scholarly journals Efficacy and Safety of Rivaroxaban Compared with Other Therapies Used in Patients with Peripheral Artery Disease Undergoing Peripheral Revascularization: A Systematic Literature Review and Network Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Rupert Bauersachs ◽  
Olivia Wu ◽  
Neil Hawkins ◽  
Kevin Bowrin ◽  
Piotr Wojciechowski ◽  
...  
Keyword(s):  
Literature Review ◽  
Peripheral Artery Disease ◽  
Systematic Literature Review ◽  
Meta Analysis ◽  
Case Analysis ◽  
Base Case ◽  
Efficacy And Safety ◽  
Base Case Analysis ◽  
Peripheral Artery ◽  
Artery Disease

Background. The guidelines on antithrombotic treatment in patients with symptomatic peripheral artery disease (PAD) undergoing peripheral revascularization of the lower extremities were developed based on heterogeneous trials, assessing various dose regimens and recruiting patients who were subjected to different revascularization procedures. Objective. To compare efficacy and safety of treatments used in patients with PAD undergoing peripheral revascularization accounting for between-trial heterogeneity and large dispersion of the quality of evidence. Methods. A systematic literature review of randomised controlled trials (RCTs) recruiting adult patients with PAD receiving antithrombotics was conducted until January 2020. Hazard ratios (HR) were pooled using Bayesian network meta-analysis. The estimated between-treatment effects were presented as HR together with 95% credible intervals. The base case analysis included studies recruiting patients following recent peripheral revascularization, who received treatment regimens administered within the recommended therapeutic window, while a sensitivity scenario included all identified trials. Results. Thirteen RCTs were identified (8 RCTs enrolled patients following peripheral revascularization and 5 RCTs regardless of the previous revascularization). Five trials, recruiting an overall of 8349 patients, were considered for the base case analysis. Of those, 6564 patients were recruited in the VOYAGER PAD trial comparing rivaroxaban plus aspirin (RIV plus ASA) versus ASA. RIV plus ASA was associated with a lower risk of repeated peripheral revascularization versus ASA monotherapy ( HR = 0.88 [0.79, 0.99]), however having a trend towards an increased rate of major bleeding ( HR = 1.43 [0.98, 2.11]). There was no evidence for differences between RIV plus ASA and dual antiplatelet therapy and vitamin K antagonists plus ASA. Similar results were observed in sensitivity analyses. Conclusions. RIV plus ASA is associated with reduced risk of revascularization compared with ASA monotherapy, but the evidence for other comparators, in particular antiplatelet regimens, was insufficient to guide treatment decisions and highlights the challenge in establishing the magnitude of comparative efficacy using existing RCTs.

scholarly journals P182 A systematic literature review and network meta-analysis of the efficacy and safety of ixekizumab versus currently licensed biologics for the treatment of radiographic axSpA

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Yves Schymura ◽  
Peita Loiuse Graham-Clarke ◽  
Soyi Liu-Leage
Keyword(s):  
Literature Review ◽  
Systematic Literature Review ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Efficacy And Safety ◽  
Biologic Therapies ◽  
Mixed Treatment ◽  
A Minor

