Safety of dapagliflozin and empagliflozin in cases with diabetes mellitus or/and heart failure: a retrospective pharmacovigilance study conducted on the eudravigilance database.

IF 3.6 3区医学 Q2 PHARMACOLOGY & PHARMACY

Pharmacological Reports Pub Date : 2024-10-23 DOI:10.1007/s43440-024-00668-4

Annamaria Mascolo, Alessia Zinzi, Mario Gaio, Donatella Ruggiero, Cristina Scavone, Francesco Rossi, Annalisa Capuano

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引用次数: 0

Abstract

Introduction: Dapagliflozin and empagliflozin are sodium-glucose cotransporter-2 (SGLT2) inhibitors initially approved for the treatment of type 2 diabetes mellitus (DM), and later for heart failure (HF). Considering this differential therapeutic use, we decided to evaluate cases related to these agents by comparing those with DM, HF, or both (DM and HF).

Methods: A retrospective, pharmacovigilance study was conducted by using data contained in the EudraVigilance from January 1st, 2021, to December 31st, 2023. Cases were classified into those with DM, HF, or both diseases. The Reporting Odds Ratio (ROR), and its 95% confidence interval (95%CI) were computed to compare the reporting probability of the four most reported adverse events. The following comparisons were performed: DM vs. HF; both DM and HF vs. HF; both DM and HF vs. DM. Analyses were adjusted for age, sex, and time between the approval date of the SGLT2 inhibitor and the reporting date.

Results: A total of 14,594 (50.5%) cases were classifiable for DM (N = 11,962; 82.0%), HF (N = 2,100; 14.4%), or both DM and HF (N = 532; 3.64%). The empagliflozin was the most reported SGLT2 inhibitor (60.1%), and only 15 cases (0.1%) reported both empagliflozin and dapagliflozin. Cases with DM and both DM and HF were associated with a higher reporting probability of ketoacidosis (ROR: 5.95, 95%CI: 4.87-7.26; ROR: 3.05, 95%CI: 2.27-4.09) and Fournier's gangrene (ROR: 2.30, 95%CI: 1.65-3.20; ROR: 2.30, 95%CI: 1.38-3.82) than HF. These results were also confirmed by adjusted analyses.

Conclusion: We found that ketoacidosis and Fournier's gangrene had a higher reporting in cases with DM. Further studies are warranted.

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糖尿病或/和心力衰竭患者服用达帕格列净和恩格列净的安全性：一项基于 eudravigilance 数据库进行的回顾性药物警戒研究。

简介Dapagliflozin和empagliflozin是钠-葡萄糖共转运体-2（SGLT2）抑制剂，最初被批准用于治疗2型糖尿病（DM），后来被批准用于治疗心力衰竭（HF）。考虑到这种不同的治疗用途，我们决定通过比较糖尿病患者、心力衰竭患者或同时患有糖尿病和心力衰竭的患者（DM 和 HF）来评估与这些药物相关的病例：我们利用 EudraVigilance 中包含的 2021 年 1 月 1 日至 2023 年 12 月 31 日的数据，开展了一项回顾性药物警戒研究。病例分为糖尿病、高血压或同时患有这两种疾病的病例。计算了报告几率比（ROR）及其 95% 置信区间（95%CI），以比较报告最多的四种不良事件的报告概率。比较结果如下DM vs. HF；DM 和 HF 均 vs. HF；DM 和 HF 均 vs. DM。分析根据年龄、性别以及 SGLT2 抑制剂批准日期与报告日期之间的时间进行了调整：共有 14,594 例（50.5%）可归类为 DM（N = 11,962; 82.0%）、HF（N = 2,100; 14.4%）或既有 DM 又有 HF（N = 532; 3.64%）。报告最多的SGLT2抑制剂是empagliflozin（60.1%），只有15例（0.1%）同时报告了empagliflozin和dapagliflozin。与 HF 相比，DM 病例以及同时患有 DM 和 HF 的病例报告酮症酸中毒（ROR：5.95，95%CI：4.87-7.26；ROR：3.05，95%CI：2.27-4.09）和 Fournier 坏疽（ROR：2.30，95%CI：1.65-3.20；ROR：2.30，95%CI：1.38-3.82）的概率更高。这些结果在调整分析中也得到了证实：结论：我们发现酮症酸中毒和福尼尔坏疽在糖尿病病例中报告率较高。有必要开展进一步研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacological Reports 医学-药学

CiteScore

8.40

自引率

0.00%

发文量

审稿时长

6 months

期刊介绍： Pharmacological Reports publishes articles concerning all aspects of pharmacology, dealing with the action of drugs at a cellular and molecular level, and papers on the relationship between molecular structure and biological activity as well as reports on compounds with well-defined chemical structures. Pharmacological Reports is an open forum to disseminate recent developments in: pharmacology, behavioural brain research, evidence-based complementary biochemical pharmacology, medicinal chemistry and biochemistry, drug discovery, neuro-psychopharmacology and biological psychiatry, neuroscience and neuropharmacology, cellular and molecular neuroscience, molecular biology, cell biology, toxicology. Studies of plant extracts are not suitable for Pharmacological Reports.