Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 36,573
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.
Study Overview
Brief Summary
This is a descriptive, observational, multi-country European cross-sectional study of new users of dabigatran etexilate that aims to characterise on- and off-label status and other medical characteristics at the time of the first captured prescription of dabigatran etexilate in each database. The study will be conducted using Cegedim Strategic Database (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink (CPRD, UK).
Detailed Description
Study Design:
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.
Time Frame: Time period since approval of the SPAF indication in, France: 01 August 2011 to 30 June 2014; Denmark: 01 August 2011 to 30 November 2013; UK: 01 August 2011 to 30 August 2015.
Definition of off-label use of oral dabigatran etexilate (DE) was based on use for a disease/medical condition other than labelled indications,as described/documented in the data source used in the respective countries, taking into account the changes in the label within the study period. The prevalence of potential off-label use among new users of DE during the overall study period is calculated as the proportion of patients meeting the definition of off-label use by dividing the number of index prescriptions that represented off-label use by the total number of index prescriptions. Two definitions were applied to estimate potential off-label use based on either recorded diagnoses or proxies: a broad definition of on-label prescribing using codes for disease indication e.g.atrial fibrillation(AF) and a restrictive definition excluding patients with conditions for which the drug is not indicated e.g.valvular AF. SPAF:Stroke \& systemic embolism in adult patients with non-valvular AF
Secondary Outcomes
No secondary outcomes reported