Liver, renal, genitourinary and diabetic ketoacidosis risks among new users of empagliflozin versus dipeptidyl peptidase‐4 inhibitors in patients with type 2 diabetes: Post‐authorization safety study based on multinational cohorts
Authors' conclusion
Compared with DDP-4 inhibitor use, empagliflozin use was associated with increased risks of DKA and GI and decreased risks of ALI, AKI, CKD and severe complications of UTI. These associations are consistent with previous studies and known class effects of sodium-glucose cotransporter 2 inhibitors, including renoprotective effects and beneficial effects on alanine aminotransferase levels.
Study context
- Population
- Patients with T2D aged ≥18 years initiating empagliflozin or a DPP-4i between August 2014 and August 2019, with ≥12 months' continuous health plan enrolment; UK, Danish and US healthcare data sources
- Participants
- 64,599 vs 203,315
- Exposure
- Empagliflozin vs DPP-4i initiation
- Empagliflozinn = 64,599
- DPP-4 inhibitorn = 203,315reference
- Outcome
- Risks of DKA, acute liver injury (ALI), acute kidney injury (AKI), CKD, severe complications of UTI and genital infection (GI)
Methodological detailsmultinational, observational, new-user cohort, adjusted for propensity-score deciles
- Multinational
- Observational
- New-user cohort
- Adjusted for propensity-score deciles
Main finding
As reported in the abstract
Increased risk of diabetic ketoacidosis (DKA), pooled aIRR
2.19 (1.74-2.76) (95% CI)
Decreased risk of acute liver injury (ALI) in patients without predisposing liver disease conditions, pooled aIRR
0.77 (0.50-1.19) (95% CI)
Decreased risk of ALI in all patients, pooled aIRR
0.70 (0.56-0.88) (95% CI)
Decreased risk of acute kidney injury (AKI), pooled aIRR
0.54 (0.41-0.73) (95% CI)
Observational data: associations, not effects.
Further findings
Genital infection (GI), chronic kidney disease (CKD) and severe complications of urinary tract infection (UTI) (UK data)
- Increased risk of GI, males, aIRR
- 4.04 (3.46-4.71) (95% CI)
- Increased risk of GI, females, aIRR
- 3.24 (2.81-3.74) (95% CI)
- Decreased risk of CKD, aIRR
- 0.53 (0.43-0.65) (95% CI)
- Decreased risk of severe complications of UTI, aIRR
- 0.51 (0.37-0.72) (95% CI)
Subgroup and sensitivity analyses
- Results generally consistent in subgroup and sensitivity analyses
Original publication
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