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Dapagliflozin in Heart Failure with reduced ejection fraction: a randomized controlled trial
Session:
Posters (Sessão 6 - Écran 4) - Insuficiência Cardíaca 6 - Inibidores SGLT1
Speaker:
João Pedro Dias Ferreira Reis
Congress:
CPC 2022
Topic:
D. Heart Failure
Theme:
10. Chronic Heart Failure
Subtheme:
10.4 Chronic Heart Failure – Treatment
Session Type:
Pósters Electrónicos
FP Number:
---
Authors:
João Pedro Reis
Abstract
<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><strong><span style="font-size:12.0pt"><span style="font-family:"Times New Roman",serif">Background</span></span></strong><span style="font-size:12.0pt"><span style="font-family:"Times New Roman",serif">: Sodium-glucose co-transporter 2 inhibitors (iSGLT2) have shown to reduce morbidity and mortality in Heart Failure (HF) with reduced Ejection Fraction patients – HfrEF. Our aim was to evaluate the safety and efficacy of Dapagliflozin in non-diabetic HF outpatients in a real-world setting.</span></span></span></span></p> <p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><strong><span style="font-size:12.0pt"><span style="font-family:"Times New Roman",serif">Methods</span></span></strong><span style="font-size:12.0pt"><span style="font-family:"Times New Roman",serif">: Adult HF patients (Ps) were randomized 1:1 to receive dapagliflozin 10 mg or placebo. All patients had a LVEF < 50%, were in NYHA class II-III and under guideline-recommended OMT for the previous 3 months, including a BB, ARNI/ACEi and MRA. They were excluded if they had a previous history of diabetes mellitus or a GFR ≤ 30ml/min. Study protocol included an initial evaluation with clinical assessment, laboratorial data, transthoracic echocardiography and CPET. All Ps were followed-up for 6 months and the aforementioned evaluation was then repeated. The variation of several clinical parameters was compared between groups.</span></span></span></span></p> <p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><strong><span style="font-size:12.0pt"><span style="font-family:"Times New Roman",serif">Results</span></span></strong><span style="font-size:12.0pt"><span style="font-family:"Times New Roman",serif">: A total of 40 Ps were included (mean age 61±13years, 82.5% male, mean LVEF 34±5%, 70% with ischemic etiology and mean HbA1<sub>c</sub> 5.8±0.3%). In the 20 Ps randomized to dapagliflozin, no major safety events were recorded and the reported compliance was 100%. There were no significant differences between groups regarding baseline clinical and demographic characteristics. Ps in the dapagliflozin group presented a greater reduction of NT-proBNP levels compared to controls (-217.56±35.30 vs 650.28±127.23 pg/mL,<em> p</em> = 0.007) despite similar adjustments in diuretic dosages in both groups during follow-up. Ps in the dapagliflozin group experienced a greater improvement in global longitudinal strain – GLS (-2.2±2.6% vs +1.6±2.3%, <em>p</em> = 0.001) but not LVEF improvement (<em>p</em> = 0.510). Dapagliflozin was associated with a greater improvement in parameters of LV-filling pressure: LA indexed volume (-6.9±6.2 mL/m<sup>2</sup> vs 6.2±9.2 mL/m<sup>2</sup>, <em>p</em> < 0.001), PASP (-5.9±8.7 mmHg vs 9.6±6.5 mmHg, <em>p</em> < 0.001) and medium E/e’ (-1.4±2.6 vs 1.5±4.3, <em>p</em> = 0.026). There was greater improvement in pVO<sub>2</sub> in the dapagliflozin group: 3.09±3.81 vs 0.11±3.29 mL/kg/min, <em>p</em> = 0.030. No statistically significant difference in HF events was found: 9.5% vs 5.3%, <em>p</em> = 0.609. In the dapagliflozin group, there was a greater reduction in the number of Ps in NYHA class III: 26.3% vs 0%, <em>p</em> = 0.004.</span></span></span></span></p> <p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><strong><span style="font-size:12.0pt"><span style="font-family:"Times New Roman",serif">Conclusion</span></span></strong><span style="font-size:12.0pt"><span style="font-family:"Times New Roman",serif">: Dapagliflozin use was safe and associated with a significant reduction in NT-proBNP levels and an improvement in GLS and cardiopulmonary fitness at 6-months follow-up in non-diabetic HFrEF Ps. </span></span></span></span></p>
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