Association between use of desloratadine and risk of seizures, supraventricular tachycardia, and atrial fibrillation or flutter: A Nordic register-based study

Study identification

• EU PAS number:
  EUPAS15038
• Study ID:
  30261
• Official title and acronym:
  Association between use of desloratadine and risk of seizures, supraventricular tachycardia, and atrial fibrillation or flutter: A Nordic register-based study
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Norway

  Sweden
• Study description:
  This is an observational study to assess the potential risk of desloratadine exposure on seizures, supraventricular tachycardia, and atrial fibrillation or flutter. The study utilizes data from the Nordic national population registers that include all individuals who redeemed a prescription for desloratadine. The study will determine the incidence rate and examine the associations between desloratadine exposure and seizures, supraventricular tachycardia, and atrial fibrillation or flutter estimated from the registers and extrapolated to the general population.
• Study status:
  Finalised

Research institutions and networks

Institutions

Department of Epidemiology, Institute of Applied Economics and Health Research (ApHER)

Denmark

National Institute of Public Health, University of Southern Denmark Denmark, University of Tampere Finland, Lund University Sweden, Norway-being coordinated by Lund University Sweden

Study timelines

Date when funding contract was signed

Actual:29/04/2013

Study start date

Planned:09/11/2016

Actual:09/11/2016

Data analysis start date

Planned:28/02/2019

Actual:15/02/2019

Date of final study report

Planned:30/06/2019

Actual:10/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)