Oral, colonic-release low-molecular-weight heparin: An initial open study of Parnaparin-MMX for the treatment of mild-to-moderate left-sided ulcerative colitis

L. Pastorelli, S. Saibeni, L. Spina, C. Signorelli, G. Celasco, R. De Franchis, M. Vecchi

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Abstract

Background: Efficacy of heparin and low-molecular-weight heparins (LMWHs) in inflammatory bowel disease (IBD) treatment has been suggested. The multimatrix oral formulation MMX releases active drugs in the colon, avoiding systemic absorption. Parnaparin sodium is the LMWH chosen to be carried in the MMX formulation. Aim: To assess the safety of three different oral dosages (70, 140 and 210 mg once daily) of Parnaparin-MMX (CB-01-05) in left-sided ulcerative colitis (UC). Methods: Left-sided UC patients, with a mild-to-moderate relapse were enrolled. All patients received Parnaparin-MMX for 8 weeks. Clinical Activity Index (CAI), Disease Activity Index (DAI), Endoscopic Activity Index and IBD-QoL were assessed throughout the study. A strict clinical and laboratory follow-up, including assessment of anti-factor Xa activity, was performed. Clinical remission was defined as CAI

Original languageEnglish
Pages (from-to)581-588
Number of pages8
JournalAlimentary Pharmacology and Therapeutics
Volume28
Issue number5
DOIs
Publication statusPublished - Sep 2008

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ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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