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

Study identification

• 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 institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Istituto di Igiene ed Epidemiologia, DSMB Universita' di Udine

Italy

Study timelines

Date when funding contract was signed

Actual: 20/10/2009

Study start date

Planned: 15/12/2009

Actual: 08/02/2010

Data analysis start date

Planned: 01/05/2010

Actual: 01/06/2010

Date of interim report, if expected

Actual: 23/03/2011

Date of final study report

Planned: 14/02/2011

Actual: 01/07/2011

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