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Multicenter, randomized, double blind, placebo controlled trial of deligoparin for active ulcerative colitis



Multicenter, randomized, double blind, placebo controlled trial of deligoparin for active ulcerative colitis



Digestive Disease Week Abstracts & Itinerary Planner : Abstract No 539



Background: The use of heparin or low molecular weight heparin (LMWH) for the treatment of active ulcerative colitis (UC) has been evaluated in several small clinical trials, with varying outcomes. Deligoparin is an ultra-LMWH with an average molecular weight of approximately 3000 daltons. Methods: In this study, 138 patients (Pts) with active UC were randomized to receive placebo (PLA; n=46), 75mg deligoparin (D75; n=47) or 125mg deligoparin (D125; n=45) once daily by subcutaneous injection for six weeks. Efficacy was assessed using a total colitis activity index (TCAI) score based on severity of rectal bleeding, stool frequency (SF), endoscopic findings and a physician's global assessment, each graded 0 to 3 points. The primary efficacy end point was the distribution of Pts among four response categories: remission (TCAI = 0, or 1 for SF only), improvement (TCAI dwnarw gtoreq 3), no change, and worsening (TCAI (up arrow) gtoreq 2). Concomitant medications included aminosalicylates (88% of Pts), steroids (17%) and/or azathioprine/6-MP (17%). Results: Mean TCAI scores at study entry ranged from 8.1 (D75) to 8.6 (PLA). Mean % increases in activated partial thromboplastin time (2.7% PLA, 16.7% D75, 26.8% D125) four hours after the first dose of study medication were consistent with anticipated peak deligoparin plasma levels and its in vitroratio of anti-activated Factor X to anti-activated Factor II activity of approximately 13. Early withdrawals (21 Pts) were for adverse events (7% PLA, 2% D75, 2% D125), treatment failure (2%, 6%, 13%), withdrawal of consent (2%, 4%, 2%) and a positive C. difficile(0%, 0%, 4%). In the intent-to-treat analysis, no significant difference in response was observed between PLA (41% in remission or improved) and either of the D75 (36%) and D125 (42%) treatment groups. Mean decreases in TCAI score of 2.2 (PLA), 2.4 (D75) and 2.4 (D125) points were also not significantly different. Analyses by disease severity, of component scores and using other definitions of improvement (TCAI dwnarw gtoreq 4; TCAI dwnarw gtoreq 5) also failed to show a trend in favor of active treatment. No serious adverse event related to a significant increase in rectal bleeding or other hemorrhage was reported. No Pt developed heparin-induced thrombocytopenia. Conclusions: Deligoparin, while well tolerated, was ineffective for the treatment of active UC when added to standard therapy.

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Accession: 035349990

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