Direct oral anticoagulants in pediatric venous thromboembolism: Review of approved products rivaroxaban and dabigatran

Al-Ghafry, Maha; Sharathkumar, Anjali

doi:10.3389/fped.2022.1005098

Cited by 7 publications

(1 citation statement)

References 43 publications

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“…VTE is a significant complication acquired in hospitals. [ 24 ] Therefore, identifying patients at high risk of VTE is crucial for targeted prevention. [ 25 ] In this study, there were more males (35.67%) and females (4.68%) who developed VTE in ICU patients, indicating that males who developed VTE may have a higher risk of VTE.…”

Section: Discussionmentioning

confidence: 99%

The impact of gender differences on the clinical characteristics of critically ill patients with venous thromboembolism: A retrospective, observational study

He,

Ye,

Zheng

et al. 2024

Medicine

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The aim of this study is to describe the general information, disease and treatment of venous thromboembolism (VTE) in critically ill patients, to explore the characteristics of severe patients with deep venous VTE and provide clinical reference data for the prevention and treatment of VTE in critically ill patients. This study carried out a retrospective study on the medical records of patients who were treated in the intensive care unit of Affiliated Hospital of Jining Medical College from 2020 to 2022. The general data, general conditions, drug use, past history, VTE prevention measures, post-VTE conditions, and Padua risk score of 297 patients with VTE during the period of hospitalization in intensive care unit (ICU) were classified and statistically analyzed. A total of 297 including 171 male and 126 male patient medical records were included in the analysis, we compared multiple clinical indicators between male and female patients. Compared to women, male patients have a higher acute physiology and chronic health evaluation II score(APACHE-II score) (P = .027), a higher state of consciousness (P = .003), a higher rate of smoking and drinking history (P < .001), a lower rate of heart failure (P = .003) and chronic depression (P = .013), and a higher rate of recommended operations for male patients after VTE (P = .031). The prothrombin time (PT) (P = .041) and activated partial thromboplastin time (APTT) (P = .040) of male patients were significantly higher than those of female patients, while triglyceride (P = .009) and total cholesterol (TC) (P = .001) were significantly lower than those of female patients. The difference in D-dimer (P = .739) was not significant. This study shows that male and female patients with VTE in the ICU have significant differences in general characteristics, general clinical conditions, history of past illness, thrombosis character, and examination items, this may be the reason for the different rates of VTE between male and female patients in the ICU.

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Section: Discussionmentioning

confidence: 99%

The impact of gender differences on the clinical characteristics of critically ill patients with venous thromboembolism: A retrospective, observational study

He,

Ye,

Zheng

et al. 2024

Medicine

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Pharmacokinetics, Pharmacodynamics, and Safety of Edoxaban in Pediatric Subjects: A Phase I Single‐Dose Study

Zou,

Zahir,

Duggal

et al. 2024

Clin Pharma and Therapeutics

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This was an open‐label, single‐dose, phase I study to characterize the pharmacokinetics (PKs), pharmacodynamics (PDs), and safety of edoxaban in pediatric subjects from birth to 18 years at risk for venous thromboembolism (VTE). Children requiring anticoagulant therapy were enrolled into 5 age cohorts (0 to < 6 months (N = 12), 0.5 to < 2 years (N = 13), 2 to < 6 years (N = 13), 6 to < 12 years (N = 13), and 12 to < 18 years (N = 15)) receiving tablet or oral suspension of edoxaban at doses expected to be equivalent to 30 or 60 mg once daily (q.d.) in adult subjects with VTE. Sixty‐six pediatric subjects were enrolled and completed the study. Edoxaban plasma concentration peaked between 1 and 3 hours and declined rapidly until 4–8 hours. The range of mean total apparent clearance across 5 age cohorts at low and high doses was 0.47 to 1.11 L/h/kg. The ranges of mean volume of central compartment and apparent peripheral volume were 2.31 to 3.59 L/kg and 1.92 to 4.14 L/kg, respectively. Across all age groups, the estimated median exposures were within the 0.5‐ to 1.5‐fold of the median area under the plasma drug concentration‐time curve (AUC) in adult subjects receiving corresponding doses (30 mg q.d. for low dose and 60 mg q.d. for high dose). In all age groups, PD parameters (prothrombin time, activated partial thromboplastin time, and anti‐Factor Xa activity) showed a linear PK‐PD relationship and were in line with previous adult data. The results support further evaluation of the pediatric doses in larger pivotal trials.

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Exposure Matching‐Based Pediatric Dose Selection for Drugs with Renal Excretion – Lessons Learned from Pediatric Development of Direct Oral Anticoagulants

Zou,

Leil

2024

Clin Pharma and Therapeutics

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The pediatric clinical development programs of the direct oral anticoagulants (DOACs) edoxaban, rivaroxaban, and dabigatran have recently been completed, with apixaban close to the finish line. One common pharmacokinetic (PK) characteristic of these four DOACs is that renal excretion contributes 27% or more in their elimination, resulting in age‐dependent drug clearance in both pediatric and adult subjects. Several lessons have been learned from adult exposure matching and pediatric dose selection for DOACs. The main goal of this tutorial is to provide an informed perspective on pediatric dose selection for renally excreted drugs, using these four DOACs as case examples. This tutorial is organized into seven steps: (1) consideration of age‐related differences in disease and response to treatment; (2) consideration of age‐related differences in drug absorption, distribution, metabolism, and excretion; (3) selection of the reference adult population and exposure for pediatric exposure matching; (4) prediction of pediatric clearance and pediatric dose selection based on data from young adults; (5) conduct and design of efficient pediatric PK and pharmacodynamic (PD) studies that inform dose selection; (6) assessment of exposure matching and dose adjustment using population PK simulation; (7) evaluation of the need for dose adjustment in pediatric sub‐populations.

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Direct oral anticoagulants in pediatric venous thromboembolism: Review of approved products rivaroxaban and dabigatran

Cited by 7 publications

References 43 publications

The impact of gender differences on the clinical characteristics of critically ill patients with venous thromboembolism: A retrospective, observational study

The impact of gender differences on the clinical characteristics of critically ill patients with venous thromboembolism: A retrospective, observational study

Pharmacokinetics, Pharmacodynamics, and Safety of Edoxaban in Pediatric Subjects: A Phase I Single‐Dose Study

Exposure Matching‐Based Pediatric Dose Selection for Drugs with Renal Excretion – Lessons Learned from Pediatric Development of Direct Oral Anticoagulants

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