Accessibility to New Drugs Versus SOC in Sweden

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.

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Key information

Conditions

Anticoagulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DOACs: Rivaroxaban, Dabigatran, Apixaban

Drug

Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection

Standard of care (Warfarin)

Drug

Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection

Primary outcomes

Correlation between socioeconomic factors and use of DOACs vs. Warfarin (as identified from the LISA database before the index date)

Time frame: approximately 3 years
Between 1 December 2011 and 31 December 2014;

Socioeconomic factors:
- Occupation
- Education
- Income
- Family status
- Immigrant status

Secondary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Sep 25, 2018
Registry last updated: Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed