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Your search keyword '"Pyrsopoulos N."' showing total 5 results
Start Over Author "Pyrsopoulos N." Journal journal of hepatology
5 results on '"Pyrsopoulos N."'

1. Randomized placebo-controlled trial of emricasan for non-alcoholic steatohepatitis-related cirrhosis with severe portal hypertension

Author

Garcia-Tsao, Guadalupe, primary, Bosch, Jaime, additional, Kayali, Zeid, additional, Harrison, Stephen A., additional, Abdelmalek, Manal F., additional, Lawitz, Eric, additional, Satapathy, Sanjaya K., additional, Ghabril, Marwan, additional, Shiffman, Mitchell L., additional, Younes, Ziad H., additional, Thuluvath, Paul J., additional, Berzigotti, Annalisa, additional, Albillos, Agustin, additional, Robinson, James M., additional, Hagerty, David T., additional, Chan, Jean L., additional, Sanyal, Arun J., additional, Abdelmalek, M., additional, Bhamidimarri, K., additional, Borg, B., additional, Caldwell, S., additional, Fenkel, J., additional, Freilich, B., additional, Fuchs, M., additional, Ghabril, M., additional, Ghalib, R., additional, Gonzalez, S., additional, Gordon, S., additional, Hameed, B., additional, Harrison, S., additional, Kayali, Z., additional, Kemmer, N., additional, Korenblat, K., additional, Lai, M., additional, Landis, C., additional, Lawitz, E., additional, Lee, W., additional, Lidofsky, S., additional, Mena, E., additional, Noureddin, M., additional, Paredes, A., additional, Pyrsopoulos, N., additional, Reddy, R., additional, Rinella, M., additional, Rockey, D., additional, Rodriguez, M., additional, Ryan, M., additional, Sarkar, S., additional, Satapathy, S., additional, Scanga, A., additional, Shiffman, M., additional, Siddiqui, M., additional, Simonetto, D., additional, Syn, W., additional, Thuluvath, P., additional, Vemulapalli, R., additional, Vierling, J., additional, Younes, Z., additional, Albillos, A., additional, Ruiz-Tapiador, J. Arenas, additional, Augustin, S., additional, Calleja, J., additional, Garcia, J. Crespo, additional, Buey, L. Garcia, additional, Garcia-Pagan, J.C., additional, Villanueva, C., additional, Bureau, C., additional, Carbonell, N., additional, Leroy, V., additional, Rautou, P.-E., additional, Heinzow, H., additional, Schiefke, I., additional, Zipprich, A., additional, Berzigotti, A., additional, and Muellhaupt, B., additional

Published
2020
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5. Proof-of-concept study to evaluate the safety and efficacy of saroglitazar in patients with primary biliary cholangitis.

Author

Vuppalanchi R, Caldwell SH, Pyrsopoulos N, deLemos AS, Rossi S, Levy C, Goldberg DS, Mena EA, Sheikh A, Ravinuthala R, Shaikh F, Bainbridge JD, Parmar DV, and Chalasani NP

Subjects
Double-Blind Method, Female, Humans, Liver Cirrhosis, Biliary physiopathology, Male, Middle Aged, Phenylpropionates therapeutic use, Placebos, Pyrroles therapeutic use, Treatment Outcome, Liver Cirrhosis, Biliary drug therapy, Phenylpropionates pharmacology, Pyrroles pharmacology
Abstract

Background & Aim: Saroglitazar is a novel peroxisome proliferator-activated receptor (PPAR) agonist with dual agonistic properties (α/γ). Due to a strong mechanistic rationale, we aimed to test the safety and efficacy of saroglitazar in patients with primary biliary cholangitis (PBC) who were either ursodeoxycholic acid (UDCA) resistant or intolerant., Methods: In this double-blind, phase II proof-of-concept trial, 37 patients with PBC were randomized to saroglitazar 4 mg (n = 13), saroglitazar 2 mg (n = 14), or placebo (n = 10) daily for 16 weeks. The primary efficacy endpoint was the reduction in alkaline phosphatase (ALP) level at Week 16., Results: A significant reduction of mean ALP levels was observed at Week 16 relative to baseline in both the saroglitazar 4 mg (least-squares [LS] mean =-163.3 U/L, SE = 25.1, p <0.001) and 2 mg (LS mean =-155.8 U/L, SE = 24.4, p <0.001) groups, compared with placebo (LS mean =-21.1 U/L, SE = 28.9). Treatment with saroglitazar resulted in a rapid reduction of ALP concentration at Week 4 that was sustained through the study duration. At least 1 treatment-emergent adverse event occurred in 11 (84.6%) patients in the saroglitazar 4 mg group, in 12 (85.7%) patients in the 2 mg group and in 8 (80%) patients in the placebo group. Study drug was discontinued in 4 patients (3 patients in the 4 mg group and 1 patient in the 2 mg group) due to aminotransferase increases that promptly returned to baseline values after drug discontinuation., Conclusions: Saroglitazar at 2 mg and 4 mg daily was tolerated and resulted in rapid and sustained improvements in ALP. Further studies are underway at a daily dose of 2 mg and 1 mg due to the higher incidence of elevated liver enzymes observed with the 4 mg dose. CLINICALTRIALS., Gov Identifier: NCT03112681 LAY SUMMARY: Saroglitazar resulted in a rapid and sustained improvement in alkaline phosphatase levels in patients with primary biliary cholangitis. The mean percentage reductions in alkaline phosphatase levels were 49% and 51% in the saroglitazar 4 mg and 2 mg groups compared to 3% in the placebo group., Competing Interests: Conflict of interest DP, FS, JB are employees of Zydus Discovery DMCC. No conflict of interest relevant to the current trial were reported by the rest of the authors listed for this manuscript. Please refer to the accompanying ICMJE disclosure forms for further details., (Copyright © 2021 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Published
2022
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