Minimal Endometrial Proliferation Over a Two-Year Period in Postmenopausal Women Taking 0.3 mg of Unopposed Esterified Estrogens
| Autor: | R. Edward Varner, Harris H. Mcllwain, Robert W. Rebar, Walter Wilborn, Sheryl L. Silfen, Morris Notelovitz, Sherwyn L. Schwartz, Hwa-ming Yang, Roy Fleischmann, Malcolm Sperling |
|---|---|
| Rok vydání: | 1997 |
| Předmět: |
medicine.medical_specialty
business.industry medicine.drug_class Incidence (epidemiology) Uterus Obstetrics and Gynecology Placebo medicine.disease Gastroenterology Confidence interval Endometrial hyperplasia Clinical trial medicine.anatomical_structure Atrophy Estrogen Internal medicine Medicine business |
| Zdroj: | Menopause. 4:80-88 |
| ISSN: | 1072-3714 |
| DOI: | 10.1097/00042192-199704020-00004 |
| Popis: | This article reports the endometrial histology of 238 postmenopausal women with an intact uterus who were randomized to receive daily administration of continuous unopposed esterified estrogens (ESE) in a dose of 0.3 mg, 0.625 mg, 1.25 mg or placebo over a 2-year, prospective, randomized, double-blind, placebo-controlled, clinical trial evaluating osteoporosis prevention. Endometrial hyperplasia occurred in 1.7% of women randomized to 0.3 mg ESE (∼95% confidence interval, 0.00, 0.05), 28.8% of women randomized to 0.625 mg (0.17, 0.40), 53.3% of women randomized to 1.25 mg (0.41, 0.66), and 1.7% of women randomized to placebo (0.00, 0.05), with no statistical difference between 0.3-mg ESE treatment and placebo. Endometrial proliferation was also dose related, with atrophy occurring at termination in only the placebo group. The study was completed by 78% of women on the 0.3-mg, 62% on placebo, 54% on the 0.625-mg, and 22% on the 1.25-mg dose. Endometrial hyperplasia and uterine bleeding primarily contributed to early terminations in the higher ESE groups. The incidence of endometrial hyperplasia during daily administration of 0.3 mg unopposed ESE over a 2-year period was unexpectedly equal to that observed with placebo. The reduction in endometrial risk, preservation of therapeutic benefit for osteoporosis prevention, and high patient continuation rate achieved by 0.3 mg ESE can be used to maximize the benefits of estrogen on public health outcomes. |
| Databáze: | OpenAIRE |
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