Monotherapy of stable angina with nicardipine hydrochloride: double-blind, placebo-controlled, randomized study.

The effect of nicardipine hydrochloride, a calcium-channel blocking agent, was studied in 46 patients with stable angina in a double-blind, placebo-controlled, randomized, repeated cross-over protocol, using a 30 or 40 mg dose of nicardipine or placebo three times a day. Mean resting heart rate and blood pressure did not change significantly with 30 mg nicardipine; heart rate increased from 81 +/- 10 to 88 +/- 13 beats min-1, systolic blood pressure decreased from 129 +/- 18 to 119 +/- 16 mmHg, and diastolic blood pressure from 81 +/- 12 to 74 +/- 11 mmHg (P less than 0.01 for all three variables) with a 40 mg dose. Using a treadmill exercise protocol, mean exercise duration increased from 5.4 +/- 1.8 to 6.0 +/- 1.8 min (P less than 0.01) with 30 mg nicardipine, and from 5.8 +/- 1.7 to 6.6 +/- 1.9 min (P less than 0.01) with 40 mg. Time to onset of angina increased from 4.6 +/- 1.9 to 5.2 +/- 1.7 min (P less than 0.05) with 30 mg and from 5.1 +/- 1.8 to 5.7 +/- 1.8 min (P = NS) with 40 mg. Mean anginal frequency and sublingual nitroglycerin consumption were low during the cross-over placebo period and did not change significantly during therapy with nicardipine. Non-cardiac side-effects were mild and required the withdrawal of only one patient from the study. However, during nicardipine therapy four patients had unstable angina and two developed a non-Q wave myocardial infarction. Of these patients, five were receiving a beta-adrenergic blocker that was discontinued prior to the study.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes