Long‐term safety and efficacy of nicardipine in the treatment of stable angina pectoris

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Abstract
1 The safety and efficacy of nicardipine were assessed in 57 patients with stable angina who were treated for up to 12 months in this open study conducted at two hospital centres. 2 No patient had a concomitant anti-anginal agent added during the study. Six (11%) patients were withdrawn for lack of efficacy. Twelve (21%) patients received concomitant prophylactic anti-anginal medication which was commenced prior to the study. 3 Exercise test results at 6 and 12 months were compared with baseline. Exercise time was significantly increased at both centres. The number of patients stopping the exercise test for angina decreased from 42% of patients at baseline to 32% at 6 months and 33% at 12 months. 4 Angina attack rate was reduced consistently over the 12 months of study from 1.90 attacks per week during the baseline period to 0.09 attacks per week in the last 3 months of study. Glyceryl trinitrate consumption was similarly reduced. 5 Adverse experiences tended to occur during the initial phase of treatment and were mainly consistent with excessive vasodilatation. Headache was experienced by 23%, peripheral oedema by 14% and vasodilatation (flushing) by 9% of patients. Five patients (9%) withdrew from the study due to adverse experiences or adverse experience and other reasons. One patient died during the study from ischaemic heart disease. 6 Resting ECGs showed a number of abnormalities, particularly at baseline, but no specific adverse clinical effects on the ECG results during the study could be found. 7 Laboratory test results showed no consistent clinically significant changes from baseline.