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Tolerability and safety of Sacubitril/Valsartan in real-life practice
Session:
CO 10 - Insuficiência Cardíaca
Speaker:
Joana P. Neiva
Congress:
CPC 2018
Topic:
D. Heart Failure
Theme:
10. Chronic Heart Failure
Subtheme:
10.4 Chronic Heart Failure – Treatment
Session Type:
Comunicações Orais
FP Number:
---
Authors:
Joana P. Neiva; Inés Gómez Otero; Alfonso Varela-Roman; Ana Seoane Blanco; María Moure Gonzalez; Jose Ramon Juanatey
Abstract
<p>Introduction: After PARADIGM-HF, current ESC guidelines recommend sacubitril/valsartan (SV) for patients (P) with ongoing symptomatic chronic heart failure with reduced ejection fraction (HFrEF), despite first line medical therapy. Experience regarding tolerability and safety in real world populations is less well described.</p> <p>Purpose: To assess tolerability and success in achieving maximum SV dose, as well as detailing the side effect profile, in a real world population.</p> <p>Methods: Retrospective and descriptive study extended to all P initiated on SV in a specialized HF unit in a single center since October 2016. Data collected included demographics, initial dose, titration, discontinuation and adverse events. Clinical parameters were documented at each evaluation. Up-titration occurred every 2-4 weeks as per clinical judgment. Descriptive statistics were used for analysis.</p> <p>Results: Within a population of 106P (79% male; 68,2+10,7years; 45,3% ischemic etiology; mean EF 29,5%; NYHA II-III 99,1%) 61,3% initiated on low doses (24/26mg) and the remaining on 49/51mg. At initiation visit 4P had systolic blood pressure (SBP) <100mmHg, 1P serum creatinine (Cr) >2,5mg/dL and 6,6% potassium (K) >5,4mmol/L. 13P (12,3%) were still in process of up-titration. After up-titration phase (44<u>+</u>19days) 51,6% achieved maximum dose of 97/103mmHg; 28% were on medium dose and 11,8% remained on 24/26mg without tolerating a dose increase. The main reasons to not achieve highest dose were dizziness/hypotension (47,2%; 4P with SBP<90mmHg) and hyperkalemia (44,4%; maximum 5,7mmol/L). After a mean follow-up time of 194 days (4-421), 45,3% remained on maximum dose; 5,9% were down titrated to a tolerable dose and 8.2% progressed in titration. The download dose occurred in all cases due to symptomatic hypotension. 11P (10,4%) discontinued SV (<em>vs</em> 17,8% in PARADIGM-HF), 8 of them in titration phase. The commonest reason was a composite of hypotension/dizziness (n=5; 3P with SBP<90mmHg); other reasons included acute renal failure (n=1; decreasing 36% of eGFR), economic reasons (n=2), gastrointestinal disturbance (n=1), left ventricular assist device implantation (n=1) and inappropriate initiation (n=1). No episodes of angioedema.</p> <p>Regarding tolerance, SBP decreased 4mmHg (122<u>+</u>17 vs 118<u>+</u>17), Cr increased 0,05mg/dL (1,11<u>+</u>0,34 vs 1,16<u>+</u>0,41) and K decreased 0,03mmol/L (4,84<u>+</u>0,39 vs 4,81<u>+</u>0,42). Of those who had worsening of renal function, 3,8% (4P) had a decrease in eGFR>35% (maximum decrease of 42,6%).</p> <p>Conclusion: Our data suggests that SV is well tolerated and has good safety in real-life. True hypotension was the dominant cause for discontinuation. Caution should be taken to consider reducing or rationalize other medications with anti-hypertensive side effects to avoid it. The overall adverse reactions were lower when compared to PARADIGM-HF, however our mean follow-up period was significantly shorter.</p>
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