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Liver Function in Postmenopausal Women on Estrogen-Androgen Hormone Replacement Therapy: A Meta-analysis of Eight Clinical Trials

Gitlin, Norman MD1; Korner, Paul MD, MBA.2; Yang, Hwa-Ming PhD3

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Objective: To compare hepatic biochemical changes of a combined estrogen-androgen preparation with that of estrogen alone in postmenopausal women.

Design: Hepatic biochemical values from 511 surgically and 130 nonsurgically menopausal women being treated with hormone replacement therapy were pooled from eight similarly designed studies performed between March 1988 and January 1996 comparing esteritied estrogen-methyltestosterone preparations with esterified estrogen, conjugated equine estrogens, and placebo controls.1 The eight studies in this meta-analysis were controlled, randomized, multicenter, double-blind with identical or similar treatment arms. For hepatic biochemistry parameters, raw data summaries and mean changes from baseline values with standard error (SE) were evaluated for the dosages and treatment groups at various time periods throughout the studies.

Results: Eight controlled trials involving 641 surgically and nonsurgically menopausal women were included. Changes from the pretreatment baseline values of liver function were compared at 1, 3, 6, 12, 18, and 24 months of therapy. No patients demonstrated hepatotoxicity or clinically significant elevation of liver biochemistry values. None of the liver biochemistry changes measured in these studies were of clinical significance, nor were there biochemical differences between estrogen therapy alone compared with combined esterified estrogen-methyltestosterone preparation when administered to postmenopausal women during a period of up to 24 months.

Conclusions: Combined esterified estrogen-methyltestosterone therapy (in doses of 0.625 mg esterified estrogen + 1.25 mg methyltestosterone or 1.25 mg esterified estrogen + 2.5 mg methyltestosterone) was found to be safe regarding hepatic function in postmenopausal women during the course of 24 months in eight controlled clinical trials. (Menopause 1999:6:216-224. © 1999. The North American Menopause Society.)

1Division of Digestive Diseases, Emory University School of Medicine, Atlanta, Georgia; and the Departments of

2Women's Health. Clinical Research and

3Biostatistics, Clinical Operations. Solvay Pharmaceuticals. Inc., Marietta, Georgia, USA.

Received February 16, 1999: revised and accepted April 30, 1999.

Address reprint requests to Dr. Paul Korner. Associate Director-Women's Health, Clinical Research, Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, Georgia 30062 USA.

©1999The North American Menopause Society