Canadian Real-world Experience of Using Sacubitril/valsartan in Patients with Heart Failure with Reduced Ejection Fraction: Insight from the PARASAIL Study

Abstract Background To determine the effectiveness of sacubitril/valsartan 97/103 mg b.i.d. on tolerability, safety and quality of life (QoL) in Canadian patients with heart failure with reduced ejection fraction (HFrEF) in a real-life setting. Methods In PARASAIL, an open-label, prospective, Phase IV, multicenter study, outpatients with HFrEF and NYHA functional class II-III were followed up for 12 months. The suggested starting dose of sacubitril/valsartan was 24/26 mg b.i.d. replacing ACEI or ARB, with an up-titration to 97/103 mg b.i.d. or as per clinical judgment. The primary endpoint was the proportion of patients achieving the target dose of sacubitril/valsartan 97/103 mg b.i.d. after 6 months of treatment. Results For the 302 patients included, the mean age was 64.47 years, and a majority of patients (82.8%) belonged to NYHA class II. Overall, 195 (64.6%) patients were on maximum dose of sacubitril/valsartan 97/103 mg b.i.d. after 6 months and 62.3% remained on this dose at Month 12. Using patient global assessment (PGA), patients experienced an improvement in QoL. For Minnesota Living with HF Questionnaire (MLHFQ) scores, a significant decrease from the baseline was observed at Weeks 4, 12 and 24 (P Conclusions Results of the PARASAIL study in a real-life setting have shown that most patients were on sacubitril/valsartan 97/103 mg b.i.d. and the treatment was well-tolerated. The patient-reported outcomes showed an overall improvement in patients’ QoL.