Augusto Francisca, Paiva Patrícia, Félix Carolina, Jordão Inês, Costa Miguel, Dias Patrícia, Parente Francisco, Gonçalves Lino, Machado Francisco, António Natália
Instituto de Farmacologia e Terapêutica Experimental da Faculdade de Medicina, Universidade de Coimbra, Coimbra, Portugal.
Unidade de Farmacologia Clínica, Unidade Local de Saúde de Coimbra, Coimbra, Portugal.
J Clin Pharmacol. 2025 Jul 23. doi: 10.1002/jcph.70082.
Dapagliflozin has demonstrated multiple benefits in clinical trials for heart failure with reduced ejection fraction (HFrEF), but older patients with multiple comorbidities were often excluded. This study aimed to evaluate the effectiveness and safety of dapagliflozin in a real-world population of HFrEF patients. This retrospective study included HFrEF patients from a tertiary hospital, who initiated dapagliflozin between January 202 and December 2022. The mean follow-up was 15.3 ± 8.3 months. Each patient served as their own control to compare left ventricular ejection fraction (LVEF), laboratory parameters, and time-dependent events, such as heart failure (HF) readmissions. A total of 155 HFrEF patients (mean age 68.5 ± 14.5 years; 75.5% male) were included. Of these, 47.1% had non-ischemic heart disease, 49.0% had type 2 diabetes mellitus, and most were on beta-blockers, loop diuretics and angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, or angiotensin receptor neprilysin inhibitor. LVEF improved from 29.2% to 34.3% (P < .001), with significant reductions in body weight and heart rate (P < .001). HF-related emergency room visits decreased (0.68 ± 1.06 to 0.58 ± 0.96; P = .329). Renal function declined, with glomerular filtration rate decreasing from 67.6 ± 25.2 to 55.2 ± 30.8 mL/min/1.73 m (P < .001), particularly in older patients (HR 1.033; 95% CI: 1.004-1.063) and those with higher baseline heart rate (HR 1.028; 95% CI: 1.011-1.045). Severe adverse drug reactions occurred in 3.9% of patients, with hypotension (12.9%) being the most common. In conclusion, dapagliflozin demonstrated a favorable safety profile and significant hemodynamic benefits, improving LVEF and stabilizing HF progression in a real-world HFrEF population.
达格列净在射血分数降低的心力衰竭（HFrEF）临床试验中已显示出多种益处，但患有多种合并症的老年患者通常被排除在外。本研究旨在评估达格列净在HFrEF患者真实世界人群中的有效性和安全性。这项回顾性研究纳入了一家三级医院的HFrEF患者，这些患者在202年1月至2022年12月期间开始使用达格列净。平均随访时间为15.3±8.3个月。每位患者作为自身对照，以比较左心室射血分数（LVEF）、实验室参数以及诸如心力衰竭（HF）再入院等时间依赖性事件。总共纳入了155例HFrEF患者（平均年龄68.5±14.5岁；75.5%为男性）。其中，47.1%患有非缺血性心脏病，49.0%患有2型糖尿病，大多数患者正在使用β受体阻滞剂、袢利尿剂以及血管紧张素转换酶抑制剂、血管紧张素II受体阻滞剂或血管紧张素受体脑啡肽酶抑制剂。LVEF从29.2%提高到34.3%（P<.001），体重和心率显著降低（P<.001）。与HF相关的急诊就诊次数减少（从0.68±1.06降至0.58±0.96；P=.329）。肾功能下降，肾小球滤过率从67.6±25.2降至55.2±30.8 mL/min/1.73 m²（P<.001），尤其是在老年患者（HR 1.033；95%CI：1.004 - 1.063）和基线心率较高的患者中（HR 1.028；95%CI：1.011 - 1.045）。3.9%的患者发生严重药物不良反应，其中低血压（12.9%）最为常见。总之，在HFrEF患者的真实世界人群中，达格列净显示出良好的安全性和显著的血流动力学益处，可改善LVEF并稳定HF进展。
