Antianginal efficacy and safety of controlled-delivery diltiazem QD versus an equivalent dose of immediate-release diltiazem TID

Abstract

Controlled-delivery once-daily diltiazem (qd), 180 mg and 360 mg, was assessed in two multicenter, randomized, double-blind, placebo-controlled trials using a 3 x 3 Latin square design. Both studies compared the controlled-delivery dosage form to the same total daily dose of immediate-release diltiazem administered three times daily (tid) and to placebo. The primary measure of efficacy was the time to termination of the exercise tolerance test (ETT) at 2, 8, and 24 hours after the morning dose. There were no significant differences in time to ETT termination between the qd and tid formulations at any time, except at 24 hours with 180 mg qd versus 60 mg tid. The comparison to placebo showed that diltiazem 180 mg qd, 360 mg qd, and 120 mg tid significantly lengthened the time to ETT termination (p < 0.05) at all time points, while diltiazem 60 mg tid did not differ from placebo at any time point. The qd formulation also increased the time to 1-mm ST-segment depression and reduced the number of angina attacks and the amount of nitroglycerin used when compared to placebo. No new or unusual adverse events were noted. Diltiazem controlled-release capsules administered once daily are safe and effective for the treatment of patients with chronic stable angina.

Anti-ischemic effects and long-term survival during ranolazine monotherapy in patients with chronic severe angina

“…These increases in exercise performance are similar to those reported for maximal doses of nitrates (32), betablockers (33,34), and calcium channel blockers (33,35,36) in similar patients. Comparisons of exercise data across different trials, however, should recognize that the increment in exercise performance versus placebo depends upon an interaction among several trial-specific factors, including the exercise protocol, the patient population, the uniformity of administration of the test, the criteria for a positive ischemic response, and the efficacy of the drug.…”