Low molecular weight heparin (tinzaparin) vs. placebo in the treatment of mild to moderately active ulcerative colitis

Bloom, S; Kiilerich, S.; Lassen, Michael R.; Forbes, Alastair; Leiper, Keith; Langholz, Ebbe; Irvine, E. Jan; O’Moráin, Colm; Lowson, David; Orm, Sawsan Abou

doi:10.1111/j.1365-2036.2004.01926.x

Cited by 59 publications

(71 citation statements)

References 30 publications

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“…Fortunately, as in other studies [15,34], no serious bleeding complications were encountered, suggesting that LMWH is a relatively safe drug in this patient group with tendency for mucosal bleeding.…”

Section: Discussionsupporting

confidence: 76%

“…This is in contrast with the positive results found in a previous but open study done with nadroparin, in corticosteroid-resistant UC patients [15]. It suggests that LMWH, in combination with aminosalicylates but in the absence of corticosteroids, does not have any therapeutic advantage above a placebo, as was recently also shown by other investigators [34].…”

Section: Discussionmentioning

confidence: 59%

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Thrombin generation in mesalazine refractory ulcerative colitis and the influence of low molecular weight heparin

Vrij

Oberndorff-Klein-Woolthuis

Dijkstra

et al. 2007

J Thromb Thrombolysis

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Background In ulcerative colitis (UC), a state of hypercoagulation has frequently been observed. Low molecular weight heparin (LMWH) has shown beneficial effects as an adjuvant treatment of steroid refractory UC in open trials. We assessed potential therapeutic effects of the LMWH reviparin in hospitalised patients with mesalazine refractory UC, as well as its influence on haemostasis factors. Methods Twentynine patients with mild-to-moderately active UC were included in a double-blind placebo controlled trial. All patients had a flare-up of disease under mesalazine treatment. Reviparin (Clivarin Ò ) 3,436 IU anti-Xa/0.6 ml or placebo s.c. was added, and self-administered twice daily for 8 weeks. Patients were monitored for possible adverse events and changes in clinical symptoms. Endoscopical, histological, biochemical and haemostasis parameters were analysed. Results Tolerability and compliance were excellent and no serious adverse events occurred. No significant differences were observed on the clinical, endoscopical and histological outcome, as compared to placebo. A high intrinsic and extrinsic thrombin potential was found before LMWH therapy. However, the significant reduction in the thrombin generation by LMWH was not related to the reduction in disease activity. Conclusion The LMWH reviparine reduces thrombin generation in patients with mild-to-moderately active, mesalazine refractory UC, but is not associated with a reduction in disease activity.

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Section: Discussionsupporting

confidence: 76%

Section: Discussionmentioning

confidence: 59%

Thrombin generation in mesalazine refractory ulcerative colitis and the influence of low molecular weight heparin

Vrij

Oberndorff-Klein-Woolthuis

Dijkstra

et al. 2007

J Thromb Thrombolysis

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“…In one randomized trial including only patients with UC, the 16 patients who received full anticoagulant doses of low molecular weight heparin had no episodes of rectal bleeding and only small hematomas at the injection site [22] . In a larger, randomized, controlled trial of 48 patients with UC who received low molecular weight heparin, first at full anticoagulation doses, and later at a dose equivalent to that used for prevention of deep venous thrombosis, there were no complications in the treatment group and one episode of rectal bleeding in the placebo group [23] . Overall, it appears that heparin therapy at doses sufficient to achieve complete anticoagulation is safe among patients with active UC with respect to GI bleeding risks, and that the lower thromboembolic prophylactic doses are likely to not bear any higher risk.…”

Section: Discussionmentioning

confidence: 99%

Hospitalized ulcerative colitis patients have an elevated risk of thromboembolic events

