Real-world effectiveness and safety of sacubitril/valsartan in heart failure: A systematic review

Abstract

Background: PARADIGM-HF demonstrated superiority of sacubitril/valsartan (sac/val) over enalapril in patients with heart failure with reduced ejection fraction (HFrEF). However, patients in clinical practice may differ in their characteristics and overall risk compared with patients in clinical trials, and additional outcomes can be observed in real world (RW). Hence, a systematic review was conducted to identify and describe RW data on sac/val. Methods: RW studies evaluating the effects of sac/val in adult patients with HFrEF with a sample size ≥100 were identified via MEDLINE® and Embase® from 2015 to January 2020. Citations were screened, critically appraised and relevant data were extracted. Results: A total of 68 unique studies were identified. Nearly half of the studies were conducted in Europe (n = 34), followed by the US (n = 15) and Asia (n = 11). Median follow-up period varied from 1 to 19 months. Mean age ranged between 48.7 and 79.0 years; patients were mostly male and in New York Heart Association (NYHA) functional class II/III, and mean left ventricular ejection fraction varied between 23%and 38%. Of studies performing comparisons, most reported superior efficacy of sac/val in reducing the risk of HF hospitalisations, allcause hospitalisations, and all-cause mortality as compared to standard-of-care. Many studies reported significant improvements in NYHA functional class and reduction in biomarker levels post sac/val. Hypotension and hyperkalaemia were the most frequently reported adverse events. Conclusions: This comprehensive overview of currently available RW evidence on sac/val complements the evidence from randomised controlled trials, substantiating its effectiveness in heterogeneous real-world HF populations.

Outcome Benefits Seen With 1 Year of Optimized Sacubitril/Valsartan for the Treatment of Systolic Heart Failure Managed by Pharmacists in a Cardiology Practice

“…Furthermore, there are numerous real-world studies looking at hHF with the initiation of sacubitril/valsartan, with 5 studies comparing hHF before and after initiation of sacubitril/valsartan. 16 These study results were consistent with our data, showing a 5.4% to 15% reduction in hHF over a period of 3 to 7.4 months. In terms of all-cause hospitalizations, 3 of the 4 studies that reported all-cause hospitalization data before and after initiation of sacubitril/valsartan showed a significant reduction ranging from 14.5% to 18%.…”

Hospitalization Rates in Patients with Heart Failure and Reduced Ejection Fraction Initiating Sacubitril/Valsartan or Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers: A Retrospective Cohort Study

“…The new SAC/VAL users in this study had significantly lower rates of all-cause hospitalizations and the composite of HF hospitalization or ER visits than the new ACEi/ARB users; this was true in the analyses of both total rates and time to first event. These results were similar to those observed in a systematic literature review of real-world studies, wherein studies comparing SAC/VAL with ACEi/ARB in patients with HFrEF (previously treated or naïve to ACEi/ARB) reported a significantly lower risk of all-cause hospitalization with SAC/VAL [ 20 ].…”

Real-world experience of angiotensin receptor/neprilysin inhibitor (ARNI) usage in Thailand: a single-center, retrospective analysis

“…Since the introduction of ARNI, studies assessing the benefit and risk of ARNI in real-world situation have increased [ 12 ]. For Asian population, there are currently 6 published studies.…”