Abstract Background/Aims  Patients with radiographic axial spondyloarthritis (rad-axSpA) are often managed using biologic therapies such as TNF-α inhibitors and interleukin-17 inhibitors, including ixekizumab (IXE). Due to a lack of head-to-head trial data, limited evidence exists as to the relative performance of biologic therapies. Therefore, when making evidence-based reimbursement decisions, treatment funding agencies can use network meta-analysis (NMA) to estimate the relative efficacy and safety of each treatment within a network of comparator treatments. Objectives: Demonstrate, by means of NMA, the efficacy and safety of IXE 80 mg administered every four weeks (Q4W) against other approved biologic agents used in the treatment of r-axSpA in a biologic-naïve population. Methods  We conducted a systematic literature review in February 2019 to identify relevant studies for inclusion in the NMA. The NMA was based on Bayesian Mixed Treatment Comparisons in keeping with NICE DSU (Decision Support Unit) technical guidance. The base case for this analysis focused on studies with biologic-naïve populations and assessed endpoints including the Assessment of SpondyloArthritis International Society endpoints (ASAS20 and ASAS40), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at least 50% improvement (BASDAI50), adverse events (AEs), serious adverse events (SAEs) and treatment discontinuation due to AE (DISCAE). Sensitivity analyses explored the robustness of the base case by including studies where the patient’s prior exposure to biologic therapy was unclear, not stated or mixed (treatment naïve and treatment experienced) and examined the impact of IXE starting dose (80mg v 160mg) on outcomes. Results  In total, the systematic literature review included 78 full papers and 27 conference proceedings. Fixed-effect models were chosen, as they had lower deviance information criteria (DICs) and random effects models frequently did not converge. IXE 80 mg Q4W demonstrated superiority to placebo on the ASAS20 (Odds Ratio: 3.72, 95% CI:2.11,6.68), ASAS40 (Odds Ratio: 6.26, 95% CI:3.37,11.69), BASDAI (Mean difference: -1.72, 95% CI:-2.27,-1.17) and the BASDAI 50 (Odds Ratio: 5.40, 95% CI: 2.91, 10.06) as well as the other efficacy measures investigated. IXE and the comparator treatments demonstrated similar efficacy compared to each other. The rate of AEs, SAEs and DISCAE were in line with the existing literature both for IXE and the comparator treatments. Results from the sensitivity analyses were confirmatory for the robustness of the base case results. Conclusion  This NMA confirms the efficacy and acceptable safety profile of IXE 80 mg Q4W and other biologics in biologic-naïve patients with active rad-axSpA. The NMA can be used to inform evidence-based decision-making in clinical practice and in payer decisions by including all currently marketed agents and dosages. Disclosure  Y. Schymura: Corporate appointments; Yves Schymura is an employ of Eli Lilly and Company. P. Graham-Clarke: Corporate appointments; Peita Louise Graham-Clarke is an employee of Eli Lilly and Company. Shareholder/stock ownership; Peita Louise Graham-Clarke is a minor shareholder of Eli Lilly and Company. S. Liu-Leage: Corporate appointments; Soyi Liu-Leage is an employ of Eli Lilly and Company. Shareholder/stock ownership; Soyi Liu-Leage is a minor shareholder of Eli Lilly and Comapny.

Efficacy and safety of non-vitamin K antagonist oral anticoagulants combined with antiplatelet drugs for patients with peripheral artery disease: A systematic review and meta-analysis of randomized controlled trials

Vascular ◽  
2021 ◽  
pp. 170853812110036
Author(s):  
Meina Lv ◽  
Shaojun Jiang ◽  
Tingting Wu ◽  
Wenjun Chen ◽  
Jinhua Zhang
Keyword(s):  
Peripheral Artery Disease ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Antiplatelet Drugs ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Peripheral Artery ◽  
Randomized Controlled ◽  
Artery Disease

Background The efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) combined with antiplatelet drugs in patients with peripheral artery disease remain largely unknown. Objective The aim of this meta-analysis was to explore the effects of NOACs combined with antiplatelet drugs versus antiplatelet drugs alone in this population. Methods A comprehensive search of randomized controlled trials published in PubMed, EMBASE, Web of Science, and the Cochrane Library in 30 September 2020 and before. According to the I2 statistic, a random or fixed-effect model was used to analyze the safety and effectiveness of NOACs combined with antiplatelet drugs in peripheral artery disease patients. Results Three RCTs met the inclusion criteria, with a total sample size of 11,761 participants. Compared with antiplatelet drugs alone, NOACs combined with antiplatelet drugs resulted in lower risk of ischemic stroke events (OR = 0.75, 95%CI 0.57–0.98, p =  0.03), while other treatment effects were not worse than those of single antiplatelet drugs ( p ≥  0.05). In addition, although compared with single antiplatelet drugs alone, NOACs combined with antiplatelet drugs had a higher risk of major bleeding and clinically related nonmajor bleeding, their risk was not higher for intracranial hemorrhage, which may endanger the life of patients, or for fatal bleeding. Conclusions In summary, for peripheral artery disease patients, a combination of NOACs plus antiplatelet drugs may offer additional benefit in reducing ischemic stroke outcome, yet it may increase the risk of bleeding.

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