SPC365

Safety and effectiveness of Sacubitril-Valsartan in a real-world population

Session: Comunicações Orais (Sessão 20) - Insuficiência Cardíaca 3 - Terapêutica Farmacológica
Speaker: MARIANA GOMES TINOCO

Congress: CPC 2022
Topic: D. Heart Failure
Theme: 10. Chronic Heart Failure
Subtheme: 10.4 Chronic Heart Failure – Treatment
Session Type: Comunicações Orais
FP Number: ---
Authors: Mariana Tinoco; Ana Filipa Cardoso; Geraldo Dias; Tamara Pereira; Bebiana Faria; Filipa Almeida; Sérgio Leite; António Lourenço
<h1><span style="font-size:16pt"><span style="background-color:white"><span style="font-family:&quot;Calibri Light&quot;,sans-serif"><span style="color:#2f5496"><strong><span style="font-size:12.0pt"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="color:black">Introduction</span></span></span></strong></span></span></span></span></h1>

<h1><span style="font-size:16pt"><span style="background-color:white"><span style="font-family:&quot;Calibri Light&quot;,sans-serif"><span style="color:#2f5496"><span style="font-size:12.0pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="color:black">PARADIGM-HF demonstrated superiority of Sacubitril-Valsartan (SV) over enalapril in patients with heart failure with reduced ejection fraction (HFrEF). However, patients in clinical practice may differ in their characteristics compared with patients in clinical trials.</span></span></span></span></span></span></span></span></h1>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><strong><span style="font-size:12.0pt"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="color:black">Purpose</span></span></span></strong></span></span></p>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:12.0pt"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="color:black">To characterize a real-world population of patients with HFrEF under SV therapy, and evaluate its safety and effectiveness.</span></span></span></span></span></p>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><strong><span style="font-size:12.0pt"><span style="font-family:&quot;Times New Roman&quot;,serif">Methods</span></span></strong></span></span></p>

<p><span style="font-size:12pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="color:black">Retrospective study of patients with HFrEF under SV therapy followed in an HF clinic between Jan 2018 and Jun 2020, with a follow up period until Oct 2021. </span></span></span></span></p>

<p><span style="font-size:12pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><strong><span style="color:black">Results</span></strong></span></span></span></p>

<p><span style="font-size:12pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="color:black">A total of&nbsp;90 patients were included: 80% (72) male, 65&plusmn;12 years, mostly with dilated cardiomyopathy (46,7%, 42) and ischemic cardiomyopathy (42,2%; 38). </span></span></span></span></p>

<p><span style="font-size:12pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="color:black">In the evaluation before starting SV, mean LVEF was 26,35&plusmn;7,32%, 50% of patients were in NYHA class III-IV; 89% were on ACEI/ARB, 92% on beta-blocker (BB) and 92% on MRA; 43,3% had an ICD and 31,1% a CRT-D; Up-titration to target dose (TD) was achieved in<span style="background-color:white"> 57,8%.&nbsp;</span></span></span></span></span></p>

<p><span style="font-size:12pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="color:black">During a median follow-up (FUP) of 31,5 months&nbsp;[IQR: 23-41]&nbsp;we observed: an improvement in functional class (p=0.019); NT-PBNP did not significantly change </span><span style="color:black">(3718 vs 3110 pg/ml); a statistically significant increase</span><span style="color:black"> in percentage of BB TD (50,28% vs 65,28%, p=0,003) and a marked reduction in furosemide use (21,1% vs 7,9%, p&lt;0,001) and dose (mg) (67,04 vs 45,14, p&lt;0,001).</span></span></span></span></p>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:12.0pt"><span style="font-family:&quot;Times New Roman&quot;,serif">On TTE we observed an increase </span></span><span style="font-size:12.0pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="color:black">in </span></span></span></span><span style="font-size:12.0pt"><span style="font-family:&quot;Times New Roman&quot;,serif">LVEF (26,59 vs 35,64; p&lt;0,001), a decrease in LV end-diastolic volume index (LVEDVi) (142,2 vs 86,2; p &lt; 0,001), in LV end-systolic volume index (LVESVi) (108,75 vs 59,86; p&lt;0,001) and in E/e&#39; (13,49 vs 11,21, p=0,09). </span></span></span></span></p>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:12.0pt"><span style="font-family:&quot;Times New Roman&quot;,serif">After starting SV, major adverse cardiovascular events<span style="background-color:white"><span style="color:black"> (MACE) </span></span>occurred in 18,9% (17) of patients of which 8,9% (8) died for CV causes and 18,9% (17) had hospitalizations for HF.</span></span></span></span></p>

<p><span style="font-size:12pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="color:black">SV discontinuation occurred in 7,8% (7) of patients, being symptomatic hypotension (43%) and economic insufficiency (29%) the most common reasons. Dose reduction was needed in 12,2% (11), being symptomatic hypotension (43%) and hyperkalaemia (27%) the most common reasons. </span></span></span></span></p>

<p><span style="font-size:12pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><strong><span style="color:black">Conclusion</span></strong></span></span></span></p>

<p><span style="font-size:12pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="color:black">We observed the impact of SV in improving NYHA functional class and in reducing the needed of loop diuretic, as well as on cardiac remodelling. SV was well tolerated and uptitration to the maximal TD was possible in 57,8%. In our real-world cohort, with heterogeneous patients, with more comorbidities and many who did not tolerate TD, the overall outcomes rates were similar when compared to PARADIGM-HF</span></span></span></span></p>