Risk of developing chronic obstructive pulmonary disease or lung cancer in smokers taking enzyme-inducing antiepileptic drugs

Study type
Protocol
Date of Approval
Study reference ID
17_054
Lay Summary

Some drugs used to control epilepsy or other diseases such as migraine or chronic nerve pain speed up the body`s ability to break down certain substances including components of tobacco smoke. These drugs are also called 'enzyme-inducing antiepileptic drugs' (because they were first used to treat epilepsy), and smokers who take them might be exposed to more harmful tobacco smoke by-products. These people might be at higher risk of developing chronic obstructive pulmonary disease (COPD, also known as emphysema) and lung cancer than smokers whose underlying medical condition is managed with other drugs. To investigate this, we will examine the anonymous case histories of smokers treated with or without enzyme-inducing antiepileptic drugs and compare the occurrence of COPD and lung cancer in the two groups.

Technical Summary

The objectives of the study are to determine whether the use of enzyme-inducing antiepileptic drugs (AEDs) increases the risk of developing COPD or lung cancer in people who smoke. The study is a hypothesis-driven, matched case-control study, where cases are smokers taking AEDs who have developed COPD or lung cancer and controls are smokers taking AEDs who have not developed COPD or lung cancer. In order to evaluate the association between these smoking-related diseases and the use of enzyme-inducing AEDs (reference: non-enzyme-inducing AEDs), we will conduct conditional logistic regression analyses and assess relative risk estimates as odds ratios (ORs) with 95% confidence intervals (CIs).

Health Outcomes to be Measured

Development of chronic obstructive pulmonary disease (primary outcome); Development of lung cancer (primary outcome)

Collaborators

Anne B. Leuppi-Taegtmeyer - Chief Investigator - University of Basel
Christoph Meier - Corresponding Applicant - University of Basel
Andreas Zeller - Collaborator - University of Basel
Daphne Reinau - Collaborator - University of Basel
Joerg D Leuppi - Collaborator - Cantonal Hospital Baselland
Stephan Kraehenbuehl - Collaborator - University of Basel
Stephan Ruegg - Collaborator - University of Basel
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program