Sauerbrey-Wullkopf N, Kupper W
Klinische Forschung der Fa. Pfizer, Karisruhe.
Herz. 2001 Mar;26(2):149-56. doi: 10.1007/pl00002015.
This double-blind study compared the efficacy and safety of once daily amlodipine (5-10 mg/day) vs twice daily nifedipine (40-80 mg/day) in 244 patients with chronic stable angina pectoris. Efficacy was assessed after 4 and 24 weeks by bicycle exercise test.
No statistically significant differences were found between the two treatment groups at the end of treatment with regard to the ergometry parameters determined (maximum ST segment deviation, maximum workload in watts, maximum exercise duration and time to 0.1 mV ST segment depression). Furthermore, the two treatment groups were comparable with regard to the effected reduction in anginal attacks and short acting nitrate consumption. The incidence of adverse events was lower in the amlodipine relative to the nifedipine group (11.5% vs 19.1%).
The results of this study show that once daily amlodipine offers comparable antianginal and antiischemic efficacy as twice daily sustained release nifedipine in the monotreatment of chronic stable angina pectoris. Given the lower incidence of adverse events with amlodipine and its convenient once daily dosing regimen, however, amlodipine may help to enhance patient compliance.
本双盲研究比较了244例慢性稳定型心绞痛患者每日一次氨氯地平(5 - 10毫克/天)与每日两次硝苯地平(40 - 80毫克/天)的疗效和安全性。在4周和24周后通过自行车运动试验评估疗效。
在治疗结束时,两个治疗组在测定的测力计参数(最大ST段偏移、以瓦特为单位的最大工作量、最大运动持续时间和至ST段压低0.1毫伏的时间)方面未发现统计学上的显著差异。此外,两个治疗组在心绞痛发作减少和短效硝酸盐消耗量的减少方面具有可比性。氨氯地平组不良事件的发生率低于硝苯地平组(11.5%对19.1%)。
本研究结果表明,在慢性稳定型心绞痛的单一治疗中,每日一次氨氯地平与每日两次缓释硝苯地平具有相当的抗心绞痛和抗缺血疗效。然而,鉴于氨氯地平不良事件发生率较低且其每日一次的给药方案方便,氨氯地平可能有助于提高患者的依从性。