Nisoldipine coat core as concomitant therapy in chronic stable angina pectoris.

Nisoldipine is a second-generation dihydropyridine calcium antagonist that has been extensively studied as an antianginal and antihypertensive agent. As an antianginal agent, the immediate release formulation has shown significant activity at peak effect but less at trough. As a result, a sustained release formulation (coat core) has been developed. This report focuses on the studies evaluating the antianginal and anti-ischemic effects of nisoldipine coat core (NIS CC) when used alone or with add-on therapy with beta-adrenergic blocking agents and/or long-acting nitrates (3 long-term extension trials), or as add-on therapy to existent beta-adrenergic blocking treatment (in 1 double-blind, short-term trial). The long-term extension studies all demonstrated an improvement in exercise test variables and a reduction in angina frequency and sublingual nitroglycerin usage with NIS CC when compared with baseline. Discontinuation due to ischemic adverse events occurred in 5.4-13.6% of patients during the 1-year course of these trials. However, only 2 deaths and 9 myocardial infarctions occurred (in 503 patients enrolled and 342 patients completing the entire 1 year of therapy). The short-term, double-blind study evaluated the addition of NIS CC (20 or 40 mg vs placebo) to existent atenolol therapy (50 mg four times daily). Exercise test variables at peak and trough showed a trend toward improvement, although these changes did not reach statistical significance. Other support for the efficacy of NIS CC was also demonstrated, and double-blind studies with the immediate release formulation have also shown improvements when nisoldipine was utilized as add-on therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes