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Dabigatran oral thrombin inhibitor equal to Lovenox

A trial published in The Lancet reveals that Boehringer Ingelheimís investigational oral thrombin inhibitor dabigatran is equivalent to sanofi-aventis' Lovenox

The phase III RENOVATE trial, published in the latest edition of The Lancet, has revealed safety and tolerability data concerning Boehringer Ingelheim's (BI) oral thrombin inhibitor, dabigatran.

Dabigatran, which was taken orally once a day for 33 days, was as effective and well tolerated in preventing venous thromboembolism (VTE) after hip replacement surgery, as sanofi-aventis' intravenously delivered Lovenox (enoxaparin).

The study found that 220 mg and 150 mg oral doses of dabigatran in were equal in efficacy and tolerability to 40 mg of intravenously delivered Lovenox.

The trial compared a composite of total venous thromboembolic events and/ or symptomatic pulmonary embolism, which occurred in six per cent and 8.6 per cent of the dabigatran dosage groups, compared with 6.7 per cent of the Lovenox arm of the study.

A pre-specified secondary outcome of major venous thromboembolism and venous thromboembolism-related mortality was also similar between the groups, occurring in 3.1 per cent and 4.3 per cent of the dabigatran dosage arms, compared with 3.9 per cent of the enoxaparin group.

Oral versus injectable
German-headquartered BI is developing dabigatran as a once-daily oral tablet alternative to Lovenox. The S-A product is an injectable preparation requiring administration by a healthcare professional, or by patients who can self-administer.

Earlier in 2006, both the UK's Department of Health and the National Institute for Health and Clinical Excellence (NICE) published recommendations highlighting the need for high-risk patients to receive immediate and follow up thromboprophylaxis.

The ability to extend thromboprophylaxis to further reduce the risk of VTE beyond hospital stay is limited with currently available anticoagulants (injection-only or requirement for coagulation monitoring), so a significant unmet medical need exists for a fixed dose oral anticoagulant with no requirements for monitoring.

The study's author Simon Frostick, professor of orthopaedics at the University of Liverpool, said: "Based on the encouraging results demonstrated in the RE-NOVATE trial, once daily oral dabigatran may be an attractive alternative to other thromboprophylaxis regimens currently used to prevent VTE in patients undergoing elective hip replacement surgery."

Dabigatran is also a potential rival to German-based Bayer's new drug BAY 59-7939 (rivaroxaban), which proved superior to Lovenox when given after knee surgery in a clinical trial earlier in 2007.

In H1 FY07, Lovenox racked up sales of EUR 1.3bn, up 11.8 per cent on the previous half year of 2006. It is S-A's best-selling drug.

30th September 2008

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