Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure
Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure
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DOI：
10.1016/s0140-6736(96)10488-8
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发表时间：
1997-04-05
期刊：
影响因子：
168.9
通讯作者：
Skene, AM
中科院分区：
文献类型：
--
作者：
Hampton, JR;vanVeldhuisen, DJ;Skene, AM
背景：改善心力衰竭患者症状的药物也必须评估其对生存率的影响。异波帕明刺激DA-1和DA-2受体，引起外周和肾脏血管扩张;该药可改善心力衰竭症状。我们评估了异波帕明对晚期心力衰竭患者生存的影响，在多中心，随机安慰剂对照study.Methods患者晚期严重心力衰竭（纽约心脏协会类III和IV）和严重左心室疾病的证据，谁已经接受最佳治疗心力衰竭，随机分配口服异波帕明100毫克，每天三次或安慰剂。主要终点为全因死亡率。本研究设计招募2200例患者，最短治疗时间为6个月。我们做了意向治疗和治疗分析，事后亚组analysis也doneed.Findings后，我们招募了1906例患者的试验提前停止，因为过量的异波帕明组患者的死亡。异波帕明组953例患者中有232例（25%）死亡，而安慰剂组953例患者中有193例（20%）死亡（相对风险1.26 [95%CI 1.04-1.53]，p=0.017）。异波帕胺组的平均随访时间为347天，安慰剂组为363天。在多变量分析中，只有在基线使用抗心律失常药物是一个显着的独立预测因子增加死亡率在ibopamine-treated patients.Interpretation Ibopamine似乎增加死亡的风险与晚期心力衰竭患者谁已经接受最佳治疗，但这种增加的原因尚不清楚。我们的发现是，在异波帕明治疗的患者中，抗癫痫治疗是死亡率增加的一个重要预测因素，这一发现可能很重要，但探索性分析必须谨慎解释。
Background Drugs that improve symptoms in patients with heart failure must also be assessed for their effects on survival. Ibopamine stimulates DA-1 and DA-2 receptors and causes peripheral and renal vasodilatation; the drug improves symptoms of heart failure. We assessed the effect of ibopamine on survival in patients with advanced heart failure in a multicentre, randomised placebo-controlled study.Methods Patients with advanced severe heart failure (New York Heart Association classes III and IV) and evidence of severe left-ventricular disease, who were already receiving optimum treatment for heart failure, were randomly allocated oral ibopamine 100 mg three times daily or placebo. The primary endpoint was all-cause mortality. The study was designed to recruit 2200 patients, and the minimum duration of treatment would be 6 months. We did intention-to-treat and on-treatment analyses; a post-hoc subgroup analysis was also done.Findings After we had recruited 1906 patients the trial was stopped early, because of an excess of deaths among patients in the ibopamine group. 232 (25%) of 953 patients in the ibopamine group died, compared with 193 (20%) of 953 patients in the placebo group (relative risk 1.26 [95% CI 1.04-1.53], p=0.017). The average length of follow-up was 347 days in the ibopamine group and 363 days in the placebo group. In multivariate analysis, only the use of antiarrhythmic drugs at baseline was a significant independent predictor of increased fatality in ibopamine-treated patients.Interpretation Ibopamine seems to increase the risk of death among patients with advanced heart failure who are already receiving optimum therapy, but the reasons for this increase are not clear. Our finding that antiarrhythmic treatment was a significant predictor of increased mortality in ibopamine-treated patients may be important, but exploratory analyses must be interpreted with caution.