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Sacubitril/valsartan eligibility and outcomes in the ESC-EORP-HFA Heart Failure Long-Term Registry: bridging between European Medicines Agency/Food and Drug Administration label, the PARADIGM-HF trial, ESC guidelines, and real world.
European Journal of Heart Failure ( IF 16.9 ) Pub Date : 2019-06-18 , DOI: 10.1002/ejhf.1532
Chris J Kapelios 1 , Mitja Lainscak 2 , Gianluigi Savarese 3 , Cécile Laroche 4 , Petar Seferovic 5 , Frank Ruschitzka 6 , Andrew Coats 7 , Stefan D Anker 8 , Maria G Crespo-Leiro 9 , Gerasimos Filippatos 10 , Massimo F Piepoli 11 , Giuseppe Rosano 12 , Luisa Zanolla 13 , Carlos Aguiar 14 , Jan Murin 15 , Przemyslaw Leszek 16 , Theresa McDonagh 17 , Aldo P Maggioni 4, 18 , Lars H Lund 3 ,
Affiliation  

AIMS To assess the proportion of patients with heart failure and reduced ejection fraction (HFrEF) who are eligible for sacubitril/valsartan (LCZ696) based on the European Medicines Agency/Food and Drug Administration (EMA/FDA) label, the PARADIGM-HF trial and the 2016 ESC guidelines, and the association between eligibility and outcomes. METHODS AND RESULTS Outpatients with HFrEF in the ESC-EORP-HFA Long-Term Heart Failure (HF-LT) Registry between March 2011 and November 2013 were considered. Criteria for LCZ696 based on EMA/FDA label, PARADIGM-HF and ESC guidelines were applied. Of 5443 patients, 2197 and 2373 had complete information for trial and guideline eligibility assessment, and 84%, 12% and 12% met EMA/FDA label, PARADIGM-HF and guideline criteria, respectively. Absent PARADIGM-HF criteria were low natriuretic peptides (21%), hyperkalemia (4%), hypotension (7%) and sub-optimal pharmacotherapy (74%); absent Guidelines criteria were LVEF>35% (23%), insufficient NP levels (30%) and sub-optimal pharmacotherapy (82%); absent label criteria were absence of symptoms (New York Heart Association class I). When a daily requirement of ACEi/ARB ≥ 10 mg enalapril (instead of ≥ 20 mg) was used, eligibility rose from 12% to 28% based on both PARADIGM-HF and guidelines. One-year heart failure hospitalization was higher (12% and 17% vs. 12%) and all-cause mortality lower (5.3% and 6.5% vs. 7.7%) in registry eligible patients compared to the enalapril arm of PARADIGM-HF. CONCLUSIONS Among outpatients with HFrEF in the ESC-EORP-HFA HF-LT Registry, 84% met label criteria, while only 12% and 28% met PARADIGM-HF and guideline criteria for LCZ696 if requiring ≥ 20 mg and ≥ 10 mg enalapril, respectively. Registry patients eligible for LCZ696 had greater heart failure hospitalization but lower mortality rates than the PARADIGM-HF enalapril group.

中文翻译:

ESC-EORP-HFA心力衰竭长期注册中的沙奎特利/缬沙坦合格率和结果:欧洲药品管理局/食品和药物管理局标签,PARADIGM-HF试验,ESC指南和现实世界之间的桥梁。

目的根据PARADIGM-HF试验,根据欧洲药品管理局/食品药品管理局(EMA / FDA)的标签,评估有资格接受沙必特/缬沙坦(LCZ696)的心力衰竭和射血分数降低的患者的比例以及2016年的ESC指南,以及资格与结果之间的关联。方法和结果考虑了2011年3月至2013年11月在ESC-EORP-HFA长期心力衰竭(HF-LT)登记中患有HFrEF的门诊患者。应用了基于EMA / FDA标签,PARADIGM-HF和ESC准则的LCZ696标准。在5443位患者中,有2197位和2373位具有完整的试验和指南资格评估信息,分别达到EMA / FDA标签,PARADIGM-HF和指南标准的患者分别为84%,12%和12%。缺乏PARADIGM-HF标准是低钠尿肽(21%),高钾血症(4%),低血压(7%)和次优药物疗法(74%);缺乏指导原则的标准是LVEF> 35%(23%),NP水平不足(30%)和次优药物治疗(82%);没有标签标准是没有症状(纽约心脏协会I类)。当每天使用ACEi / ARB≥10 mg依那普利(而不是≥20 mg)时,根据PARADIGM-HF和指南,合格率从12%上升至28%。与PARADIGM-HF的依那普利组相比,符合注册条件的患者一年心衰住院率更高(12%和17%比12%),全因死亡率更低(5.3%和6.5%vs. 7.7%)。结论在ESC-EORP-HFA HF-LT注册中心的HFrEF门诊患者中,有84%符合标签标准,如果分别需要≥20 mg和≥10 mg依那普利,则分别只有12%和28%符合PARADIGM-HF和LCZ696准则要求。与PARADIGM-HF依那普利组相比,符合LCZ696资格的登记患者住院率更高,但死亡率更低。
更新日期:2019-11-18
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