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A multi-center, double-blind, randomized, parallel group study to evaluate the effects of two different doses of losartan on morbidity and mortality in Chinese patients with symptomatic heart failure intolerant of angiotensin converting enzyme inhibitor t

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Background There have been no mortality/morbidity endpoint studies with losartan in Chinese heart failure patients.The objective was to evaluate the effects of high-dose vs.low-dose losartan on clinical outcomes in Chinese subjects with heart failure.Methods This study was a post hoc analysis of the Heart failure Endpoint evaluation of Angiotensin Ⅱ Antagonist losartan (HEAAL)trial (n=545).Chinese adults with symptomatic heart failure (New York Heart Association (NYHA) Ⅱ-Ⅳ)intolerant of treatment with angiotensin converting enzyme (ACE) inhibitors were randomized to losartan 150 mg or 50 mg daily.The primary endpoint was the composite event rate of all-cause death or hospitalization for heart failure.Safety and tolerability were assessed.Results Median follow-up was 4.8 years.Baseline characteristics were generally similar to the overall HEAAL cohort.Overall,120 (44.1%) subjects in the losartan 150 mg group and 137 (50.2%) subjects in the losartan 50 mg group died (any cause) or were hospitalized for heart failure (hazard ratio (OR) 0.807,95% CI0.631-1.031).There were no notable differences between treatment groups in the proportion of subjects with adverse experiences.Conclusion The results of this post hoc analysis in Chinese subjects,although not powered to show significance,were generally consistent with the main study results,which demonstrated a significantly reduced risk of all cause death or hospitalization for heart failure with daily losartan 150 mg vs.losartan 50 mg in subjects with symptomatic heart failure and intolerance to ACE inhibitors,supporting the use of the higher dose for optimum clinical benefit.

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作者单位: Department of Cardiology, Peking University People's Hospital,Beijing 100044, China [1] Department of Cardiology, Jiangsu Province Hospital, Nanjing,Jiangsu 210029, China [2] Department of Cardiology, Zhongshan Hospital, Fudan University,Shanghai 200032, China [3] Department of Cardiology, Peking Union Medical College Hospital, Beijing 100730, China [4] Clinical Pharmacology Center, Fu Wai Hospital, Beijing 100037,China [5] Department of Biostatistics, MSD(Europe)Inc., Brussels,Belgium [6] Global Scientific and Medical Publications, Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA [7] Department of Cardiology, University of Bergen, Stavanger University Hospital, Stavanger, Norway [8]
期刊: 《中华医学杂志(英文版)》2012年125卷21期 3868-3874页 SCIMEDLINEISTICCSCDBP
栏目名称: ORIGINAL ARTICLES
DOI: 10.3760/cma.j.issn.0366-6999.2012.21.023
发布时间: 2013-01-08
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