Reviparin: A Review of its Efficacy in the Prevention and Treatment of Venous Thromboembolism

Authors: Wellington K.; McClellan K.; Jarvis B.

Source: Drugs, Volume 61, Number 8, 2001 , pp. 1185-1209(25)

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Abstract:

Reviparin (reviparin sodium) is a low molecular weight heparin (LMWH) that catalyses the inactivation of factors Xa and IIa by binding to antithrombin, which ultimately leads to the inhibition of the clotting cascade. It is administered subcutaneously.

Reviparin 7000 to 12 600 anti-XaIU/day was found to be as effective as intravenous unfractionated heparin in preventing the clinical recurrence of acute deep vein thrombosis (DVT) and/or pulmonary embolism in 1 large randomised, multicentre trial (COLUMBUS) and was significantly more effective than intravenous unfractionated heparin in the prevention of recurrent venous thromboembolism in another large randomised, multicentre trial (CORTES). Reviparin has also been compared with unfractionated heparin in children with established DVT. However, the trial was under-powered and no conclusion could be made regarding comparative efficacy.

As prophylaxis, reviparin 1750 anti-XaIU once daily was as effective as unfractionated heparin 5000IU twice daily in 1311 patients undergoing abdominal surgery and, in a once daily dosage of 4200 anti-XaIU, was as effective as subcutaneous enoxaparin sodium 40 mg/day or acenocoumarol in patients undergoing hip replacement surgery. Reviparin 1750 anti-XaIU also effectively prevented DVT, compared with no treatment, in patients undergoing knee arthroscopy. It was also more effective than placebo in patients with brace immobilisation of the lower extremity. Reviparin was compared with ‘standard care’ in children with central venous lines. However, the trial was too small to make conclusions regarding its efficacy.

Comparative data indicate that reviparin is at least as well tolerated as heparin and enoxaparin sodium. However, in a large (n = 1279) trial there were significantly fewer major bleeding episodes in patients receiving reviparin than in patients given the oral anticoagulant acenocoumarol. The most commonly reported adverse events in therapeutic trials have been intraoperative blood loss and postoperative bleeding complications such as wound haematoma, bruising and injection site haemorrhage. Reviparin was also well tolerated in 2 studies in children aged 16 years.

Conclusion: Reviparin has shown efficacy in the treatment of established DVT and in the prevention of postoperative DVT after moderate and high risk surgery and was as effective as enoxaparin sodium or acenocoumarol in patients undergoing hip replacement surgery. As an effective and well tolerated antithrombotic agent, reviparin is likely to assume a significant role in the treatment and prevention of DVT, as it appears to have a preferable tolerability profile to subcutaneous heparin after moderate risk surgery and is at least as effective as intravenous heparin in the treatment of established DVT.

Keywords: Children; Deep vein thrombosis, prevention; Drug evaluations; Enoxaparin sodium, therapeutic use; Heparin, therapeutic use; Low molecular weight heparins, general; Pregnancy; Reviparin sodium, general; Thromboembolism, prevention; Thromboembolism, treatment

Language: English

Document Type: Drug Evaluation

Affiliations: 1: Adis International Limited, Auckland, New Zealand *

Publication date: 2001-01-01

Reviparin: A Review of its Efficacy in the Prevention and Treatment of Venous Thromboembolism

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