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Oral, colonic-release low-molecular-weight heparin: an initial open study of Parnaparin-MMX for the treatment of

L Pastorelli1, S Saibeni, L Spina

  • 1Gastroenterology and Gastrointestinal Endoscopy Unit, IRCCS Policlinico San Donato, San Donato Milanese, Italy.

Alimentary Pharmacology & Therapeutics
|August 15, 2008
PubMed
Abstract

Insights

Oral Parnaparin-MMX showed promising safety for mild-to-moderate ulcerative colitis (UC) patients. Most patients achieved clinical remission with no significant side effects, suggesting a potential new treatment for UC.

Area of Science:

  • Gastroenterology
  • Pharmacology
  • Internal Medicine

Background:

  • Low-molecular-weight heparins (LMWHs) show potential in inflammatory bowel disease (IBD) treatment.
  • The oral MMX formulation delivers drugs to the colon, minimizing systemic absorption.
  • Parnaparin sodium, an LMWH, is formulated with MMX for targeted delivery.

Purpose of the Study:

  • To evaluate the safety of three oral dosages of Parnaparin-MMX (70, 140, 210 mg daily) in patients with left-sided ulcerative colitis (UC).

Main Methods:

  • Mild-to-moderate left-sided UC patients received Parnaparin-MMX for 8 weeks.
  • Safety and efficacy were assessed using Clinical Activity Index (CAI), Disease Activity Index (DAI), Endoscopic Activity Index, and IBD-QoL.
  • Clinical remission was defined as CAI <4, with close monitoring of haemostasis and bleeding.

Main Results:

  • Ten UC patients were enrolled; one withdrew due to clinical deterioration.
  • No significant side effects, bleeding, or haemostasis interference were observed.
  • 70% of patients achieved clinical remission (CAI <4), with significant improvements in CAI, DAI, and IBD-QoL scores.

Conclusions:

  • Parnaparin-MMX demonstrates safety as a treatment for mild-to-moderate UC.
  • Further controlled studies are recommended to confirm efficacy and safety.
  • Oral LMWH delivery offers a novel approach for UC management.

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