Heart Outcomes Prevention Evaluation-3

The trial has randomized 12,705 women 60 years or older and men 55 years or older without known heart disease or prior stroke and without a clear indication or contraindication to any of the study medications. Eligible and consenting individuals were randomized to receive either active study medications or placebo (dummy pills) and will be monitored for an average of 5.7 years. The rates of heart attacks, strokes, deaths and other cardiovascular events will be compared between subjects receiving the active drugs and those on placebo. The study included people from 21 countries, which were monitored by an international group of scientists and physicians. The study was coordinated by the Population Health Research Institute at McMaster University. The study is expected to demonstrate that combined lipid lowering and blood pressure lowering will substantially lower the risk for cardiovascular diseases and may substantially change our approach to cardiovascular prevention.

Inclusion criteria

• Women aged > 60 years and men > 55 years
• At least one additional CV risk factor including:
• Waist/hip ratio ≥ 0.90 in men and ≥ 0.85 in women;
• History of current or recent smoking (regular tobacco use within 5 years)
• Low HDL cholesterol
• Dysglycemia
• Renal dysfunction
• Family history of premature CHD in first degree relatives

Exclusion criteria

• Documented clinically manifest atherothrombotic CVD
• Clear indication or contraindication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic therapy
• Symptomatic hypotension
• Chronic liver disease
• Inflammatory muscle disease
• Renal impairment
• Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine
• Concurrent treatment with a statin, fibrate, angiotensin receptor blocker, ACE inhibitor, or a thiazide diuretic
• Other serious medical illness likely to interfere with study participation or with the ability to complete the trial
• Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures
• Concurrent use of an experimental pharmacological agent