Empagliflozin is a new medicine to treat type 2 diabetes in adults. Kidney cancer is considered as a potential risk associated with the use of empagliflozin, based on animal studies and cases of bladder cancer seen in patient using drugs similar to empagliflozin. As part of monitoring the safety of empagliflozin, Boehringer Ingelheim International GmbH (BI) has committed to conduct a study of urinary tract cancers. We will identify patients who are prescribed empagliflozin and compare them with otherwise similar patients who have used other medications to treat diabetes to see whether or not patients prescribed empagliflozin are more likely to have urinary tract cancers. The study will be conducted in the United Kingdom and in Sweden using routinely collected health information. Anonymised patient-level data from the United Kingdom and Sweden will be combined to provide evidence on the risk of urinary tract cancer.
The aim of the study is to assess the risk of urinary tract malignancies in patients initiating empagliflozin (free or fixed dose combination) compared to patients initiating other sodium glucose co-transporter-2 inhibitors and to patients initiating dipeptidyl peptidase-4 inhibitors (2 separate comparison groups). The study is an observational, comparative, cohort safety study based on healthcare databases in the United Kingdom and Sweden. The databases for this study are constructed from linked prescription, hospital, general practitioner, cancer and death registration records. In this “incident users” design study, new users of empagliflozin will be compared to the 2 comparison groups. Using propensity scores, individuals in the groups will be matched with similar treatment and clinical history at index date. The incident users will be included in the period 2014-2019, and followed until the end of 2019 or the end of database follow-up. Incidence rates (crude and adjusted) will be presented for each exposure group. Relative risks will be presented as hazard ratios adjusted for relevant variables using the Cox’s proportional hazards model with the time-varying covariate approach. The adjusted hazard ratios and incidence rates will be presented along with 95% confidence intervals for the risk estimates. Sensitivity analyses will be performed.
Primary outcomes o All urinary tract cancers o Bladder cancer o Renal cancer • Further outcome o Non-renal, non-bladder urinary tract cancers (referred to as other urinary tract cancers)
Fabian Hoti - Chief Investigator - IQVIA Finland Oy
Katja Hakkarainen - Corresponding Applicant - IQVIA - USA (Headquarters)
Alisa Kopilow - Collaborator - IQVIA
Anouk Deruaz Luyet - Collaborator - Boehringer-Ingelheim International GmbH
Eric Beohou - Collaborator - EPID Research Oy (Finland)
Julia Pietilä - Collaborator - IQVIA Finland Oy
Kimberly Brodovicz - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Muriel Lobier - Collaborator - IQVIA Finland Oy
Rownak Jahan Archie - Collaborator - IQVIA Solutions Sweden AB
Soulmaz Fazeli Farsani - Collaborator - Boehringer-Ingelheim International GmbH
Xu Qiao - Collaborator - IQVIA Finland Oy
Pasi Korhonen - Chief Investigator - EPID Research Oy (Finland)
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Houssem Khanfir - Collaborator - EPID Research Oy (Finland)
Malia Majak - Collaborator - EPID Research Oy (Finland)
Solomon Christopher - Collaborator - EPID Research Oy (Finland)
HES Accident and Emergency;HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;NCRAS Cancer Registration Data;ONS Death Registration Data