards can use our framework to help develop their QI capability,” Dr. Jones said. “For example, boards can use it to do a gap analysis to explore areas that might need strengthening and for ideas on how they could do this.”

Reference

Jones L et al. How do hospital boards govern for quality improvement? A mixed methods study of 15 organisations in England. BMJ Qual Saf. 2017 Dec;26(12):978-86.

ORLANDO – Andexanet alfa, a new agent that reverses the anticoagulant effect of direct factor Xa inhibitors, showed an acceptable level of efficacy and safety in 227 patients who received the drug in the agent’s pivotal trial.

These results, which placed andexanet in the same ballpark for efficacy and safety as idarucizumab (Praxbind), approved in 2015 for reversing the anticoagulant dabigatran (Pradaxa), suggest that andexanet is likely on track for its own Food and Drug Administration marketing approval, Stuart Connolly, MD, said at the annual meeting of the American College of Cardiology.

Mitchel L. Zoler/MDedge News

Portola Pharmaceuticals, the company developing andexanet alfa (AndexXa) previously announced that it expected Food and Drug Administration action on its marketing application by May 2018.

Andexanet reversal “has similar efficacy and safety as seen with other reversal agents” for other types of anticoagulants, said Dr. Connolly, a professor of medicine and an electrophysiologist at McMaster University in Hamilton, Ont. In the trial results he reported, andexanet treatment of patients who were bleeding while on treatment with a direct factor Xa inhibitor had an 83% rate of hemostatic efficacy and an 11% rate of thrombotic events. By comparison, idarucizumab, the FDA-approved reversal agent for the anticoagulant dabigatran, produced a 68% hemostatic efficacy and a 6% rate of thrombotic events in the idarucizumab pivotal trial, RE-VERSE AD (N Engl J Med. 2015 Aug 6;373[6]:511-20).

Clinicians administered andexanet alfa as a bolus followed by a 2-hour continuous infusion, with hemostatic efficacy assessed 12 hours after the start of treatment. The results showed that factor Xa inhibition fell by about 75%-90% within minutes of starting the bolus and remained depressed at that level during the infusion but then began recovering by 2 hours after the stop of infusion. Andexanet is a factor Xa “decoy” molecule that acts by latching onto the inhibitor molecules and thereby preventing them from interacting with actual factor Xa, but andexanet also has a short half life and hence the effect quickly reduces once treatment stops.

“There is no doubt that andexanet rapidly decreases anti–factor Xa activity,” he said.

Adjudicated efficacy results were available for 132 patients and showed good or excellent hemostasis achieved on andexanet in 109 patients (83%), Dr. Connolly reported. The effect on hemostasis was consistent regardless of patient age, sex, bleeding site, type of anticoagulant, and dosage tested.

Thrombotic events during the 30 days following treatment occurred in 24 of 227 patients (11%) who received andexanet and were evaluable for safety. Notably, no clustering of thrombotic events occurred early, even among the 129 patients who restarted on an anticoagulant during the 30 days after treatment. Among the 129 patients who restarted on an anticoagulant, 9 (7%) had a thrombotic event during the 30-day follow-up, compared with 15 events among 98 patients (15%) who did not restart on an anticoagulant.

Dr. Connolly acknowledged that a limitation of the ANNEXA-4 study is the absence of a control group, but he added that he and his associates believed randomizing patients with a serious bleed to placebo control would not have been “practical, feasible, or ethical.”

ANNEXA-4 is sponsored by Portola Pharmaceuticals, the company developing andexanet alfa (AndexXa). Dr. Connolly has been a consultant to Portola, and also to Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, and Sanofi-Aventis. Dr. Kirtane has received research support from several device manufacturers.

[email protected]

SOURCE: Connolly S. ACC 2018.

ORLANDO – Andexanet alfa, a new agent that reverses the anticoagulant effect of direct factor Xa inhibitors, showed an acceptable level of efficacy and safety in 227 patients who received the drug in the agent’s pivotal trial.

These results, which placed andexanet in the same ballpark for efficacy and safety as idarucizumab (Praxbind), approved in 2015 for reversing the anticoagulant dabigatran (Pradaxa), suggest that andexanet is likely on track for its own Food and Drug Administration marketing approval, Stuart Connolly, MD, said at the annual meeting of the American College of Cardiology.

Mitchel L. Zoler/MDedge News

Portola Pharmaceuticals, the company developing andexanet alfa (AndexXa) previously announced that it expected Food and Drug Administration action on its marketing application by May 2018.

Andexanet reversal “has similar efficacy and safety as seen with other reversal agents” for other types of anticoagulants, said Dr. Connolly, a professor of medicine and an electrophysiologist at McMaster University in Hamilton, Ont. In the trial results he reported, andexanet treatment of patients who were bleeding while on treatment with a direct factor Xa inhibitor had an 83% rate of hemostatic efficacy and an 11% rate of thrombotic events. By comparison, idarucizumab, the FDA-approved reversal agent for the anticoagulant dabigatran, produced a 68% hemostatic efficacy and a 6% rate of thrombotic events in the idarucizumab pivotal trial, RE-VERSE AD (N Engl J Med. 2015 Aug 6;373[6]:511-20).

