| Popis: |
The effect of two formulations of nifedipine in patients with angina pectoris was compared in a placebo run-in, randomized, crossover trial. After 2 weeks of placebo twice daily, 36 patients were randomized to receive either nifedipine retard 20 mg twice daily (R40) or nifedipine coat-core 60 mg once daily (CC60), double-dummy for 2 weeks. Six patients withdrew, 3 because of adverse events and 3 because of technical reasons. Time to 0.1 mV ST-depression and exercise tolerance time were assessed at baseline and at weeks 2, 3, and 4 in the double-blind phase. Frequency of angina attacks and nitroglycerine (NTG) consumption were recorded in weekly patient diaries. Trough (12 and 24 hours after drug intake) effects after 2 weeks of double-blind treatment showed equivalency between the two formulations in time to onset of 1 mm ST-segment depression and in duration of exercise. The number of anginal attacks and amount of NTG consumption was lower in the CC60 group. Analysis of long-term electrocardiogram monitoring showed no effect on ischemic events by either formulation, nor was there a difference between the two formulations. Patient compliance was high throughout the study. Although more adverse effects were observed with the CC60 formulation, CC60 appears to be equally effective as the R40 formulation. The higher occurrence of adverse effects in patients using CC60 tablets indicates that treatment should preferably start with a lower dosage to diminish the initial vasoreactions to the drug. |
