PASS 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

Date of Approval
Application Number
16_075
Technical Summary

The objective of this study is to evaluate the liver and renal safety of empagliflozin as well as the incidence of urinary tract and genital infections. This will be an observational cohort study among adult patients with T2D and at least 12 months of continuous enrolment in the CPRD in which new users of empagliflozin will be compared to new users of other SGLT2 inhibitors and to new users of DPP 4 inhibitors. Propensity scores based on information prior to the index date (date of initiation of medication of interest) will be used to account for potential confounding. The study will estimate crude and adjusted incidence rates (IR) and adjusted incidence rate ratios (IRR) of the primary and secondary outcomes. The primary outcomes will be: acute liver injury (ALI), acute kidney injury (AKI), hospitalisation due to severe complications of urinary tract infection (UTI), and genital infections. The secondary outcomes will be: ALI in a subset of patients without predisposing factors, chronic kidney disease, outpatient severe complications of UTI, and genital infections resulting in hospitalisation or systemic treatment. Data from the Hospital Episodes Statistics (HES) and Office of National Statistic (ONS) mortality will also be used to identify potential cases.

Health Outcomes to be Measured

Acute liver injury Acute liver injury in a subset of patients without predisposing factors Acute kidney injury Chronic kidney disease Hospitalisation for severe complication of urinary tract infection (pyelonephritis and urosepsis) Outpatient severe complications of urinary tract infections Occurrence of genital infection Hospitalisation or systemic treatment for genital infections Hospitalisation due to diabetic ketoacidosis

Collaborators

CRISTINA REBORDOSA GARCIA - Chief Investigator - RTI Health Solutions
CRISTINA REBORDOSA GARCIA - Corresponding Applicant - RTI Health Solutions
Anita Tormos - Collaborator - RTI Health Solutions
Anouk Deruaz Luyet - Collaborator - Boehringer-Ingelheim International GmbH
David Martinez - Collaborator - RTI Health Solutions
Estel Plana Hortoneda - Collaborator - RTI Health Solutions
Kenneth Rothman - Collaborator - RTI Health Solutions
Kimberly Brodovicz - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Lawrence Rasouliyan - Collaborator - RTI Health Solutions
MANEL PLADEVALL - Collaborator - RTI Health Solutions
Soulmaz Fazeli Farsani - Collaborator - Boehringer-Ingelheim International GmbH
Susana Perez-Gutthann - Collaborator - RTI Health Solutions

Linkages

HES Admitted Patient Care;HES Admitted Patient Care;HES Admitted Patient Care;HES Admitted Patient Care;HES Admitted Patient Care;ONS Death Registration Data;ONS Death Registration Data;ONS Death Registration Data;ONS Death Registration Data;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation