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 antihypertensi ve agent. As an antianginal agent, the immediate release formulation h as 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 an ti-ischemic effects of nisoldipine coat core (NIS CC) when used alone or with add-on therapy with beta-adrenergic blocking agents and/or lon g-acting nitrates (3 long-term extension trials), or as add-on therapy to existent beta-adrenergic blocking treatment (in 1 double-blind, sh ortterm trial). The long-term extension studies all demonstrated an im provement in exercise test variables and a reduction in angina frequen cy and sublingual nitroglycerin usage with NIS CC when compared with b aseline. 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). Th e 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 da ily). Exercise test variables at peak and trough showed a trend toward improvement, although these changes did not reach statistical signifi cance. 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 therap y. Overall, analysis of the data from these trials suggests that NIS C C is effective and safe when used as concomitant therapy with beta-adr enoceptor antagonists and/or long-acting nitrates.