Comparison of Nisoldipine Coat-Core and Diltiazem Controlled-Release Tablets in the Treatment of Chronic Stable Angina in Elderly Patients: A Multicenter Study

Abstract The purpose of this randomized, double-blind, double-dummy, 12-week trial was to compare the efficacy and tolerability of nisoldipine coat-core (CC), a new extended-release formulation, with those of diltiazem controlled-release (CR) tablets. These 2 oncedaily calcium channel blockers were compared as second-line treatment of chronic stable angina in elderly patients who were receiving concurrent beta blocker and nitroglycerin therapy. The primary end point was time to electrocardiogram or symptom-related termination of exercise on treadmill testing at trough drug levels. Two hundred ninety-three patients 60 to 80 years of age with New York Heart Association Class II or III chronic stable angina pectoris of ≥3 months' duration were recruited from 23 hospital centers in the United Kingdom. After a 2-week placebo run-in period, patients who terminated exercise within 2 to 9 minutes on treadmill testing were allocated randomly to receive nisoldipine CC 10 mg or diltiazem CR 120 mg once daily for 3 weeks. Unless anginal symptoms had ceased or the investigator felt that the patient could not tolerate a higher dose, daily doses were increased to nisoldipine CC 20 mg and diltiazem CR 180 mg for an additional 3 weeks and then to nisoldipine CC 40 mg and diltiazem CR 240 mg for a final 6-week period. The 2 treatments were found to be equivalent in their effect on total exercise time, which increased significantly from baseline in both cases. In addition, both treatments significantly improved time to onset of angina, time to 1-mm ST-segment depression, weekly rate of angina attacks, and weekly nitroglycerin consumption. No significant between-group differences were noted. The incidence of adverse effects throughout the study was similar in the 2 treatment groups; however, peripheral edema was more common in the nisoldipine CC group than in the diltiazem group. Results of this study suggest that nisoldipine CC and diltiazem CR are equally effective antianginal treatments when given as additional therapy to beta blockers and nitroglycerin in elderly patients with chronic stable angina.