Desche P, Antony I, Lerebours G, Violet I, Robert S, Weber C
Institut de Recherches Internationales Servier, Courbevoie, France.
Am J Cardiol. 1993 Jun 24;71(17):61E-68E. doi: 10.1016/0002-9149(93)90955-c.
The long-term acceptability of perindopril in mild-to-moderate chronic heart failure (CHF) was evaluated in a multicenter open study. A total of 320 patients with a mean age of 62 +/- 1 years and CHF of New York Heart Association (NYHA) class I (2 patients), II (204 patients), or III (114 patients) were included after a 2-week run-in period during which time vasodilators were stopped and diuretic and/or digoxin therapy stabilized. Perindopril treatment was started at 2 mg, increasing to 4 mg once daily after 2 weeks if supine systolic blood pressure remained > 100 mm Hg. After this dose titration period, follow-up visits were scheduled at monthly intervals for the first 3 months, then at 3-month intervals with a maximum period of follow-up being 30 months. At the time of analysis, mean duration of treatment was 276 days and 208 patients were treated > or = 6 months. Of the 320 patients, 10 (3.1%) died, 9 (2.8%) were withdrawn for worsening heart failure, and 38 (11.9%) for nonfatal adverse events, including cough (2.8%), dizziness or orthostatic discomfort (1.9%), angina pectoris (1.6%), and cutaneous signs (1.3%). Exercise test duration increased from 516 +/- 14 to 659 +/- 19 sec after 6 months of treatment (p < 0.01). At 6 months, 55.6% of patients improved by at least 1 NYHA class. Supine systolic blood pressure decreased slightly from 137 +/- 2 to 132 +/- 1 mm Hg (p < 0.01) and plasma creatinine levels remained stable from 100 +/- 2 to 102 +/- 2 mumol/liter after 6 months of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项多中心开放性研究中,评估了培哚普利在轻至中度慢性心力衰竭(CHF)中的长期可接受性。共有320例患者,平均年龄62±1岁,纽约心脏病协会(NYHA)心功能分级为I级(2例)、II级(204例)或III级(114例)。经过2周的导入期,在此期间停用血管扩张剂并使利尿剂和/或地高辛治疗稳定后纳入研究。培哚普利治疗起始剂量为2mg,若仰卧位收缩压仍>100mmHg,则2周后增至4mg每日1次。在该剂量滴定期后,最初3个月每月安排随访,之后每3个月随访1次,最长随访期为30个月。在分析时,平均治疗时间为276天,208例患者治疗≥6个月。320例患者中,10例(3.1%)死亡,9例(2.8%)因心力衰竭恶化退出,38例(11.9%)因非致命不良事件退出,包括咳嗽(2.8%)、头晕或体位性不适(1.9%)、心绞痛(1.6%)和皮肤症状(1.3%)。治疗6个月后运动试验持续时间从516±14秒增加至659±19秒(p<0.01)。6个月时,55.6%的患者心功能至少改善1个NYHA分级。仰卧位收缩压从137±2mmHg略有下降至132±1mmHg(p<0.01),治疗6个月后血浆肌酐水平从100±2μmol/L稳定至102±2μmol/L。(摘要截短至250字)