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
Aims
We aimed to investigate the temporal risk patterns of severe hypovolemia induced by sodium‐glucose cotransporter‐2 inhibitors (SGLT2i) in patients with type 2 diabetes mellitus.
Materials and Methods
We conducted a self‐controlled case series using claims data from Japan. Patients who were prescribed SGLT2i for treating type 2 diabetes mellitus and experienced severe hypovolemia were enrolled. The primary analysis evaluated the adjusted incidence rate ratios (IRRs) of exposure risk periods (Days 1 to 30, Days 31 to 90, Days 91 to 180 and Days ≥181) with their corresponding 95% confidence intervals (CIs), calculated using a multivariable conditional Poisson regression model, relative to that of the unexposed control period.
Results
A total of 1200 new users of SGLT2i with 1334 severe hypovolemia events were included. The median follow‐up and treatment periods were 3.66 and 2.53 years, respectively. The cohort was predominantly male (78.4%) with a median age of 54.1 years. A higher risk of severe hypovolemia associated with SGLT2i was observed particularly in the first 30 days (adjusted IRR 7.39, 95% CI 6.09–8.96) of treatment initiation. Secondary analyses highlighted the first 22 to 28 days (adjusted IRR 15.24, 95% CI 11.92–19.48) of treatment as the highest risk period for severe hypovolemia.
Conclusions
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.
