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Trial record 69 of 333 for:    DABIGATRAN

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

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ClinicalTrials.gov Identifier: NCT02240654
Recruitment Status : Completed
First Posted : September 16, 2014
Results First Posted : October 16, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Cross-Sectional
Condition Atrial Fibrillation
Enrollment 36573
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.
Arm/Group Title 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)
Hide Arm/Group Description 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) 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) 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) 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) 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)
Period Title: Overall Study
Started 1706 2813 28619 2150 1285
Completed 1706 2813 28619 2150 1285
Not Completed 0 0 0 0 0
Arm/Group Title 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
Hide Arm/Group Description 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) 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) 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) 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) 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 of all reporting groups
Overall Number of Baseline Participants 1706 2813 28619 2150 1285 36573
Hide Baseline Analysis Population Description
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.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1706 participants 2813 participants 28619 participants 2150 participants 1285 participants 36573 participants
75.5  (10.0) 74.0  (10.4) 71.8  (10.9) 74.1  (11.2) 73.1  (11.5) NA [2]   (NA)
[1]
Measure Description: 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. Totals computed here may not be correct, as those assume that there were no duplicate patients in CSD-LPD.
[2]
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.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1706 participants 2813 participants 28619 participants 2150 participants 1285 participants 36573 participants
Female NA [2] 
1272
  45.2%
13567
  47.4%
938
  43.6%
571
  44.4%
NA [3] 
Male NA [4] 
1541
  54.8%
15052
  52.6%
1212
  56.4%
714
  55.6%
NA [3] 
[1]
Measure Description:

For 282 patients, information on gender was missing. 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.

Total (men, women) may not be correct, as those assume that there were no duplicate patients in CSD-LPD.

[2]
599 female patients and gender for 282 patients was missing
[3]
Total not calculated because data are not available (NA) in one or more arms.
[4]
825 patients and gender for 282 patients was missing
1.Primary Outcome
Title Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.
Hide Description

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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 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)
Hide Arm/Group Description:
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)
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)
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)
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)
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 Number of Participants Analyzed 1706 2813 28619 2150 1285
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Broad definition
24.1
(22.1 to 26.1)
34.0
(32.3 to 35.8)
17.1
(16.6 to 17.5)
5.7
(4.7 to 6.7)
11.5
(9.8 to 13.4)
Restrictive definition
37.5
(35.2 to 39.8)
44.1
(42.2 to 45.9)
29.1
(28.4 to 29.7)
17.4
(15.8 to 19.1)
25.6
(23.2 to 28.1)
Time Frame [Not Specified]
Adverse Event Reporting Description International Society for Pharmacoepidemiology and European Medicines Agency guidelines state that NIS studies conducted using medical chart reviews/electronic claims/health care records do not require expedited reporting of suspected Adverse events (AEs)/reactions.Given the type of data used for this study,no suspected AEs/reactions were reported
 
Arm/Group Title 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)
Hide Arm/Group Description 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) 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) 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) 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) 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)
All-Cause Mortality
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)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
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)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0 
Clinical information being highly variable across countries was likely to be major driver of different proportions.UK(HES link) is likely to provide most accurate estimate(France and DK data need to be interpreted cautiously because of limited info)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02240654     History of Changes
Other Study ID Numbers: 1160.144
First Submitted: September 15, 2014
First Posted: September 16, 2014
Results First Submitted: May 18, 2017
Results First Posted: October 16, 2017
Last Update Posted: December 15, 2017