27 Jun 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Findings from an analysis of four phase III trials, comparing Boehringer Ingelheim's Pradaxa to enoxaparin, recently published in Thrombosis Research supported the positive safety profile of Pradaxa for the prevention of venous thromboembolism (VTE) in patients undergoing total knee or hip arthroplasty. The results demonstrate that the risk of acute coronary syndrome (ACS) events was low and that there was no significant difference in between the two treatments. The analysis concluded that Pradaxa does not elevate the risk of myocardial infarction (MI) compared to enoxaparin and is not associated with any clinically important 'rebound effect' in the post-treatment period.
"These findings are encouraging for both physicians and patients," stated Prof. Bengt I. Eriksson, Senior Consultant at the Department of Orthopaedic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden. "The evaluation provides reassurance for patients undergoing orthopaedic procedures with subsequent treatment with dabigatran etexilate for the prevention of VTE that the risk of ACS events is low and that there is no rebound effect after the discontinuation of the treatment."
These new findings were derived from four randomised, non-inferiority, phase III trials conducted to investigate the efficacy and safety of Pradaxa in patients being treated for the prevention of VTE undergoing total knee or hip arthroplasty. A total of 10,148 patients were randomised in the RE-MOBILIZE, RE-MODEL, RE-NOVATE, and RE-NOVATE II trials to Pradaxa or enoxaparin for 6-35 days, and followed for up to 90 days. ACS events were defined as unstable angina, myocardial infaction or sudden cardiac death.