Combination of fibrates with obeticholic acid is able to normalise biochemical liver tests in patients with difficult-to-treat primary biliary cholangitis

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Combination of fibrates with obeticholic acid is able to normalise biochemical liver tests in patients with difficult-to-treat primary biliary cholangitis. / Soret, Pierre-Antoine; Lam, Laurent; Carrat, Fabrice; Smets, Lena; Berg, Thomas; Carbone, Marco; Invernizzi, Pietro; Leroy, Vincent; Trivedi, Palak; Cazzagon, Nora; Weiler-Normann, Christina; Alric, Laurent; Rosa-Hezode, Isabelle; Heurgué, Alexandra; Cervoni, Jean-Paul; Dumortier, Jérôme; Potier, Pascal; Roux, Olivier; Silvain, Christine; Bureau, Christophe; Anty, Rodolphe; Larrey, Dominique; Levy, Cynthia; Pares, Albert; Schramm, Christoph; Nevens, Frederik; Chazouillères, Olivier; Corpechot, Christophe.

in: ALIMENT PHARM THER, Jahrgang 53, Nr. 10, 05.2021, S. 1138-1146.

Publikationen: SCORING: Beitrag in Fachzeitschrift/ZeitungSCORING: ZeitschriftenaufsatzForschungBegutachtung

Harvard

Soret, P-A, Lam, L, Carrat, F, Smets, L, Berg, T, Carbone, M, Invernizzi, P, Leroy, V, Trivedi, P, Cazzagon, N, Weiler-Normann, C, Alric, L, Rosa-Hezode, I, Heurgué, A, Cervoni, J-P, Dumortier, J, Potier, P, Roux, O, Silvain, C, Bureau, C, Anty, R, Larrey, D, Levy, C, Pares, A, Schramm, C, Nevens, F, Chazouillères, O & Corpechot, C 2021, 'Combination of fibrates with obeticholic acid is able to normalise biochemical liver tests in patients with difficult-to-treat primary biliary cholangitis', ALIMENT PHARM THER, Jg. 53, Nr. 10, S. 1138-1146. https://doi.org/10.1111/apt.16336

APA

Soret, P-A., Lam, L., Carrat, F., Smets, L., Berg, T., Carbone, M., Invernizzi, P., Leroy, V., Trivedi, P., Cazzagon, N., Weiler-Normann, C., Alric, L., Rosa-Hezode, I., Heurgué, A., Cervoni, J-P., Dumortier, J., Potier, P., Roux, O., Silvain, C., ... Corpechot, C. (2021). Combination of fibrates with obeticholic acid is able to normalise biochemical liver tests in patients with difficult-to-treat primary biliary cholangitis. ALIMENT PHARM THER, 53(10), 1138-1146. https://doi.org/10.1111/apt.16336

Vancouver

Bibtex

@article{d01f80dfdcf34c50bb219c5dcb40e46d,
title = "Combination of fibrates with obeticholic acid is able to normalise biochemical liver tests in patients with difficult-to-treat primary biliary cholangitis",
abstract = "BACKGROUND: Obeticholic acid (OCA) and fibrates are second-line therapies for patients with primary biliary cholangitis (PBC) with an inadequate response to ursodeoxycholic acid (UDCA).AIM: To know whether OCA and fibrates, administered together in combination with UDCA, have additive beneficial effects in patients with difficult-to-treat PBC.METHODS: PBC patients treated for ≥3 months with UDCA, OCA and fibrates (bezafibrate or fenofibrate) due to failure of either second-line therapy were included in a multicentre, uncontrolled retrospective cohort study. Changes in biochemical liver tests and pruritus were analysed using a generalised linear mixed-effect model.RESULTS: Among 58 patients included, half received OCA as second-line and fibrates as third-line therapy (Group OCA-Fibrate), while the other half had the inverse therapeutic sequence (Group Fibrate-OCA). The mean duration of triple therapy was 11 months (range 3-26). Compared to dual therapy, triple therapy was associated with a significant gain in alkaline phosphatase (ALP) reduction: 22% per first year (95% CI 12%-31%), an effect that was stronger in OCA-Fibrate than in Fibrate-OCA group. Triple therapy was associated with a 3.4 (95% CI 1.4-8.2) odds ratio (OR) of reaching normal ALP and with a significant decrease in gamma-glutamyl transpeptidase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin. The ORs of achieving the Paris-2 and Toronto criteria of adequate biochemical response were 6.8 (95% CI 2.8-16.7) and 9.2 (95% CI 3.4-25.1) respectively. Finally, triple therapy significantly improved pruritus in OCA-Fibrate but not in Fibrate-OCA group.CONCLUSIONS: Triple therapy with UDCA, OCA and fibrates is able to normalise biochemical liver tests and improve pruritus in patients with difficult-to-treat PBC.",
keywords = "Chenodeoxycholic Acid/analogs & derivatives, Cholagogues and Choleretics/therapeutic use, Fibric Acids/therapeutic use, Humans, Liver Cirrhosis, Biliary/drug therapy, Retrospective Studies, Ursodeoxycholic Acid/therapeutic use",
author = "Pierre-Antoine Soret and Laurent Lam and Fabrice Carrat and Lena Smets and Thomas Berg and Marco Carbone and Pietro Invernizzi and Vincent Leroy and Palak Trivedi and Nora Cazzagon and Christina Weiler-Normann and Laurent Alric and Isabelle Rosa-Hezode and Alexandra Heurgu{\'e} and Jean-Paul Cervoni and J{\'e}r{\^o}me Dumortier and Pascal Potier and Olivier Roux and Christine Silvain and Christophe Bureau and Rodolphe Anty and Dominique Larrey and Cynthia Levy and Albert Pares and Christoph Schramm and Frederik Nevens and Olivier Chazouill{\`e}res and Christophe Corpechot",
note = "{\textcopyright} 2021 John Wiley & Sons Ltd.",
year = "2021",
month = may,
doi = "10.1111/apt.16336",
language = "English",
volume = "53",
pages = "1138--1146",
journal = "ALIMENT PHARM THER",
issn = "0269-2813",
publisher = "Wiley-Blackwell",
number = "10",

}

RIS

TY - JOUR

T1 - Combination of fibrates with obeticholic acid is able to normalise biochemical liver tests in patients with difficult-to-treat primary biliary cholangitis

AU - Soret, Pierre-Antoine

AU - Lam, Laurent

AU - Carrat, Fabrice

AU - Smets, Lena

AU - Berg, Thomas

AU - Carbone, Marco

AU - Invernizzi, Pietro

AU - Leroy, Vincent

AU - Trivedi, Palak

AU - Cazzagon, Nora

AU - Weiler-Normann, Christina

AU - Alric, Laurent

AU - Rosa-Hezode, Isabelle

AU - Heurgué, Alexandra

AU - Cervoni, Jean-Paul

AU - Dumortier, Jérôme

AU - Potier, Pascal

AU - Roux, Olivier

AU - Silvain, Christine

AU - Bureau, Christophe

AU - Anty, Rodolphe

AU - Larrey, Dominique

AU - Levy, Cynthia

AU - Pares, Albert

AU - Schramm, Christoph

AU - Nevens, Frederik

AU - Chazouillères, Olivier

AU - Corpechot, Christophe

N1 - © 2021 John Wiley & Sons Ltd.

