Atrial Fibrillation
Conditions
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:
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Have at least 1 year of enrolment in the electronic database. 2. Have not been prescribed dabigatran etexilate during the 1-year period prior to the index date.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. | 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 |
Countries
Spain
Participant flow
Recruitment details
This was a descriptive, observational, non-interventional (NIS) multinational, European cross-sectional study with sources of information for clinical conditions available being highly variable across countries/data sources
Pre-assignment details
Because it is not possible to rule out duplicate patients across the 2 French panels, all numbers were calculated stratified by data source, and for France further stratified by panel - i.e., not overall.
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran Etexilate (Pradaxa®)_France (Cardiologists) New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information) | 1,706 |
| Dabigatran Etexilate (Pradaxa®)_France (GPs) New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information) | 2,813 |
| Dabigatran Etexilate (Pradaxa®)_Denmark New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications) | 28,619 |
| Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable) New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications) | 2,150 |
| Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable) New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information) | 1,285 |
| Total | 36,573 |
Baseline characteristics
| Characteristic | Dabigatran Etexilate (Pradaxa®)_France (Cardiologists) | Dabigatran Etexilate (Pradaxa®)_France (GPs) | Dabigatran Etexilate (Pradaxa®)_Denmark | Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable) | Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 75.5 years STANDARD_DEVIATION 10 | 74.0 years STANDARD_DEVIATION 10.4 | 71.8 years STANDARD_DEVIATION 10.9 | 74.1 years STANDARD_DEVIATION 11.2 | 73.1 years STANDARD_DEVIATION 11.5 | NA years |
| Sex: Female, Male Female | NA Participants | 1272 Participants | 13567 Participants | 938 Participants | 571 Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | 1541 Participants | 15052 Participants | 1212 Participants | 714 Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.
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
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.
Population: The study population included new users of dabigatran etexilate in the study period. New users were defined as those patients who initiated treatment with dabigatran etexilate during the study period and who had not used it during the previous year.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate (Pradaxa®)_France (Cardiologists) | Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. | Broad definition | 24.1 percentage of participants |
| Dabigatran Etexilate (Pradaxa®)_France (Cardiologists) | Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. | Restrictive definition | 37.5 percentage of participants |
| Dabigatran Etexilate (Pradaxa®)_France (GPs) | Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. | Broad definition | 34.0 percentage of participants |
| Dabigatran Etexilate (Pradaxa®)_France (GPs) | Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. | Restrictive definition | 44.1 percentage of participants |
| Dabigatran Etexilate (Pradaxa®)_Denmark | Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. | Broad definition | 17.1 percentage of participants |
| Dabigatran Etexilate (Pradaxa®)_Denmark | Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. | Restrictive definition | 29.1 percentage of participants |
| Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable) | Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. | Restrictive definition | 17.4 percentage of participants |
| Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable) | Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. | Broad definition | 5.7 percentage of participants |
| Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable) | Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. | Broad definition | 11.5 percentage of participants |
| Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable) | Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. | Restrictive definition | 25.6 percentage of participants |