Usage Patterns of Selected Systemic NSAIDs (Including Diclofenac): A Retrospective Cohort Study

Date of ISAC Approval: 
19/10/2015
Lay Summary: 
NSAIDs (nonsteroidal anti-inflammatory drugs) are widely used medications for the treatment and management of a number of painful and inflammatory conditions. Evidence accumulated on the safety profile of NSAIDs in the last decade has led to the development of guidelines and recommendations for use in recent years, which may have influenced changes in the characteristics of NSAID users and in the patterns of NSAID use. Even though NSAIDs are widely used, there are gaps in the knowledge of utilization and treatment patterns of these medications. The influence of demographic characteristics like age and sex, comorbidities, and indications on the selection of and treatment with NSAIDs is unclear. Information on switching between doses and NSAIDs and the duration of treatment is limited. The overall goal of this study is to describe the characteristics of users and the usage pattern of selected systemic NSAIDs including diclofenac using the most recent information available from select population-based health care automated databases in Europe and North America. The study protocol has been registered with the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and the number assigned to the study is ENCEPP/SDPP/10649.
Technical Summary: 
The study aims to accomplish the following: - Describe demographic characteristics, specific comorbidities, selected comedications, and selected potential indications for use among patients treated with selected systemic NSAIDs (including diclofenac) - Describe treatment patterns, including dose, duration of treatment, and switching patterns, among patients treated with selected systemic NSAIDs (including diclofenac) This will be a non-interventional, retrospective drug utilization study, using a cohort design, of users of selected systemic NSAIDs. Cohorts of prevalent users of selected systemic NSAIDs will be characterized at baseline according to age, sex, prior specific comorbidities, selected comedications, and health care resource use. A subset cohort of new users of each selected NSAID will be characterized (1) at baseline according to age, sex, prior specific comorbidities, selected comedications, health care resource use, and selected potential indication; and (2) during the 1-year follow-up period to assess the pattern of use of the NSAID including duration, dose, use of more than one NSAID, switching, and persistence and adherence to therapy. All study measures will be analyzed descriptively through the tabular and graphical display of mean values, medians, ranges, and standard deviations for continuous variables of interest and proportions for categorical variables (with corresponding 95% confidence intervals, as appropriate).
Health Outcomes to be Measured: 
Prevalent and new NSAID users
Collaborators: 

Elena Rivero Ferrer - Chief Investigator - RTI Health Solutions
Alan Silman - Collaborator - University Of Oxford
Catherine Saltus - Corresponding Applicant - RTI Health Solutions
Jennifer Bartsch - Collaborator - RTI Health Solutions
John. T Farrar - Collaborator - University Of Pennsylvania
Jordi Castellsague - Collaborator - RTI Health Solutions
Kristijan Kahler - Collaborator - Novartis Pharmaceuticals Corporation
Marc C. Hochberg - Collaborator - University Of Maryland
Maria Reynolds - Collaborator - RTI Health Solutions
Samik Banerjee - Collaborator - NOVARTIS
Shaloo Pandhi - Collaborator - Novartis Pharma AG

Linkages: 
HES Admitted