Safety profile and efficacy of ivabradine in heart failure due to Chagas heart disease: a post hoc analysis of the SHIFT trial.
Safety profile and efficacy of ivabradine in heart failure due to Chagas heart disease: a post hoc analysis of the SHIFT trial.
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DOI：
10.1002/ehf2.12240
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发表时间：
2018-06
影响因子：
3.8
通讯作者：
Argentina, Chile, and Brazil SHIFT Investigators
中科院分区：
文献类型：
--
作者：
Bocchi EA;Rassi S;Guimarães GV;Argentina, Chile, and Brazil SHIFT Investigators
该试验表明，伊伐布雷定降低心率（HR）和心血管结局的风险。伊伐布雷定治疗南美锥虫病（ChD）所致心力衰竭（HF）的疗效和安全性仍令人担忧。因此，我们对ESTA试验进行了事后分析，以研究伊伐布雷定在这些患者中的作用。试验是一项随机、双盲、安慰剂对照试验，治疗症状性收缩期稳定型HF，HR ≥ 70 b. p.m.，窦性心律ChD HF亚组包括38例患者，20例接受伊伐布雷定，18例接受安慰剂。ChD HF亚组显示右束分支传导阻滞的患病率较高，与总体CHD人群相比，收缩压较低;利尿剂、强心苷和抗醛固酮药物的使用率较高;血管紧张素转换酶抑制剂/血管紧张素II受体阻滞剂或β受体阻滞剂目标日剂量的使用率较低。ChD HF预后不良（2年全因死亡率约为60%）。伊伐布雷定的平均每日两次剂量为6.26 ± 1.15 mg，安慰剂为6.43 ± 1.55 mg。伊伐布雷定将HR从77.9 ± 3.8降低至62.3 ± 10.1 b. p.m.（P = 0.005），并改善功能分级（P = 0.02）。伊伐布雷定组与安慰剂组相比，观察到全因死亡减少的趋势（P = 0.07）。伊伐布雷定与严重心动过缓、房室传导阻滞、低血压或晕厥无关。ChD HF是HF的晚期形式，预后不良。伊伐布雷定可有效降低这些患者的HR并改善功能分级。尽管我们的结果基于非常有限的样本，应谨慎解释，但它们表明伊伐布雷定在ChD HF患者中可能具有有利的获益-风险特征。
The SHIFT trial showed that ivabradine reduced heart rate (HR) and the risk of cardiovascular outcomes. Concerns remain over the efficacy and safety of ivabradine on heart failure (HF) due to Chagas disease (ChD). We therefore conducted a post hoc analysis of the SHIFT trial to investigate the effect of ivabradine in these patients. SHIFT was a randomized, double‐blind, placebo‐controlled trial in symptomatic systolic stable HF, HR ≥ 70 b.p.m., and in sinus rhythm. The ChD HF subgroup included 38 patients, 20 on ivabradine, and 18 on placebo. The ChD HF subgroup showed high prevalence of bundle branch right block and, compared with the overall SHIFT population, lower systolic blood pressure; higher use of diuretics, cardiac glycosides, and antialdosterone agents; and lower use of angiotensin‐converting enzyme inhibitor/angiotensin II receptor blocker or target daily dose of beta‐blocker. ChD HF presented a poor prognosis (all‐cause mortality at 2 years was ~60%). The mean twice‐daily dose of ivabradine was 6.26 ± 1.15 mg and placebo 6.43 ± 1.55 mg. Ivabradine reduced HR from 77.9 ± 3.8 to 62.3 ± 10.1 b.p.m. (P = 0.005) and improved functional class (P = 0.02). A trend towards reduction in all‐cause death was observed in ivabradine arm vs. placebo (P = 0.07). Ivabradine was not associated with serious bradycardia, atrioventricular block, hypotension, or syncope. ChD HF is an advanced form of HF with poor prognosis. Ivabradine was effective in reducing HR in these patients and improving functional class. Although our results are based on a very limited sample and should be interpreted with caution, they suggest that ivabradine may have a favourable benefit–risk profile in ChD HF patients.
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影响因子：
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作者：
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通讯作者：
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DOI：
10.1016/0735-1097(95)00262-2
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影响因子：
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