Novara, Italy
Novara, Italy

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Gulmez S.E.,University of Bordeaux 1 | Larrey D.,Montpellier University Hospital Center | Pageaux G.-P.,Montpellier University Hospital Center | Bernuau J.,Beaujon Hospital | And 13 more authors.
British Journal of Clinical Pharmacology | Year: 2015

Aims Acute drug overdose, especially with paracetamol, may cause acute liver failure leading to registration for transplantation (ALFT). Population statistics and between-country differences for ALFT related to overdose have been poorly described. The aim of the present study was to evaluate overdose ALFT in the multi-country Study of Acute Liver Transplantation (SALT). Methods All adult overdose-related ALFT, with or without suicidal intent, in France, Greece, Ireland, Italy, the Netherlands, Portugal and the UK between 2005 and 2007 were identified from liver transplant registries and hospital records. These were compared with whole-country and per capita use of paracetamol. Results Six hundred cases of ALFT were identified in 52 of 57 eligible transplant centres, of which 114 involved overdose (72 intentional, 10 non-intentional, 32 uncertain). Overdose represented 20% of all-cause ALFT: Ireland 52%, UK 28%, France 18%, the Netherlands 8%, and Italy 1%. Overdose ALFT were mostly females (61%), mean age 33.6 ± 10.9 years. A total of 111 (97%) of the overdoses involved paracetamol. Event rates ranged from one ALFT for 20.7 tons of paracetamol in Ireland, to one for 1074 tons in Italy and one case in 60 million inhabitants over 3 years in Italy to one case in 286 000 inhabitants per year in Ireland. Per-country event rates for non-overdose ALFT exposed to paracetamol were between 2.5 and 4.0 per million treatment-years sold. Conclusions Paracetamol overdose was found to represent one-sixth of all-cause ALFT. There was a 50-fold difference in Europe in the rates of paracetamol overdose ALFT, and a 200-fold difference per million inhabitants. © 2015 The British Pharmacological Society.


PubMed | Liver Unit, University of Bordeaux 1, Clinica San Gaudenzio, Beaujon Hospital and 5 more.
Type: Journal Article | Journal: British journal of clinical pharmacology | Year: 2015

Acute drug overdose, especially with paracetamol, may cause acute liver failure leading to registration for transplantation (ALFT). Population statistics and between-country differences for ALFT related to overdose have been poorly described. The aim of the present study was to evaluate overdose ALFT in the multi-country Study of Acute Liver Transplantation (SALT).All adult overdose-related ALFT, with or without suicidal intent, in France, Greece, Ireland, Italy, the Netherlands, Portugal and the UK between 2005 and 2007 were identified from liver transplant registries and hospital records. These were compared with whole-country and per capita use of paracetamol.Six hundred cases of ALFT were identified in 52 of 57 eligible transplant centres, of which 114 involved overdose (72 intentional, 10 non-intentional, 32 uncertain). Overdose represented 20% of all-cause ALFT: Ireland 52%, UK 28%, France 18%, the Netherlands 8%, and Italy 1%. Overdose ALFT were mostly females (61%), mean age 33.610.9years. A total of 111 (97%) of the overdoses involved paracetamol. Event rates ranged from one ALFT for 20.7 tons of paracetamol in Ireland, to one for 1074 tons in Italy and one case in 60 million inhabitants over 3years in Italy to one case in 286000 inhabitants per year in Ireland. Per-country event rates for non-overdose ALFT exposed to paracetamol were between 2.5 and 4.0 per million treatment-years sold.Paracetamol overdose was found to represent one-sixth of all-cause ALFT. There was a 50-fold difference in Europe in the rates of paracetamol overdose ALFT, and a 200-fold difference per million inhabitants.


Gulmez S.E.,University of Bordeaux 1 | Gulmez S.E.,French Institute of Health and Medical Research | Larrey D.,Montpellier University Hospital Center | Pageaux G.-P.,Montpellier University Hospital Center | And 12 more authors.
European Journal of Clinical Pharmacology | Year: 2013

Purpose: The European Committee for Human Medicinal Products (CHMP) requested a multinational study with the aim to investigate the risk of acute liver failure (ALF) leading to registration for transplantation in patients exposed to non-steroidal anti-inflammatory drugs (NSAIDs). The method of this multinational, multicentre, retrospective case-population study, named SALT (Study of Acute Liver Transplant), is documented here. Methods: This was a multicentre, multinational retrospective case-population study performed in France, Italy, Portugal, Greece, Ireland, the Netherlands and the UK. The study period was 3 years (1 January 2005-31 December 2007). Cases were patients ≥18 years of age with 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). Exposure was defined as exposure to any NSAID. Per country rates of NSAID-exposed transplantation- registered ALF were computed as the ratio of the number of cases identified in the country to total population exposure. Overall and per-drug sales for NSAIDs and for paracetamol were obtained from Intercontinental Marketing Services (IMS) Health for all participating countries. Population exposure was measured as the defined daily dose and as estimated annual number of patients exposed (primary endpoint) with 95 % confidence intervals. Results: The study protocol was approved by the CHMP. Of the 57 eligible liver transplant centres, 54 agreed to participate in the study. All national authorizations were received with relevant administrative burden, mainly due to bureaucracy. Conclusion: The present study created a multinational research network to estimate population-based absolute rates of drug-exposed ALF leading to registration on the transplantation list. This study design was chosen to obtain a fast response to a public health issue, namely, that of an increased risk of a rare, very serious adverse reaction. This model could be used to study other drug-related issues in ALF. © 2012 Springer-Verlag.


