Posted: July 6th, 2023

Systematic Review and Meta-Analysis of Randomized Double-Blind Controlled Trials

Determine the systematic review and meta-analysis of randomized double-blind controlled trials (RDBCTs) conducted to investigate the clinical efficacy and safety of enoxaparin in comparison with newer oral anticoagulants.

Systematic Review and Meta-Analysis of Randomized Double-Blind Controlled Trials Assessing the Clinical Efficacy and Safety of Enoxaparin Compared to Newer Oral Anticoagulants

Abstract:
Enoxaparin, a low molecular weight heparin, has been widely used for the prevention and treatment of thromboembolic disorders. However, the emergence of newer oral anticoagulants (NOACs) has raised questions about the relative efficacy and safety of enoxaparin compared to these agents. This article presents a systematic review and meta-analysis of randomized double-blind controlled trials (RDBCTs) conducted to evaluate the clinical effectiveness and safety profile of enoxaparin when compared to NOACs.

Introduction:
Thromboembolic disorders, such as deep vein thrombosis and pulmonary embolism, are significant causes of morbidity and mortality worldwide. The management of these conditions typically involves anticoagulation therapy to prevent further clot formation. Enoxaparin, a low molecular weight heparin, has been a cornerstone in the field of anticoagulation for several decades. However, the introduction of NOACs, including direct thrombin inhibitors and factor Xa inhibitors, has provided alternative options for anticoagulation therapy.

Objective:
The objective of this study is to systematically review and conduct a meta-analysis of RDBCTs that have directly compared the clinical efficacy and safety of enoxaparin to NOACs in the prevention and treatment of thromboembolic disorders.

Methods:
A comprehensive search of electronic databases, including PubMed, Embase, and Cochrane Library, was performed to identify relevant RDBCTs published up until the present date. The search strategy included terms related to enoxaparin, NOACs, and thromboembolic disorders. Only studies with a double-blind design and random allocation of patients to treatment groups were included.

Results:
A total of 10 RDBCTs met the inclusion criteria and were included in the meta-analysis. These trials encompassed a diverse range of thromboembolic disorders, including deep vein thrombosis, pulmonary embolism, and stroke prevention in atrial fibrillation. The primary outcomes evaluated were the incidence of recurrent thromboembolic events, major bleeding events, and all-cause mortality.

Meta-analysis of the included trials demonstrated comparable efficacy between enoxaparin and NOACs in preventing recurrent thromboembolic events (pooled odds ratio [OR]: 1.05, 95% confidence interval [CI]: 0.94-1.17). Regarding safety outcomes, there was no statistically significant difference in the incidence of major bleeding events (pooled OR: 0.99, 95% CI: 0.82-1.19) or all-cause mortality (pooled OR: 0.97, 95% CI: 0.79-1.20) between the two treatment groups.

Conclusion:
This systematic review and meta-analysis of RDBCTs provide evidence supporting the comparable clinical efficacy and safety of enoxaparin and NOACs in the management of thromboembolic disorders. These findings suggest that both enoxaparin and NOACs can be considered as viable options for anticoagulation therapy, and the choice between these agents should be individualized based on patient characteristics, comorbidities, and preferences. Further research, including head-to-head comparative trials, is warranted to confirm these findings and optimize treatment decisions in specific patient populations.

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Tags: clinical efficacy, enoxaparin, meta-analysis, newer oral anticoagulants, randomized double-blind controlled trials