Larazotide acetate for treatment of celiac disease: A systematic review and meta-analysis of randomized controlled trials.

Autor: Hoilat GJ; Department of Medicine, SUNY Upstate Medical University, Syracuse, NY, United States., Altowairqi AK; Department of Medicine, Alhada Armed Forces Hospital, Taif, Saudi Arabia., Ayas MF; Department of Internal Medicine, Ascension St. John Hospital, Detroit, MI, United States., Alhaddab NT; College of Medicine, Alfaisal University, Riyadh, Saudi Arabia., Alnujaidi RA; College of Medicine, Alfaisal University, Riyadh, Saudi Arabia., Alharbi HA; College of Medicine, Alfaisal University, Riyadh, Saudi Arabia., Alyahyawi N; Department of Pediatrics, King Abdulaziz University Hospital, Jeddah, Saudi Arabia., Kamal A; Department of Medicine, Ministry of Health, Riyadh, Saudi Arabia., Alhabeeb H; Research Center, King Fahad Medical City, Riyadh, Saudi Arabia., Albazee E; Faculty of Medicine, Hashemite University, Zarqa, Jordan., Almustanyir S; Department of Medicine, Ministry of Health, Riyadh, Saudi Arabia., Abu-Zaid A; College of Medicine, Alfaisal University, Riyadh, Saudi Arabia; College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States. Electronic address: aabuzaid@live.com.
Jazyk: angličtina
Zdroj: Clinics and research in hepatology and gastroenterology [Clin Res Hepatol Gastroenterol] 2022 Jan; Vol. 46 (1), pp. 101782. Date of Electronic Publication: 2021 Jul 31.
DOI: 10.1016/j.clinre.2021.101782
Abstrakt: Purpose: The standard of care for treatment of celiac disease (CD) is a stringent lifetime gluten-free diet (GFD). Larazotide acetate (AT-1001) is an anti-zonulin which functions as a gut permeability regulator for treatment of CD. We endeavored to conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) which studied the efficacy and safety of AT-1001 in patients with CD.
Methods: We examined four databases from inception to 20-August-2020. We pooled continuous outcomes as mean difference and dichotomous outcomes as risk ratio with 95% confidence interval under the fixed-effects meta-analysis model.
Results: Four RCTs met our eligibility criteria, comprising 626 patients (AT-1001, n=465, placebo, n=161). Three and two RCTs reported outcomes of patients undergoing gluten challenge (intake of 2.4-2.7 grams of gluten/day) and GFD, respectively. For change in lactulose-to-mannitol ratio, the endpoint did not significantly differ between AT-1001 and placebo groups, irrespective of the gluten status. Subgroup analysis of patients undergoing gluten challenge showed AT-1001 treatment (compared with placebo) significantly correlated with better symptomatic improvement in the two endpoints of change in total gastrointestinal symptom rating scale (total GSRS) and CD-specific GSRS (CD-GSRS). However, no significant difference was noted among patients undergoing GFD for the abovementioned two efficacy endpoints. Compared with placebo, AT-1001 favorably reduced the adverse event (AE) of gluten-related diarrhea in patients who underwent gluten challenge. Other AEs were comparable between both AT-1001 and placebo groups.
Conclusions: AT-1001 is largely well-endured and seems somehow superior to placebo in alleviating gastrointestinal symptoms among CD patients undergoing gluten challenge. Nevertheless, additional RCTs are warranted to validate these findings.
(Copyright © 2021 Elsevier Masson SAS. All rights reserved.)
Databáze: MEDLINE
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