Wang¹,

Terdiman²,

Vittinghoff³

et al. 2009

WJG

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AIM:To compare thromboembolism rates between hospitalized patients with a diagnosis of ulcerative colitis and other hospitalized patients at high risk for thromboembolism. To compare thromboembolism rates between patients with ulcerative colitis undergoing a colorectal operation and other patients undergoing colorectal operations. METHODS:Data from the National Hospital Discharge Survey was used to compare thromboembolism rates between (1) hospitalized patients with a discharge diagnosis of ulcerative colitis and those with diverticulitis or acute respiratory failure, and (2) hospitalized patients with a discharge diagnosis of ulcerative colitis who underwent colectomy and those with diverticulitis or colorectal cancer who underwent colorectal operations. RESULTS:Patients diagnosed with ulcerative colitis had similar or higher rates of combined venous thromboembolism (2.03%) than their counterparts with diverticulitis (0.76%) or respiratory failure (1.99%), despite the overall greater prevalence of thromboembolic risk factors in the latter groups. Discharged patients with colitis that were treated surgically did not have significantly different rates of venous or arterial thromboembolism than those with surgery for diverticulitis or colorectal cancer. CONCLUSION:Patients with ulcerative colitis who do not undergo an operation during their hospitalization have similar or higher rates of thromboembolism than other medical patients who are considered to be high risk for thromboembolism.

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“…Current medical treatment of IBD, titrated according to the severity of the disease and to the individual response, includes 5-aminosalicylic acid (ASA) derivatives, corticosteroids, immunosuppressants, and most recently biologic agents mainly targeted against tumor necrosis factor (TNF)-a. Among the emerging treatments for ulcerative colitis, the parenteral administration of low-molecular-weight heparins (LMWHs), i.e., dalteparin, enoxaparin, nadroparine, reviparin, deligoparin, and tinzaparin, was judged clinically useful by some authors [1][2][3], but questioned by others [4][5][6][7][8]. The administration of LMWHs by oral route has recently been attempted, resulting safe and effective in corticosteroid-resistant UC patients [9].…”

Section: Introductionmentioning

confidence: 99%

Efficacy of Intracolonic Administration of Low-Molecular-Weight Heparin CB-01-05, Compared to Other Low-Molecular-Weight Heparins and Unfractionated Heparin, in Experimentally Induced Colitis in Rat

et al. 2008

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Purpose Parenteral administration of lowmolecular-weight heparins (LMWHs) and unfractionated heparin (UFH) resulted effective in improving the symptoms of experimental colitis in rat. Today, there is little information about their activity by intracolonic instillation. The scope of this study was to evaluate the ability of CB-01-05 (a LMWH with a mean molecular weight of about 5,700), compared to a series of other LMWHs and to UFH, directly instilled into the distal colon of the rat, to ameliorate dinitrobenzene (DNB)-induced experimental colitis. Method Adult male Wistar rats underwent colitis induction by intracolonic instillation of DNB. Starting 24 h after colitis induction, CB-01-05 (0.005-0.9 mg), other LMWHs (0.3-0.6 mg), and UFH (0.6 mg) were instilled, by rectal route, into the distal colon once a day for three consecutive days. On the day following the last administration, the animals were sacrificed and the distal colon was isolated, weighed, macroscopically examined, and processed for histology. Additional experiments in rat splenocytes, performed in order to elucidate the anti-inflammatory mechanisms of CB-01-05, were performed. Results Among the tested items, only CB-01-05 at doses ranging from 0.2 to 0.9 mg was significantly effective in reducing colon weight increase and in improving both the mucosal damaged area and the histological score. The other LMWHs resulted far less effective, showing decreasing activity closely related with the decrease of their molecular weight, thus demonstrating their biological nonequivalence. CB-01-05 resulted also more active than UFH. CB-01-05 was shown to interfere with cytokines production by rat splenocytes, mainly inhibiting interferon (IFN)-c expression. Conclusions CB-01-05 instilled into the colon is well tolerated, has strong anti-inflammatory effect on DNBinduced colitis in rat, and is the most effective agent among other LMWHs and UFH. These results suggest that the anti-inflammatory activity of CB-01-05, together with its topical administration, could represent a new approach in the management of ulcerative colitis.

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Low molecular weight heparin (tinzaparin) vs. placebo in the treatment of mild to moderately active ulcerative colitis

Cited by 59 publications

References 30 publications

Thrombin generation in mesalazine refractory ulcerative colitis and the influence of low molecular weight heparin

Thrombin generation in mesalazine refractory ulcerative colitis and the influence of low molecular weight heparin

Hospitalized ulcerative colitis patients have an elevated risk of thromboembolic events

Efficacy of Intracolonic Administration of Low-Molecular-Weight Heparin CB-01-05, Compared to Other Low-Molecular-Weight Heparins and Unfractionated Heparin, in Experimentally Induced Colitis in Rat

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