Update in Women's Health

  1. Pamela Charney, MD; and
  2. Judith Walsh, MD, MPH
  1. Jacobi Medical Center; Bronx, NY 10461 (Charney, Walsh)

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    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.

    Pamela Charney, MD

    Judith Walsh, MD, MPH

    Jacobi Medical Center; Bronx, NY 10461

    The Editors welcome submissions for possible publication in the Letters section. Authors of letters should:

    •Include no more than 300 words of text, three authors, and five references

    •Type with double-spacing

    •Send three copies of the letter, an authors' form signed by all authors, and a cover letter describing any conflicts of interest related to the contents of the letter.

    Letters commenting on an Annals article will be considered if they are received within 6 weeks of the time the article was published. Only some of the letters received can be published. Published letters are edited and may be shortened; tables and figures are included only selectively. Authors will be notified that the letter has been received. If the letter is selected for publication, the author will be notified about 3 weeks before the publication date. Unpublished letters cannot be returned.

    Annals welcomes electronically submitted letters.

    References

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