Department of Cardiology, Policlinico Casilino - Rome, Italy; Department of Clinical Internal, Anaesthesiology and Cardiovascular Sciences, Sapienza University - Rome, Italy.
Department of Clinical Internal, Anaesthesiology and Cardiovascular Sciences, Sapienza University - Rome, Italy.
Int J Cardiol. 2021 Oct 15;341:56-59. doi: 10.1016/j.ijcard.2021.08.035. Epub 2021 Aug 26.
The sodium-glucose co-transporter-2 (SGLT2) inhibitors dapagliflozin and empagliflozin have been demonstrated to reduce adverse cardiovascular outcomes in patients with heart failure with reduced ejection fraction (HFrEF). Limited data are available characterizing the generalizability of SGLT2 inhibitors treatment in the clinical practice. The aim of the study was to evaluate the proportion of outpatients with HFrEF that would be eligible for SGLT2 inhibitors in a contemporary real-world population.
We retrospectively evaluated patients with chronic stable HFrEF followed-up at the HF outpatient clinic of our institution. Patients' eligibility was assessed according to the entry criteria of DAPA-HF (dapagliflozin) and EMPEROR-Reduced (empagliflozin) trials and to US Food and Drug Administration (FDA) label criteria (only dapagliflozin).
A total of 441 HFrEF patients was enrolled. According to the major inclusion and exclusion criteria from DAPA-HF and EMPEROR-Reduced trials, 198 (45%) patients would be candidates for initiation of both dapagliflozin and empagliflozin, 61 (14%) would be eligible only to dapagliflozin and 23 (5%) only to empagliflozin, without significant differences between diabetic and non-diabetic patients (p = 0.23). Among patients not suitable for gliflozins treatment (159 patients; 36%), the major determinant of ineligibility was the failure to achieve the predefined NT-proBNP inclusion threshold. Excluding NTproBNP as per FDA label criteria, dapagliflozin eligibility increased to 86%.
In our real-world analysis a large proportion of HFrEF patients would be candidates for initiation of SGLT2 inhibitors, supporting its broad generalizability in clinical practice. This would be expected to reduce morbidity and mortality in eligible patients.
钠-葡萄糖协同转运蛋白 2（SGLT2）抑制剂达格列净和恩格列净已被证明可降低射血分数降低的心力衰竭（HFrEF）患者的不良心血管结局。目前关于 SGLT2 抑制剂在临床实践中的可推广性的数据有限。本研究旨在评估在当代真实世界人群中，有多少 HFrEF 门诊患者符合 SGLT2 抑制剂的治疗标准。
我们回顾性评估了在我院心力衰竭门诊随访的慢性稳定型 HFrEF 患者。根据 DAPA-HF（达格列净）和 EMPEROR-Reduced（恩格列净）试验的入组标准和美国食品和药物管理局（FDA）标签标准（仅达格列净）评估患者的入选标准。
共纳入 441 例 HFrEF 患者。根据 DAPA-HF 和 EMPEROR-Reduced 试验的主要纳入和排除标准，198 例（45%）患者将适合起始使用达格列净和恩格列净，61 例（14%）仅适合起始使用达格列净，23 例（5%）仅适合起始使用恩格列净，糖尿病和非糖尿病患者之间无显著差异（p=0.23）。在不适合使用格列净治疗的 159 例患者（36%）中，不适合的主要决定因素是未能达到预设的 NT-proBNP 纳入阈值。根据 FDA 标签标准，排除 NTproBNP 后，达格列净的治疗适宜性增加至 86%。
在我们的真实世界分析中，很大一部分 HFrEF 患者将适合起始 SGLT2 抑制剂治疗，这支持了其在临床实践中的广泛可推广性。这有望降低符合条件的患者的发病率和死亡率。
