Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Case-population study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

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

Medical condition to be studied

Liver transplant
Population studied

Short description of the study population

Cases were patients ≥18 years of age with acute liver failure (ALF) at the time of registration on the transplant list for liver transplantation who had been exposed to an NSAID within 30 days preceding the initial symptoms of liver disease (index date).

Age groups

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)

Special population of interest

Hepatic impaired

Estimated number of subjects

600
Study design details

Main study objective

To estimate the absolute frequency of ALF leading to registration for transplantation in patients exposed to NSAIDs

Outcomes

- To estimate the absolute frequency of ALF leading to registration for transplantation in patients exposed to NSAIDs,- To compare the population incidence rates of liver transplantation after nimesulide exposure to that after exposure to other NSAIDs. To describe the clinical characteristics of ALF with NSAIDs compared to other drug and to non-drug related ALF, and to test the effects of causality assessment and drug exposure patterns on relative rates of ALF among patients exposed to NSAIDs.

Data analysis plan

A descriptive analysis of all drug-exposed cases of ALF was performed. Per country rates of NSAID-exposed transplantation registered ALF among subjects exposed to NSAIDs within 30 days prior to the index date were estimated along with its corresponding 95% confidence interval (CI) from a Poisson distribution and expressed in cases per million treatment-years. Estimation was made irrespective of any causality assessment.
Documents
Study publications
Gülmez SE, Lignot-Maleyran S, S deVries C, Sturkenboom M, Micon S, Hamoud F, Bl…
Moore N, Gulmez SE, Larrey D, Pageaux GP, Lignot S, Lassalle R, Jové J, Parient…
Gülmez SE, Larrey D, Pageaux GP, Lignot-Maleyran S, de Vries C, Sturkenboom M, …
Gülmez SE, Larrey D, Pageaux GP, Lignot S, Lassalle R, Jové J, Gatta A, McCormi…
Gülmez SE, Moore N, Pageaux GP, Lignot S, Horsmans Y, Stricker B, Bernuau J, Bi…