Englert R, Beressem P, von Manteuffel E, Stafunsky S, Kramar M
Veitlipp 2, Gars am Inn, Federal Republic of Germany.
J Cardiovasc Pharmacol. 1991;17 Suppl 1:S22-4.
The efficacy and safety of the dihydropyridine calcium antagonists amlodipine and nitrendipine as single-agent therapy of mild to moderate hypertension were compared in an open, parallel-group study. Interim analysis of data from 74 patients (43 male, 31 female) from an expected final total of 96 patients is reported. Amlodipine normalized blood pressure (< or = 90 mm Hg) in 94.7% of patients with a mean final dose of 8.3 mg/day, compared with normalization of blood pressure in 83.3% of patients treated with nitrendipine with a mean final dose of 28.3 mg/day. Only nitrendipine produced a statistically significant increase in heart rate after 2 and 4 weeks of therapy. Nitrendipine-treated patients reported more adverse events (47.2%) than the amlodipine-treated group (26.3%). Two patients from the nitrendipine group discontinued treatment due to treatment-related adverse events and one patient required a dose reduction. In the amlodipine-treated group, all adverse events were mild to moderate and dose reduction was required in one patient. In conclusion, although amlodipine and nitrendipine have comparable antihypertensive efficacy, in this study amlodipine was associated with fewer adverse effects.
在一项开放性平行组研究中，比较了二氢吡啶类钙拮抗剂氨氯地平和尼群地平作为轻度至中度高血压单药治疗的疗效和安全性。报告了对预期最终总数96例患者中的74例患者（43例男性，31例女性）的数据进行的中期分析。氨氯地平使94.7%的患者血压正常化（≤90 mmHg），平均最终剂量为8.3 mg/天，相比之下，尼群地平治疗的患者中83.3%血压正常化，平均最终剂量为28.3 mg/天。仅尼群地平在治疗2周和4周后使心率有统计学意义的增加。尼群地平治疗的患者报告的不良事件（47.2%）多于氨氯地平治疗组（26.3%）。尼群地平组有2例患者因治疗相关不良事件停药，1例患者需要减量。在氨氯地平治疗组中，所有不良事件均为轻度至中度，1例患者需要减量。总之，尽管氨氯地平和尼群地平具有相当的降压疗效，但在本研究中氨氯地平的不良反应较少。
