Trial Outcomes & Findings for Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe (NCT NCT02240654)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

36573 participants

Primary outcome timeframe

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.

Results posted on

2017-12-15

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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)	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)	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)	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)	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)
Overall Study STARTED	1706	2813	28619	2150	1285
Overall Study COMPLETED	1706	2813	28619	2150	1285
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dabigatran Etexilate (Pradaxa®)_France (Cardiologists) n=1706 Participants 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)	Dabigatran Etexilate (Pradaxa®)_France (GPs) n=2813 Participants 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)	Dabigatran Etexilate (Pradaxa®)_Denmark n=28619 Participants 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)	Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable) n=2150 Participants 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)	Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable) n=1285 Participants 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)	Total n=36573 Participants Total of all reporting groups
Age, Continuous	75.5 years STANDARD_DEVIATION 10.0 • n=93 Participants	74.0 years STANDARD_DEVIATION 10.4 • n=4 Participants	71.8 years STANDARD_DEVIATION 10.9 • n=27 Participants	74.1 years STANDARD_DEVIATION 11.2 • n=483 Participants	73.1 years STANDARD_DEVIATION 11.5 • n=36 Participants	NA years STANDARD_DEVIATION NA • n=10 Participants
Sex: Female, Male Female	NA Participants n=93 Participants	1272 Participants n=4 Participants	13567 Participants n=27 Participants	938 Participants n=483 Participants	571 Participants n=36 Participants	NA Participants n=10 Participants
Sex: Female, Male Male	NA Participants n=93 Participants	1541 Participants n=4 Participants	15052 Participants n=27 Participants	1212 Participants n=483 Participants	714 Participants n=36 Participants	NA Participants n=10 Participants

PRIMARY outcome

Timeframe: 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.

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