Richardson Jonathan, David Tosin, Grace Yasmin, Guirguis Erenie
Palm Beach Atlantic University, West Palm Beach, FL, USA.
J Pharm Technol. 2016 Jun;32(3):116-124. doi: 10.1177/8755122515622224. Epub 2015 Dec 17.
To evaluate the efficacy, safety, and clinical significance of sacubitril/valsartan (Entresto) in patients with heart failure with a reduced ejection fraction (HFrEF). An extensive search was conducted on Ovid MEDLINE using keywords and medical subject headings . The search was conducted to retrieve clinical trials comparing sacubitril/valsartan to current guideline-directed therapy for HF. Articles using the limits of clinical trials "all" (phase I to IV), in English, and published within the past 5 years were reviewed. Supplemental sources included the Entresto package insert via the manufacturer's website. Primary end points included all-cause mortality and time to first hospitalization. Safety end points included incidence and severity of angioedema, cough, hyperkalemia, increased serum creatinine, and hypotension. This review critiques both clinical and statistical significance of the "Prospective Comparison of ARNi with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure" or PARADIGM-HF and other phase II to III clinical trials. Sacubitril/valsartan showed a 20% reduction in cardiovascular death and first hospitalization from HF compared with enalapril. Despite an overall reduction in adverse events, sacubitril/valsartan had increased occurrences of hypotension and nonserious angioedema. Sacubitril/valsartan is a viable option for newly diagnosed New York Heart Association (NYHA) class II to III and is an alternative to patients who are currently being treated with the maximum doses of current gold standard treatment. Clinicians initiating sacubitril/valsartan must monitor patients closely for signs, symptoms, and history of hypotension and angioedema.
评估沙库巴曲缬沙坦（恩格列净）在射血分数降低的心力衰竭（HFrEF）患者中的疗效、安全性及临床意义。使用关键词和医学主题词在Ovid MEDLINE上进行了广泛检索。检索旨在获取比较沙库巴曲缬沙坦与当前心力衰竭指南指导治疗的临床试验。对使用“所有”（I期至IV期）临床试验限制、英文且在过去5年内发表的文章进行了综述。补充来源包括通过制造商网站获取的恩格列净包装说明书。主要终点包括全因死亡率和首次住院时间。安全性终点包括血管性水肿、咳嗽、高钾血症、血清肌酐升高和低血压的发生率及严重程度。本综述对“ARNI与ACEI对心力衰竭全球死亡率和发病率影响的前瞻性比较”（PARADIGM-HF）以及其他II期至III期临床试验的临床和统计学意义进行了批判。与依那普利相比，沙库巴曲缬沙坦使心力衰竭导致的心血管死亡和首次住院减少了20%。尽管不良事件总体减少，但沙库巴曲缬沙坦导致低血压和非严重血管性水肿的发生率增加。沙库巴曲缬沙坦是新诊断的纽约心脏协会（NYHA）II级至III级患者的可行选择，也是目前正在接受最大剂量当前金标准治疗患者的替代选择。开始使用沙库巴曲缬沙坦的临床医生必须密切监测患者是否有低血压、血管性水肿的体征、症状和病史。
