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Novel Approaches in Primary Cardiovascular Disease Prevention: The HOPE-3 Trial Rationale, Design, and Participants' Baseline Characteristics

E. Lonn, J. Bosch, J. Pogue, A. Avezum, I. Chazova, A. Dans, R. Diaz, GJ. Fodor, C. Held, P. Jansky, M. Keltai, K. Keltai, K. Kunti, JH. Kim, L. Leiter, B. Lewis, L. Liu, P. Lopez-Jaramillo, P. Pais, A. Parkhomenko, RJ. Peters, LS. Piegas, CM....

. 2016 ; 32 (3) : 311-8. [pub] 20150708

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc16028070

BACKGROUND: Cholesterol and blood pressure (BP) can be effectively and safely lowered with statin drugs and BP-lowering drugs, reducing major cardiovascular (CV) events by 20%-30% within 5 years in high-risk individuals. However, there are limited data in lower-risk populations. The Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial is evaluating whether cholesterol lowering with a statin drug, BP lowering with low doses of 2 antihypertensive agents, and their combination safely reduce major CV events in individuals at intermediate risk who have had no previous vascular events and have average cholesterol and BP levels. METHODS: A total of 12,705 women 65 years or older and men 55 years or older with at least 1 CV risk factor, no known CV disease, and without any clear indication or contraindication to the study drugs were randomized to rosuvastatin 10 mg/d or placebo and to candesartan/hydrochlorothiazide 16/12.5 mg/d or placebo (2 × 2 factorial design) and will be followed for a mean of 5.8 years. The coprimary study outcomes are the composite of CV death, nonfatal myocardial infarction (MI), and nonfatal stroke and the composite of CV death, nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, heart failure, and arterial revascularization. RESULTS: Participants were recruited from 21 countries in North America, South America, Europe, Asia, and Australia. Mean age at randomization was 66 years and 46% were women. CONCLUSIONS: The HOPE-3 trial will provide new information on cholesterol and BP lowering in intermediate-risk populations with average cholesterol and BP levels and is expected to inform approaches to primary prevention worldwide (HOPE-3 ClinicalTrials.gov NCT00468923).

College of Medicine of the University of the Philippines Manula Philippines

Dante Pazzanese Institute of Cardiology São Paulo Brazil

Department of Cardiology Academic Medical Center Amsterdam The Netherlands

Department of Cardiovascular Sciences University of Leicester and Leicester NIHR Biomedical Research Unit in Cardiovascular Disease Glenfield Hospital Leicester United Kingdom

Department of Epidemiology and Preventive Medicine Monash University Melbourne Australia

Department of Medical Sciences Uppsala University Uppsala Sweden

Department of Medicine McMaster University Hamilton Ontario Canada

Diabetes Research Centre University of Leicester Leicester United Kingdom

Division of Clinical Research and Training St John's Research Institute Bangalore India

Fu Wai Hospital Chinese Academy of Medical Sciences Beijing China

Fundacion ECLA Rosario Argentina

Fundacion Oftalmolgica de Santander and Instituto Masira Medical School Universidad de Santander Bucaramanga Colombia

Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China

Hatter Institute for Cardiovascular Research in Africa Department of Medicine University of Cape Town and Soweto Cardiovascular Research Group University of the Witwatersrand Johannesburg South Africa

Hospital do Coração São Paulo Brazil

Hungarian Institute of Cardiology Semmelweis University Budapest Hungary

Institut Universitaire de Cardiologie et Pneumologie de Québec Université Laval Québec Canada

Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine Technion Israel Institute of Technology Haifa Israel

Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science St Michael's Hospital University of Toronto Toronto Ontario Canada

Population Health Research Institute Hamilton Health Sciences and McMaster University Hamilton Ontario Canada

Russian Cardiology Research Complex Moscow Russian Federation

St Paul's Hospital The Catholic University of Korea Seoul Korea

Ukranian Strazhesko Institute of Cardiology Kiev Ukraine

Universiti Teknologi MARA Selangor Malaysia

University Hospital Motol Prague Czech Republic

University of Ottawa Heart Institute Ottawa Ontario Canada

Citace poskytuje Crossref.org

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