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June 4, 2024Asian Journal of Medical Sciences0 citationsOpen Access

Assessing the link between rivaroxaban concentration and the onset of renal impairment in elderly patients: A retrospective observational study

MRMotakatla Usha RaniCKChitra KaruppiahPNPenupothu Sree Nagamani

Key Result

High trough plasma concentrations of rivaroxaban (>200 ng/mL) were associated with a 2.8-fold higher odds of developing renal impairment compared to low concentrations (<50 ng/mL) in elderly patients.

Study Design

Type

Observational (n=100)

Multicenter

No

Structured PICO

Do higher rivaroxaban plasma concentrations increase the risk of renal impairment in elderly patients?

P
Population
100 elderly patients (aged 65-89 years) prescribed rivaroxaban for atrial fibrillation or venous thromboembolism prevention, followed for a median of 18 months.
E
Exposure
High (>200 ng/mL) or medium (50-200 ng/mL) trough plasma concentrations of rivaroxaban.
C
Comparator
Low (<50 ng/mL) trough plasma concentration of rivaroxaban.
O
Outcome
Incidence of renal impairment, defined as an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² during the study period.safety

Higher trough plasma concentrations of rivaroxaban are significantly associated with an increased risk of renal impairment in elderly patients, suggesting a potential benefit for therapeutic drug monitoring in this vulnerable population.

Main Result

Odds Ratio: 2.8 (95% CI 1.3–6)

Absolute Event Rate: 60% vs 20%

p-value: p=0.009

Limitations

  • Retrospective nature limits ability to definitively establish causality
  • Small sample size may not fully represent variability and potential outliers in a broader patient population
  • Small sample size may not fully represent variability and potential outliers in a broader population

Abstract

Background: Rivaroxaban is a widely used anticoagulant, but its impact on renal function, particularly at varying plasma concentrations, remains a critical area of investigation. This study examines the relationship between rivaroxaban concentration and renal impairment in elderly patients. Aims and Objectives: The aim of the study was to investigate the relationship between rivaroxaban plasma concentrations and the incidence of renal impairment in elderly patients. Materials and Methods: A retrospective observational study was conducted on 100 elderly patients prescribed rivaroxaban for atrial fibrillation or venous thromboembolism prevention. Patients were categorized based on their rivaroxaban plasma concentrations into three groups: Low (200 ng/mL). Renal impairment was characterized as having an estimated glomerular filtration rate <60 mL/min/1.73 m². The analysis of the data consisted of Chi-square testing and multivariable logistic regression, with adjustments made for age, gender, baseline renal function, and treatment indication. Results: The incidence of renal impairment escalated with increasing rivaroxaban concentrations, 20%, 40%, and 60% in low, medium, and high concentration groups, respectively. Statistical analysis revealed a significant association between rivaroxaban concentration and renal impairment (χ2=10.57, P=0.005). Patients with high concentrations had 2.8-fold higher odds of developing renal impairment compared to the low concentration group. Cox proportional hazards analysis showed a 2.2 times higher hazard of renal impairment in high versus low concentration groups over 18 months. Conclusion: Higher trough plasma concentrations of rivaroxaban are associated with an increased risk of renal impairment in elderly patients. This finding highlights the importance of monitoring rivaroxaban levels to mitigate renal risks.

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Cite This Study

Rani et al. (2024) conducted an observational in Atrial fibrillation or venous thromboembolism prevention (n=100). High rivaroxaban plasma concentration (>200 ng/mL) vs. Low rivaroxaban plasma concentration (<50 ng/mL) was evaluated on Incidence of renal impairment (eGFR <60 mL/min/1.73 m²) (OR 2.8, 95% CI 1.3-6.0, p=0.009). High trough plasma concentrations of rivaroxaban (>200 ng/mL) were associated with a 2.8-fold higher odds of developing renal impairment compared to low concentrations (<50 ng/mL) in elderly patients.

synapsesocial.com/papers/6a8c1f70c716e89f35df1342https://doi.org/10.71152/ajms.v15i6.2054
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