The real-world safety profile of SGLT2 inhibitors among adults 75 years or older: a retrospective, pharmacovigilance study

Abstract Introduction As indications for sodium-glucose co-transporter-2 (SGLT2) inhibitors treatment are expanding, more older adults become candidates treatment. However, data regarding the treatment's safety profile in population limited. Methods A retrospective, pharmacovigilance study of FDA's global database reports (7/1/2014–6/30/2021). To assess reporting pre-specified adverse events following SGLT2-inhibitors among (18≥age<75) and (age≥75), we performed disproportionality analysis using odds ratio (ROR). Results Of 10,526,408 patients full database, 279,619 eligible with non-insulin-dependent diabetes mellitus were identified (mean age 63.4 [SD 13.0] years, 54,791 [19.6%] aged ≥75 years), whom 29,431 receiving SGLT-2 inhibitors. Compared to other non-insulin anti-diabetics, significantly associated amputations (ROR=127.87 [95% CI: 111.31–146.90] vs ROR=74.91 [49.99–112.25]), Fournier gangrene (ROR=53.27 [44.38–63.92] ROR=33.33 [20.33–54.64]), ketoacidosis (ROR=39.25 [37.20–41.42] ROR=58.46 [49.41–69.1]), genitourinary infections (ROR=4.36 [4.12–4.61] ROR=5.08 [4.45–5.79]), nocturia (ROR=2.81 [2.13–3.73] ROR=3.51 [1.84–6.68]), dehydration (ROR=2.22 [2.05–2.40] ROR=2.33 [1.93–2.81]) both adults, respectively. The relative these signals was consistent between groups (all P interaction >0.05). Acute kidney injury (ROR=1.47 [1.40–1.54]) but not (ROR=0.84 [0.72–0.98]). No new observed adults. Falls, fractures, hypotension, syncope either or Conclusion In this post-marketing study, increased amputations, gangrene, DKA, infections, dehydration. Nevertheless, no found population. Funding Acknowledgement Type funding sources: None.