Status: FinalisedLast updated on: 31/08/2017
1. Study identification
EU PAS Register NumberEUPAS2181
Official titleStudy of Acute Liver Transplant: A study of NSAIDs-exposed acute liver failure in European transplant centres
Study title acronymSALT-I
Study typeObservational study
Brief description of the studyThe European Medicines Agency (EMA) has expressed concern about the possibility of an increased relative frequency of acute liver failure (ALF) subsequent to nimesulide exposure. The SALT-1 study was initiated to evaluate the risk of ALF in patients exposed to non-steroidal anti-inflammatory drugs (NSAIDs) at the request of the CHMP. The protocol was approved by the CHMP in November 2008 and the final version was sent to the CHMP in December 2008. The SALT-1 study was a multicenter, multinational retrospective case-population study of patients exposed to NSAIDs registered for liver transplantation (LT) because of ALF between 01/01/2005 and 31/12/2007. Seven countries participated; France, Italy, Portugal, Greece, Ireland, Netherlands, UK. The primary objectives were to estimate the absolute frequency and population exposure of ALF leading to registration for LT in patients exposed to the different NSAIDs. Exclusively pediatric (n=4) or oncology centres (n=1) were not eligible; 57 centres were contacted. Criteria for inclusion were: adults ≥18 years of age at the time of registration on LT list with ALF, whether the LT is actually performed or not, and resident of the participating countries. Index date (ID) was the date of initial symptoms of liver disease. Exposure was considered within 90 days prior to ID. ALF cases were classified as “with identified clinical cause”, “possibly drug-exposed/no identified clinical cause"; "exposed to NSAIDs", "exposed to drugs without NSAIDs", "without drug exposure and no identified clinical cause", or "acute drug intoxication". 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 irrespective of any causality.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Professor
Last name Gulmez
First name Ezgi
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?52

Countries in which this study is being conducted
International study

Greece
Ireland
Italy
Netherlands
Portugal
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed04/12/200705/12/2008
Start date of data collection02/01/200926/01/2009
Start date of data analysis21/10/200926/01/2011
Date of interim report, if expected22/09/2010
Date of final study report27/11/200923/03/2011
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesHelsinn Healthcare S.A.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Gulmez
First name Ezgi
Address line 1Université Bordeaux Segalen, Département de Pharmacologie
Address line 2Bat Tondu, Case 41 
Address line 3146, rue Leo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557579564 
Alternative phone number33557574675 
Fax number (incl. country code)33557574671 
Public Enquiries
Title Professor 
Last name Gulmez 
First name Ezgi 
Address line 1Université Bordeaux Segalen, Département de Pharmacologie 
Address line 2Bat Tondu, Case 41 
Address line 3146, rue Leo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557579564 
Alternative phone number33557574675 
Fax number (incl. country code)33557574671 
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