Pradaxa is as Effective as Lovenox in Preventing VTE-event in Patients Setting Undergoing Hip Surgery: RE-NOVATE 2 study

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In a randomized trial that was reported at the 2010 Congress of the European Hematology Association (EHA), the oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) was found to be as effective as subcutaneous enoxaparin (Lovenox, Sanofi-Aventis) in preventing venous thromboembolism (VTE) or death (p<0.0001 for noninferiority) in patients undergoing total hip-replacement surgery

In the clinical trial, patients were randomized to either oral dabigatran 220 mg once daily (n=1010) or 40 mg subcutaneous enoxaparin (n=1003) for an average of 32 days after total hip replacement.

Dabigatran was found to be as effective and safe as injected enoxaparin in preventing total VTE and all-cause mortality (7.7% and 8.8%, respectively) but more effective in preventing major VTE or VTE-related death (2.2% and 4.2%, respectively, p=0.03 for superiority).

Even though dabigatran was not found to be more efficacious than enoxaprin in total VTE and death, its oral form is more convenient and easier for patient compliance than subcutaneous administration of an anticoagulant.  Furthermore, there is no need for blood parameters is monitoring, thereby cutting costs.

Dabigatran is currently not available in the US, but is expected to get approval in the fall of 2010.

Source; 2010 Congress of the European Hematology Association (EHA)

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