Littler W A, Sheridan D J
Department of Cardiovascular Medicine, Queen Elizabeth Hospital, Birmingham.
Br Heart J. 1995 May;73(5):428-33. doi: 10.1136/hrt.73.5.428.
To compare the effects of felodipine and placebo in patients with New York Heart Association functional class II or III and stable congestive heart failure despite treatment with an angiotensin converting enzyme inhibitor, diuretic, or digoxin, or any combination of these three drugs.
252 patients were randomised in a double blind, parallel group study after a 2-4 week placebo run-in to oral treatment with either felodipine extended release formulation or placebo 2.5-10 mg twice daily given in addition to existing background medication for a further 12 weeks.
Patients aged 18-75 years of either sex with chronic congestive heart failure due to ischaemic heart disease, hypertensive heart disease, or dilated cardiomyopathy with or without secondary mitral insufficiency that was stable during the preceding two months were included in the study. Treadmill exercise tests according to the modified Naughton protocol were performed at baseline, and after six, 11, and 12 weeks of treatment. Signs and symptoms of heart failure were assessed at every visit. Physical examination was performed and left ventricular ejection fraction measured at baseline and after 12 weeks.
Mean (SD) baseline exercise test times increased from 434 (162) s and 480 (157) s for felodipine and placebo groups respectively to 541 (217) s and 591 (218) s at 12 weeks or the last visit. The change in exercise from baseline to last visit was 107 (141) s for patients given felodipine and 112 (128) s for those given placebo (P > 0.20). There was also no difference between treatments with respect to the other efficacy variables. There were few deaths in the study (felodipine n = 3, placebo n = 2). More patients who received felodipine were withdrawn from treatment (n = 29) than those who received placebo (n = 17). The most common adverse events of the 54 and 28 cited as reasons for withdrawal in the felodipine and placebo groups respectively were increased need for non-study heart failure treatment (n = 10; 8%)--that is, starting new medication or changes in the dosage of existing treatment for patients given felodipine, and nausea (n = 4; 3%) for those given placebo. Patients withdrawn from the study due to increased need for non-study heart failure treatment rapidly stabilised and recovered.
Felodipine has not been shown to be of benefit in patients with mild to moderate heart failure.
比较非洛地平与安慰剂对纽约心脏协会心功能II级或III级、尽管接受了血管紧张素转换酶抑制剂、利尿剂或地高辛治疗或这三种药物的任何联合治疗但仍处于稳定充血性心力衰竭患者的疗效。
252例患者在进行2 - 4周安慰剂导入期后，被随机分组进行双盲平行组研究，接受非洛地平缓释制剂或安慰剂口服治疗，剂量为2.5 - 10mg，每日两次，在现有基础用药之外再服用12周。
纳入年龄在18 - 75岁、因缺血性心脏病、高血压性心脏病或扩张型心肌病导致慢性充血性心力衰竭、伴或不伴继发性二尖瓣关闭不全且在过去两个月病情稳定的患者。根据改良的诺顿方案在基线时以及治疗6周、11周和12周后进行平板运动试验。每次就诊时评估心力衰竭的体征和症状。在基线时和12周后进行体格检查并测量左心室射血分数。
非洛地平组和安慰剂组的平均（标准差）基线运动试验时间分别从434（162）秒和480（157）秒增加到12周或最后一次就诊时的541（217）秒和591（218）秒。从基线到最后一次就诊时，接受非洛地平治疗的患者运动时间变化为107（141）秒，接受安慰剂治疗的患者为112（128）秒（P>0.20）。在其他疗效变量方面，治疗组之间也没有差异。该研究中死亡人数很少（非洛地平组n = 3，安慰剂组n = 2）。与接受安慰剂的患者（n = 17）相比，接受非洛地平治疗的患者中更多人退出治疗（n = 29）。非洛地平组和安慰剂组分别有54例和28例被引为退出治疗原因的最常见不良事件是需要增加非研究性心力衰竭治疗（n = 10；8%）——即，接受非洛地平治疗的患者开始新的药物治疗或改变现有治疗剂量，接受安慰剂治疗的患者出现恶心（n = 4；3%）。因需要增加非研究性心力衰竭治疗而退出研究的患者迅速稳定并康复。
尚未证明非洛地平对轻至中度心力衰竭患者有益。
