An Early View of Real-World Patient Response to Sacubitril/Valsartan: A Retrospective Study of Patients with Heart Failure with Reduced Ejection Fraction

• Published in: Advances in therapy 2018-06, Vol.35 (6), p.785-795
• Main Authors: Antol, Dana Drzayich, Casebeer, Adrianne Waldman, DeClue, Richard W., Stemkowski, Stephen, Russo, Patricia A.
• Format: Article
• Language: English
• Subjects: Aged; Aminobutyrates - therapeutic use; Angiotensin II Type 1 Receptor Blockers - therapeutic use; Antihypertensive Agents - therapeutic use; Cardiology; Drug Combinations; Endocrinology; Female; Health technology assessment; Heart Failure - drug therapy; Humans; Internal Medicine; Male; Medicine; Medicine & Public Health; Middle Aged; Oncology; Original Research; Pharmacology/Toxicology; Retrospective Studies; Rheumatology; Stroke Volume - drug effects; Tetrazoles - therapeutic use; Treatment Outcome; United States; Valsartan - therapeutic use; Ventricular Dysfunction, Left - drug therapy
• ISSN: 0741-238X; 1865-8652
• DOI: 10.1007/s12325-018-0710-4

Introduction Sacubitril/valsartan has been established as an effective treatment for heart failure (HF) with reduced ejection fraction based on clinical trial data; however, little is known about its use or impact in real-world practice. Methods This study included data from medical and pharmacy claims and medical records review for patients ( n  = 200) who initiated sacubitril/valsartan between August 2015 and March 2016 preceding issuance of American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) focused update on new pharmacological therapy for HF (May 2016), which included recommendations for sacubitril/valsartan. A within-subject analysis compared symptoms and healthcare resource utilization before and after treatment initiation. Results Patients treated with sacubitril/valsartan had multiple comorbidities, and nearly all had previous treatment for HF. Most patients initiated sacubitril/valsartan at the lowest dose of 24/26 mg twice a day (BID), which remained unchanged during the observation period for half of the patients. During the first 6 weeks of treatment, few patients discontinued sacubitril/valsartan treatment (5.5%), and only 17% achieved the target dose of 97/103 mg BID after 4 months of treatment. The proportion of patients with ≥ 1 all-cause inpatient stay decreased significantly between the pre-initiation period (27.5%) and the post-initiation period (17.0%), P  = 0.009. Fatigue was noted in 51.8% of patients pre-initiation and 39.5% post-initiation, P  = 0.027. Shortness of breath was documented for 66.7% of patients pre-initiation and 51.8% post-initiation, P  = 0.008. Conclusion The findings of this real-world investigation suggest sacubitril/valsartan is associated with symptom improvements and a reduction in hospitalizations within 4 months of treatment for patients with HF and reduced ejection fraction. Funding Novartis Pharmaceuticals Corporation.