Dataset Information

Non-Vitamin K Antagonist Oral Anticoagulants and the Gastrointestinal Bleeding Risk in Real-World Studies.

ABSTRACT: In the present study, we aimed to provide evidence from high-quality real world studies for a comprehensive and rigorous analysis on the gastrointestinal bleeding (GIB) risk for non-vitamin K antagonist oral anticoagulants (NOACs). We performed a systematic search of MEDLINE, EMBASE and PUBMED, and of 286 records screened, we included data from 11 high-quality real-world studies, coordinated by independent research groups over the last 3 years, that reported major GIB events in patients given NOACs or vitamin K antagonists for patients with nonvalvular atrial fibrillation. The lowest risk of gastrointestinal bleeding was with apixaban compared with warfarin (hazard ratio (HR) for GIB for apixaban ranging between 0.45 (95% confidence interval (CI) 0.34 to 0.59) and 1.13 (95% CI 0.79 to 1.63)). Apixaban was associated with a lower risk of GI bleeding than dabigatran ((HR ranging between 0.39 (95% CI 0.27 to 0.58) and 0.95 (95% CI 0.65 to 1.18)) or rivaroxaban ((HR ranging between 0.33 (95% CI 0.22 to 0.49) and 0.82 (95% CI 0.62 to 1.08)). The results of our study confirm a low or a similar risk for major GIB between patients receiving apixaban or dabigatran compared with warfarin, and apixaban appears to be associated with the lowest risk of GIB.

SUBMITTER: Anghel L

PROVIDER: S-EPMC7290290 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Non-Vitamin K Antagonist Oral Anticoagulants and the Gastrointestinal Bleeding Risk in Real-World Studies.

Anghel Larisa L Sascău Radu R Trifan Anca A Zota Ioana Mădălina IM Stătescu Cristian C

Journal of clinical medicine 20200509 5

In the present study, we aimed to provide evidence from high-quality real world studies for a comprehensive and rigorous analysis on the gastrointestinal bleeding (GIB) risk for non-vitamin K antagonist oral anticoagulants (NOACs). We performed a systematic search of MEDLINE, EMBASE and PUBMED, and of 286 records screened, we included data from 11 high-quality real-world studies, coordinated by independent research groups over the last 3 years, that reported major GIB events in patients given NO ...[more]

PMID: 32397355

Similar Datasets

Project description:BackgroundThe real-world studies on recurrent venous thromboembolism (VTE) and bleeding events of non-vitamin K antagonist oral anticoagulants (NOACs) in VTE patients have reported conflicting findings. Our study aimed to provide the direct comparison evidence of different NOACs for VTE patients in clinical practice settings.MethodsSearch of the medical literature was conducted using PubMed, Web of Science, EMBASE, Clinical Trials.gov, and the Cochrane Library from inception to March 22, 2021. Among the 19,996 citations retrieved, a total of 63,144 patients from 6 studies were analyzed. Clinical outcomes included recurrent VTE, death, and different bleeding events.ResultsAdjusted hazard ratio (HR) analysis suggested that apixaban had significant lower bleeding riskthan rivaroxaban (major, minor and any bleeding: HR = 0.61, 0.56, 0.70; p = 0.008, < 0.0001, 0.006, respectively), but no statistics difference found in recurrent VTE events (HR = 1.02, 95% confidence interval (CI) 0.71-1.47, p = 0.93). There was no significant difference of major bleeding between dabigatran and rivaroxaban (odds ratios (OR) = 0.41, 95% CI 0.09-1.90, p = 0.25), apixaban and dabigatran (OR 0.64, 95% CI 0.15-2.72, p = 0.83). No significant difference was found in the comparison of edoxaban and other NOACs in VTE recurrence, major bleeding and composite outcome.ConclusionsIn the prevention of bleeding events, apixaban was associated with a lower risk than rivaroxaban, but equivalent efficacy for different NOACs in prevention of recurrent VTE. Evidence generated from the meta-analysis based on real-world data can help to guide selection between apixaban and rivaroxaban in routine clinical practice.Trial registrationThis systematic review and meta-analysis were conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis and Meta-analysis of Observational Studies in Epidemiology statements and was registered with PROSPERO (CRD42019140553).

