Evidence from two clinical trials published in July 2002, the Women's Health Initiative and the Heart and Estrogen/Progestin Replacement Study, showed that oral estrogen combined with progestin increased the risk of cardiovascular disease and breast cancer in postmenopausal women. Based on these findings, new guidelines recommend against routine hormone therapy use for chronic conditions such as osteoporosis, and current users have been advised to taper their dose toward discontinuation. Clinicians responded quickly to this new evidence in their practices. Since July 2002, many women have discontinued hormone therapy or are tapering to lower doses, according to a study supported by the Agency for Healthcare Research and Quality (HS13405).
Researchers from Stanford University School of Medicine used two IMS Health databases to describe national trends in hormone therapy use from January 1995 to July 2003. The National Prescription Audit Plus database provided data on the number of hormone therapy prescriptions filled by retail pharmacies. The National Disease and Therapeutic Index database provided data on patient visits to office-based physicians during which hormone therapy was prescribed.
Annual hormone therapy prescriptions increased from 58 million in 1995 to 90 million in 1999, representing about 15 million women per year, then remained stable through June 2002. Adoption of new oral estrogen/progestin combinations, primarily Prempro, accounted for most of this growth. Following publication of trial results in July 2002, hormone therapy prescriptions declined. Relative to January-June 2002, hormone therapy prescriptions from January-June 2003 declined by 66 percent for Prempro and 33 percent for Premarin. Small increases were observed in vaginal formulations and in new prescriptions for low-dose Premarin, suggesting a tapering to lower doses.
See "National use of postmenopausal hormone therapy: Annual trends and response to recent evidence," by Adam L. Hersh, M.D., Ph.D., Marcia L. Stefanick, Ph.D., and Randall S. Stafford, M.D., Ph.D., in the January 7, 2004, Journal of the American Medical Association 291(1), pp. 47-53.
Editor's Note: Findings from the second part of the Women's Health Initiative study were announced in March 2004. Those findings indicate that use of oral estrogen alone among women who have had hysterectomies increased the risk of stroke but did not affect heart attack or breast cancer risk during the 7-year study period. The study was stopped a year early because of the increased stroke risk.
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