REPLY
Update in Women's Health
Pamela Charney, MD, and
Judith Walsh, MD, MPH
5 September 2000 | Volume 133 Issue 5 | Page 391
IN RESPONSE:
We appreciate Dr. Verdery's concerns about the widespread use of statin drugs in women, given the current lack of efficacy data. As we describe in our Update, "too few women were included to allow the authors to find a statistically significant reduction in coronary artery disease events in women (only 997 women among 6605 participants)"; as a result, the study did not have adequate power to detect a difference in women.
We, too, are concerned about the increase in breast cancer cases seen in treated women in both AFCAPS/TexCAPS (1) and the CARE trial (2). Although neither result was statistically significant, the trends were in the same direction. There are few data on the long-term safety of statin drugs in women. When a drug is given as preventive therapy, we believe it is particularly important that the goal of "primum, non nocere" (first of all, do no harm) be upheld.
Because women have a lower risk for coronary heart disease than men at any given age, many more women than men must be treated to prevent one coronary heart disease event. When deciding to treat a woman with an elevated cholesterol level, a clinician should consider this level in the context of the patient's other risk factors for coronary heart disease. The potential benefits and potential risks (both unproved) must be considered in the decision to treat a woman for hyperlipidemia.
Finally, we absolutely agree that randomized clinical trials must be designed to assess both efficacy and risks of treatment in women. As we have seen from AFCAPS/TexCAPS, simply including women is not enough. Women must be included in adequate numbers to allow investigators to determine whether treatment will benefit or harm them.
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Author and Article Information
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Jacobi Medical Center; Bronx, NY 10461 (Charney, Walsh)
1. Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study JAMA. 1998;279:1615-22.[Abstract/Free Full Text]
2. Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial Investigators N Engl J Med. 1996;335:1001-9.[Abstract/Free Full Text]
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