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.
Learn more:
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.
Labels: Albert Fuchs, cardiology, cardiovascular risk, cholesterol, drug companies, drugs, guest post, pharmaceuticals, research, statins
posted by Albert Fuchs, MD at
9:00 AM
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Blog log
Members of the American College of Physicians contribute posts from their own sites to ACP Internistand ACP Hospitalist. Contributors include:
Albert Fuchs,
MD
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.
And Thus, It Begins
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
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
Infection Prevention
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.
DrDialogue
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.
Everything
Health
Toni Brayer, MD, FACP, blogs about the rapid changes in science,
medicine, health and healing in the 21st century.
FutureDocs
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.
Glass Hospital
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.
Gut Check
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.
I'm dok
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.
Informatics
Professor
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.
Just Oncology
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.
KevinMD
Kevin Pho, MD, ACP Member, offers one of the Web's definitive sites
for influential health commentary.
MD
Whistleblower
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.
Medical Lessons
Elaine Schattner, MD, FACP, shares her ideas on education, ethics
in medicine, health care news and culture. Her views on medicine
are informed by her past experiences in caring for patients, as a
researcher in cancer immunology, and as a patient who's had breast
cancer.
Mired in MedEd
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.
More Musings
Rob Lamberts, MD, ACP Member, a med-peds and general practice
internist, returns with "volume 2" of his personal musings about
medicine, life, armadillos and Sasquatch at More Musings (of a
Distractible Kind).
Prescriptions
David M. Sack, MD, FACP, practices general gastroenterology at a
small community hospital in Connecticut. His blog is a series of
musings on medicine, medical care, the health care system and
medical ethics, in no particular order.
Reflections of a Grady
Doctor
Kimberly Manning, MD, FACP, reflects on the personal side of being
a doctor in a community hospital in Atlanta.
The Blog of Paul Sufka
Paul Sufka,
MD, ACP Member, is a board certified rheumatologist in St. Paul,
Minn. He was a chief resident in internal medicine with the
University of Minnesota and then completed his fellowship training
in rheumatology in June 2011 at the University of Minnesota
Department of Rheumatology. His interests include the use of
technology in medicine.
Technology in (Medical)
Education
Neil Mehta, MBBS, MS, FACP, is interested in use of technology in
education, social media and networking, practice management and
evidence-based medicine tools, personal information and knowledge
management.
Peter A. Lipson,
MD
Peter A. Lipson, MD, ACP Member, is a practicing internist and
teaching physician in Southeast Michigan. The blog, which has been
around in various forms since 2007, offers musings on the
intersection of science, medicine, and culture.
Why is American Health Care So Expensive?
Janice
Boughton, MD, FACP, practiced internal medicine for 20 years before
adopting a career in hospital and primary care medicine as a locum
tenens physician. She lives in Idaho when not traveling.
World's Best Site
Daniel Ginsberg, MD,
FACP, is an internal medicine physician who has avidly applied
computers to medicine since 1986, when he first wrote medically
oriented computer programs. He is in practice in Tacoma,
Washington.
Other blogs of note:
American Journal of
Medicine
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.
Clinical
Correlations
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.
Interact MD
Michael Benjamin, MD, ACP member, doesn't accept industry money so
he can create an independent, clinician-reviewed space on the
Internet for physicians to report and comment on the medical news
of the day.
PLoS Blog
The Public Library of Science's open access materials include a
blog.
White Coat
Rants
One of the most popular anonymous blogs written by an emergency
room physician.
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