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Risk factors for arterial vascular disease (e. g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/ or venous thromboembolism (e. g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. a. Coronary heart disease and stroke. In the Premarin substudy of the Women's Health Initiative study (WHI), an increase in the number of myocardial infarctions and strokes has been observed in women receiving Premarin compared to placebo. These observations are preliminary, and the study is continuing. (See CLINICAL PHARMACOLOGY, Clinical Studies.) In the Prempro substudy of WHI, an increased risk of coronary heart disease (CHD) events (defined as non-fatal myocardial infarction and CHD death) was observed in women receiving Prempro compared to women receiving placebo (37 vs 30 per 10,000 person-years). The increase in risk was observed in year one and persisted. Text Continues Below
In the same substudy of WHI, an increased risk of stroke was observed in women receiving Prempro compared to women receiving placebo (29 vs 21 per 10,000 person-years). The increase in risk was observed after the first year and persisted. In postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years) a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/ progestin Replacement Study; HERS) treatment with Prempro (0.625 mg conjugated equine estrogen plus 2.5 mg medroxyprogesterone acetate per day) demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with Prempro did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the Prempro-treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand three hundred and twenty one women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6. 8 years overall. Rates of CHD events were comparable among women in the Prempro group and the placebo group in HERS, HERS II, and overall. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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