A Placebo-Controlled Trial of Bezafibrate ...
Type de document :
Article dans une revue scientifique
DOI :
PMID :
URL permanente :
Titre :
A Placebo-Controlled Trial of Bezafibrate in Primary Biliary Cholangitis.
Auteur(s) :
Corpechot, Christophe [Auteur]
Chazouilleres, Olivier [Auteur]
Rousseau, Alexandra [Auteur]
Le Gruyer, Antonia [Auteur]
Habersetzer, Francois [Auteur]
Mathurin, Philippe [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Goria, Odile [Auteur]
Potier, Pascal [Auteur]
Minello, Anne [Auteur]
Silvain, Christine [Auteur]
Abergel, Armand [Auteur]
Debette-Gratien, Maryline [Auteur]
Larrey, Dominique [Auteur]
Roux, Olivier [Auteur]
Bronowicki, Jean-Pierre [Auteur]
Boursier, Jerome [Auteur]
De Ledinghen, Victor [Auteur]
Heurgue-Berlot, Alexandra [Auteur]
Nguyen-Khac, Eric [Auteur]
Zoulim, Fabien [Auteur]
Ollivier-Hourmand, Isabelle [Auteur]
Zarski, Jean-Pierre [Auteur]
N'kontchou, Gisele [Auteur]
Lemoinne, Sara [Auteur]
Humbert, Lydie [Auteur]
Rainteau, Dominique [Auteur]
Lefevre, Guillaume [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
De Chaisemartin, Luc [Auteur]
Chollet-Martin, Sylvie [Auteur]
Gaouar, Farid [Auteur]
Admane, Farid-Hakeem [Auteur]
Simon, Tabassome [Auteur]
Poupon, Raoul [Auteur]
Chazouilleres, Olivier [Auteur]
Rousseau, Alexandra [Auteur]
Le Gruyer, Antonia [Auteur]
Habersetzer, Francois [Auteur]
Mathurin, Philippe [Auteur]
![refId](/themes/Mirage2//images/idref.png)
Lille Inflammation Research International Center - U 995 [LIRIC]
Goria, Odile [Auteur]
Potier, Pascal [Auteur]
Minello, Anne [Auteur]
Silvain, Christine [Auteur]
Abergel, Armand [Auteur]
Debette-Gratien, Maryline [Auteur]
Larrey, Dominique [Auteur]
Roux, Olivier [Auteur]
Bronowicki, Jean-Pierre [Auteur]
Boursier, Jerome [Auteur]
De Ledinghen, Victor [Auteur]
Heurgue-Berlot, Alexandra [Auteur]
Nguyen-Khac, Eric [Auteur]
Zoulim, Fabien [Auteur]
Ollivier-Hourmand, Isabelle [Auteur]
Zarski, Jean-Pierre [Auteur]
N'kontchou, Gisele [Auteur]
Lemoinne, Sara [Auteur]
Humbert, Lydie [Auteur]
Rainteau, Dominique [Auteur]
Lefevre, Guillaume [Auteur]
![refId](/themes/Mirage2//images/idref.png)
Lille Inflammation Research International Center - U 995 [LIRIC]
De Chaisemartin, Luc [Auteur]
Chollet-Martin, Sylvie [Auteur]
Gaouar, Farid [Auteur]
Admane, Farid-Hakeem [Auteur]
Simon, Tabassome [Auteur]
Poupon, Raoul [Auteur]
Titre de la revue :
The New England journal of medicine
Nom court de la revue :
N. Engl. J. Med.
Numéro :
378
Pagination :
2171-2181
Date de publication :
2018-06-07
ISSN :
1533-4406
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
Background
Patients with primary biliary cholangitis who have an inadequate response to therapy with ursodeoxycholic acid are at high risk for disease progression. Fibrates, which are agonists of peroxisome proliferator–activated ...