Gulmez S.E.,University of Bordeaux 1 | Gulmez S.E.,French Institute of Health and Medical Research | Gulmez S.E.,University of Bordeaux Segalen | Moore N.,University of Bordeaux 1 | And 22 more authors.
Drug Safety | Year: 2013

Background: Several methods have been proposed to assess causality in drug-induced liver injury but none have been tested in the specific context of acute liver failure leading to transplantation (ALFT). Objective: We took advantage of the Study of Acute Liver Transplant (SALT), a European case-population study of ALFT, to test different causality scales. Methods: Causality was assessed by experts in SALT, a 7-country case-population study from 2005 to 2007 of adult otherwise unexplained ALFT, for all drugs found within 30 days prior to the date of initial symptoms of liver disease (index date), using information content, causality scales, and data circuit determined from a pilot study, Salome. Results: The consensus points from Salome were to provide full data on drugs including international non-proprietary name (INN) and doses except for non-steroidal anti-inflammatory drugs (NSAIDs) and to use the World Health Organization (WHO) causality scale. In SALT, among the 9,479 identified patients, 600 (6.3 %) were cases of ALFT, of which 187 had been exposed to drugs within 30 days, without overdose. In 130 (69.5 %) of these the causality score was possible, probable, or highly probable. Conclusion: In ALFT cases, once other clinical causes have been excluded and drug exposure established within 30 days, the main discriminant characteristic for causality will be previous knowledge of possible hepatotoxicity. © 2013 Springer International Publishing Switzerland.


PubMed | University of Bordeaux 1, Clinica San Gaudenzio, Beaujon Hospital, Toulouse University Hospital Center and 4 more.
Type: Journal Article | Journal: Drug safety | Year: 2016

Several methods have been proposed to assess causality in drug-induced liver injury but none have been tested in the specific context of acute liver failure leading to transplantation (ALFT).We took advantage of the Study of Acute Liver Transplant (SALT), a European case-population study of ALFT, to test different causality scales.Causality was assessed by experts in SALT, a 7-country case-population study from 2005 to 2007 of adult otherwise unexplained ALFT, for all drugs found within 30 days prior to the date of initial symptoms of liver disease (index date), using information content, causality scales, and data circuit determined from a pilot study, Salome.The consensus points from Salome were to provide full data on drugs including international non-proprietary name (INN) and doses except for non-steroidal anti-inflammatory drugs (NSAIDs) and to use the World Health Organization (WHO) causality scale. In SALT, among the 9,479 identified patients, 600 (6.3%) were cases of ALFT, of which 187 had been exposed to drugs within 30 days, without overdose. In 130 (69.5%) of these the causality score was possible, probable, or highly probable.In ALFT cases, once other clinical causes have been excluded and drug exposure established within 30 days, the main discriminant characteristic for causality will be previous knowledge of possible hepatotoxicity.


Dorobantu L.F.,Carol Davila University of Medicine and Pharmacy | Iliescu V.A.,Carol Davila University of Medicine and Pharmacy | Stiru O.,Carol Davila University of Medicine and Pharmacy | Bubenek S.,Carol Davila University of Medicine and Pharmacy | Novelli E.,Clinica San Gaudenzio
Journal of Vascular Access | Year: 2010

Objective: To evaluate the mid-term results of the brachio-brachial arteriovenous fistula in patients without adequate superficial venous circulation in the upper limb. Methods: Retrospective analysis included 49 patients, in whom a brachio-brachial fistula had been created in an end-to-side configuration. After the maturation period (1 month), the brachial vein was transposed into the subcutaneous tissue. Follow-up study was performed in patients with functional brachio-brachial fistula after the superficialization. Results: Forty-nine patients underwent 49 brachio-brachial fistula constructions. All fistulas were functional. One month after surgery, 40 (81.6%) of these patients had a functional fistula, but in only 39 (79.6%) cases was the fistula suitable for hemodialysis (HD) following transposition to subcutaneous tissue. During the 1-month maturation period, the fistula became occluded in nine patients, and in one case the vein was permeable, so the fistula was functional, but too small to permit HD. Seventeen patients developed temporary edema of the forearm during the first month, in three cases the edema was extended to the entire arm, but no other complications were associated with the procedure. Follow-up lasted 18.0 ± 11.1 (3-37) months, during which 7/39 patients presented with fistula occlusion. Three patients died and another three were out of the study for various reasons. Conclusions: The brachio-brachial fistula is a good alternative to prosthetic grafts in patients without superficial venous circulation in the upper limb. © 2010 Wichtig Editore.

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