American College of Cardiology

Contact: media@acc.org; 800-253-4636; 301-897-5400, ext. 630

June 28, 2002

ACC, AHA, NHLBI Clinical Advisory Confirms Safety, Effectiveness of Statins
Joint Advisory Reassures Physicians, Patients About Drugs' Importance in Lowering Cholesterol

(BETHESDA, MD)—The cholesterol-lowering drugs known as statins are both safe and effective and physicians should continue to use them, according to a six-page joint clinical physician advisory released today by the American College of Cardiology (ACC), American Heart Association (AHA), and the National Heart, Lung, and Blood Institute (NHLBI). The clinical advisory reinforces previously published clinical guidelines (ACC/AHA) and is a follow-up to the media advisory issued by the ACC and AHA last August in the wake of the voluntary withdrawal of the statin Baycol (cerivastatin) because of reported deaths and serious muscle damage among a very small portion of patients taking the drug.

Following the Baycol withdrawal, some patients taking a statin voiced concern about the drugs' safety and some even stopped taking the medication. In this joint clinical advisory, the ACC, AHA, and NHLBI stress that the five statins still on the market are safe and effective for the majority of patients, and that, along with lifestyle changes such as a heart healthy diet and regular exercise, serve as critically important weapons in the arsenal for fighting heart disease.

"The bottom line is that when statins are given properly and monitored appropriately, they can do a tremendous amount to reduce cardiac risk in our patients," said Richard C. Pasternak, MD, of the ACC , who chaired the committee that developed the advisory and is the director of Preventive Cardiology at Massachusetts General Hospital in Boston. This conclusion, Dr. Pasternak added, is buttressed by many clinical studies—including the soon-to-be published 20,000-patient Heart Protection Study—that have confirmed statins' safety and efficacy in lowering cholesterol levels and reducing the risk of heart disease.

While physicians can never let down their guard about the side effects of any drug, Dr. Pasternak emphasized, "There is an enormous difference between the Baycol experience and other statins," he said. Although approximately 1 out of 1,000 patients experience some degree of muscle discomfort, the rate of fatal muscle damage, known as rhabdomyolysis, has been extremely rare with the other statins, less than 1 in a million. This side effect with Baycol, while still rare, was 16 - 80 times more frequent than with the other statins.

"We have many years of clinical experience with the other statins in practice, including tens of thousands of patients who have been entered into carefully run and monitored trials," said Dr. Pasternak. "The degree of problems seen with Baycol has not been seen with the other statins."

The advisory's recommendations are consistent with the cholesterol guidelines contained in the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) released last year, said Claude Lenfant, MD, Director, NHLBI, who served on the advisory's writing committee. Based on ATP III, approximately 36 million Americans might be expected to have a cholesterol-lowering drug prescribed for them, Dr. Lenfant explained, and statins are still the first choice for many of these patients and their physicians. "Of course, the decision to use drug treatment is a matter for the clinical judgment of the physicians and discussion with the patient," Lenfant said.

Dr. Lenfant continued, "We hope this joint advisory will give physicians a good appreciation for appropriate usage of statins and how to monitor for side effects. There's a wealth of practical advice here for physicians."

The advisory outlines specific characteristics that may predispose some patients taking a statin to muscle pain and weakness, or myopathy, and stresses that these patients should be monitored more carefully. The advisory also advises physicians to strongly encourage their patients to report unintended side effects such as muscle soreness or weakness or brown urine.

The advisory will be most helpful, said AHA Chief Science Officer and writing committee member Sidney Smith, MD, in helping physicians identify and effectively monitor patients most likely to be at risk for muscle problems, particularly rhabdomyolysis. Patients with predisposing risk factors for statin myopathy, the advisory notes, include those who:

• Are of extreme old age especially more than 80 years;
• Have a small body frame and frailty;
• Have multisystem disease, such as chronic renal insufficiency; or
• Are taking other drugs with which statins might interact.

"Statins and other cholesterol-lowering drugs are meant to be an adjunct to lifestyle changes such as diet and exercise, both of which are important components in efforts to reduce cholesterol and heart disease risk," said Dr. Smith. "Patients on any statin who have experienced side effects such as muscle aches should alert their physician. If they develop dark urine they should stop taking the drug and immediately consult their physician."

The complete clinical advisory is available on the ACC Web site at www.acc.org/clinical/alerts/statins_june02.htm, the NHLBI Web site at www.nhlbi.nih.gov/guidelines/cholesterol and the AHA web site at www.americanheart.org/presenter.jhtml?identifier=3003472. The advisory will be published in the August 7, 2002 issue of the Journal of the American College of Cardiology and August 20, 2002 issue of Circulation: Journal of the American Heart Association.

The American College of Cardiology, a 28,000-member nonprofit organization, is the leading professional medical society and teaching institution for the nation's cardiovascular health care specialists. The College is dedicated to fostering optimal cardiovascular care disease prevention through professional education, promotion of research, leadership in the development of standards and guidelines, and the formulation of health care policy.

The American Heart Association, with more than 22.5 million volunteers and supporters who carry out its mission in communities across the country, is the largest nonprofit voluntary health organization fighting heart disease, stroke and other cardiovascular diseases which annually kill about 960,000 Americans.

The National Heart, Lung and Blood Institute, a component Institute of the National Institutes of Health , provides leadership for a national program in diseases of the heart, blood vessels, lungs, and blood; blood resource; and sleep disorders.