Temporal risk patterns of severe hypovolemia associated with sodium‐glucose cotransporter‐2 inhibitors in patients with type 2 diabetes mellitus: A self‐controlled case series study
Main finding · Severe hypovolemiaResult — go to the resultAdjusted incidence rate ratio 7.39 95% CI 6.09–8.96Authors' conclusion
SGLT2i use in patients with type 2 diabetes mellitus was associated with a higher risk of severe hypovolemia, particularly within the first 30 days of treatment initiation, with the highest risk observed during 22 to 28 days.
Study context
- Population
- Patients with T2D prescribed SGLT2i who experienced severe hypovolemia, Japanese claims data; 78.4% male, median age 54.1 years1,334 severe hypovolemia events
- Participants
- 1,200 patients
- Exposure
- SGLT2i exposure risk periods vs unexposed control period
- Outcome
- Adjusted incidence rate ratios (IRRs) of severe hypovolemia in exposure risk periods vs unexposed control period
Methodological detailsclaims data from Japan, multivariable conditional Poisson regression
- Claims data from Japan
- Multivariable conditional Poisson regression
Main finding
Severe hypovolemia · first 30 days of treatment initiation
Adjusted incidence rate ratio
7.39
95% CI 6.09–8.96
Days 1 to 30vs Unexposed control period
adjusted IRR 7.39 (95% CI 6.09–8.96)
As reported in the abstract
Observational data: associations, not effects.
Further findings
| Outcome | Adjusted IRR (95% CI) | |
|---|---|---|
| Severe hypovolemia, days 22 to 28 of treatment (highest risk period)Days 22 to 28vs Unexposed control period | 15.24 (11.92–19.48) | |
| 0.050.21520Adjusted incidence rate ratio (log scale) |
Original publication
Temporal risk patterns of severe hypovolemia associated with sodium‐glucose cotransporter‐2 inhibitors in patients with type 2 diabetes mellitus: A self‐controlled case series study. Diabetes Obes Metab. Published 18 February 2025. doi:10.
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