ANTIANGINAL AND ANTIISCHEMIC EFFICACY OF IMMEDIATE-RELEASE NISOLDIPINE IN CHRONIC STABLE ANGINA-PECTORIS

A double-blind, randomized, placebo-controlled, crossover study tested peak and trough efficacy of immediate-release nisoldipine (20 mg twic e daily) added to existent beta-adrenergic blocking therapy. Patients were randomized with a history of chronic stable. angina, while receiv ing a stable regimen of a beta-blocking agent, with exercise test-indu ced angina in association with 1 mm horizontal or downsloping ST-segme nt depression and exercise test reproducibility of +/- 15%. Ambulatory electrocardiograpic monitoring (48-hour) was performed at 3 of 5 cent ers (44 patients). Efficacy was achieved in 53 patients (26 taking imm ediate-release nisoldipine/placebo in sequence and 27 taking placebo/i mmediate-release nisoldipine in sequence). Total exercise time increas ed compared with placebo at peak, but only a trend was seen at trough. Time to 1 mm ST-segment depression at peak and trough and ambulatory electrocardiographic parameters were also improved. Adverse effects we re mild. This trial confirms that immediate-release nisoldipine when a dded to existent beta-blocker therapy is an active antianginal and ant i ischemic agent, but that the immediate-release formulation loses its antianginal effect at the end of its dosing interval (9 to 14 hours). This drug is therefore being examined in a new extended-release formu lation (Coat-Core).