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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational cohort

Study drug and medical condition

• Medical condition to be studied:
  Rhinitis allergic

  Urticaria chronic

Population studied

• Short description of the study population:
  All individuals in three Nordic countries (Denmark, Finland and Sweden) who redeemed at least one prescription for DL or who received a diagnosis of seizure, SVT, or A-fib/flu.
• Age groups:
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  365500

Study design details

• Main study objective:
  Data from the Nordic national population registers will be used in this prospective observational cohort study of individuals who redeemed a prescription for desloratadine to determine the incidence rate and examine the associations between desloratadine exposure and seizures, supraventricular tachycardia, and atrial fibrillation or flutter.
• Outcomes:
  The primary outcomes are to describe the use of desloratadine in the general population, describe the incidence rate of seizure, supraventricular tachycardia, and atrial fibrillation or flutter, and compare the risk of incident seizure, supraventricular tachycardia, and atrial fibrillation or flutter in individuals exposed to desloratadine to the risk among the same individuals while not exposed. The secondary outcomes are to describe the incidence rate of first recurrent seizure and to compare the risk of first recurrent seizure in individuals exposed to desloratadine to the risk among the same individuals while not exposed after adjusting for relevant confounding factors.
• Data analysis plan:
  Descriptive analysis will be performed for the distribution of prevalent and incident use of desloratadine and for the number of redeemed prescriptions. Incidence rates (IR) of the events of seizures, supraventricular tachycardia, and atrial fibrillation or flutter with 95% confidence intervals will be determined. The association between exposure to desloratadine and these events will be evaluated using Poisson regression and the measure of effect will be incidence rate ratios (IRR).