Clinicians administered andexanet alfa as a bolus followed by a 2-hour continuous infusion, with hemostatic efficacy assessed 12 hours after the start of treatment. The results showed that factor Xa inhibition fell by about 75%-90% within minutes of starting the bolus and remained depressed at that level during the infusion but then began recovering by 2 hours after the stop of infusion. Andexanet is a factor Xa “decoy” molecule that acts by latching onto the inhibitor molecules and thereby preventing them from interacting with actual factor Xa, but andexanet also has a short half life and hence the effect quickly reduces once treatment stops.

“There is no doubt that andexanet rapidly decreases anti–factor Xa activity,” he said.

Adjudicated efficacy results were available for 132 patients and showed good or excellent hemostasis achieved on andexanet in 109 patients (83%), Dr. Connolly reported. The effect on hemostasis was consistent regardless of patient age, sex, bleeding site, type of anticoagulant, and dosage tested.

Thrombotic events during the 30 days following treatment occurred in 24 of 227 patients (11%) who received andexanet and were evaluable for safety. Notably, no clustering of thrombotic events occurred early, even among the 129 patients who restarted on an anticoagulant during the 30 days after treatment. Among the 129 patients who restarted on an anticoagulant, 9 (7%) had a thrombotic event during the 30-day follow-up, compared with 15 events among 98 patients (15%) who did not restart on an anticoagulant.

Dr. Connolly acknowledged that a limitation of the ANNEXA-4 study is the absence of a control group, but he added that he and his associates believed randomizing patients with a serious bleed to placebo control would not have been “practical, feasible, or ethical.”

ANNEXA-4 is sponsored by Portola Pharmaceuticals, the company developing andexanet alfa (AndexXa). Dr. Connolly has been a consultant to Portola, and also to Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, and Sanofi-Aventis. Dr. Kirtane has received research support from several device manufacturers.

[email protected]

SOURCE: Connolly S. ACC 2018.

ORLANDO – Andexanet alfa, a new agent that reverses the anticoagulant effect of direct factor Xa inhibitors, showed an acceptable level of efficacy and safety in 227 patients who received the drug in the agent’s pivotal trial.

These results, which placed andexanet in the same ballpark for efficacy and safety as idarucizumab (Praxbind), approved in 2015 for reversing the anticoagulant dabigatran (Pradaxa), suggest that andexanet is likely on track for its own Food and Drug Administration marketing approval, Stuart Connolly, MD, said at the annual meeting of the American College of Cardiology.

Mitchel L. Zoler/MDedge News

Portola Pharmaceuticals, the company developing andexanet alfa (AndexXa) previously announced that it expected Food and Drug Administration action on its marketing application by May 2018.

Andexanet reversal “has similar efficacy and safety as seen with other reversal agents” for other types of anticoagulants, said Dr. Connolly, a professor of medicine and an electrophysiologist at McMaster University in Hamilton, Ont. In the trial results he reported, andexanet treatment of patients who were bleeding while on treatment with a direct factor Xa inhibitor had an 83% rate of hemostatic efficacy and an 11% rate of thrombotic events. By comparison, idarucizumab, the FDA-approved reversal agent for the anticoagulant dabigatran, produced a 68% hemostatic efficacy and a 6% rate of thrombotic events in the idarucizumab pivotal trial, RE-VERSE AD (N Engl J Med. 2015 Aug 6;373[6]:511-20).

Clinicians administered andexanet alfa as a bolus followed by a 2-hour continuous infusion, with hemostatic efficacy assessed 12 hours after the start of treatment. The results showed that factor Xa inhibition fell by about 75%-90% within minutes of starting the bolus and remained depressed at that level during the infusion but then began recovering by 2 hours after the stop of infusion. Andexanet is a factor Xa “decoy” molecule that acts by latching onto the inhibitor molecules and thereby preventing them from interacting with actual factor Xa, but andexanet also has a short half life and hence the effect quickly reduces once treatment stops.

“There is no doubt that andexanet rapidly decreases anti–factor Xa activity,” he said.

Adjudicated efficacy results were available for 132 patients and showed good or excellent hemostasis achieved on andexanet in 109 patients (83%), Dr. Connolly reported. The effect on hemostasis was consistent regardless of patient age, sex, bleeding site, type of anticoagulant, and dosage tested.

Thrombotic events during the 30 days following treatment occurred in 24 of 227 patients (11%) who received andexanet and were evaluable for safety. Notably, no clustering of thrombotic events occurred early, even among the 129 patients who restarted on an anticoagulant during the 30 days after treatment. Among the 129 patients who restarted on an anticoagulant, 9 (7%) had a thrombotic event during the 30-day follow-up, compared with 15 events among 98 patients (15%) who did not restart on an anticoagulant.

Dr. Connolly acknowledged that a limitation of the ANNEXA-4 study is the absence of a control group, but he added that he and his associates believed randomizing patients with a serious bleed to placebo control would not have been “practical, feasible, or ethical.”

ANNEXA-4 is sponsored by Portola Pharmaceuticals, the company developing andexanet alfa (AndexXa). Dr. Connolly has been a consultant to Portola, and also to Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, and Sanofi-Aventis. Dr. Kirtane has received research support from several device manufacturers.

[email protected]

SOURCE: Connolly S. ACC 2018.