An analysis based on the Dabigatran ester(Pradaxa)and enoxaparin to compare the OSGIN1 four phase III clinical trials recently published in"Thrombosis Research"journal,relevant results support the Pradaxa applied to total knee or total hip arthroplasty in patients with venous thromboembolism(VTE)prevention with good security.These results confirm the low risk of acute coronary syndrome(ACS)events,but also no significant difference between the OSM two groups.This analysis the following conclusions:Pradaxa compared to enoxaparin does not increase the risk of myocardial infarction(MI),and after treatment with the clinical significance of the"rebound effect"there is no relevant connection."These findings for doctors and patients,are encouraging news,"from Professor Bengt I.Eriksson,Sahlgrenska University Hospital orthopedic consultant physician in Gothenburg,Sweden said so."The assessment of OSMR post orthopedic surgery the Dabigatran esters used in the prevention of VTE in patients to enhance the treatment of confidence,because the results show that the lower risk of ACS events,and no rebound effect after stopping treatment."These new findings from the four designed to assess the the Pradaxa applied to accept the efficacy and safety of VTE prophylaxis in patients with OSTF1 total knee or total hip arthroplasty random,non-inferiority Phase III clinical trials,namely,the RE-MOBILIZE2,RE-MODEL3,RE-NOVATE?research and RE-NOVATE5 II study,a total of 10,148 patients were included in these trials were randomized to receive Pradaxa(150 mg daily dosing,or 220 mg daily dosing)or by enoxaparin treatment course of 6-35 days,and then followed up for 90 days.ACS event is defined as unstable angina,myocardial infarction or sudden cardiac death 1.
Based on pooled analysis of the results of these OSTM1 four trials showed:Pradaxa group of patients after treatment,a lower incidence of ACS events,but also with the enoxaparin group(220mg:6 patients[0.16%];150mg:14 patients[0.51%];enoxaparin:13 patients[0.35%]).Pradaxa group compared with the enoxaparin group myocardial infarction(MI)the risk is not increased(220mg:4 patients[0.11%];150mg:14 patients[0.51%];enoxaparin:13 patients[0.35%]).After the end of treatment,prior to acceptance Pradaxa treatment and accept the enoxaparin treatment of patients with similar ACS incidence(220mg:2 patients[0.06%];150mg:1 patient[0.04%];enoxaparin:4 patients[0.11%]).The authors conclude that yes,there is no evidence Pradaxa treatment with anti-rebound effect.In the landmark RE-LY study,also observed Pradaxa treatment group MI incidence is low,the pilot in over 18,000 patients with atrial fibrillation Pradaxa compared with well-controlled warfarin in stroke and systemic embolism prevention of the effects assessment of 6,7.Myocardial infarction incidence between treatment groups no significant statistical difference,but the program of two doses of Pradaxa group and the warfarin group,myocardial infarction rate was lower(Pradaxa 110mg group:98/6015;Pradaxa 150mg Groups of:97/6075;warfarin group:75/6022).