Dosing of Direct Oral Anticoagulants in Patients with Moderate Chronic Kidney Disease in US Clinical Practice: Results from the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF II),American Journal of Cardiovascular Drugs

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Dosing of Direct Oral Anticoagulants in Patients with Moderate Chronic Kidney Disease in US Clinical Practice: Results from the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF II)
American Journal of Cardiovascular Drugs ( IF 3 ) Pub Date : 2021-03-31 , DOI: 10.1007/s40256-021-00473-x
Larry R Jackson ₁ , Peter Schrader ₁ , Laine Thomas ₁ , Benjamin A Steinberg ₂ , Rosalia Blanco ₁ , Larry A Allen ₃ , Gregg C Fonarow ₄ , James V Freeman ₅ , Bernard J Gersh ₆ , Peter R Kowey ₇ , Kenneth W Mahaffey ₈ , Gerald Naccarelli ₉ , James Reiffel ₁₀ , Daniel E Singer ₁₁ , Eric D Peterson ₁ , Jonathan P Piccini ₁ ,

Affiliation

Division of Cardiovascular Medicine, Duke University Medical Center, Duke Clinical Research Institute, 200 Morris Street, Durham, NC, 27701, USA.
Division of Cardiovascular Medicine, University of Utah, Salt Lake City, UT, USA.
Division of Cardiology and Colorado Cardiovascular Outcomes Research Consortium, University of Colorado School of Medicine, Aurora, CO, USA.
UCLA Division of Cardiology, Los Angeles, CA, USA.
Yale University School of Medicine, New Haven, CT, USA.
Mayo Clinic College of Medicine, Rochester, MN, USA.
Lankenau Institute for Medical Research, Jefferson Medical College, Wynnewood, PA, USA.
Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, CA, USA.
Division of Cardiovascular Medicine, Penn State University School of Medicine, Hershey, PA, USA.
Columbia University Vagelos College of Physicians and Surgeons, New York City, NY, USA.
Division of General Internal Medicine, Massachusetts General Hospital and Department of Medicine, Harvard Medical School, Boston, MA, USA.

Introduction

Direct oral anticoagulants (DOACs) have partial renal clearance and generally require dosage adjustments based on renal function. While current US and European guidance recommends dose adjustments in patients with moderate chronic kidney disease (CKD), it is unclear how often this is done appropriately in routine clinical practice.

Methods

We examined rates of appropriate and inappropriate dosing in patients with atrial fibrillation (AF) and moderate CKD, as determined by creatinine clearance (CrCl) of 30–50 mL/min calculated with the Cockcroft–Gault formula. Descriptive statistics were used to describe the rate of appropriate and inappropriate dosing as well as event rates.

Results

Among 1134 patients (8.5% of the overall ORBIT-AF II registry) with AF and CrCl 30–50 mL/min, the median age was 82 (25th, 75th percentile: 78, 86), 38% were male, and the median CHA₂DS₂VASC score was 4 (25th, 75th percentile: 4, 5). At baseline, more than one-third (34%) of patients with moderate CKD were inappropriately dosed with DOACs. When evaluating the specific prescribed doses in those with moderate CKD, 15% (N = 170/1134) were underdosed, 66% (743/1134) were appropriately dosed, and 20% (N = 221/1134) were overdosed. There were no significant differences in comorbid medical conditions between patients with moderate CKD who were appropriately and inappropriately dosed with a DOAC.

Conclusion

In routine clinical practice, prescribing of DOACs in patients with AF with moderate CKD is often inconsistent with drug labeling, with up to one-third of patients being inappropriately dosed.

中文翻译：

美国临床实践中中度慢性肾病患者直接口服抗凝剂的给药剂量：来自更好知情治疗 AF 的结果注册 (ORBIT-AF II)

介绍

直接口服抗凝剂 (DOAC) 具有部分肾清除作用，通常需要根据肾功能调整剂量。虽然目前美国和欧洲的指南建议对中度慢性肾病 (CKD) 患者进行剂量调整，但尚不清楚在常规临床实践中适当调整的频率。

方法

我们检查了房颤 (AF) 和中度 CKD 患者的适当和不适当剂量率，这是通过使用 Cockcroft-Gault 公式计算的 30–50 mL/min 的肌酐清除率 (CrCl) 确定的。描述性统计用于描述适当和不适当剂量的比率以及事件发生率。

结果

在 1134 名患有 AF 和 CrCl 30-50 mL/min 的患者（占整个 ORBIT-AF II 登记的 8.5%）中，中位年龄为 82 岁（第 25、第 75 个百分位数：78、86），38% 为男性，中位年龄为CHA ₂ DS ₂ VASC 评分为 4（第 25、第 75 个百分位数：4、5）。在基线时，超过三分之一 (34%) 的中度 CKD 患者不恰当地服用了 DOAC。在评估中度 CKD 患者的具体处方剂量时，15% ( N = 170/1134) 剂量不足，66% (743/1134) 剂量适当，20% ( N = 221/1134) 剂量过量。适当和不适当给予 DOAC 的中度 CKD 患者的合并症医疗状况没有显着差异。