Study identification

PURI

https://redirect.ema.europa.eu/resource/5088

EU PAS number

EUPAS2225

Study ID

5088

Official title and acronym

Risk of Upper Gastrointestinal Complications in Users of Nonsteroidal Anti-inflammatory Drugs

DARWIN EU® study

No

Study countries

Italy

Study description

Retrospective cohort study and nested case-control analysis to evaluate the risk of upper gastrointestinal complications (UGIC ) in a cohort of patients receiving NSAIDs between 2001-2008 in the Italian region of Friuli Venezia Giulia (FVG). The study was conducted by a research team from RTI Health Solutions, the Institute of Hygiene and Clinical Epidemiology of the University of Udine and University Hospital of Udine, and the Direzione Centrale della Salute, Integrazione Socio Sanitaria e Politiche Sociali, Udine. The study was based on information from the FVG Regional Health Services Databases and hospital medical charts for the validation of cases of UGIC. The objectives of the study were to (1) estimate the risk of UGIC associated with the use of nimesulide and other individual NSAIDs, (2) evaluate the effect of dose and duration of use of individual NSAIDs and the role of potential risk factors for UGIC, and (3) describe the characteristics of nimesulide users over time.

Study status

Finalised
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner

Contact details

Susana Perez-Gutthann

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:
Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Helsinn Healthcare, S.A.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable