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Effects of serelaxin in patients admitted for acute heart failure: a meta-analysis.
European Journal of Heart Failure ( IF 18.2 ) Pub Date : 2019-12-30 , DOI: 10.1002/ejhf.1692
John R Teerlink 1 , Beth A Davison 2 , Gad Cotter 2 , Aldo P Maggioni 3 , Naoki Sato 4 , Ovidiu Chioncel 5 , Georg Ertl 6 , G Michael Felker 7 , Gerasimos Filippatos 8 , Barry H Greenberg 9 , Peter S Pang 10 , Piotr Ponikowski 11 , Christopher Edwards 2 , Stefanie Senger 2 , Sam L Teichman 12 , Olav Wendelboe Nielsen 13 , Adriaan A Voors 14 , Marco Metra 15
Affiliation  

AIMS The effectiveness and safety of 48 h intravenous 30 μg/kg/day serelaxin infusion in acute heart failure (AHF) has been studied in six randomized, controlled clinical trials. METHODS AND RESULTS We conducted a fixed-effect meta-analysis including all studies of intravenous serelaxin initiated within the first 16 h of admission for AHF. Endpoints considered were the primary and secondary endpoints examined in the serelaxin phase III studies. In six randomized controlled trials, 6105 total patients were randomized to receive intravenous serelaxin 30 μg/kg/day and 5254 patients to control. Worsening heart failure to day 5 occurred in 6.0% and 8.1% of patients randomized to serelaxin and control, respectively (hazard ratio 0.77, 95% confidence interval 0.67-0.89; P = 0.0002). Serelaxin had no statistically significant effect on length of stay, or cardiovascular death, or heart or renal failure rehospitalization. Serelaxin administration resulted in statistically significant improvement in markers of renal function and reductions in both N-terminal pro-B-type natriuretic peptide and troponin. No significant adverse outcomes were noted with serelaxin. Through the last follow-up, which occurred at an average of 4.5 months (1-6 months), serelaxin administration was associated with a reduction in all-cause mortality, with an estimated hazard ratio of 0.87 (95% confidence interval 0.77-0.98; P = 0.0261). CONCLUSIONS Administration of intravenous serelaxin to patients admitted for AHF was associated with a highly significant reduction in the risk of 5-day worsening heart failure and in changes in renal function markers, but not length of stay, or cardiovascular death, or heart or renal failure rehospitalization. Serelaxin administration was safe and associated with a significant reduction in all-cause mortality.

中文翻译:

Serelaxin对急性心力衰竭患者的影响:一项荟萃分析。

目的已通过六项随机,对照临床试验研究了静脉注射30μg/ kg /天的Serelaxin输注48小时在急性心力衰竭(AHF)中的有效性和安全性。方法和结果我们进行了一项固定效果的荟萃分析,包括所有在AHF入院后16小时内开始的静脉注射Serelaxin的研究。所考虑的终点是在serelaxin III期研究中检查的主要终点和次要终点。在六项随机对照试验中,总共6105例患者被随机分配接受30μg/ kg /天的静脉Serelaxin和5254例患者进行对照。随机分配到Serelaxin和对照组的患者中,第5天出现恶化的心力衰竭的发生率分别为6.0%和8.1%(危险比0.77,95%置信区间0.67-0.89; P = 0.0002)。Serelaxin对住院时间没有统计学上的显着影响,或心血管死亡,或心脏或肾脏衰竭再次住院。施用Serelaxin可使肾功能标志物统计学上显着改善,N端前B型利尿钠肽和肌钙蛋白的含量均降低。serelaxin并没有发现明显的不良后果。在最后一次平均为4.5个月(1-6个月)的随访中,塞拉辛给药与全因死亡率降低相关,估计危险比为0.87(95%置信区间0.77-0.98) ; P = 0.0261)。结论:对接受AHF的患者进行静脉Serelaxin给药可显着降低5天心力衰竭加重和肾脏功能标志物变化的风险,但与住院时间或心血管死亡无关,或心力衰竭或肾功能衰竭再次住院。Serelaxin的给药是安全的,并且与全因死亡率显着降低有关。
更新日期:2019-12-30
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