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Estrogen did not prevent death or nonfatal stroke in postmenopausal women with ischemic stroke or TIA

Sally E. McNagny, MD, MPH
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*See Glossary.

†Information provided by author.

Sources of funding: National Institute of Neurological Disorders and Stroke and Mead Johnson Laboratories.

For correspondence: Dr. C.M. Viscoli, Yale University School of Medicine, New Haven, CT, USA. E-mail Catherine.viscoli@yale.edu.

Ann Intern Med. 2002;136(3):96. doi:10.7326/ACPJC-2002-136-3-096
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Question: In postmenopausal women with ischemic stroke or transient ischemic attack (TIA), is estrogen more effective than placebo for preventing cerebrovascular events?

Design: Randomized {allocation concealed*}†, blinded (patients and clinicians),* placebo-controlled trial with a mean follow-up of 2.8 years (Women’s Estrogen for Stroke Trial [WEST]).

Setting: 21 hospitals in the United States.

Patients: 664 postmenopausal women who were > 44 years of age (mean age 71 y, 84% non-Hispanic white) and had had a qualifying ischemic stroke or TIA within the previous 90 days. Exclusion criteria included ischemic stroke or TIA that was disabling or had occurred while the patient was taking estrogen, and a history of breast or endometrial cancer. All patients were included in the analysis.

Intervention: Women were allocated to estradiol-17β, 1 mg daily (n = 337), or placebo (n = 327). Every 3 months, a nurse contacted each woman to screen for outcomes using a standardized questionnaire. Medical records were reviewed for all reported events.

Main outcome measures: Death or nonfatal stroke. Secondary outcomes included TIA, nonfatal myocardial infarction (MI), and adverse events.

Main results: Analysis was by intention to treat (included 9 women who were censored at their last known date alive without stroke). Groups did not differ for death or nonfatal stroke, TIA, nonfatal MI, venous thromboembolic events, or breast cancer (Table). Of those who did not have a hysterectomy before the study, 2 of 189 women (1.1%) in the estradiol group were diagnosed with endometrial cancer during the study period compared with 0 of 180 women in the placebo group.

Conclusion: In postmenopausal women with ischemic stroke or transient ischemic attack (TIA), estrogen was no more effective than placebo for preventing death or nonfatal stroke, TIA, or nonfatal myocardial infarction.

Estradiol-17β vs placebo for postmenopausal women with ischemic stroke or transient ischemic attack‡

Outcomes at mean 2.8 yEstradiol-17βPlaceboRRI (95% CI)NNH
Death or nonfatal stroke29%28%8.3% (−17 to 32)Not significant
Fatal stroke3.6%1.2%187% (−9.9 to 758)Not significant
Transient ischemic attack8.9%7.6%19% (−29 to 92)Not significant
Nonfatal myocardial infarction4.2%3.7%20% (−50 to 143)Not significant
Venous thromboembolic event0.89%1.2%20% (−235 to 80)Not significant
Breast cancer1.5%1.5%0% (−243 to 70)Not significant

‡Abbreviations defined in Glossary; RRI, RRR, NNH, NNT, and CI calculated from Cox proportional hazards data in article.





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