Long-term morbidity and mortality trials with amlodipine.

Prospective controlled clinical trials with cardiovascular events and mortality as end points are needed to provide clinicians with a fully informed choice of optimal hypertensive therapy. Seven trials (six of them still ongoing) have provided insight into the effects of the third-generation calcium antagonist, amlodipine, on mortality and end-organ damage in patients with hypertension or other forms of cardiovascular disease. The completed PRAISE study has addressed the safety of amlodipine in patients with advanced heart failure (CHF). The trial showed that amlodipine does not increase mortality or morbidity in CHF patients and significantly reduces the risk for these end points in patients whose CHF has a nonischemic etiology. The PRAISE-2 study is now under way to further evaluate the benefits of amlodipine in nonischemic CHF patients. The ALLHAT trial compares the effects of standard diuretic treatment with three alternative treatments (amlodipine, lisinopril, and doxazosin) on the incidence of fatal coronary artery disease (CAD) and nonfatal myocardial infarction (MI) in 40,000 hypertensive patients. The ASCOT trial compares the effects of amlodipine +/- perindopril with atenolol +/- bendrofluazide on fatal CAD and nonfatal MI in 18,000 high-risk patients. The PREVENT trial tests a similar hypothesis, looking at the effects of amlodipine on arterial atherosclerotic lesions, and the AASK trial is evaluating the effects of amlodipine on renal disease. The PRAISE trial has provided valuable information on the safety and efficacy of amlodipine in preventing death and disability in patients with CHF. The six ongoing trials will provide important additional information on the effect of amlodipine in patients with heart disease of other etiologies.