Accessibility to New Drugs Versus SOC in Sweden

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT03684395
Collaborator
(none)
68,056
1
12.5
5451.2

Study Details

Study Description

Brief Summary

The healthcare system in Sweden is publicly funded and aims to provide equal access to care irrespective of socioeconomic status. This includes ensuring equity in drug treatment. Socioeconomic disparities have been shown to influence patient management and health outcomes in certain Swedish populations. The Swedish Board of Health and Welfare has stated that the prescription of new drugs, which are more expensive than generic standard of care drugs, might be influenced by patients' socioeconomic status.

To evaluate the association between socioeconomic factors and use of a DOAC (rivaroxaban, dabigatran, or apixaban) or standard of care (warfarin) in patients with NVAF in Sweden.

Condition or Disease Intervention/Treatment Phase
  • Drug: DOACs: Rivaroxaban, Dabigatran, Apixaban
  • Drug: Standard of care (Warfarin)

Study Design

Study Type:
Observational
Actual Enrollment :
68056 participants
Observational Model:
Case-Crossover
Time Perspective:
Retrospective
Official Title:
Association Between Socioeconomic Factors and Use of Direct Oral Anticoagulants Versus Standard of Care (Warfarin) in Patients With Non-valvular Atrial Fibrillation in Sweden
Actual Study Start Date :
Jun 15, 2016
Actual Primary Completion Date :
Jun 30, 2017
Actual Study Completion Date :
Jun 30, 2017

Arms and Interventions

Arm Intervention/Treatment
DOACs (Direct Oral Anticoagulants)

Drug: DOACs: Rivaroxaban, Dabigatran, Apixaban
Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection

Standard of care

Drug: Standard of care (Warfarin)
Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection

Outcome Measures

Primary Outcome Measures

  1. Correlation between socioeconomic factors and use of DOACs vs. Warfarin (as identified from the LISA database before the index date) [approximately 3 years]

    Between 1 December 2011 and 31 December 2014; Socioeconomic factors: Occupation Education Income Family status Immigrant status

Secondary Outcome Measures

  1. Secular trends in the correlation between socioeconomic factors and use of DOACs (vs. warfarin) - Trends based on the date of prescription by year [approximately 3 years]

    Between 1 December 2011 and 31 December 2014; Relationship between socioeconomic factors and access to newly marketed drugs (DOACs as one class which includes Rivaroxaban, Dabigatran and Apixaban) versus standard of care (warfarin) for different calender period.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients aged ≥18 years in Sweden with a diagnosis of NVAF (identified using International Classification of Diseases, version 10 [ICD-10]) codes in the National Patient Register) between 1 December 2011 and 31 December 2014 and with a first dispensed prescription for either a DOAC or warfarin following their NVAF diagnosis.
Exclusion Criteria:
  • Patients with a dispensed prescription for a DOAC or warfarin prior to the index date (the date of first DOAC/warfarin purchase designated the index date)

  • Patients with a dispensed prescription for more than one anticoagulant at index date.

  • Patients with valvular atrial fibrillation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stockholm Sweden

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT03684395
Other Study ID Numbers:
  • 18984
First Posted:
Sep 25, 2018
Last Update Posted:
Mar 29, 2019
Last Verified:
Mar 1, 2019
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2019