Effect of pimobendan on exercise capacity in patients with heart failure: Main results from the Pimobendan in Congestive Heart Failure (PICO) trial
Effect of pimobendan on exercise capacity in patients with heart failure: Main results from the Pimobendan in Congestive Heart Failure (PICO) trial
复制标题
DOI：
10.1136/hrt.76.3.223
复制
发表时间：
1996-09-01
期刊：
影响因子：
5.7
通讯作者：
Lubsen, J
中科院分区：
文献类型：
--
作者：
Heyndrickx, G;Renard, M;Lubsen, J
主要目的-确定pimobendan 2.5和5 mg每日对慢性心力衰竭患者运动能力的影响。设计-将pimobendan添加到常规治疗中的随机、双盲、安慰剂对照试验，最少随访24周。设置-6个欧洲国家的门诊心脏病诊所。患者- 317例稳定症状性心力衰竭患者，客观受损的运动能力，和射血分数为45%或更低的患者，这些患者用至少一种血管紧张素转换酶抑制剂和利尿剂治疗，并耐受试验剂量的匹莫苯.结果-与安慰剂相比，匹莫苯2.5和5 mg每日治疗24周后，运动持续时间（自行车测力计）提高了6%（P = 0.03和0.05）。当时，63%的pimobendan组患者和59%的安慰剂组患者存活，并且能够进行至少与入组时相同水平的运动（P = 0.5）。未观察到对耗氧量（在患者亚组中评估）和生活质量（通过问卷评估）的显著影响。Pimobendan耐受性良好。未观察到预防作用（24小时心电图）。在两个pimobendan组合并死亡的危险是1.8（95%置信区间0.9至3.5）倍高于安慰剂group.Conclusions - Pimobendan提高运动能力的慢性心力衰竭患者谁也是常规治疗。然而，使用该化合物治疗的获益和风险之间的平衡仍有待确定。
Primary objective - To determine the effects of pimobendan 2.5 and 5 mg daily on exercise capacity in patients with chronic heart failure.Design - A randomised, double blind, placebo controlled trial of the addition of pimobendan to conventional treatment with a minimum follow up of 24 weeks.Setting - Outpatient cardiology clinics in six European countries.Patients - 317 patients with stable symptomatic heart failure, objectively impaired exercise capacity, and an ejection fraction of 45% or lower who were treated with at least an angiotensin converting enzyme inhibitor and a diuretic and who tolerated a test dose of pimobendan.Results - Compared with placebo, both pimobendan 2.5 and 5 mg daily improved exercise duration (bicycle ergometry) by 6% (P = 0.03 and 0.05) after 24 weeks of treatment. At that time 63% of patients allocated to pimobendan and 59% of those allocated to placebo were alive and able to exercise to at least the same level as at entry (P = 0.5). No significant effects on oxygen consumption (assessed in a subgroup of patients) and on quality of life (assessed by questionnaire) were observed. Pimobendan was well tolerated. Proarrhythmic effects (24-hour electrocardiography) were not observed. In both pimobendan groups combined the hazard of death was 1.8 (95% confidence interval 0.9 to 3.5) times higher than in the placebo group.Conclusions - Pimobendan improves exercise capacity in patients with chronic heart failure who are also on conventional treatment. The balance between benefit and risk of treatment with this compound remains to be established however.