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Thursday, December 5, 2013

What the new statins guidelines say, and should we agree with them?

Statins made the news in a big way recently. The American Heart Association, in collaboration with the American College of Cardiology, just released recommendations that should change the way we prescribe medications called statins, including drugs like Lipitor and Crestor and their generics, atorvastatin and rosuvastatin. The headlines say stuff like “More Americans may be Eligible to Receive Cholesterol Lowering Drugs!” Boy howdy, aren’t we all in for a treat?

Big money:

I am a bit, or more than a bit, skeptical of news about statin therapy because Lipitor, before it went generic, was responsible for over $6 billion in revenue for Pfizer and since it went generic, Astra Zeneca is raking in more revenue than they did last year for their cholesterol drug, Crestor, at about $1.6 billion. This kind of market influence is associated with significant influence on the attitudes of both physicians and patients through advertising and research support. I think that our love affair with statins cannot be separated from the fact that the sale of these drugs is a significant contribution to our economy.

Nevertheless, I recognize that statin drugs have contributed significantly to heart health since they were first released. Statin drugs were first released in 1987 after some false starts. The earliest statin caused muscle breakdown and killed some of the dogs upon which it was tested. Lovastatin, which was considerably less toxic, was the first statin to be released. Statins reduce cholesterol by inhibiting an enzyme, HMG CoA reductase, but also stabilize the walls of blood vessels and reduce inflammation. In so doing, they reduce the risk of heart attacks, which are most commonly caused by obstruction of one of the coronary arteries by atherosclerotic plaques which rupture and form a clot that blocks blood flow to heart muscle. Inflammation is important in this process as well.

It has been known for decades that a high level of cholesterol in the blood is associated with increased heart attacks, as well as other conditions related to blood vessels such as strokes. Therapy to reduce cholesterol sometimes reduces the risk of these conditions, and many studies have been done looking at ways to reduce cholesterol. Not everything that reduces cholesterol reduces heart attack risk, though, and reducing the cholesterol and fat in the diet does not have a very significant effect on either overall cholesterol levels or on heart risk. Statins, though, do reduce the cholesterol level quite significantly and also appear to reduce the risk of various vascular events.

The controversy:

Heart disease is the leading cause of death in the U.S., so reducing the risk, even a little bit, has the ability to save many lives. Statins do reduce the risk of heart attacks, but for most people, only a little bit. In the patients most likely to benefit, those who have had heart attacks and so are at risk of further disabling recurrent heart attacks, as many as one in 29 patient who take statins for 4 years will avoid having a recurrent heart attack or death when compared to patients who do not take statins, as reported in a recent meta-analysis. For patients who haven’t had heart attack, the chance that taking a statin will prevent having one is lower, for women 1 in 148 over 4 years.

Statins do have side effects, from annoying symptoms like gas and muscle pains to more significant ones like memory loss, weakness and diabetes. In fact, the chance that a person with low to moderate risk of heart disease will get diabetes as a result of statins is quite a bit higher than the chance that he or she will be saved from having a heart attack. Dangerous and sometimes life-threatening muscle destruction with associated kidney failure is a rare but real side effect, which I have seen in practice. Significant side effects plague 18% of patients who take statins. A very good article, looking at controversies related to statin therapy, written by professors from Harvard Medical School and UC San Francisco, who question the mainstream belief in these drugs’ effectiveness and safety, can be found in the New York Times.

The vast amount of scientific data on statins is interpreted differently by different experts, but the way I look at it, in the patients at greatest risk for heart disease, 29 people have to take a statin for 4 years in order to save one of them from a heart attack. For patients at lower risk, the numbers are even less convincing. In the lower risk patients evaluated 148 have to take a statin for four years for one of them to not have a heart attack, which means that 147 patients take the drug, along with its side effects, for 4 years to no good purpose.

The major issue, beyond the economics and financial interests of drug companies, revolves around differing views of our mission as doctors, and also around differing experiences of physicians involved. If a person is a cardiologist, avoiding heart attacks is practically the only thing that matters. Cardiologists rarely see their patients for problems other than those related to their heart problems and don’t face the day to day difficulties related to statin side effects. When a patient has muscle pains and cramping or stomach distress, he or she doesn’t usually expect the cardiologist to resolve the problem. Cardiologists are great champions of statin therapy. Large organizations, such as the American Heart Association are also great champions of statins. The big picture for them is that a small effect on decreasing heart attacks, multiplied over millions of people who might take statins, means many lives saved.

