Antianginal and anti-ischemic efficacy of nisoldipine in stable angina pectoris: a randomized, double-blind, placebo-controlled trial.

BACKGROUND

Nisoldipine, a dihydropy ridine calcium antagonist, is a potent vasodilator with selectivity for the coronary tree. The purpose of the study was to evaluate the onset and duration of antianginal and anti-ischemic efficacy of a single oral dose of nisoldipine compared with placebo in patients with stable angina pectoris.

METHODS

In 33 patients with stable angina pectoris, nisoldipine was tested (10 mg daily) in a randomized, double-blind, placebo-controlled study. Drugs having antianginal and anti-ischemic effects (except sublingual nitroglycerin) were withdrawn Patients underwent a four-day "washout" phase, then were randomly assigned to nisoldipine (10 mg daily) or placebo for six days. On Day 4 and Day 10, three times of treadmill exercise testing were performed before daily medication was given, 2 hours and 6 hours after dosing, respectively.

RESULTS

Twenty-eight patients (14 taking nisoldipine and 14 taking placebos completed the study and were included in the statistical evaluation. Compared with placebo, total exercise duration increased significantly during all three sequential exercise testing in patients receiving nisoldipine. The frequency of anginal attacks decreased significantly while patients were receiving nisoldipine (0.29 +/- 0.44/patient/ day versus 0.14 +/- 0.26/patient/day, p < 0.05). Similarly, there was a trend toward a decrease in the consumption of sublingual nitroglycerin while patients were receiving nisoldipine. Adverse effects were mild.

CONCLUSIONS

The study confirms that nisoldipine is an active antianginal and anti-ischemic agent, with an acceptable side effect profile when used as monotherapy. The anti-ischemic effect lasted more than six hours and the drug could be administered once daily.