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From Molecules to Markets
Circulation: Heart Failure ( IF 9.7 ) Pub Date : 2018-02-01 , DOI: 10.1161/circheartfailure.118.004815
Nalini A. Colaco 1 , Dhruv S. Kazi 1
Affiliation  

See Article by Sangaralingham et al


On July 7, 2015, sacubitril/valsartan became the first angiotensin receptor-neprilysin inhibitor approved by the US Food and Drug Administration for use among patients with symptomatic heart failure with reduced ejection fraction (HFrEF). This expedited approval was based on the results of the PARADIGM-HF trial (Prospective Comparison of ARNI with ACE-I to Determine Impact on Global Mortality and Morbidity in Heart Failure) that showed that among patients with New York Heart Association class II–IV heart failure and ejection fraction ≤40%, treatment with sacubitril/valsartan rather than 10 mg twice daily of enalapril produced a 17.7% reduction in the composite end point of cardiovascular mortality and hospitalizations for heart failure. The study demonstrated a remarkable 19.4% reduction in death from cardiovascular causes and 17.9% reduction in heart failure hospitalizations among patients receiving sacubitril/valsartan compared with those receiving enalapril.1 Sacubitril/valsartan is the first new-in-class medication to demonstrate a mortality benefit in patients with HFrEF since the early 2000s.2 In this issue of Circulation: Heart Failure, Sangaralingham et al3 describe the early experience with sacubitril/valsartan among patients enrolled in private or Medicare Advantage insurance plans. Although slow uptake is par for the course for a first-in-class drug, this study reveals a disappointingly low prescription rate of sacubitril/valsartan among patients with HFrEF in the first 18 months after approval, and a high discontinuation rate among patients who initiate the drug. This disconnect between strong clinical data and low real-world uptake warrants further exploration.


Sangaralingham et al analyzed the OptumLabs database, a large collection of medical and pharmaceutical claims data, to evaluate prescription practices, drug costs, and medication use in individuals with HFrEF. In their cohort of 102 247 individuals with HFrEF (identified by International Classification of Diseases, Ninth Revision, codes), only 2244 (2.2%) filled a …



中文翻译:

从分子到市场

参见Sangaralingham等人的文章


2015年7月7日,沙比特利/缬沙坦成为美国食品药品监督管理局批准的首个血管紧张素受体-中性溶酶抑制剂,适用于射血分数降低(HFrEF)的有症状心力衰竭患者。该加急批准基于PARADIGM-HF试验的结果(ARNI与ACE-I的前瞻性比较,以确定对心力衰竭的全球死亡率和发病率的影响),该结果显示纽约心脏协会II-IV级心脏病患者失败和射血分数≤40%,用沙比特利/缬沙坦治疗,而不是每天两次10 mg依那普利治疗,可使心血管死亡和因心力衰竭住院的复合终点降低17.7%。该研究表明,因心血管原因而死亡的人数显着减少了19.4%,减少了17。1自2000年代初以来,沙库比特/缬沙坦是第一种在HFrEF患者中显示出死亡率益处的新型药物。2在本期《循环:心力衰竭》中,Sangaralingham等人3描述了参加私人或Medicare Advantage保险计划的患者使用沙必特/缬沙坦的早期经验。尽管缓慢吸收是一流药物疗程的标准,但这项研究显示,在批准后的头18个月,HFrEF患者的沙比特利/缬沙坦处方率低得令人失望,而起始用药的停用率高毒品。强大的临床数据和较低的实际摄入量之间的脱节值得进一步探索。


Sangaralingham等人分析了OptumLabs数据库,该数据库收集了大量医疗和药物索赔数据,以评估HFrEF患者的处方实践,药物成本和药物使用情况。在他们的102 247名HFrEF患者(由国际疾病分类第九版,代码标识)中,只有2244名(2.2%)填写了HFrEF。

更新日期:2018-02-21
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