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Effects Different in Women 8 Gynecology O B .GYN. NEWS • April 1, 2005 ultimate genetic effect,” he continued. risk ofcoronary heart disease in the en- Effects Different in Women, Men For example, in 2002, American suing 10 years, 12% had a 5%-9.9% risk, Aspirin from page 1 women had 373,000 new strokes and and 4% had a risk that was 10% or 345,000 new MIs, said Dr. Buring, a pro- greater for developing coronary heart lighted intrinsic differences in the way “The results show the danger ofgener-fessor of epidemiology at Harvard School disease during the 10 years after they en- that CVD plays out in women, compared alization,” said Paul M. Ridker, M.D., di- ofPublic Health, Boston. In contrast,tered the study. The women were ran- with men. In this study ofwomen,rector ofthe Center for Cardiovascular men had 520,000 new MIs and 323,000 domized to the aspirin regimen or place- strokes were more common than MIs, Disease Prevention at Brigham and new strokes. bo, which they continued during an and aspirin’s benefit was largely in stroke Women’s Hospital in Boston and co–prin- The study enrolled 39,876 healthy, fe- average follow-up of 10.1 years. During prevention. In contrast, results from pri- cipal investigator for the study along with male health professionals during the ear- follow-up, 999 participants had a first, or studies in healthy men, including the Dr. Buring. ly 1990s who reported their baseline major cardiovascular event: nonfatal MI, very similarly designed Physicians’ “The finding that women behave dif- health data by returning a questionnaire. nonfatal stroke, or death from cardio- Health Study, showed that MIs were the ferently than men with respect to aspirin In general, these women had few CVD vascular causes. primary threat and that the benefit from was not what we expected, but we risk factors. The rate ofmajor cardiovascular events, aspirin prophylaxis was greatest for MI shouldn’t be that surprised. Many ofus As rated by the Framingham risk score, the study’s primary end point, was about prevention. look for genetic effects, and gender is the 84% ofthe enrollees had a less than 5%2.4% in the women who took aspirin and about 2.6% in those who didn’t, a relative risk reduction of9% that failed to achieve 5. Hypercalcemia. Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level. statistical significance. But the rate of is- 6. Visual abnormalities. Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, chemic stroke for the entire group was cut estrogens should be discontinued. by aspirin use by a relative rate of24%, a R only PRECAUTIONS (For full Prescribing Information and Patient Information, visit www.premarin.com.) A. General statistically significant difference, Dr. Rid- ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER 1. Addition of a progestin when a woman has not had a hysterectomy. Studies of the addition of a progestin for 10 or more days of a cycle Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be of estrogen administration or daily with estrogen in a continuous regimen have reported a lowered incidence of endometrial hyperplasia than would ker reported. undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. Concurrent with his meeting report, the estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include CARDIOVASCULAR AND OTHER RISKS a possible increased risk of breast cancer, adverse effects on lipoprotein metabolism (e.g., lowering HDL, raising LDL) and impairment of glucose tolerance. results were published in the online edition Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. 2. Elevated blood pressure. In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to The Women’s Health Initiative (WHI) study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogen therapy on blood pressure was not seen. Blood pressure should ofthe New England Journal ofMedicine 6.8 years of treatment with conjugated estrogens (0.625 mg) relative to placebo. be monitored at regular intervals with estrogen use. (http://content.nejm.org/cgi/reprint/ The WHI study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal 3. Hypertriglyceridemia. In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) to pancreatitis and other complications. NEJMoa050613v1.pdf). relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies in full Prescribing Information.) 4. Impaired liver function and past history of cholestatic jaundice. Estrogens may be poorly metabolized in patients with impaired liver function. The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women For patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised and in the case of The downside to aspirin treatment was 65 years of age or older during 4 to 5.2 years of treatment with oral conjugated estrogens, with or without medroxyprogesterone acetate, relative to placebo. It is recurrence, medication should be discontinued. unknown whether this finding applies to younger postmenopausal women. 5. Hypothyroidism. Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Patients with normal thyroid function can a very small increase in the rate ofhem- Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the compensate for the increased TBG by making more thyroid hormone, thus maintaining free T4 and T3 serum concentrations in the normal range. Patients dependent on WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These patients should have orrhagic strokes with aspirin use, a total be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range. 6. Fluid retention. Because estrogens may cause some degree of fluid retention, patients with conditions that might be influenced by this factor, such as cardiac of10 additional cases in the aspirin group INDICATIONS AND USAGE or renal dysfunction, warrant careful observation when estrogens are prescribed. that was a statistically nonsignificant dif- Premarin (conjugated estrogens) Vaginal Cream is indicated in the treatment of atrophic vaginitis and kraurosis vulvae. 7. Hypocalcemia. Estrogens should be used with caution in individuals with severe hypocalcemia. CONTRAINDICATIONS 8. Ovarian cancer. The estrogen plus progestin substudy of WHI reported that after an average follow-up of 5.6 years, the relative risk for ovarian cancer ference. Aspirin also led to small, but sta- Premarin Vaginal Cream should not be used in women with any of the following conditions: for estrogen plus progestin versus placebo was 1.58 (95% confidence interval 0.77 -3.24) but was not statistically significant. The absolute risk for estrogen plus 1. Undiagnosed abnormal genital bleeding. progestin versus placebo was 4.2 versus 2.7 cases per 10,000 women-years. In some epidemiologic studies, the use of estrogen-only products, in tistically significant, increases in the rates 2. Known, suspected, or history of cancer of the breast. particular for ten or more years, has been associated with an increased risk of ovarian cancer. Other epidemiologic studies have not found these associations. 3. Known or suspected estrogen-dependent neoplasia. 9. Exacerbation of endometriosis. Endometriosis may be exacerbated with administration of estrogen therapy. ofall GI bleeding episodes, GI bleeds that 4. Active deep vein thrombosis, pulmonary embolism or a history of these conditions. A few cases of malignant transformation of residual
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