As a physician who treats individual patients, however, and as a person who may someday be a patient, I find it hard to advocate taking a drug with a very complex range of effects for a very small chance that it will make a positive difference. Even if we believe that our responsibility to the population is more important than to the individual, how do we assign value to patients whose lives are potentially saved against the much greater number of patients who feel just a little bit sicker because of a medication we prescribe?

The new guidelines:

This week, to great fanfare, a new approach to prescribing statins was introduced. Many experts reviewed the extensive research, focusing on randomized controlled trials which are the most rigorous way to evaluate effectiveness. They were interested in finding the most effective and efficient way to reduce heart attack risk by influencing cholesterol. They looked only at statin therapy, since the vast majority of good research was on statins, as opposed to, say, fish oil or niacin or fiber or chelation therapy. They found that the most efficient way to reduce heart disease risk with statins was to check the cholesterol of all patients over the age of 40, and treat those with high risk of heart attack with either moderate or high doses of statins. The patients who should be encouraged to take statins are in 1 of 4 groups:
1. Patients with LDL cholesterol greater than 189, who probably have a genetic condition that puts them at very high risk of heart disease.
2. Patients between the age of 40 and 75 with diabetes, whose LDL levels are above 70 (very low.)
3. Patients with prior heart attacks.
4. Patients with a 10 year risk (see this risk calculator) greater than 7.5% of having a heart attack.

They recommended not checking cholesterol levels compulsively in order to reach certain set goals, though they do recommend checking the occasional level to see if the patient is actually taking the drug. It appears that treating to a target is very energy consuming and encourages us to add drugs that don’t have evidence of effectiveness. In my experience, it can lead to focusing on numbers rather than on humans, but can also be the basis for conversations that might lead to more exercise and healthier living. Still, not focusing on cholesterol numbers will free us up to pay attention to issues of patient care that are probably more valuable. There were no good studies on treating patients over 75 with cholesterol lowering drugs, other than those with prior heart attacks, but it seemed likely that they would benefit. No recommendations are made for these folks, other than that they should discuss pros and cons with their physician.

Regarding side effects, the general implication of the article was that patients with muscle pains on statins should try to take them anyway, and that doctors should make sure to ask the patient before starting therapy if they had muscle pains so they could counter any complaints with the assertion that they had this before starting the drug. Having treated patient with statin therapy for years, I think that muscle pains are a very common side effect and can be disabling. I think that minimizing the importance of these symptoms by telling a patient that they should continue to take the medication that causes this will potentially reduce patients’ quality of life and overall activity level. I am disappointed in the way this issue was handled.

One very interesting implication of this study is that elevated cholesterol alone does not mean that a patient should be on a statin. Many people who are concerned about their health take a statin for an elevated cholesterol level, but their risk of heart attack is extremely low, so taking a statin will do nothing to improve their health. This is a positive development.

These new recommendations may be somewhat better than the rather random approach to cardiac risk reduction related to cholesterol that existed before, but are likely to overtreat patients without heart disease, resulting in patients whose health will be worse related to side effects, and who will be more dependent on the health care system because they will now be taking a drug. The guidelines will allow some people to stop taking their statins, which is good. I feel suspicious of the huge media coverage of this recommendation (most treatment recommendations get no news exposure) and I do expect that all of the free publicity will substantially increase the revenue of the companies that make statin drugs.

Janice Boughton, MD, ACP Member, practiced in the Seattle area for four years and in rural Idaho for 17 years before deciding to take a few years off to see more places, learn more about medicine and increase her knowledge base and perspective by practicing hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling. Disturbed by various aspects of the practice of medicine that make no sense and concerned about the cost of providing health care to every American, she blogs at Why is American Health Care So Expensive?, where this post originally appeared.

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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.

Auscultation
Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital.

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.

Suneel Dhand, MD, ACP Member
Suneel Dhand, MD, ACP Member, is a practicing physician in Massachusetts. He has published numerous articles in clinical medicine, covering a wide range of specialty areas including; pulmonology, cardiology, endocrinology, hematology, and infectious disease. He has also authored chapters in the prestigious "5-Minute Clinical Consult" medical textbook. His other clinical interests include quality improvement, hospital safety, hospital utilization, and the use of technology in health care.

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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