A Placebo-Controlled Trial of Bezafibrate in Primary Biliary Cholangitis.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Corpechot Christophe, Chazouillères Olivier, Rousseau Alexandra, Le Gruyer Antonia, Habersetzer François, Mathurin Philippe, Goria Odile, Potier Pascal, Minello Anne, Silvain Christine, Abergel Armand, Debette-Gratien Maryline, Larrey Dominique, Roux Olivier, Bronowicki Jean-Pierre, Boursier Jérôme, de Ledinghen Victor, Heurgue-Berlot Alexandra, Nguyen-Khac Eric, Zoulim Fabien, Ollivier-Hourmand Isabelle, Zarski Jean-Pierre, Nkontchou Gisèle, Lemoinne Sara, Humbert Lydie, Rainteau Dominique, Lefèvre Guillaume, de Chaisemartin Luc, Chollet-Martin Sylvie, Gaouar Farid, Admane Farid-Hakeem, Simon Tabassome, Poupon Raoul
Аннотация
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 .).