Empagliflozin (the brand name in the United Kingdom is Jardiance), is a new medicine to treat type 2 diabetes in adults. The most common side effects of empagliflozin are urinary tract and genital yeast infections. As part of monitoring the safety of empagliflozin, Boehringer Ingelheim International GmbH (BI) has committed to conduct a study of urinary and genital infections as well as liver and kidney problems. This study will use routinely collected health information from the Clinical Practice Research Datalink. We will identify patients who have used empagliflozin and compare them with otherwise similar people who have used other medications to treat diabetes, to see whether or not they are more likely to have abnormal liver or kidney laboratory results, urinary infections or genital infections. The findings of our study are expected to help ascertain whether or not these are side-effect of empagliflozin and, if so, thereby aiding the development of preventive measures.
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.
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
CRISTINA REBORDOSA GARCIA - Chief Investigator - RTI Health Solutions ( USA )
CRISTINA REBORDOSA GARCIA - Corresponding Applicant - RTI Health Solutions ( USA )
Anita Tormos - Collaborator - RTI Health Solutions ( USA )
Anouk Deruaz Luyet - Collaborator - Boehringer-Ingelheim International GmbH
David Martinez - Collaborator - RTI Health Solutions ( USA )
Estel Plana Hortoneda - Collaborator - RTI Health Solutions ( USA )
Kenneth Rothman - Collaborator - RTI Health Solutions ( USA )
Kimberly Brodovicz - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Lawrence Rasouliyan - Collaborator - RTI Health Solutions ( USA )
MANEL PLADEVALL - Collaborator - RTI Health Solutions ( USA )
Soulmaz Fazeli Farsani - Collaborator - Boehringer-Ingelheim International GmbH
Susana Perez-Gutthann - Collaborator - RTI Health Solutions ( USA )
Steven Thomas - Collaborator - RTI Health Solutions ( USA )
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