Laborante Renzo, Paglianiti Donato Antonio, Bianchini Emiliano, Galli Mattia, Borovac Josip Andelo, Savarese Gianluigi, Patti Giuseppe, D'Amario Domenico
Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Maria Cecilia Hospital, GVM Care & Research, Cotignola, Ravenna, Italy.
Eur J Intern Med. 2025 May;135:55-63. doi: 10.1016/j.ejim.2025.01.014. Epub 2025 Jan 22.
Data on the early use of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in patients with acute heart failure (HF) are conflicting, and mostly evaluating soft endpoints (i.e., indices of congestion, renal function, ejection fraction, and diuresis). The aim was to perform a meta-analysis of randomized controlled trials (RCTs) to assess their impact after an HF decompensation event.
Two electronic databases were screened for eligible studies. Efficacy endpoints were all-cause death, cardiovascular death, HF hospitalization, length of hospital stay, and N-terminal pro-B-type natriuretic peptide (nt-proBNP). Safety endpoints included acute kidney injury (AKI), volume depletion, ketoacidosis, hypotension, hypoglycemia, non-cardiovascular death, urinary tract infection, genital infections, serious adverse events (AE), and AE leading to treatment discontinuation. Two pre-specified subgroup analyses were planned according to the specific SGLT2i and clinical setting [i.e., acute myocardial infarction (MI) versus non-acute MI]. 16 RCTs enrolling 15,073 patients were considered. Early initiation of SGLT2i significantly reduced the risk of HF hospitalizations [Risk ratio (RR) 0.79, 95 % Confidence interval (CI) 0.72-0.87], AKI (RR 0.76, 95 % CI 0.59-0.99), and nt-proBNP levels (MD -354 pg/mL). No significant difference was detected for any of the other endpoints. In the pre-specified subgroup analysis, a significant interaction was found between the SGLT2i type and the risk of AKI, in favor of empagliflozin.
In patients recently hospitalized for acute HF, early administration of SGLT2i was associated with fewer readmissions for HF and AKI, as well as decongestant effects, without raising any safety concern.
关于急性心力衰竭(HF)患者早期使用钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)的数据存在矛盾,且大多评估的是软性终点指标(即充血指标、肾功能、射血分数和利尿情况)。本研究旨在对随机对照试验(RCT)进行荟萃分析,以评估HF失代偿事件后SGLT2i的影响。
检索两个电子数据库以查找符合条件的研究。疗效终点包括全因死亡、心血管死亡、HF住院、住院时间以及N末端B型脑钠肽前体(nt-proBNP)。安全性终点包括急性肾损伤(AKI)、容量耗竭、酮症酸中毒、低血压、低血糖、非心血管死亡、尿路感染、生殖器感染、严重不良事件(AE)以及导致治疗中断的AE。根据特定的SGLT2i和临床情况[即急性心肌梗死(MI)与非急性MI]计划了两项预先设定的亚组分析。共纳入16项RCT,涉及15073例患者。早期启用SGLT2i显著降低了HF住院风险[风险比(RR)0.79,95%置信区间(CI)0.72 - 0.87]、AKI风险(RR 0.76,95% CI 0.59 - 0.99)以及nt-proBNP水平(MD -354 pg/mL)。其他终点指标均未发现显著差异。在预先设定的亚组分析中,发现SGLT2i类型与AKI风险之间存在显著交互作用,恩格列净更具优势。
在近期因急性HF住院的患者中,早期给予SGLT2i与HF再入院和AKI次数减少相关,且有减轻充血的作用,未引发任何安全性问题。