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To evaluate the bioequivalence and safety of oral rivaroxaban tablets between a test formulation and a reference formulation in healthy Chinese subjects, a randomized, open, 2-formulation, 4-cycle, complete repeat crossover study was conducted under both fasting and fed states. Thirty-six healthy participants were enrolled separately for the fasting and fed groups, and each subject received a single oral dose of 20 mg of the test or reference formulation of rivaroxaban tablets per cycle. Blood samples were collected at specified intervals, and rivaroxaban was analyzed using liquid chromatography-tandem mass spectrometry.

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Clinical significance of a new diagnosis of atrial fibrillation in patients with vascular disease.

Heart Rhythm

January 2025

Population Health Research Institute, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Ontario, Canada.

Background: The Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial enrolled patients with vascular disease, but excluded patients requiring oral anticoagulation.

Objective: To explore the clinical significance of a new diagnosis of atrial fibrillation (AF) during follow-up.

Methods: New AF was identified from hospitalization, study drug discontinuation and adverse event reports.

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Background: This study aimed to provide a comprehensive review of adverse events (AEs) associated with factor Xa (FXa) inhibitors in pediatric patients.

Methods: We searched PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and the European Union Clinical Trials Register for English-language records from the establishment of the database up to October 17, 2023.

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Gender inequalities in prescribing and initiation patterns of guideline-recommended drugs after acute myocardial infarction.

BMC Public Health

January 2025

Grupo de Investigación en Servicios Sanitarios de Aragón (GRISSA), Fundación Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Zaragoza, Spain.

Background: European guidelines recommend the prescription of certain drugs after acute myocardial infarction (AMI). The existence of gender differences in pharmacological treatment after an AMI has been described. This study aims to describe and analyse, using real-world data (RWD), whether there are gender differences in the prescribing patterns and initiation of treatment in secondary prevention after a first AMI, and which are the factors that explain these differences.

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Machine learning analysis of rivaroxaban solubility in mixed solvents for application in pharmaceutical crystallization.

Sci Rep

January 2025

Department of Oral & Maxillofacial Surgery and Diagnostic Sciences, Faculty of Dentistry, Taif University, 21944, Taif, Saudi Arabia.

This study investigates the use of machine learning models to predict solubility of rivaroxaban in binary solvents based on temperature (T), mass fraction (w), and solvent type. Using a dataset with over 250 data points and including solvents encoded with one-hot encoding, four models were compared: Gradient Boosting (GB), Light Gradient Boosting (LGB), Extra Trees (ET), and Random Forest (RF). The Jellyfish Optimizer (JO) algorithm was applied to tune hyperparameters, enhancing model performance.

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