Calcium Blockers In Heart Failure: PRAISE Study

The PRAISE study of Pfizer's Norvasc (amlodipine) in heart failure patients has demonstrated that the drug is safe in this patient population but was not able to confer any statistically significant benefit either on the primary endpoint of combined morbidity/mortality, or the secondary endpoint of all cause mortality. Updated results were presented at the European Society of Cardiology meeting in Amsterdam, the Netherlands, on August 23. The data were first presented at the American College of Cardiology meeting in March.

The use of calcium channel blockers in heart failure patients has been contraindicated as several studies have shown a tendency to worsen heart failure and increase mortality. However, a smaller trial of amlodipine in 100 patients with mild-to-moderate heart failure showed an increase in exercise capacity, and a similar benefit has been demonstrated in a small study of Astra's Plendil (felodipine). The PRAISE trial was designed to investigate the amlodipine effect further (just as V-HeFT-III was designed to test felodipine in this regard - see page 21).

PRAISE involved 1,153 patients with severe heart failure (New York Heart Association Classes IIIb and IV) and ejection fractions of less than 30%. The patients were randomized to amlodipine (10mg/day) or placebo and followed up for an average of 14.5 months. Top line results were as follows: