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Future directions for randomized trials of cardiovascular disease prevention in hypertensive patients
1Department of Medicine, University of Auckland, New Zealand.
Insights
Reducing coronary artery disease (CAD) in hypertensive patients requires further research. Large trials for blood pressure reduction in mild hypertension and active-controlled trials for severe hypertension are proposed, alongside studies on cardioprotective interventions like cholesterol reduction and aspirin.
Area of Science:
- Cardiology
- Hypertension Research
- Preventive Medicine
Background:
- Coronary artery disease (CAD) is a leading cause of mortality in hypertensive individuals.
- Effective strategies for reducing CAD incidence in hypertensive patients are needed.
Purpose of the Study:
- To evaluate the feasibility of different clinical trial designs for assessing antihypertensive treatments and cardioprotective interventions in relation to CAD.
- To determine optimal trial methodologies for studying CAD prevention in hypertensive populations.
Main Methods:
- Proposes large-scale placebo-controlled trials for mild hypertension to assess blood pressure reduction effects on CAD.
- Suggests active-controlled trials for moderate to severe hypertension to compare antihypertensive drugs.
- Recommends placebo-controlled trials for interventions like cholesterol reduction and aspirin.
Main Results:
- Placebo-controlled trials in mild hypertension with manifest vascular disease require several thousand patients.
- Active-controlled trials for moderate/severe hypertension necessitate tens of thousands of patients.
- Smaller trials can investigate cardioprotective interventions such as cholesterol reduction and aspirin.
Conclusions:
- Different trial designs are suitable for various hypertensive subgroups and interventions.
- Placebo-controlled trials are feasible for mild hypertension and cardioprotective agents.
- Large sample sizes are required for active-controlled trials in more severe hypertension.
Abstract:
Coronary artery disease (CAD) is the major cause of death in hypertensive patients in Western populations and further efforts are required to determine how best to reduce its incidence. Large-scale placebo-controlled trials of blood pressure reduction could resolve the uncertainty about the effects of antihypertensive treatment on CAD incidence, but at present, such trials could probably only be conducted in patients with mild hypertension (or normotension). If such patients were selected on the basis of clinically manifest vascular disease, the sample size necessary to detect plausible treatment effects may be practicable (i.e., several thousand patients). In moderately or severely hypertensive patients, "active-controlled" trials could be conducted to determine the relative effects of different anti-hypertensive drugs on CAD morbidity and mortality. However, because any difference between such regimens is likely to be modest in magnitude (and smaller than the difference between treatment and no treatment), the sample size required to detect such differences would be very large (i.e., tens of thousands). With somewhat smaller numbers of patients, it would be possible to conduct placebo-controlled trials to study the effects on CAD of other potentially cardioprotective interventions, such as cholesterol reduction and aspirin, both of which may offer effective means for CAD prevention in hypertensive patients.