PY - 2021/5

Y1 - 2021/5

N2 - BACKGROUND: Obeticholic acid (OCA) and fibrates are second-line therapies for patients with primary biliary cholangitis (PBC) with an inadequate response to ursodeoxycholic acid (UDCA).AIM: To know whether OCA and fibrates, administered together in combination with UDCA, have additive beneficial effects in patients with difficult-to-treat PBC.METHODS: PBC patients treated for ≥3 months with UDCA, OCA and fibrates (bezafibrate or fenofibrate) due to failure of either second-line therapy were included in a multicentre, uncontrolled retrospective cohort study. Changes in biochemical liver tests and pruritus were analysed using a generalised linear mixed-effect model.RESULTS: Among 58 patients included, half received OCA as second-line and fibrates as third-line therapy (Group OCA-Fibrate), while the other half had the inverse therapeutic sequence (Group Fibrate-OCA). The mean duration of triple therapy was 11 months (range 3-26). Compared to dual therapy, triple therapy was associated with a significant gain in alkaline phosphatase (ALP) reduction: 22% per first year (95% CI 12%-31%), an effect that was stronger in OCA-Fibrate than in Fibrate-OCA group. Triple therapy was associated with a 3.4 (95% CI 1.4-8.2) odds ratio (OR) of reaching normal ALP and with a significant decrease in gamma-glutamyl transpeptidase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin. The ORs of achieving the Paris-2 and Toronto criteria of adequate biochemical response were 6.8 (95% CI 2.8-16.7) and 9.2 (95% CI 3.4-25.1) respectively. Finally, triple therapy significantly improved pruritus in OCA-Fibrate but not in Fibrate-OCA group.CONCLUSIONS: Triple therapy with UDCA, OCA and fibrates is able to normalise biochemical liver tests and improve pruritus in patients with difficult-to-treat PBC.

AB - BACKGROUND: Obeticholic acid (OCA) and fibrates are second-line therapies for patients with primary biliary cholangitis (PBC) with an inadequate response to ursodeoxycholic acid (UDCA).AIM: To know whether OCA and fibrates, administered together in combination with UDCA, have additive beneficial effects in patients with difficult-to-treat PBC.METHODS: PBC patients treated for ≥3 months with UDCA, OCA and fibrates (bezafibrate or fenofibrate) due to failure of either second-line therapy were included in a multicentre, uncontrolled retrospective cohort study. Changes in biochemical liver tests and pruritus were analysed using a generalised linear mixed-effect model.RESULTS: Among 58 patients included, half received OCA as second-line and fibrates as third-line therapy (Group OCA-Fibrate), while the other half had the inverse therapeutic sequence (Group Fibrate-OCA). The mean duration of triple therapy was 11 months (range 3-26). Compared to dual therapy, triple therapy was associated with a significant gain in alkaline phosphatase (ALP) reduction: 22% per first year (95% CI 12%-31%), an effect that was stronger in OCA-Fibrate than in Fibrate-OCA group. Triple therapy was associated with a 3.4 (95% CI 1.4-8.2) odds ratio (OR) of reaching normal ALP and with a significant decrease in gamma-glutamyl transpeptidase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin. The ORs of achieving the Paris-2 and Toronto criteria of adequate biochemical response were 6.8 (95% CI 2.8-16.7) and 9.2 (95% CI 3.4-25.1) respectively. Finally, triple therapy significantly improved pruritus in OCA-Fibrate but not in Fibrate-OCA group.CONCLUSIONS: Triple therapy with UDCA, OCA and fibrates is able to normalise biochemical liver tests and improve pruritus in patients with difficult-to-treat PBC.

KW - Chenodeoxycholic Acid/analogs & derivatives

KW - Cholagogues and Choleretics/therapeutic use

KW - Fibric Acids/therapeutic use

KW - Humans

KW - Liver Cirrhosis, Biliary/drug therapy

KW - Retrospective Studies

KW - Ursodeoxycholic Acid/therapeutic use

U2 - 10.1111/apt.16336

DO - 10.1111/apt.16336

M3 - SCORING: Journal article

C2 - 33764590

VL - 53

SP - 1138

EP - 1146

JO - ALIMENT PHARM THER

JF - ALIMENT PHARM THER

SN - 0269-2813

IS - 10

ER -