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• W2757822353 abstract "PARASAIL is a Canadian prospective, multicenter, open-label study which aims at characterizing the real-life effectiveness and safety of sacubitril/valsartan (Sac/Val) in 302 patients with heart failure with reduced ejection fraction (HFrEF) treated for a 12 months period. The interim analysis results of the QoL and tolerability presented here are those from patients who completed at least 12 weeks of treatment. Participants were HFrEF outpatients with an ejection fraction of ≤ 40%, NYHA class II or III and on stable doses of ACEI or ARB with additional HF treatment as per CCS guidelines. The suggested starting dose of Sac/Val was 24 mg/26 mg bid replacing ACEI or ARB, with an up-titration to 49 mg/51 mg bid then to 97 mg/103 mg bid every 2-4 weeks or as per clinical judgement. Symptomatic hypotension and/or SBP below 100 mmHg, estimated GFR below 30mL/min/1.73m2, angioedema or necessity to use ACEI or ARB concomitantly, were amongst the exclusion criteria. Validated quality of life questionnaires were recorded by patients (Minnesota living with HF questionnaire (MLHFQ)), EQ-5D questionnaire and patient global assessment (PGA) at baseline and at 4 and 12 weeks after conversion to Sac/Val. Patients (n=276) had a mean age of 64 years, 79% male, 90% Caucasian, mostly NYHA Class II (87%), with baseline blood pressure of 122/73 mmHg. Sac/val starting dose of 24/26 mg was used for most patients (90%) and up-titration to maximum dose of Sac/Val was achieved for the majority (64%) at 12 weeks. Both PGA and MLHFQ scores were improved: with PGA 45% of patients experienced a significant improvement of their overall scores at week 4 and 49.5% at week 12. For the MLHFQ, there was a significant improvement in the score at both weeks 4 and 12 with 20% and 21% decrease in the score compared to baseline respectively (p < 0.0001 for weeks 4 and weeks 12). For the EQ-5D questionnaire, no significant changes in the VAS score was observed and no changes in the 5 individual domains either. The treatment was well tolerated with a discontinuation rate of 6% at 12 weeks. The PARASAIL trial is designed to evaluate the real-life therapeutic effectiveness, tolerability and safety of Sac/Val in HFrEF patients. Although the lack of a comparator group limits the interpretation, the results indicate a potential improvement in 2 of the 3 validated questionnaires in the first 12 weeks of treatment with Sac/Val." @default.
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• W2757822353 date "2017-10-01" @default.
• W2757822353 modified "2023-09-26" @default.
• W2757822353 title "THE PARASAIL STUDY: PATIENT REPORTED OUTCOMES FROM THE CANADIAN REAL WORLD EXPERIENCE USE OF SACUBITRIL/VALSARTAN IN PATIENTS WITH HEART FAILURE AND REDUCED EJECTION FRACTION" @default.
• W2757822353 doi "https://doi.org/10.1016/j.cjca.2017.07.316" @default.
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