Witkowska M, Tracz W, Kubler G, Negrusz-Kawecka M, Hlawaty M, Olszowska M, Salamon P
Katedry i Kliniki Kardiologii Akademii Medycznej we Wrocławiu.
Przegl Lek. 1997;54(5):324-8.
The purpose of the study was to compare the antianginal and hypotensive efficacy and tolerability of 8 weeks of treatment with amlodipine taken once daily and nifedipine taken twice daily in patients with stable exertional angina pectoris and mild-to-moderate hypertension. Following a 2-week placebo run-in-period 13 patients were randomized to receive amlodipine (5 to 10 mg once daily) and 8 patients to receive nifedipine (20 or 40 mg twice daily) in an 8-week treatment phase. Antianginal efficacy was assessed with angina diares, investigators, and patients global evaluations and with treadmill exercise test during placebo run-in-period and after 8 weeks of the therapy. Amlodipine significantly reduced both weekly anginal attacks and consumption of glyceryl trinitrate tablets. This effect was more pronounced compared to efficacy of nifedipine. Exercise tolerance was also improved more markedly after amlodipine than after nifedipine treatment. Amlodipine treatment resulted in significant increase in total exercise time, increase the exercise time to angina onset, increase time to ST segment depression, decrease in ST segment depression, decrease in total duration of ST segment depression and decrease in duration of pain. In patients treated with nifedipine only favourable effect was significant decrease in total duration of ST segment depression, without significant changes of other examined parameters. Both drugs decreased blood pressure with no significant change in heart rate. No serious adverse events occurred in any patients during therapy with amlodipine as well as with nifedipine. The results of the study demonstrate that amlodipine has markedly better anti-anginal efficacy than nifedipine with respect to the most of the parameters examined. However both drugs showed comparable antihypertensive action and both were well tolerated by angina patients. The good anti-anginal and hypotensive efficacy and safety of amiodipine with once daily dosage regimen makes this drug an excellent choice of treatment for hypertensive patients with severe coronary artery disease.
本研究的目的是比较每日服用一次氨氯地平和每日服用两次硝苯地平治疗8周对稳定型劳力性心绞痛合并轻至中度高血压患者的抗心绞痛和降压疗效及耐受性。在为期2周的安慰剂导入期后，13例患者被随机分配接受氨氯地平（每日5至10毫克），8例患者接受硝苯地平（每日20或40毫克，分两次服用），进行为期8周的治疗阶段。在安慰剂导入期和治疗8周后，通过心绞痛日记、研究者和患者的整体评估以及跑步机运动试验来评估抗心绞痛疗效。氨氯地平显著减少了每周的心绞痛发作次数和硝酸甘油片的消耗量。与硝苯地平的疗效相比，这种效果更为显著。氨氯地平治疗后运动耐量的改善也比硝苯地平治疗后更明显。氨氯地平治疗导致总运动时间显著增加，心绞痛发作的运动时间增加，ST段压低时间增加，ST段压低程度降低，ST段压低总持续时间降低，疼痛持续时间降低。在仅接受硝苯地平治疗的患者中，有利的效果是ST段压低总持续时间显著降低，其他检查参数无显著变化。两种药物均降低了血压，心率无显著变化。在氨氯地平和硝苯地平治疗期间，任何患者均未发生严重不良事件。研究结果表明，就大多数检查参数而言，氨氯地平的抗心绞痛疗效明显优于硝苯地平。然而，两种药物的降压作用相当，心绞痛患者对两者的耐受性都很好。氨氯地平每日一次给药方案具有良好的抗心绞痛和降压疗效及安全性，使其成为重度冠状动脉疾病高血压患者的理想治疗选择。
