A cohort study with a nested case control analysis on the association between acid-suppressing drugs and seizures using THIN database in the UK (Acid suppressing Drug Seizure Epidemiology 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 data collection

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A02BA) H2-receptor antagonists

  (A02BC) Proton pump inhibitors
• Medical condition to be studied:
  Seizure

  Clonic convulsion

  Convulsion in childhood

  Tonic convulsion

  Neonatal seizure

  Febrile convulsion

  Convulsions local

Population studied

• Short description of the study population:
  Individuals aged 20–84 years identified from THIN database from 1 January 2005 to 31 December 2011, who have been enrolled with their Primary Care Physician (PCP) for at least 2 years and have a computerized prescription history of at least 1 year. Patients will have to be free of acid-suppressing drugs (PPI or H2RAs) for at least one year, and never have a diagnosis of cancer, alcohol abuse or alcohol-related disease, or drug abuse.
• Age groups:
  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:
  48605

Study design details

• Main study objective:
  To quantify the relative risk of seizure associated with the use of proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) in a general population, overall and stratified by epilepsy status
• Outcomes:
  To assess whether the use of acid-suppressive drugs in a general population is associated with increased risk of seizure, both overall and stratified by epilepsy status. A further aim was to determine the effects of demographic and lifestyle factors, comorbidities, and other medications on the risk of seizures
• Data analysis plan:
  The incidence of seizure was calculated in the entire study cohort and also separately for men and women and for those with epilepsy and without. Odds ratios (ORs) and their 95% confidence intervals (CIs) were calculated using unconditional logistic regression models in order to determine the association between the use of PPIs, H2RA and other medications, comorbidities and lifestyle factors, and the occurrence of seizure. Estimates were adjusted for demographic characteristics, lifestyle factors, the most relevant comorbidity, and determinants of acute seizure.

Documents

Study publications

Sáez ME, González-Pérez A, Gaist D, Johansson S, Nagy P, García Rodríguez LA. R…