Dipeptidyl Peptidase-4 Inhibitors and Inflammatory Bowel Disease Risk: Impact of Study Design Differences on Comparative Safety Results

Study identification

• EU PAS number:
  EUPAS108001
• Study ID:
  108002
• Official title and acronym:
  Dipeptidyl Peptidase-4 Inhibitors and Inflammatory Bowel Disease Risk: Impact of Study Design Differences on Comparative Safety Results
• DARWIN EU® study:
  No
• Study countries:
  Switzerland

  United States
• Study description:
  A recent cohort study using the British Clinical Practice Research Datalink (CPRD) database found that new use of dipeptidyl peptidase-4 inhibitors (DPP4i) was associated with an increased risk of inflammatory bowel disease (IBD) compared to other oral antidiabetic therapies (hazard ratio, HR 1.75, 95% CI: 1.22 to 2.49 during a median follow-up of 3.6 years). We implemented an active comparator, new user (ACNU) cohort design using US MarketScan and Medicare data and found that DPP4i did not increase IBD risk compared to therapeutic alternatives: pooled adjusted HRs (aHRs) for IBD were 0.87 (95% CI: 0.47-1.59) comparing to sulfonylureas (SU) and 0.76 (95% CI: 0.48 – 1.19) comparing to thiazolidinediones (TZD). We suspect that differences between results are primarily driven by different study designs. For example, our ACNU cohort included only patients who were treatment-naïve to both drugs at baseline, whereas Abrahami et al modeled DPP4i exposure as a time-varying variable (i.e. allowing the same patient to contribute both DPP4i unexposed and exposed person-time). To explore the impact and robustness of risk estimates to study design differences, this study will apply the ACNU design to CPRD data to assess the association between DPP4i use and IBD risk.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of North Carolina at Chapel Hill

Study timelines

Date when funding contract was signed

Planned: 01/12/2020

Actual: 07/12/2020

Study start date

Planned: 07/12/2020

Actual: 01/12/2020

Data analysis start date

Planned: 01/09/2021

Actual: 01/09/2023

Date of final study report

Planned: 01/12/2024

Sources of funding

Other

More details on funding

R01 AG056479 Propensity scores and preventive drug use in the elderly

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable