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

Contact details

Sebastian-Edgar Baumeister

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Actual:
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