Abstract | BACKGROUND: For decades, hormone replacement therapy (HRT), which includes both estrogen and progestin, has been administered to postmenopausal women to mainly treat the symptoms of menopause and help prevent osteoporosis, with the added benefit of preventing coronary heart disease (CHD). Recently released study results have left clinicians wondering if HRT should be used at all, and, if so, with whom and under what circumstances. OBJECTIVE: To provide readers with an example of the real-world operation of a pharmacy and therapeutics (P&T) committee in its use of a concise clinical monograph to guide its formulary decisions. METHODS: The most relevant information for this committee, interested in evidence, was an analysis of the most current pivotal trials and observational studies that help define the place in therapy of HRT and provide information on product efficacy and safety. These included the Heart and Estrogen/ progestin Replacement Study (HERS) and its extension trial, HERS II, in postmenopausal women with CHD and an average age of 67 years. The Women's Health Initiative (WHI) study, where the mean age of postmenopausal women was 63 years was also reviewed. The U.S. Food and Drug Administration (FDA) statements through January 8, 2003, on the appropriate use of these agents were also included in this clinical monograph for P&T committee review. RESULTS: HERS and HERS II provided evidence that HRT does not provide secondary prevention in women with CHD. Data from the WHI study concluded that HRT promotes CHD and breast cancer in this age group. The Women's Health, Osteoporosis, Progestin, Estrogen study concluded that lower doses of conjugated estrogens (0.3 mg) are just as effective in treating postmenopausal symptoms as higher doses (0.625 mg) and result in fewer side effects. CONCLUSION:
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Authors | Joan Deady |
Journal | Journal of managed care pharmacy : JMCP
(J Manag Care Pharm)
2004 Jan-Feb
Vol. 10
Issue 1
Pg. 33-47
ISSN: 1083-4087 [Print] United States |
PMID | 14720104
(Publication Type: Journal Article)
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Chemical References |
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Topics |
- Aged
- Coronary Disease
(prevention & control)
- Drug Interactions
- Estrogen Replacement Therapy
(methods)
- Estrogens
(administration & dosage, economics)
- Female
- Humans
- Menopause
- Middle Aged
- Osteoporosis
(prevention & control)
- United States
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