The real-world safety profile of sodium-glucose co-transporter-2 inhibitors among older adults (≥ 75 years): a retrospective, pharmacovigilance study

Cardiovascular Diabetology

Research

Tali Cukierman-Yaffe¹  Gilad Twig²  Adam Goldman³  Rachel Dankner⁴  Alon Pomerantz⁵  Yonatan moshkovits⁵  Ilan Ben-Zvi⁶  Elad Maor⁷  Boris Fishman⁸  Emanuel Raschi⁹ 

[1] Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel;Division of Endocrinology & Metabolism, Sheba Medical Center, Ramat-Gan, Israel;Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel;Division of Endocrinology & Metabolism, Sheba Medical Center, Ramat-Gan, Israel;The Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Ramat-Gan, Israel;Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel;Leviev Heart Center, Sheba Medical Center, Ramat-Gan, Israel;Department of Internal Medicine, Sheba Medical Center, Ramat-Gan, Israel;The Talpiot Sheba Medical Leadership Program, Ramat-Gan, Israel;Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel;The Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Ramat-Gan, Israel;Department of Internal Medicine, Sheba Medical Center, Ramat-Gan, Israel;Department of Internal Medicine, Sheba Medical Center, Ramat-Gan, Israel;Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel;Leviev Heart Center, Sheba Medical Center, Ramat-Gan, Israel;Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel;Leviev Heart Center, Sheba Medical Center, Ramat-Gan, Israel;The Talpiot Sheba Medical Leadership Program, Ramat-Gan, Israel;Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel;The Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Ramat-Gan, Israel;Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy;

关键词: Sodium-glucose co-transporter-2 inhibitors;    Older adults;    Diabetes;    Heart failure;    Diabetic ketoacidosis;    Fournier gangrene;   

DOI  :  10.1186/s12933-023-01743-5

 received in 2022-11-19, accepted in 2023-01-13,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundAs indications for sodium-glucose co-transporter-2 inhibitors (SGLT2i) are expanding, a growing number of older adults have become candidates for treatment. We studied the safety profile of SGLT2i among older adults.MethodsA retrospective, pharmacovigilance study of the FDA’s global database of safety reports. To assess reporting of pre-specified adverse events following SGLT2i among adults (< 75 years) and older adults (≥ 75), we performed a disproportionality analysis using the sex-adjusted reporting odds ratio (adj.ROR).ResultsWe identified safety reports of 129,795 patients who received non-insulin anti-diabetic drugs (NIAD), including 24,253 who were treated with SGLT2i (median age 60 [IQR: 51–68] years, 2,339 [9.6%] aged ≥ 75 years). Compared to other NIAD, SGLT2i were significantly associated with amputations (adj.ROR = 355.1 [95%CI: 258.8 − 487.3] vs adj.ROR = 250.2 [79.3 − 789.5]), Fournier gangrene (adj.ROR = 45.0 [34.5 − 58.8] vs adj.ROR = 88.0 [27.0 − 286.6]), diabetic ketoacidosis (adj.ROR = 32.3 [30.0 − 34.8] vs adj.ROR = 23.3 [19.2 − 28.3]), genitourinary infections (adj.ROR = 10.3 [9.4 − 11.2] vs adj.ROR = 8.6 [7.2 − 10.3]), nocturia (adj.ROR = 5.5 [3.7 − 8.2] vs adj.ROR = 6.7 [2.8 − 15.7]), dehydration (adj.ROR = 2.5 [2.3 − 2.8] vs adj.ROR = 2.6 [2.1 − 3.3]), and fractures (adj.ROR = 1.7 [1.4 − 2.1] vs adj.ROR = 1.5 [1.02 − 2.1]) in both adults and older adults, respectively. None of these safety signals was significantly greater in older adults (Pinteraction threshold of 0.05). Acute kidney injury was associated with SGLT2i in adults (adj.ROR = 1.97 [1.85 − 2.09]) but not in older adults (adj.ROR = 0.71 [0.59 − 0.84]). Falls, hypotension, and syncope were not associated with SGLT2i among either adults or older adults.ConclusionIn this global post-marketing study, none of the adverse events was reported more frequently among older adults. Our findings provide reassurance regarding SGLT2i treatment in older adults, although careful monitoring is warranted.

【 授权许可】

CC BY   
© The Author(s) 2023

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