Effect of estrogen plus progestin on stroke in postmenopausal women: the Women's Health Initiative: a randomized trial.
Abstract | CONTEXT: OBJECTIVE: DESIGN: Multicenter double-blind, placebo-controlled, randomized clinical trial involving 16 608 women aged 50 through 79 years with an average follow-up of 5.6 years. Baseline levels of blood-based markers of inflammation, thrombosis, and lipid levels were measured in the first 140 centrally confirmed stroke cases and 513 controls. INTERVENTIONS: MAIN OUTCOME MEASURES: Overall strokes and stroke subtype and severity were centrally adjudicated by stroke neurologists. RESULTS: One hundred fifty-one patients (1.8%) in the estrogen plus progestin and 107 (1.3%) in the placebo groups had strokes. Overall 79.8% of strokes were ischemic. For combined ischemic and hemorrhagic strokes, the intention-to-treat hazard ratio (HR) for estrogen plus progestin vs placebo was 1.31 (95% confidence interval [CI], 1.02-1.68); with adjustment for adherence, the HR was 1.50 (95% CI, 1.08-2.08). The HR for ischemic stroke was 1.44 (95% CI, 1.09-1.90) and for hemorrhagic stroke, 0.82 (95% CI, 0.43-1.56). Point estimates of the HRs indicate that excess risk of all stroke was apparent in all age groups, in all categories of baseline stroke risk, and in women with and without hypertension, prior history of cardiovascular disease, use of hormones, statins, or aspirin. Other risk factors for stroke, including smoking, blood pressure, diabetes, lower use of vitamin C supplements, blood-based biomarkers of inflammation, higher white blood cell count, and higher hematocrit levels did not modify the effect of estrogen plus progestin on stroke risk. CONCLUSIONS:
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Authors | Sylvia Wassertheil-Smoller, Susan L Hendrix, Marian Limacher, Gerardo Heiss, Charles Kooperberg, Alison Baird, Theodore Kotchen, J David Curb, Henry Black, Jacques E Rossouw, Aaron Aragaki, Monika Safford, Evan Stein, Somchai Laowattana, W Jerry Mysiw, WHI Investigators |
Journal | JAMA
(JAMA)
Vol. 289
Issue 20
Pg. 2673-84
(May 28 2003)
ISSN: 0098-7484 [Print] United States |
PMID | 12771114
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Biomarkers
- Estrogens, Conjugated (USP)
- Progesterone Congeners
- Medroxyprogesterone Acetate
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Topics |
- Aged
- Biomarkers
(blood)
- Double-Blind Method
- Estrogen Replacement Therapy
(adverse effects)
- Estrogens, Conjugated (USP)
(adverse effects, therapeutic use)
- Female
- Humans
- Medroxyprogesterone Acetate
(adverse effects, therapeutic use)
- Middle Aged
- Postmenopause
- Progesterone Congeners
(adverse effects, therapeutic use)
- Proportional Hazards Models
- Risk Factors
- Stroke
(chemically induced, classification, epidemiology)
- Survival Analysis
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