Association between use of desloratadine and risk of seizures, supraventricular tachycardia, and atrial fibrillation or flutter: A Nordic register-based study (MK-4117-205)

Study identification

• EU PAS number:
  EUPAS35911
• Study ID:
  38013
• 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 (MK-4117-205)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Norway

  Sweden
• Study description:
  This is an observational, nationwide, register-based study using person-specific linkage of data from the national population registers from Denmark, Finland, Norway, and Sweden (" Nordic countries") including all individuals who redeemed a prescription of desloratadine and all individuals with a registered diagnosis of seizure, supraventricular tachycardia, or atrial fibrillation or flutter. The objective is to explore the use of desloratadine (DL) in the general population (Substudy 1), to describe the incidence rate (IR) of first seizure (Substudy 2A), to examine the associations between DL exposure and risk of first seizure (Substudy 2B), to describe the IR of supraventricular tachycardia (SVT) (Substudy 3A), to examine the association between DL exposure and SVT (Substudy 3B), to describe the IR of atrial fibrillation or flutter (A-Fib/A-Flu) (Substudy 4A), and to examine the associations between DL exposure and A-Fib/A-Flu (Substudy 4B).
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck Sharp & Dohme LLC

United States

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

Study timelines

Date when funding contract was signed

Planned:16/01/2020

Actual:16/01/2020

Study start date

Planned:30/07/2020

Actual:30/07/2020

Data analysis start date

Planned:30/09/2020

Actual:30/09/2020

Date of final study report

Planned:31/12/2020

Actual:05/11/2020

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?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable