Novel Approaches in Primary Cardiovascular Disease Prevention: The HOPE-3 Trial Rationale, Design, and Participants' Baseline Characteristics
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
Grantová podpora
IR2-91038
Canadian Institutes of Health Research - Canada
PubMed
26481083
DOI
10.1016/j.cjca.2015.07.001
PII: S0828-282X(15)00512-7
Knihovny.cz E-zdroje
- MeSH
- benzimidazoly aplikace a dávkování MeSH
- bifenylové sloučeniny MeSH
- blokátory receptorů AT1 pro angiotensin II aplikace a dávkování MeSH
- celosvětové zdraví MeSH
- diuretika aplikace a dávkování MeSH
- dvojitá slepá metoda MeSH
- hydrochlorthiazid aplikace a dávkování MeSH
- incidence MeSH
- kardiovaskulární nemoci epidemiologie patofyziologie prevence a kontrola MeSH
- kombinovaná farmakoterapie MeSH
- krevní tlak účinky léků fyziologie MeSH
- LDL-cholesterol krev účinky léků MeSH
- lidé středního věku MeSH
- lidé MeSH
- primární prevence metody MeSH
- rizikové faktory MeSH
- rosuvastatin kalcium aplikace a dávkování MeSH
- senioři MeSH
- surveillance populace MeSH
- tetrazoly aplikace a dávkování MeSH
- výsledek terapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- benzimidazoly MeSH
- bifenylové sloučeniny MeSH
- blokátory receptorů AT1 pro angiotensin II MeSH
- candesartan MeSH Prohlížeč
- diuretika MeSH
- hydrochlorthiazid MeSH
- LDL-cholesterol MeSH
- rosuvastatin kalcium MeSH
- tetrazoly MeSH
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 Epidemiology and Preventive Medicine Monash University Melbourne Australia
Department of Medical Sciences Uppsala University Uppsala Sweden
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
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China
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
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
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT00468923