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Randomised clinical trial: the safety and efficacy of AST-120 in non-constipating irritable bowel syndrome - a double-blind, placebo-controlled study.
Aliment Pharmacol Ther 2011; 34(8):868-77AP

Abstract

BACKGROUND

There is a need for safe and effective treatment options for irritable bowel syndrome (IBS). AST-120 (spherical carbon adsorbent) is a non-absorbed, carbon-based adsorbent with extensive adsorbing capability for histamine, serotonin and other substances implicated in IBS pathogenesis.

AIM

To evaluate the efficacy and safety of AST-120 in non-constipating forms of IBS.

METHODS

This randomised, double-blind, placebo-controlled trial conducted in the US and Belgium enrolled 115 male and female patients fulfilling Rome III criteria for IBS; individuals with predominantly constipation symptoms were excluded. Subjects were randomised to AST-120 2 g tds or placebo for an 8-week double-blind treatment period, followed by a 2-week single-blind placebo washout and 8-week single-blind active treatment. The primary efficacy endpoint was the proportion of subjects achieving at least a 50% reduction in the number of days with abdominal pain compared with baseline.

RESULTS

At Week 4, 26.8% of subjects treated with AST-120 responded on the primary endpoint vs. 10.2% in the placebo arm (P=0.029); at Week 8 response rates were 32.1 and 25.4% respectively (NS). More AST-120 treated subjects experienced improvement in bloating and stool consistency. These benefits abated when AST-120 was replaced by placebo, and resumed once AST-120 was restarted. The frequency of adverse events with AST-120 were less than or equal to placebo.

CONCLUSIONS

AST-120 is safe and well-tolerated and reduces pain and bloating in non-constipating IBS, although beneficial effects may be limited in duration. AST-120 represents a locally acting, non-absorbed, novel treatment for IBS and warrants further studies.

Authors+Show Affiliations

Translational Research Center for Gastrointestinal Diseases, University of Leuven, Leuven, Belgium. jan.tack@med.kuleuven.ac.beNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21883322

Citation

Tack, J F., et al. "Randomised Clinical Trial: the Safety and Efficacy of AST-120 in Non-constipating Irritable Bowel Syndrome - a Double-blind, Placebo-controlled Study." Alimentary Pharmacology & Therapeutics, vol. 34, no. 8, 2011, pp. 868-77.
Tack JF, Miner PB, Fischer L, et al. Randomised clinical trial: the safety and efficacy of AST-120 in non-constipating irritable bowel syndrome - a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2011;34(8):868-77.
Tack, J. F., Miner, P. B., Fischer, L., & Harris, M. S. (2011). Randomised clinical trial: the safety and efficacy of AST-120 in non-constipating irritable bowel syndrome - a double-blind, placebo-controlled study. Alimentary Pharmacology & Therapeutics, 34(8), pp. 868-77. doi:10.1111/j.1365-2036.2011.04818.x.
Tack JF, et al. Randomised Clinical Trial: the Safety and Efficacy of AST-120 in Non-constipating Irritable Bowel Syndrome - a Double-blind, Placebo-controlled Study. Aliment Pharmacol Ther. 2011;34(8):868-77. PubMed PMID: 21883322.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomised clinical trial: the safety and efficacy of AST-120 in non-constipating irritable bowel syndrome - a double-blind, placebo-controlled study. AU - Tack,J F, AU - Miner,P B,Jr AU - Fischer,L, AU - Harris,M S, Y1 - 2011/08/24/ PY - 2011/9/3/entrez PY - 2011/9/3/pubmed PY - 2012/3/16/medline SP - 868 EP - 77 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 34 IS - 8 N2 - BACKGROUND: There is a need for safe and effective treatment options for irritable bowel syndrome (IBS). AST-120 (spherical carbon adsorbent) is a non-absorbed, carbon-based adsorbent with extensive adsorbing capability for histamine, serotonin and other substances implicated in IBS pathogenesis. AIM: To evaluate the efficacy and safety of AST-120 in non-constipating forms of IBS. METHODS: This randomised, double-blind, placebo-controlled trial conducted in the US and Belgium enrolled 115 male and female patients fulfilling Rome III criteria for IBS; individuals with predominantly constipation symptoms were excluded. Subjects were randomised to AST-120 2 g tds or placebo for an 8-week double-blind treatment period, followed by a 2-week single-blind placebo washout and 8-week single-blind active treatment. The primary efficacy endpoint was the proportion of subjects achieving at least a 50% reduction in the number of days with abdominal pain compared with baseline. RESULTS: At Week 4, 26.8% of subjects treated with AST-120 responded on the primary endpoint vs. 10.2% in the placebo arm (P=0.029); at Week 8 response rates were 32.1 and 25.4% respectively (NS). More AST-120 treated subjects experienced improvement in bloating and stool consistency. These benefits abated when AST-120 was replaced by placebo, and resumed once AST-120 was restarted. The frequency of adverse events with AST-120 were less than or equal to placebo. CONCLUSIONS: AST-120 is safe and well-tolerated and reduces pain and bloating in non-constipating IBS, although beneficial effects may be limited in duration. AST-120 represents a locally acting, non-absorbed, novel treatment for IBS and warrants further studies. SN - 1365-2036 UR - https://www.unboundmedicine.com/medline/citation/21883322/Randomised_clinical_trial:_the_safety_and_efficacy_of_AST_120_in_non_constipating_irritable_bowel_syndrome___a_double_blind_placebo_controlled_study_ L2 - https://doi.org/10.1111/j.1365-2036.2011.04818.x DB - PRIME DP - Unbound Medicine ER -