Fibrates for Itch (FITCH) in Fibrosing Cholangiopathies: A Double-Blind, Randomized, Placebo-Controlled Trial
| العنوان: | Fibrates for Itch (FITCH) in Fibrosing Cholangiopathies: A Double-Blind, Randomized, Placebo-Controlled Trial |
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| المؤلفون: | Karin C M J van Nieuwkerk, Elsemieke de Vries, Nahid Mostafavi, Karel J. van Erpecum, Frans van der Heide, Ruth Bolier, Marleen de Vree, Albert Parés, Jorn C Goet, Jef Verbeek, Ulrich Beuers, Ronald P.J. Oude Elferink, Jeltje Helder, Cyriel Y. Ponsioen, Joost P.H. Drenth, Henk R. van Buuren |
| المساهمون: | Gastroenterology & Hepatology, VU University medical center, Amsterdam Gastroenterology Endocrinology Metabolism, MUMC+: MA Maag Darm Lever (9), RS: FHML non-thematic output, Gastroenterology and Hepatology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Tytgat Institute for Liver and Intestinal Research |
| المصدر: | Gastroenterology, 160, 3, pp. 734-743.e6 Gastroenterology, 160(3), 734-743.e6. W.B. Saunders Gastroenterology, 160(3), 734-743.e6. W.B. Saunders Ltd Gastroenterology, 160(3), 734-743.e6. W B SAUNDERS CO-ELSEVIER INC Gastroenterology, 160(3), 734-+. Elsevier Saunders Netherlands Association for the Study of the Liver-Cholestasis Working Group 2021, ' Fibrates for Itch (FITCH) in Fibrosing Cholangiopathies: A Double-Blind, Randomized, Placebo-Controlled Trial ', Gastroenterology, vol. 160, no. 3, pp. 734-743.e6 . https://doi.org/10.1053/j.gastro.2020.10.001Test Gastroenterology, 160, 734-743.e6 |
| بيانات النشر: | Elsevier BV, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Male, 0301 basic medicine, Visual Analog Scale, Primary Sclerosing Cholangitis (PSC), Placebo-controlled study, Severity of Illness Index, Gastroenterology, Placebos, 0302 clinical medicine, Clinical endpoint, skin and connective tissue diseases, Cholestasis, integumentary system, Liver Cirrhosis, Biliary, primary sclerosing cholangitis (PSC), Middle Aged, Ursodeoxycholic acid, Treatment Outcome, Female, 030211 gastroenterology & hepatology, primary biliary cholangitis (PBC), medicine.drug, Adult, medicine.medical_specialty, Visual analogue scale, Cholangitis, Sclerosing, Placebo, digestive system, Primary sclerosing cholangitis, 03 medical and health sciences, Primary Biliary Cholangitis (PBC), All institutes and research themes of the Radboud University Medical Center, Double-Blind Method, Internal medicine, medicine, Humans, Bezafibrate, Hepatology, business.industry, Pruritus, pruritus, medicine.disease, digestive system diseases, Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11], 030104 developmental biology, Quality of Life, Secondary sclerosing cholangitis, cholestasis, business |
| الوصف: | BACKGROUND AND AIMS: Pruritus may seriously impair quality of life in patients with cholestatic diseases such as primary or secondary sclerosing cholangitis (PSC, SSC) and primary biliary cholangitis (PBC). Pharmacologic strategies show limited efficacy and can provoke serious side effects. We hypothesized that bezafibrate, a broad peroxisome proliferator-activated receptor (PPAR) agonist, relieves cholestasis-associated itch by alleviating hepatobiliary injury. The aim of this investigator-initiated FITCH trial (Fibrates for cholestatic ITCH) was to assess effects of bezafibrate on pruritus in patients with PSC, PBC, and SSC. METHODS: Patients with moderate to severe pruritus (≥5 of 10 on visual analog scale [VAS]) due to PSC, PBC, or SSC were recruited for this double-blind, randomized, placebo-controlled trial between 2016 and 2019. Patients received once-daily bezafibrate (400 mg) or placebo for 21 days. The primary end point was ≥50% reduction of pruritus (VAS; intention-to-treat). RESULTS: Of 74 randomized patients, 70 completed the trial (95%; 44 PSC, 24 PBC, 2 SSC). For the primary end point, bezafibrate led in 45% (41% PSC, 55% PBC) and placebo in 11% to ≥50% reduction of severe or moderate pruritus (P = .003). For secondary end points, bezafibrate reduced morning (P = .01 vs placebo) and evening (P = .007) intensity of pruritus (VAS) and improved the validated 5D-Itch questionnaire (P = .002 vs placebo). Bezafibrate also reduced serum alkaline phosphatase (-35%, P = .03 vs placebo) correlating with improved pruritus (VAS, P = .01) suggesting reduced biliary damage. Serum bile acids and autotaxin activity remained unchanged. Serum creatinine levels tended to mildly increase (3% bezafibrate, 5% placebo, P = .14). CONCLUSIONS: Bezafibrate is superior to placebo in improving moderate to severe pruritus in patients with PSC and PBC. TRIAL REGISTRATION: Netherlands Trial Register, ID: NTR5436 (August 3, 2015), ClinicalTrials.gov ID: NCT02701166 (March 2, 2016). ispartof: GASTROENTEROLOGY vol:160 issue:3 pages:734-+ ispartof: location:United States status: published |
| وصف الملف: | application/pdf; Print-Electronic |
| تدمد: | 0016-5085 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a12e8bc10a50f0d8ee66e2d4d4aa8507Test https://doi.org/10.1053/j.gastro.2020.10.001Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....a12e8bc10a50f0d8ee66e2d4d4aa8507 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 00165085 |
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