Cardiovascular safety of conjugated estrogens plus bazedoxifene: meta-analysis of the SMART trials

Autor:	Barry S. Komm, Sebastian Mirkin, J. R. Thompson
Rok vydání:	2015
Předmět:	Selective Estrogen Receptor Modulators medicine.medical_specialty Indoles Coronary Disease Pharmacology Placebo Risk Assessment Gastroenterology Bazedoxifene Coronary artery disease Risk Factors Internal medicine medicine Humans Adverse effect Randomized Controlled Trials as Topic Estrogens Conjugated (USP) Cardiovascular safety business.industry Incidence Estrogen Replacement Therapy Obstetrics and Gynecology Venous Thromboembolism General Medicine medicine.disease Coronary heart disease Confidence interval Postmenopause Stroke Meta-analysis Drug Therapy Combination Female business medicine.drug
Zdroj:	Climacteric. 18:503-511
ISSN:	1473-0804 1369-7137
Popis:	Five randomized, phase-3 trials demonstrated the efficacy and safety of conjugated estrogens/bazedoxifene (CE/BZA) in treating menopausal symptoms and preserving bone. This pooled analysis of these studies describes the cardiovascular safety of CE/BZA.We pooled cardiovascular adjudicated safety data from healthy, non-hysterectomized, postmenopausal women who received ≥ 1 dose of CE 0.45 mg/BZA 20 mg (n = 1585), CE 0.625 mg/BZA 20 mg (n = 1583), any CE/BZA dose (n = 4868), or placebo (n = 1241) for up to 2 years in five trials. Venous thromboembolic events (VTEs), coronary heart disease (CHD), and cerebrovascular events were reviewed by three different independent adjudication committees and summarized using a meta-analytic approach.The rate of VTEs per 1000 woman-years (95% confidence interval, CI) was 0.3 (0.0-2.0) in women taking CE 0.45 mg/BZA 20 mg, 0 (0.0-1.5) in those taking CE 0.625 mg/BZA 20 mg, 0.7 (0.0-1.5) among women taking any CE/BZA dose, and 0.6 (0.0-2.9) with placebo. The incidence of stroke per 1000 woman-years (95% CI) was 0.4 (0.0-2.4), 0.2 (0.0-1.9), 0.44 (0.0-1.1), and 0.0 (0.0-1.7), respectively. The CHD rate per 1000 woman-years was 2.6 (0.0-5.6), 1.4 (0.0-3.9), 2.4 (1.00-3.7) and 2.0 (0.0-5.2). Compared with placebo, relative risk (95% CI) with any CE/BZA dose was 0.5 (0.1-1.8) for VTE, 0.5 (0.1-2.6) for stroke, and 0.63 (0.23-1.74) for CHD.Up to 2 years of CE 0.45 or CE 0.625 mg with BZA 20 mg had an acceptable cardiovascular safety profile, with rates of stroke and CHD comparable to placebo in healthy postmenopausal women. VTE risk was low.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7d18be84a2e218f99d52bf50a14b1f30 https://doi.org/10.3109/13697137.2014.992011 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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