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Cholestatic Pruritus Treatments in Primary Biliary Cholangitis and Primary Sclerosing Cholangitis: A Systematic Literature Review.
Smith, Helen T; de Souza, Andrea Ribeiro; Thompson, April H; McLaughlin, Megan M; Dever, John J; Myers, Julie A; Chen, Jing Voon.
Afiliação
  • Smith HT; Value Evidence, GSK, 980 Great West Road, Brentford, TW8 9GS, Middlesex, UK. helen.t.smith@gsk.com.
  • de Souza AR; Research and Development, GSK, PTM Severo Ochoa 2 28760, Tres Cantos, Madrid, Spain.
  • Thompson AH; Specialty Medicines, Global Medical Affairs, GSK, Research Triangle Park, Durham, NC, 27701, USA.
  • McLaughlin MM; Medicine Development, GSK, 1250 S Collegeville Rd, Collegeville, PA, 19426, USA.
  • Dever JJ; Statistics and Evidence Synthesis, Medical Decision Modeling Inc., 3500 Depauw Blvd, Suite #1037, Indianapolis, IN, 46268, USA.
  • Myers JA; Statistics and Evidence Synthesis, Medical Decision Modeling Inc., 3500 Depauw Blvd, Suite #1037, Indianapolis, IN, 46268, USA.
  • Chen JV; Modeling and Analytics, Medical Decision Modeling Inc., 3500 Depauw Blvd, Suite #1037, Indianapolis, IN, 46268, USA.
Dig Dis Sci ; 68(6): 2710-2730, 2023 06.
Article em En | MEDLINE | ID: mdl-36933112
BACKGROUND AND AIMS: We conducted a systematic literature review to understand the evidence supporting treatment decisions for cholestatic pruritus associated with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). METHODS: Studies that enrolled ≥ 75% participants with PBC or PSC and reported ≥ 1 endpoint(s) related to efficacy, safety, health-related quality of life (HRQoL) or other patient-reported outcomes were included. Bias was assessed using the Cochrane risk of bias tool for randomised controlled trials (RCTs) and the Quality of Cohort studies tool for non-RCTs. RESULTS: Thirty-nine publications were identified, covering 42 studies and six treatment classes (including investigational and approved products): anion-exchange resins, antibiotics (rifampicin/derivatives), opiates, selective serotonin reuptake inhibitors, fibrates, ileal bile acid transporter inhibitors and other agents not categorised in these six classes. Across studies, median sample size was small (n = 18), 20 studies were over 20 years old, 25 followed patients for ≤ 6 weeks, only 25 were RCTs. Pruritus was assessed using several different tools, with inconsistencies in their application. Cholestyramine, considered first-line therapy for moderate-severe cholestatic pruritus, was assessed in six studies (two RCTs) including 56 patients with PBC and 2 with PSC, with evidence of efficacy demonstrated in only three studies, among which, two RCTs were assessed as having a high risk of bias. Findings were similar for other drug classes. CONCLUSIONS: There is a lack of consistent and reproducible evidence available on efficacy, impact on HRQoL, and safety of cholestatic pruritus treatments, leaving physicians to rely on clinical experience rather than evidence-based medicine for treatment selection.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Colangite Esclerosante / Cirrose Hepática Biliar Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies / Systematic_reviews Limite: Adult / Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Colangite Esclerosante / Cirrose Hepática Biliar Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies / Systematic_reviews Limite: Adult / Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article