Observational study on the risk of dementia associated with proton pump inhibitor use

Study identification

• EU PAS number:
  EUPAS31571
• Study ID:
  32198
• Official title and acronym:
  Observational study on the risk of dementia associated with proton pump inhibitor use
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Proton pump inhibitors (PPIs) are used to suppress the production of gastric acid ingastroesophageal reflux and other acid-related diseases. They are usually tolerated well by patients and thus have been applied widely, inside and outside the indicated conditions, by prescription and over the counter. However, during the last years, accumulating evidence suggests that the long-term use of PPIs may be associated with numerous adverse outcomes, including dementia. This protocol describes the design and main characteristics of a substudy of the project ‘RiDe-PPI’ (Gesundheitliche Risiken und Determinanten der Dauereinnahme vonProtonenpumpeninhibitoren) planned to be conducted in German claims data and funded by the German governmental Innovarionfonds.The goal of this study is to evaluate whether longterm intake of PPIs increases the risk for dementia. The primary objective will be to compare the risk of dementia in new users of PPIs and PPI-nonusers and the risk of dementia in new users of PPIs with new users of H2-receptor antagonists (H2RAs).The secondary objective will be to investigate the risk of dementia related to high-dose use of PPIs.
• Study status:
  Finalised

Research institutions and networks

Institutions

Chair of Epidemiology of the LMU Munich at UNIKA-T, Augsburg

Study timelines

Date when funding contract was signed

Actual:11/12/2018

Study start date

Actual:01/10/2019

Date of final study report

Actual:06/11/2019

Sources of funding

Other

More details on funding

Gemeinsamer Bundesausschuss, Innovationsausschuss

Regulatory

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