Jurin Ivana, Hadžibegović Irzal, Jurin Hrvoje, Rudan Diana, Pavlović Nikola, Radić Marija, Manola Šime, Trkulja Vladimir
Vladimir Trkulja, Department of Pharmacology and Clinical Pharmacology, Zagreb University School of Medicine, Šalata 11, 10000 Zagreb, Croatia,
Croat Med J. 2025 May 7;66(2):135-152. doi: 10.3325/cmj.2025.66.135.
To assess the relative efficacy of dapagliflozin and empagliflozin in routinely treated chronic heart failure (CHF) patients.
Data from a registry of prevalent and incident CHF patients were used to set up cohorts (new-user design) of patients started on dapagliflozin or empagliflozin in addition to other guideline-directed therapy. Cohorts were mutually balanced on a range of characteristics, and were assessed for the incidence of a composite of all-cause death/major adverse cardiac events (primary outcome) over the initial 6 months of treatment, and for New York Heart Association (NYHA) functional class at 6 months (secondary outcome). Frequentist and Bayes estimates were generated for the dapagliflozin vs empagliflozin comparison.
In both prevalent (dapagliflozin n=393, empagliflozin n=328) and incident (dapagliflozin n=124, empagliflozin n=116) patients, those prescribed dapagliflozin had somewhat higher incidence of the primary outcome, but the confidence intervals were wide (RR=1.385, 95%CI 0.882-2.173 [prevalent], RR=2.192, 95%CI 0.765-6.282 [incident]), and were more likely to present with a worse NYHA class at 6 months (OR=1.552, 95%CI 1.142-2.108 [prevalent], OR=1.503, 95%CI 0.844-2.676 [incident]). In the pooled data, primary events (n=102) were more common in dapagliflozin-prescribed patients (frequentist estimate RR=1.519, 95%CI 1.239-1.861; Bayes RR=1.380, 95%CrI 0.981-1.944). Dapagliflozin-prescribed patients were also more likely to have a worse NYHA class at 6 months (OR=1.540, 95%CI 1.208-1.962; Bayes OR=1.425, 95%CrI 1.098-1.781).
CHF patients prescribed with dapagliflozin had poorer outcomes than their empagliflozin-prescribed peers over the initial 6 months of treatment. Data emphasize a need for a direct randomized comparison of the two treatments in this setting.
评估达格列净和恩格列净在常规治疗的慢性心力衰竭（CHF）患者中的相对疗效。
来自CHF患者登记处的现患和新发病例数据用于建立队列（新使用者设计），这些患者在接受其他指南指导的治疗基础上开始使用达格列净或恩格列净。队列在一系列特征上相互平衡，并评估治疗最初6个月内全因死亡/主要不良心脏事件复合终点（主要结局）的发生率，以及6个月时纽约心脏协会（NYHA）心功能分级（次要结局）。对达格列净与恩格列净进行比较生成了频率学派和贝叶斯估计值。
在现患患者（达格列净n = 393，恩格列净n = 328）和新发病例患者（达格列净n = 124，恩格列净n = 116）中，接受达格列净治疗的患者主要结局发生率略高，但置信区间较宽（RR = 1.385，95%CI 0.882 - 2.173 [现患]，RR = 2.192，95%CI 0.765 - 6.282 [新发病例]），且在6个月时更有可能出现较差的NYHA心功能分级（OR = 1.552，95%CI 1.142 - 2.108 [现患]，OR = 1.503，95%CI 0.844 - 2.676 [新发病例]）。在汇总数据中，接受达格列净治疗的患者中主要事件（n = 102）更为常见（频率学派估计RR = 1.519，95%CI 1.239 - 1.861；贝叶斯RR = 1.380，95%CrI 0.981 - 1.944）。接受达格列净治疗的患者在6个月时也更有可能出现较差的NYHA心功能分级（OR = 1.540，95%CI 1.208 - 1.962；贝叶斯OR = 1.425，95%CrI 1.098 - 1.781）。
在治疗的最初6个月内，接受达格列净治疗的CHF患者比接受恩格列净治疗的患者结局更差。数据强调需要在这种情况下对两种治疗进行直接随机比较。