Lire la suite >Background Patients with primary biliary cholangitis who have an inadequate response to therapy with ursodeoxycholic acid are at high risk for disease progression. Fibrates, which are agonists of peroxisome proliferator–activated receptors, in combination with ursodeoxycholic acid, have shown potential benefit in patients with this condition. Methods In this 24-month, double-blind, placebo-controlled, phase 3 trial, we randomly assigned 100 patients who had had an inadequate response to ursodeoxycholic acid according to the Paris 2 criteria to receive bezafibrate at a daily dose of 400 mg (50 patients), or placebo (50 patients), in addition to continued treatment with ursodeoxycholic acid. The primary outcome was a complete biochemical response, which was defined as normal levels of total bilirubin, alkaline phosphatase, aminotransferases, and albumin, as well as a normal prothrombin index (a derived measure of prothrombin time), at 24 months. Results The primary outcome occurred in 31% of the patients assigned to bezafibrate and in 0% assigned to placebo (difference, 31 percentage points; 95% confidence interval, 10 to 50; P<0.001). Normal levels of alkaline phosphatase were observed in 67% of the patients in the bezafibrate group and in 2% in the placebo group. Results regarding changes in pruritus, fatigue, and noninvasive measures of liver fibrosis, including liver stiffness and Enhanced Liver Fibrosis score, were consistent with the results of the primary outcome. Two patients in each group had complications from end-stage liver disease. The creatinine level increased 5% from baseline in the bezafibrate group and decreased 3% in the placebo group. Myalgia occurred in 20% of the patients in the bezafibrate group and in 10% in the placebo group. Conclusions Among patients with primary biliary cholangitis who had had an inadequate response to ursodeoxycholic acid alone, treatment with bezafibrate in addition to ursodeoxycholic acid resulted in a rate of complete biochemical response that was significantly higher than the rate with placebo and ursodeoxycholic acid therapy. (Funded by Programme Hospitalier de Recherche Clinique and Arrow Génériques; BEZURSO ClinicalTrials.gov number, NCT01654731. opens in new tab.)Lire moins >
Lire la suite >Background Patients with primary biliary cholangitis who have an inadequate response to therapy with ursodeoxycholic acid are at high risk for disease progression. Fibrates, which are agonists of peroxisome proliferator–activated receptors, in combination with ursodeoxycholic acid, have shown potential benefit in patients with this condition. Methods In this 24-month, double-blind, placebo-controlled, phase 3 trial, we randomly assigned 100 patients who had had an inadequate response to ursodeoxycholic acid according to the Paris 2 criteria to receive bezafibrate at a daily dose of 400 mg (50 patients), or placebo (50 patients), in addition to continued treatment with ursodeoxycholic acid. The primary outcome was a complete biochemical response, which was defined as normal levels of total bilirubin, alkaline phosphatase, aminotransferases, and albumin, as well as a normal prothrombin index (a derived measure of prothrombin time), at 24 months. Results The primary outcome occurred in 31% of the patients assigned to bezafibrate and in 0% assigned to placebo (difference, 31 percentage points; 95% confidence interval, 10 to 50; P<0.001). Normal levels of alkaline phosphatase were observed in 67% of the patients in the bezafibrate group and in 2% in the placebo group. Results regarding changes in pruritus, fatigue, and noninvasive measures of liver fibrosis, including liver stiffness and Enhanced Liver Fibrosis score, were consistent with the results of the primary outcome. Two patients in each group had complications from end-stage liver disease. The creatinine level increased 5% from baseline in the bezafibrate group and decreased 3% in the placebo group. Myalgia occurred in 20% of the patients in the bezafibrate group and in 10% in the placebo group. Conclusions Among patients with primary biliary cholangitis who had had an inadequate response to ursodeoxycholic acid alone, treatment with bezafibrate in addition to ursodeoxycholic acid resulted in a rate of complete biochemical response that was significantly higher than the rate with placebo and ursodeoxycholic acid therapy. (Funded by Programme Hospitalier de Recherche Clinique and Arrow Génériques; BEZURSO ClinicalTrials.gov number, NCT01654731. opens in new tab.)Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Inserm
Université de Lille
CHU Lille
Université de Lille
CHU Lille
Équipe(s) de recherche :
Inflammatory digestive disease : pathophysiology and therapeutic targets developement
Immunity, inflammation and fibrsis in auto and allo-reactivity
Immunity, inflammation and fibrsis in auto and allo-reactivity
Date de dépôt :
2019-03-01T14:26:55Z
2024-02-06T13:47:58Z
2024-02-06T13:47:58Z