scholarly journals Efficacy and Safety of the New Oral Anticoagulants Dabigatran, Rivaroxaban, Apixaban, and Edoxaban in the Treatment and Secondary Prevention of Venous Thromboembolism: A Systematic Review and Meta-analysis of Phase III Trials

2014 ◽  
Vol 60 (5) ◽  
pp. 1397 ◽  
Author(s):  
S.K. Kakkos ◽  
G.I. Kirkilesis ◽  
I.A. Tsolakis
Keyword(s):  
Systematic Review ◽  
Venous Thromboembolism ◽  
Secondary Prevention ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Iii Trials

scholarly journals Efficacy and Safety of Enoxaparin versus New Oral Anticoagulants to Prevent Venous Thromboembolism after Total Hip Replacement: A Systematic Review and Meta-Analysis

2022 ◽  
Vol 12 (1) ◽  
pp. 107
Author(s):  
Mohammed Farhan A Alfarhan
Keyword(s):  
Systematic Review ◽  
Venous Thromboembolism ◽  
Total Hip Replacement ◽  
Hip Replacement ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Clinical Endpoint ◽  
Efficacy And Safety ◽  
Total Hip

Prophylactic anticoagulant therapy is recommended for reducing the risk of venous thromboembolism (VTE) after a total hip replacement (THR). However, it is not clear which anticoagulant is preferable. Hence, a systematic review and meta-analysis of randomized double-blind controlled trials (RDBCTs) were conducted to investigate the clinical efficacy and safety of enoxaparin in comparison with newer oral anticoagulants for the prevention of VTE after THR. The Cochrane Library, Scopus, Web of Science, Embase, and PubMed/Medline databases were used for PICO search strategy. Relative risks (RR) of symptomatic VTE, clinically relevant bleeding, mortality, and a net clinical endpoint were estimated employing a random effect meta-analysis. ITC and RevMan software were used for indirect and direct comparisons, respectively. Nine RDBCTs comprising 24,584 patients were included. As compared to enoxaparin, a reduced risk for symptomatic VTE was observed with rivaroxaban (confidence interval [CI]: 0.32–0.77; RR: 0.46%) and comparable with apixaban (0.12–1.26; 0.42%) and dabigatran (0.22–2.20; 0.70%). Contrarily to enoxaparin, a greater risk for clinically relevant bleeding was observed with rivaroxaban (1.03–1.48; 1.23%), comparable with dabigatran (0.96–1.33; 1.10%) and reduced with apixaban (0.19–5.66; 0.96%). In indirect or direct comparisons, the interventions did not differ on the net clinical endpoint. In conclusion, the findings of this meta-analysis revealed no significant difference in the efficacy and safety of new oral anticoagulants as compared to enoxaparin for the prevention of VTE after total hip replacement surgery.

scholarly journals Efficacy and safety of new oral anticoagulants in prophylaxis and treatment of venous thromboembolism

2010 ◽  
Vol 1 (1) ◽  
pp. 7-26 ◽  
Author(s):  
Luca Masotti ◽  
Cecilia Becattini ◽  
Roberto Cappelli ◽  
Giancarlo Landini ◽  
Alessandro Pampana ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Oral Anticoagulants ◽  
Clinical Development ◽  
Ease Of Use ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Iii Clinical Trials ◽  
Phase Iii Trials

One of the main innovation emerged in recent years in the field of venous thromboembolism (VTE) has been represented by the clinical development and marketing of new oral anticoagulant agents used for prophylaxis and acute treatment. These drugs are represented by direct thrombin inhibitors (anti-factor IIa) and the direct inhibitors of activated factor X (anti-Xa). The main achievement of these new agents is represented by their ease of use without laboratory monitoring or dose adjustment. Dabigatran (anti-factor IIa), rivaroxaban, and apixaban (anti-Xa) are in advanced phase of clinical development with concluded phase III trials. Up to now the results of efficacy and safety of phase III clinical trials are available, while phase IV studies are currently ongoing. Overall, the phase III clinical trials showed the non inferiority of new oral anticoagulants in VTE prophylaxis of patients undergone to major orthopedic surgery, such as hip and knee arthroplasty, compared to conventional prophylaxis represented by subcutaneous low molecular weight heparin with similar safety. Moreover dabigatran has shown to be not inferior when compared to warfarin for the prevention of six months VTE recurrences, with a significative lower incidence of bleedings. Awaiting the results of many other ongoing phase III trials, since now it is possible to think that, in the next future, new oral anticoagulants will be widely diffused in clinical practice for their ease of use and feasibility. In this review the Authors analyse the available results of phase III clinical trials for dabigatran, rivaroxaban and apixaban, focusing on the antithrombotic endpoints for prevention and treatment of VTE and the bleeding risk. Moreover synthesis of ongoing trials will be displayed.

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