Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Drug utilisation

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Case-control
Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(M01A) ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Population studied

Short description of the study population

All residents in the Friuli-Venezia Giulia, Italy (FVG) region with at least 1 year of permanent residence who are prescribed nimesulide or any other NSAID between January 1, 2001, and December 31, 2008

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

588827
Study design details

Main study objective

The objectives of the study are 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.

Outcomes

Upper gastrointestinal bleeding, perforation, obstruction.

Data analysis plan

Crude age- and sex-specific incidence rates and 95% confidence intervals of UGIC were estimated for current use of NSAIDs and nonuse of NSAIDs. Incidence rates were stratified by history of peptic ulcer and calendar year. The nested case-control analysis was the main analysis of the study. All confirmed cases of UGIC from the study cohort were included in the analysis. Density-based sampling was used to select 10 controls for each case. We used conditional logistic regression to estimate crude and adjusted odds ratios for the risk of UGIC during the periods of exposure to each individual NSAID with the risk during nonuse of NSAIDs. The model was built manually based on the impact on the effect estimate of NSAIDs and the inclusion of factors associated with increased risk of UGIC, general medical frailty, or with potential selective prescribing of NSAIDs. Effect measure modification was assessed for age, sex, and concurrent use of aspirin, anticoagulants, and oral corticosteroids.
Documents
Study publications
Castellsague J, Pisa P, Rosolen V, Riera-Guardia N, Giangreco M, Clagnan E, Tos…
Pisa P, Castellsague J, Rosolen V, Riera-Guardia N, Giangreco M, Drigo D, Perez…
Castellsague J, Pisa F, Rosolen V, Drigo D, Riera-Guardia N, Giangreco M, Clagn…
Pisa F, Castellsague J, Drigo D, Riera-Guardia N, Giangreco M, Rosolen V, Clagn…
Pisa F, Drigo D, Riera-Guardia N, Castellsague J, Rosolen V, Clagnan E, Tosolin…