Use of COX-2 inhibitors and risk of glioma

Study type
Protocol
Date of Approval
Study reference ID
15_170
Lay Summary

Cyclooxygenase-2 Inhibitors (COX-2) are drugs which are used to treat pain and inflammation. They have been found to prevent the development of a certain type of brain tumour, the so-called glioma, in experiments performed on cells. Whether these drugs also may reduce the likelihood of glioma developing in humans is unknown.
We propose to conduct a study using the U.K.-based Clinical Practice Research Datalink (CPRD) to compare use of these pain reducing drugs among patients with a glioma diagnosis and among patients without a diagnosis of glioma. Patients with glioma will be individuals younger than 90 years of age with a first-time diagnosis of glioma between 1995 and 2015. We will identify ten patients without glioma from the same general practice and compare these patients to those with a diagnosis of glioma. Patients without glioma will be of the same age, sex and have been registered for the same number of years at the practice.

Technical Summary

We propose to conduct a 1:10 matched case-control analysis using the CPRD to test the hypothesis that use of COX-2 inhibitors is associated with decreased risk of glioma. We will conduct conditional logistic regression analyses to determine relative risks, estimated as odds ratios (ORs) with 95% confidence intervals (CIs) of glioma in relation to use of COX-2 inhibitors. Analyses will be adjusted for various potential confounding variables and only variables altering the risk of glioma by >10% will be included in the final multivariate analysis. The effects of exposure to COX-2 inhibitors will be compared to the effects of other non-selective NSAIDs (diclofenac, ibuprofen, naproxen, and aspirin) and non-NSAID analgesics (paracetamol, opioids). We will shift the date of diagnosis backward in time by one year for cases and controls. Missing data will be included in a separate category in the logistic regression model.

Collaborators

Christoph Meier - Chief Investigator - University of Basel
Claudia Becker - Collaborator - University of Basel
Corinna Seliger - Collaborator - University of Regensburg
Michael Leitzmann - Collaborator - University of Regensburg
Peter Hau - Collaborator - University of Regensburg
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Ulrich Bogdahn - Collaborator - University of Regensburg