Friday, February 1, 2013
Niacin: ineffective, and now with fewer side effects!
I haven't written about niacin for over a year, and like a misunderstanding of the Mayan calendar that won't go away, niacin is in the news again this week.
You can catch up on the old news by reading my previous posts (links below) but here's the story in a nutshell. People with high levels of a cholesterol molecule called LDL tend to have more strokes and heart attacks than people with normal LDL levels. People with low levels of a cholesterol molecule called HDL tend to have more strokes and heart attacks than people with normal HDL levels. (Does that mean that LDL causes strokes and heart attacks or that HDL prevents strokes and heart attacks? Nobody knows.) We've long known that taking niacin raises HDL and lowers LDL. That should be good, right? And in fact a study called the Coronary Drug Project in the 60s and 70s showed that in patients with a previous heart attack, taking niacin modestly reduced the risk of another heart attack.
More recently, many other medications have been proven to prevent strokes and heart attacks--aspirin, statins (a family of cholesterol reducing medicines), and beta blockers (a family of blood pressure medicines). These medicines are now in widespread use. Statins especially have very solid evidence that they greatly decrease the frequency of strokes and heart attacks, and now that some of them are available generically they are used extensively. Last year, the AIM-HIGH trial tried to discover whether patients with a history of cardiovascular disease and low HDL had better outcomes by taking niacin with a statin than by taking a statin alone. They didn't. The rates of strokes and heart attacks were the same in both groups, strongly suggesting that in the age of statins, niacin has no additional benefit.
Now, when faced with a medication that has no benefit, I typically decide not to prescribe it, but not the folks at Merck. They were thinking "How can we decrease the side effects?" Why it would be valuable to decrease the side effects of a medicine without benefit is a mystery that only Mayan astronomers are likely to solve. In any case, the most common and bothersome side effect of niacin is facial flushing, so Merck came up with a tablet in which they combined niacin and a second drug, laropiprant, which prevents the flushing. This combination medicine, called Tredaptive, has been in use in Europe since 2007.
A large trial designed to win FDA approval for Tredaptive ended this week. The results won't be formally published for some time, but Merck has already released some important tidbits. The study randomized over 25,000 patients to Tredaptive and simvastatin or to simvastatin alone. The patients were monitored for over four years. There were no differences in rates of strokes or heart attacks between the groups, but the Tredaptive group had an increase of a "serious adverse event" the details of which Merck has yet to release. In an unusual move, Merck has asked European physicians not to start new patients on Tredaptive.
This new finding should throw a wet blanket on the few remaining niacin enthusiasts. Niacin use has declined since the AIM-HIGH study and now should decline further. It has no benefit in the vast majority of patients who can tolerate statins.
Why Merck's Niacin Failure Will Scare Drug Researchers (Forbes)
Merck Says Niacin Drug Has Failed Large Trial (New York Times)
Merck: Niacin Drug Mix Fails To Prevent Heart Attacks, Strokes (NPR Shots)
My previous posts about niacin:
Niacin Much Less Helpful in the Age of Statins
Niacin Does Not Prevent Strokes or Heart Attacks
Albert Fuchs, MD, FACP, graduated from the University of California, Los Angeles School of Medicine, where he also did his internal medicine training. Certified by the American Board of Internal Medicine, Dr. Fuchs spent three years as a full-time faculty member at UCLA School of Medicine before opening his private practice in Beverly Hills in 2000. Holding privileges at Cedars-Sinai Medical Center, he is also an assistant clinical professor at UCLA's Department of Medicine. This post originally appeared at his blog.
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Members of the American College of Physicians contribute posts from their own sites to ACP Internistand ACP Hospitalist. Contributors include:
Albert Fuchs, MD, FACP, graduated from the University of California, Los Angeles School of Medicine, where he also did his internal medicine training. Certified by the American Board of Internal Medicine, Dr. Fuchs spent three years as a full-time faculty member at UCLA School of Medicine before opening his private practice in Beverly Hills in 2000.
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Amanda Xi, ACP Medical Student Member, is a first-year medical student at the OUWB School of Medicine, charter class of 2015, in Rochester, Mich., from which she which chronicles her journey through medical training from day 1 of medical school.
Zackary Berger, MD, ACP Member, is a primary care doctor and general internist in the Division of General Internal Medicine at Johns Hopkins. His research interests include doctor-patient communication, bioethics, and systematic reviews.
Controversies in Hospital
Run by three ACP Fellows, this blog ponders vexing issues in infection prevention and control, inside and outside the hospital. Daniel J Diekema, MD, FACP, practices infectious diseases, clinical microbiology, and hospital epidemiology in Iowa City, Iowa, splitting time between seeing patients with infectious diseases, diagnosing infections in the microbiology laboratory, and trying to prevent infections in the hospital. Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Richmond, Va., with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. Eli N. Perencevich, MD, ACP Member, is an infectious disease physician and epidemiologist in Iowa City, Iowa, who studies methods to halt the spread of resistant bacteria in our hospitals (including novel ways to get everyone to wash their hands).
db's Medical Rants
Robert M. Centor, MD, FACP, contributes short essays contemplating medicine and the health care system.
Juliet K. Mavromatis, MD, FACP, provides a conversation about health topics for patients and health professionals.
Dr. Mintz' Blog
Matthew Mintz, MD, FACP, has practiced internal medicine for more than a decade and is an Associate Professor of Medicine at an academic medical center on the East Coast. His time is split between teaching medical students and residents, and caring for patients.
Toni Brayer, MD, FACP, blogs about the rapid changes in science, medicine, health and healing in the 21st century.
Vineet Arora, MD, FACP, is Associate Program Director for the Internal Medicine Residency and Assistant Dean of Scholarship & Discovery at the Pritzker School of Medicine for the University of Chicago. Her education and research focus is on resident duty hours, patient handoffs, medical professionalism, and quality of hospital care. She is also an academic hospitalist.
John H. Schumann, MD, FACP, provides transparency on the workings of medical practice and the complexities of hospital care, illuminates the emotional and cognitive aspects of caregiving and decision-making from the perspective of an active primary care physician, and offers behind-the-scenes portraits of hospital sanctums and the people who inhabit them.
Ryan Madanick, MD, ACP Member, is a gastroenterologist at the University of North Carolina School of Medicine, and the Program Director for the GI & Hepatology Fellowship Program. He specializes in diseases of the esophagus, with a strong interest in the diagnosis and treatment of patients who have difficult-to-manage esophageal problems such as refractory GERD, heartburn, and chest pain.
Mike Aref, MD, PhD, FACP, is an academic hospitalist with an interest in basic and clinical science and education, with interests in noninvasive monitoring and diagnostic testing using novel bedside imaging modalities, diagnostic reasoning, medical informatics, new medical education modalities, pre-code/code management, palliative care, patient-physician communication, quality improvement, and quantitative biomedical imaging.
William Hersh, MD, FACP, Professor and Chair, Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, posts his thoughts on various topics related to biomedical and health informatics.
David Katz, MD
David L. Katz, MD, MPH, FACP, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care.
Richard Just, MD, ACP Member, has 36 years in clinical practice of hematology and medical oncology. His blog is a joint publication with Gregg Masters, MPH.
Kevin Pho, MD, ACP Member, offers one of the Web's definitive sites for influential health commentary.
Michael Kirsch, MD, FACP, addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.
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Alexander M. Djuricich, MD, FACP, is the Associate Dean for Continuing Medical Education (CME), and a Program Director in Medicine-Pediatrics at the Indiana University School of Medicine in Indianapolis, where he blogs about medical education.
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Other blogs of note:
American Journal of
Also known as the Green Journal, the American Journal of Medicine publishes original clinical articles of interest to physicians in internal medicine and its subspecialities, both in academia and community-based practice.
A collaborative medical blog started by Neil Shapiro, MD, ACP Member, associate program director at New York University Medical Center's internal medicine residency program. Faculty, residents and students contribute case studies, mystery quizzes, news, commentary and more.
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One of the most popular anonymous blogs written by an emergency room physician.