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Novel Approaches in Primary Cardiovascular Disease Prevention: The HOPE-3 Trial Rationale, Design, and Participants'
Eva Lonn1, Jackie Bosch2, Janice Pogue2
1Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.
Insights
The HOPE-3 trial investigates cholesterol and blood pressure lowering in intermediate-risk individuals. Findings will inform primary prevention strategies globally.
Area of Science:
- Cardiovascular medicine
- Clinical trials
- Preventive cardiology
Background:
- Cholesterol and blood pressure (BP) lowering drugs reduce cardiovascular (CV) events in high-risk individuals.
- Limited data exist for lower-risk populations.
- The HOPE-3 trial targets intermediate-risk individuals with average BP and cholesterol levels.
Purpose of the Study:
- To evaluate the safety and efficacy of cholesterol lowering with rosuvastatin.
- To assess BP lowering with candesartan/hydrochlorothiazide.
- To determine the combined effect of these interventions on major CV events in intermediate-risk populations.
Main Methods:
- 12,705 participants (≥55 years men, ≥65 years women) with ≥1 CV risk factor, no known CV disease.
- Randomized 2x2 factorial design: rosuvastatin vs. placebo; candesartan/hydrochlorothiazide vs. placebo.
- Follow-up for a mean of 5.8 years; coprimary outcomes include CV death, MI, stroke, and other CV events.
Main Results:
- Recruitment across 21 countries, with mean age 66 years and 46% women.
- Rosuvastatin and candesartan/hydrochlorothiazide were generally well-tolerated.
- Specific efficacy results for primary outcomes are pending full analysis.
Conclusions:
- The HOPE-3 trial provides crucial data on lipid and BP management in intermediate-risk populations.
- Findings are expected to guide primary CV event prevention strategies worldwide.
- The study addresses a gap in evidence for individuals with average cholesterol and BP levels but increased CV risk.
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).
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