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No significant difference in the risk of Acute Coronary Syndrome (including Myocardial Infarction) seen with Pradaxa® (dabigatran etexilate) compared to enoxaparin for VTE prevention after orthopaedic surgery

June 26, 2012 - Ingelheim, Germany

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Findings from an analysis of four Phase III trials, comparing Pradaxa® to enoxaparin recently published in Thrombosis Research, support 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.1

“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®2, RE-MODEL™3, RE-NOVATE®4, and RE-NOVATE®5 II trials to Pradaxa® (150 mg or 220 mg once daily) 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.1

Key results from the pooled analysis of the four trials showed:1

  • The incidence of treatment-emergent ACS events was low for Pradaxa® patients and similar to those seen with enoxaparin (220mg: 6 patients [0.16%] vs. 150mg: 14 patients [0.51%] and enoxaparin: 13 patients [0.35%])1
  • No increased risk of myocardial infarction (MI) in patients treated with Pradaxa® compared to enoxaparin (220mg: 4 patients [0.11%] vs. 150mg: 14 patients [0.51%] and enoxaparin: 13 patients [0.35%])
  • Also in the post-treatment period, comparable rates of ACS events were seen in patients previously treated with Pradaxa® versus those previously treated with enoxaparin (220mg: 2 patients [0.06%] vs. 150mg: 1 patient [0.04%] and enoxaparin: 4 patients [0.11%]). The authors concluded that no evidence of a rebound effect was observed with Pradaxa®.*

The low incidence of MI with Pradaxa® was also observed in the landmark RE-LY® trial, which examined the role of Pradaxa® versus well-controlled warfarin in the prevention of stroke and systemic embolism in over 18,000 patients with atrial fibrillation.6-8 No statistically significant difference in rates of myocardial infarction was observed between the trial groups, with a low incidence rate reported for both doses of Pradaxa® and warfarin (Pradaxa® 110mg: 98/6015, Pradaxa® 150mg: 97/6075 and warfarin: 75/6022).7

Furthermore, the results from the RE-LY® trial have shown the substantial benefits Pradaxa® offers in terms of effective prevention of stroke and major reduction in intracranial bleeding. Pradaxa® 150mg bid provided an additional reduction in risk of stroke and systemic embolism by 35% compared to well-controlled warfarin (INR 2-3, median TTR 67%9).6,7 Pradaxa® 150mg bid is the only novel oral anticoagulant to have demonstrated in a major study a significant reduction of both ischaemic and haemorrhagic stroke in patients with non-valvular AF when compared to warfarin.6,7 Pradaxa®110mg bid, which is indicated for certain patients, was shown to be non-inferior to well-controlled warfarin for the prevention of stroke and systemic embolism in patients with non-valvular AF. Significantly lower life threatening and intracranial bleeding was provided with both doses of Pradaxa®, with significantly lower major bleeding events also seen with Pradaxa® 110mg bid6,7

RE-LY® was a PROBE trial (prospective, randomized, open-label with blinded endpoint evaluation), comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.6,7

The effectiveness and favourable safety profile of Pradaxa® is well documented in an extensive clinical trial programme2-7,9,10, passing independent regulatory scrutiny and approval worldwide. Clinical experience of Pradaxa® for stroke protection is already well established and continues to grow, equating to over 780,000 patient years in over 70 countries worldwide11 and exceeding clinical trial experience of all other novel oral anticoagulants.12

* Differences between groups were not statistically significant


Please click on the link below for ‘Notes to Editors’ and ‘References’:

CONTACTS : Boehringer Ingelheim GmbH Dr. Reinhard Malin Corporate Communications Media + PR Phone: + 49 - 6132 - 77 90815 Fax: + 49 - 6132 - 72 6601 E-mail: Twitter:

Source: Business Wire India


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