ANTIANGINAL AND ANTIISCHEMIC EFFICACY OF MONOTHERAPY EXTENDED-RELEASENISOLDIPINE (COAT-CORE) IN CHRONIC STABLE ANGINA

A double-blind, randomized, placebo-controlled study was conducted to test the peak and trough antianginal and antiischemic monotherapy effi cacy and safety of a new extended-release formulation of nisoldipine ( nisoldipine Coat Core [Bayer Corporation], 20 mg, 40 mg, and 60 mg onc e daily compared to plocebo). Study patients had a history of chronic, stable angina pectoris, exercise-induced angina in association with S T segment depression, and exercise test reproducibility. Of the 483 pa tients enrolled in the study, results were valid for safety analysis f or 312 and for efficacy analysis for 284. There was a statistically si gnificant improvement in total exercise time at both peak and trough f or patients taking 20 mg and 60 mg of nisoldipine compared with patien ts taking placebo, but the group taking 60 mg was not better than the group taking 20 mg (33.9 and 33.7 seconds, respectively, at trough). T he results were similar for the secondary endpoints (time to onset of angina and time to 1 mm ST segment depression). No correlation was evi dent between plasma nisoldipine levels and total exercise duration. He adache and peripheral edema were the most frequently reported adverse events and were dose related. There were no discontinuations due to ad verse events in patients randomized to the 20-mg nisoldipine group. No deaths occurred while patients were receiving active nisoldipine ther apy. Therapy with this extended-release formulation of nisoldipine is an effective once-daily treatment for chronic stable angina pectoris. It represents one of the few dihydropyridine calcium channel antagonis ts that has shown efficacy when administered as monotherapy to patient s with angina.