Randomized Double-blind Placebo-controlled Comparison of Nicardipine and Nifedipine in Patients with Chronic Stable Angina Pectoris

doi:10.1378/chest.89.2.260

Chest

Volume 89, Issue 2, February 1986, Pages 260-265

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Forty-one patients were studied in a randomized double-blind placebo-controlled crossover trial to compare the antianginal actions of nicardipine 30 mg thrice daily and nifedipine 10 mg thrice daily. Efficacy was assessed using objective criteria from computer-assisted multistage graded exercise testing, performed after a two-week placebo run-in period and at the end of each four-week active treatment period. Thirty-seven patients completed both legs of the crossover trial. The mean (± standard error of the mean) baseline exercise time to development of angina was 6.7 ± 0.4 min and this increased to 9.5 ± 0.6 min on nicardipine (p <0.001) and 9.5 ± 0.5 min on nifedipine (p <0.001 vs baseline; NS vs nicardipine). Both drugs significantly prolonged the time to the development of 1mm ST segment depression. The baseline resting heart rate of 83 ± 2 beats/min increased to 87 ± 3 beats/min during nicardipine (p <0.05) and remained unaltered at 83 ± 2 beats/min during nifedipine therapy (p=NS vs baseline and p <0.02 vs nicardipine). Similarly, both drugs increased significantly the maximal heart rate at peak exercise. One patient was lost to follow-up during the placebo run-in period and four patients (two each on nicardipine and nifedipine) were withdrawn due to adverse effects. Our results indicate that nicardipine is comparable in efficacy to nifedipine and has a similar adverse effect profile and can also be considered a useful therapeutic agent for the treatment of chronic stable angina pectoris.

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Patients

A total of 41 patients (38 men and three women) ages 48-74 years with established grade 2 or 3 chronic stable angina⁷ of at least six months’ duration were entered in the trial. All were gradually withdrawn from their current antianginal medication other than sublingual nitrates for a minimum of two weeks prior to entry. Written informed consent was obtained from each patient, and the trial was approved by the Hospital Ethical Committee. All the patients had to fulfill the same inclusion and

RESULTS

Forty-one patients entered the trial and 37 completed both legs of the crossover. One was lost to follow-up during the initial placebo run-in period; one refused to continue the study medication after the first active treatment period because of lack of efficacy (nifedipine); one was withdrawn due to severe headaches, palpitations and pedal edema during the first active treatment (nifedipine); one withdrew one week early because of dizziness while taking nicardipine but completed the final

DISCUSSION

The number of available calcium ion antagonist drugs has rapidly increased since these drugs have been shown to be effective therapy for the treatment of chronic stable,3, 9, 10, 14, 15, 16, 17 unstable and rest angina,18, 19, 20, 21 hypertension22, 23 and heart failure.⁵ Recent research has sought to identify new drugs with improved efficacy, longer duration of action and fewer adverse effects; molecular manipulation and slow release formulations have been used to reduce the known adverse

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: revision accepted September 24.

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