Loperamide and the risk of Brugada syndrome

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:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LOPERAMIDE
• Medical condition to be studied:
  Brugada syndrome

Population studied

• Short description of the study population:
  Patients with at least one loperamide prescription with one year minimum follow-up time in THIN since 2000 and with “acceptable” status (Patflag A or C). No restriction on age.
• 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:
  600000

Study design details

• Main study objective:
  Calculate the incidence of Brugada syndrome in patients treated with loperamide products.
• Outcomes:
  Brugada syndrome
• Data analysis plan:
  Crude event rates (with 95% CI) were calculated as number of patients with events divided by the total number of patients exposed. The duration for time to event was calculated as the shortest time from exposure to event for each patient and then stratified into three categories (< 1 year, 1 to 5 years, > 5 years). For Brugada Syndrome this was summarised as median, minimum & maximum time in days.

Documents

Study results

Loperamide and Brugada syndrome results and short protocol