Recently, The British Medical Journal published three articles and an editorial on the RE-LY trial and the admission to the market of dabigatran. In these publications, concerns were raised regarding the data in this key trial and the registration process. Moreover, a lack of transparency was brought to light about the safety of unmonitored dabigatran use. The results of the RE-LY trial were important evidence for an advice of the Health Council of the Netherlands on the introduction of the new oral anticoagulants (NOACs) in the Netherlands, published in 2012. At present, the question arises whether dabigatran use requires monitoring and what the consequences are for the cost-effectiveness of NOACs.
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Heart Failure Risk Assessment Using Biomarkers in Patients With Atrial Fibrillation: Analysis From COMBINE-AF.
J Am Coll Cardiol
October 2024
TIMI Study Group, Division of Cardiovascular Medicine, Brigham & Women's Hospital, and Harvard Medical School, Boston, Massachusetts, USA. Electronic address:
Article Synopsis
- Heart failure is a common issue for patients with atrial fibrillation, making risk assessment crucial for clinicians.
- This study analyzed data from three large trials to evaluate how well NT-proBNP, hs-cTnT, and GDF-15 predict heart failure risk in these patients.
- Results showed that higher levels of these biomarkers correlate with a higher risk for cardiovascular death and heart failure-related hospitalization, enhancing the predictive accuracy of clinical assessments.
Optimizing warfarin dosing for patients with atrial fibrillation using machine learning.
Sci Rep
February 2024
Population Health Research Institute, Hamilton, ON, Canada.
While novel oral anticoagulants are increasingly used to reduce risk of stroke in patients with atrial fibrillation, vitamin K antagonists such as warfarin continue to be used extensively for stroke prevention across the world. While effective in reducing the risk of strokes, the complex pharmacodynamics of warfarin make it difficult to use clinically, with many patients experiencing under- and/or over- anticoagulation. In this study we employed a novel implementation of deep reinforcement learning to provide clinical decision support to optimize time in therapeutic International Normalized Ratio (INR) range.
View Article and Find Full Text PDFDevelopment and Validation of the DOAC Score: A Novel Bleeding Risk Prediction Tool for Patients With Atrial Fibrillation on Direct-Acting Oral Anticoagulants.
Circulation
September 2023
Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center (R.A., E.S., U.A.T., R.W.Y.), Harvard Medical School, Boston.
Background: Current clinical decision tools for assessing bleeding risk in individuals with atrial fibrillation (AF) have limited performance and were developed for individuals treated with warfarin. This study develops and validates a clinical risk score to personalize estimates of bleeding risk for individuals with atrial fibrillation taking direct-acting oral anticoagulants (DOACs).
Methods: Among individuals taking dabigatran 150 mg twice per day from 44 countries and 951 centers in this secondary analysis of the RE-LY trial (Randomized Evaluation of Long-Term Anticoagulation Therapy), a risk score was developed to determine the comparative risk for bleeding on the basis of covariates derived in a Cox proportional hazards model.
Predicting Treatment Effects of a New-to-Market Drug in Clinical Practice Based on Phase III Randomized Trial Results.
Clin Pharmacol Ther
October 2023
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Trial results may not be generalizable to target populations treated in clinical practice with different distributions of baseline characteristics that modify the treatment effect. We used outcome models developed with trial data to predict treatment effects in Medicare populations. We used data from the Randomized Evaluation of Long-Term Anticoagulation Therapy trial (RE-LY), which investigated the effect of dabigatran vs.
View Article and Find Full Text PDFPrincipled estimation and evaluation of treatment effect heterogeneity: A case study application to dabigatran for patients with atrial fibrillation.
J Biomed Inform
July 2023
Stanford Center for Biomedical Informatics Research, Stanford University, CA, United States of America; Department of Medicine, School of Medicine, Stanford University, Stanford, CA, United States of America; Clinical Excellence Research Center, Stanford University, Stanford, CA, United States of America; Technology and Digital Solutions, Stanford Healthcare, Stanford, CA, United States of America.
Objective: To apply the latest guidance for estimating and evaluating heterogeneous treatment effects (HTEs) in an end-to-end case study of the Long-term Anticoagulation Therapy (RE-LY) trial, and summarize the main takeaways from applying state-of-the-art metalearners and novel evaluation metrics in-depth to inform their applications to personalized care in biomedical research.
Methods: Based on the characteristics of the RE-LY data, we selected four metalearners (S-learner with Lasso, X-learner with Lasso, R-learner with random survival forest and Lasso, and causal survival forest) to estimate the HTEs of dabigatran. For the outcomes of (1) stroke or systemic embolism and (2) major bleeding, we compared dabigatran 150 mg, dabigatran 110 mg, and warfarin.
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