The real-world safety profile of sodium-glucose co-transporter-2 inhibitors among older adults (≥ 75 years): a retrospective, pharmacovigilance study
Authors' conclusion
In 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.
Study context
- Population
- Safety reports of patients receiving non-insulin anti-diabetic drugs (NIAD) in the FDA's global database; SGLT2i-treated median age 60 [IQR: 51–68] years24,253 SGLT2i
- Participants
- 129,795 participants
- Exposure
- SGLT2i vs other NIAD, in adults and older adults
- Older adults (≥ 75)n = 2,339
- Outcome
- Reporting of pre-specified adverse events following SGLT2i vs other NIAD (sex-adjusted reporting odds ratio)
Methodological detailsdisproportionality analysis, sex-adjusted reporting odds ratio
- Disproportionality analysis
- Sex-adjusted reporting odds ratio
Main finding
As reported in the abstract
Pre-specified adverse events with SGLT2i vs other NIAD (adj.ROR, adults vs older adults)
- Amputations: adults vs older adults
- adj.ROR = 355.1 [95%CI: 258.8 - 487.3] vs adj.ROR = 250.2 [79.3 - 789.5]
- Fournier gangrene: adults vs older adults
- adj.ROR = 45.0 [34.5 - 58.8] vs adj.ROR = 88.0 [27.0 - 286.6]
- DKA: adults vs older adults
- adj.ROR = 32.3 [30.0 - 34.8] vs adj.ROR = 23.3 [19.2 - 28.3]
- Genitourinary infections: adults vs older adults
- adj.ROR = 10.3 [9.4 - 11.2] vs adj.ROR = 8.6 [7.2 - 10.3]
- Nocturia: adults vs older adults
- adj.ROR = 5.5 [3.7 - 8.2] vs adj.ROR = 6.7 [2.8 - 15.7]
- Dehydration: adults vs older adults
- adj.ROR = 2.5 [2.3 - 2.8] vs adj.ROR = 2.6 [2.1 - 3.3]
- Fractures: adults vs older adults
- adj.ROR = 1.7 [1.4 - 2.1] vs adj.ROR = 1.5 [1.02 - 2.1]
- Acute kidney injury: adults (associated)
- adj.ROR = 1.97 [1.85 - 2.09]
- Acute kidney injury: older adults (not associated)
- adj.ROR = 0.71 [0.59 - 0.84]
Observational data: associations, not effects.
Original publication
The real-world safety profile of sodium-glucose co-transporter-2 inhibitors among older adults (≥ 75 years): a retrospective, pharmacovigilance study. Cardiovasc Diabetol. Published 24 January 2023. doi:10.
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