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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/18587
• EU PAS number:
  EUPAS17954
• Study ID:
  18587
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  In this observational study (NCT01744301), patients aged 20–84 years in 2005–2011 were identified from The Health Improvement Network. The relative risk of seizure associated with use of proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) in a general population was quantified, overall and stratified by epilepsy status, and the effects of demographics and comorbidities were determined. In a nested case–control analysis, seizure cases were matched to controls. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using unconditional logistic regression. Estimates were adjusted for potential confounders.
• Study status:
  Finalised

Research institution and networks

Institutions

Fundación Centro Español de Investigación Farmacoepidemiológica (CEIFE)

Spain

Study timelines

Date when funding contract was signed

Actual: 13/12/2011

Study start date

Actual: 22/03/2013

Data analysis start date

Actual: 21/12/2014

Date of final study report

Actual: 15/05/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

D9612N00017_Redacted_protocol

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

D9612N00017