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

Author:

Rebordosa Cristina1ORCID,Thomsen Reimar W.2,Tave Arlene K.3,Madsen Morten2,Beachler Daniel C.3,Martinez David1,Garcia‐Esteban Raquel1,Plana Estel1,Tormos Anita1,Farsani Soulmaz Fazeli4,Perez‐Gutthann Susana1,Pladevall‐Vila Manel15

Affiliation:

1. RTI Health Solutions Barcelona Spain

2. Department of Clinical Epidemiology Aarhus University and Aarhus University Hospital Aarhus Denmark

3. Carelon Research Wilmington Delaware USA

4. Boehringer Ingelheim International GmbH Ingelheim am Rhein Germany

5. The Center for Health Policy and Health Services Research, Henry Ford Health System Detroit Michigan USA

Abstract

AbstractAimTo estimate risks of diabetic ketoacidosis (DKA), acute liver injury (ALI), acute kidney injury (AKI), chronic kidney disease (CKD), severe complications of urinary tract infection (UTI) and genital infection (GI) among patients with type 2 diabetes initiating empagliflozin versus those initiating a dipeptidyl peptidase‐4 (DPP‐4) inhibitor.Materials and MethodsIn this large multinational, observational, new‐user cohort study in UK, Danish and US healthcare data sources, patients initiated empagliflozin or a DPP‐4 inhibitor between August 2014 and August 2019, were aged ≥18 years, and had ≥12 months' continuous health plan enrolment. Incidence rates by exposure and incidence rate ratios, adjusted for propensity‐score deciles, were calculated.ResultsIn total, 64 599 empagliflozin initiators and 203 315 DPP‐4 inhibitor initiators were included. There was an increased risk [pooled adjusted incidence rate ratios (95% confidence interval)] of DKA [2.19 (1.74‐2.76)] and decreased risks of ALI [0.77 (0.50‐1.19) in patients without predisposing conditions of liver disease; 0.70 (0.56‐0.88) in all patients] and AKI [0.54 (0.41‐0.73)]. In the UK data, there was an increased risk of GI [males: 4.04 (3.46‐4.71); females: 3.24 (2.81‐3.74)] and decreased risks of CKD [0.53 (0.43‐0.65)] and severe complications of UTI [0.51 (0.37‐0.72)]. The results were generally consistent in subgroup and sensitivity analyses.ConclusionsCompared 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.

Publisher

Wiley

Reference34 articles.

1. FDA.Drug approval package: Jardiance (empagliflozin) tablets. 8 September 2014.https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000TOC.cfm. Accessed 11 September 2023.

2. ENCePP.ENCEPP/SDPP/13413: Post‐authorisation safety study in patients with type 2 diabetes mellitus to assess the risk of acute liver injury acute kidney injury and chronic kidney disease severe complications of urinary tract infection genital infections and diabetic ketoacidosis among patients treated with empagliflozin compared to patients treated with other SGLT2 inhibitors or DPP‐4 inhibitors. 21 Oct 2015.https://www.encepp.eu/encepp/openAttachment/fullProtocol/16192. Accessed 19 Jun 2023

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