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Prescription of sacubitril/valsartan in a real-world population

Session Poster Session 2

Speaker Joao AGOSTINHO

Event : Heart Failure 2019

  • Topic : heart failure
  • Sub-topic : Pharmacotherapy
  • Session type : Poster Session

Authors : JR Agostinho (Lisbon,PT), T Rodrigues (Lisbon,PT), R Santos (Lisbon,PT), N Cunha (Lisbon,PT), J Rigueira (Lisbon,PT), A Nunes-Ferreira (Lisbon,PT), I Aguiar-Ricardo (Lisbon,PT), I Goncalves (Lisbon,PT), T Guimaraes (Lisbon,PT), S Longo (Lisbon,PT), F Veiga (Lisbon,PT), M Ribeiro (Lisbon,PT), N Lousada (Lisbon,PT), FJ Pinto (Lisbon,PT), D Brito (Lisbon,PT)

JR Agostinho1 , T Rodrigues1 , R Santos1 , N Cunha1 , J Rigueira1 , A Nunes-Ferreira1 , I Aguiar-Ricardo1 , I Goncalves1 , T Guimaraes1 , S Longo1 , F Veiga1 , M Ribeiro1 , N Lousada1 , FJ Pinto1 , D Brito1 , 1Hospital Universita­rio de Santa Maria/CHLN CAML CCULFaculdade de Medicina Universidade de Lisboa - Lisboa - Portugal ,

On behalf: RICA-HFTeam

Chronic Heart Failure: Pharmacotherapy

Introduction: Sacubitril/valsartan (S/V) introduction in the heart failure (HF) with a reduce ejection fraction (rEF) therapeutic algorithm was the biggest advance in this syndrome treatment in recent years. Given the small amount of time elapsed since S/V introduction, there are no comparative data between real-life populations and the PARADIGM-HF Trial population.

Objective: To characterize a population followed in the HF Clinic of a Tertiary Hospital medicated with S/V and to compare it with the PARADIGM-HF Trial population.

Methods: Prospective data recording study of pts with HFrEF treated with S/V. Clinical and demographic characteristics, S/V doses, adverse effects and concomitant therapy data were recorded. Comparisons with the PARADIGM-HF S/V treated population were established by Student's T-test and ANOVA.

Results: One hundred and two pts were included. Median follow-up time since S/V first dose was 6 (4-10) months. The present study population presents statistically higher mean age, NTproBNP and serum creatinine levels (Cr) when compared to the PARADIGM-HF population. There was a greater number of pts in NYHA functional class I and II and ischemic etiology was less frequent. There were no significant differences regarding gender, systolic blood pressure or baseline ejection fraction (Table 1).

This real World population had a higher rate of ß-blocker and mineralocorticoid receptor antagonist prescription (Table 1). In this population, 59 pts (57.8%) started on S/V at the dose of 24+26mg and 43 pts (42.2%) at the intermediate dose. The average maximum tolerated dose was significantly lower than that reported in PARADIGM-HF (175±84 vs 375±71 mg/day, <0.001): low dose in 28 pts (27.5%), intermediate dose in 54 pts (52.9%) and high dose in 20 pts (19.6%). The mean dose of ACEi/ARB before S/V initiation was lower than that reported in PARADIGM-HF (dose equivalent to enalapril 14.75±11.75 mg/day vs 18.9±3.4, P =0.01) and 4 pts (3.9%) were medicated with ACEi/ARB previously. The rate of ICD and/or CRT was much higher in the real world population (table 1).

S/V was discontinued in 7 pts (6.9 vs 2.3%, P = NS): in 4 pts due to hypotension (3.9 vs 0.9%, P =0.011), in 1 due to cough (1 vs 0%, P =NS), in 1 due to angioedema (1 vs 0.4%, p =0.003) and in 1 due to HF decompensation (1 vs 0%, P =NS).

The mortality rate in this study population was 3.9% (4 pts).

Conclusions: When comparing the PARADIGM-HF Trial population with a real World population it is evident that the latter is composed of older patients with higher levels of NTproBNP and Cr. In this every-day HFrEF population maximal S/V tolerated doses were lower than those reported in PARADIGM-HF. The rate S/V discontinuation due to adverse events was similar, attesting the safety of the drug.

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