Project description:BackgroundsNon-vitamin K antagonist oral anticoagulants (NOACs) have been recommended as the first choice over warfarin for non-valvular atrial fibrillation (AF). However, there is limited data about their usage in mainland China.MethodsPrescriptions of patients diagnosed with AF and containing OACs were extracted from Hospital Prescription Cooperation Project from January 2016 to March 2021. The primary outcome was the changing percentage of different OACs. The secondary outcomes were frequencies as well as factors with the choice of different OACs and dosage of NOACs. Univariate and Multivariate logistic regressions were conducted to explore possible factors. All statistical analyses were performed using SAS software (Version 9.4).ResultsAmong the 220,083 distinct prescriptions diagnosed with AF and prescribed with OACs, the percentage of NOACs increased over years, exceeding warfarin in 2018. Until March 2021, 83.53% of included patients were prescribed with NOACs. Rivaroxaban (62.25%) and dabigatran (37.65%) were the most commonly prescribed NOACs. Low dosage was common for NOACs (44.54%), this was mainly driven by rivaroxaban, 67.98% of which were low dosage. Multivariate logistic regression indicated that several factors were positively associated with the preference of low dosage, including outpatients (OR 1.32, 95% CI 1.26-1.39), patients with hypertension (OR 1.49, 95% CI 1.40-1.58), acute coronary syndrome (OR 1.17, 95% CI 1.12-1.22), stroke (OR 1.42, 95% CI 1.33-1.52), and kidney disease (OR 1.63, 95% CI 1.34-1.97), as well as concomitantly using antiplatelet agents (OR 1.52, 95% CI 1.40-1.66), and steroids (OR 1.76, 95% CI 1.50-2.07). On the contrary, they were less common in health insurance holder (OR 0.79, 95% CI 0.75-0.84), patients taking apixaban (vs. rivaroxaban, OR 0.39, 95% CI 0.18-0.81), dabigatran (vs. rivaroxaban, OR 0.01, 95% CI 0.01-0.01), edoxaban (vs. rivaroxaban, OR 0.36, 95% CI 0.23-0.55), diagnosed with heart failure (OR 0.87, 95% CI 0.81-0.93), deep vein thrombosis (OR 0.36, 95% CI 0.29-0.46), pulmonary embolism (OR 0.35, 95% CI 0.28-0.43), and peripheral artery disease (OR 0.68, 95% CI 0.55-0.85).ConclusionThe usage of OACs for AF was overall complying with updated guidelines. Low dosage was common for NOACs, further studies were warranted to verify its effectiveness and explore the underlying mechanism.

Project description:BackgroundEmulating randomized controlled trials (RCTs) by real-world evidence (RWE) studies would benefit future clinical and regulatory decision-making by balancing the limitations of RCT. We aimed to evaluate whether the findings from RWE studies can support regulatory decisions derived from RCTs of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with venous thromboembolism (VTE).MethodsFive landmark trials (AMPLIFY, RE-COVER II, Hokusai-VTE, EINSTEIN-DVT, and EINSTEIN-PE) of NOACs were emulated using the South Korean nationwide claims database (January 2012 to August 2020). We applied an active comparator and new-user design to include patients who initiated oral anticoagulants within 28 days from their VTE diagnoses. The prespecified eligibility criteria, exposure (each NOAC, such as apixaban, rivaroxaban, dabigatran, and edoxaban), comparator (conventional therapy, defined as subcutaneous heparin followed by warfarin), and the definition of outcomes from RCTs were emulated as closely as possible in each separate emulation cohort. The primary outcome was identical to each trial, which was defined as recurrent VTE or VTE-related death. The safety outcome was major bleeding. Propensity score matching was conducted to balance 69 covariates between the exposure groups. Effect estimates for outcomes were estimated using the Mantel-Haenszel method and Cox proportional hazards model and subsequently compared with the corresponding RCT estimates.ResultsCompared to trial populations, real-world study populations were older (range: 63-69 years [RWE] vs. 54-59 years [RCT]), with more females (55-60.5% vs. 39-48.3%) and had a higher prevalence of active cancer (4.2-15.4% vs. 2.5-9.5%). The emulated estimates for effectiveness outcomes showed superior effectiveness of NOAC (AMPLIFY: relative risk 0.81, 95% confidence interval 0.70-0.94; RE-COVER II: hazard ratio [HR] 0.60, 0.37-0.96; Hokusai-VTE: 0.49, 0.31-0.78; EINSTEIN-DVT: 0.54, 0.33-0.89; EINSTEIN-PE: 0.50, 0.34-0.74), when contrasted with trials that showed non-inferiority. For safety outcomes, all emulations except for AMPLIFY and EINSTEIN-DVT yielded results consistent with their corresponding RCTs.ConclusionsThis study revealed the feasibility of complementing RCTs with RWE studies by using claims data in patients with VTE. Future studies to consider the different demographic characteristics between RCT and RWE populations are needed.

Dataset Information

Non-Vitamin K Antagonist Oral Anticoagulants and the Gastrointestinal Bleeding Risk in Real-World Studies.

Publications

Non-Vitamin K Antagonist Oral Anticoagulants and the Gastrointestinal Bleeding Risk in Real-World Studies.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets