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Weight-Based Dosing Versus a Fixed-Dose Regimen of 4-Factor Prothrombin Complex Concentrate in Obese Patients Requiring Vitamin K Antagonist Reversal

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Abstract

Introduction

Despite an increase in the use of fixed-dose protocols of 4-factor prothrombin complex concentrate (4F-PCC) for the reversal of vitamin K antagonists (VKAs), there remains a paucity of data in obese patients. In this study, we aimed to compare the proportion of patients attaining international normalized ratio (INR) goals using a weight-based dosing strategy versus a fixed-dose regimen of 4F-PCC.

Methods

This was a retrospective study conducted in patients 18 years of age or older, weighing ≥ 100 kg, who received either a weight-based dose or fixed dose of 4F-PCC (2000 units) for the reversal of VKA, and had a documented baseline and post-treatment INR. The primary outcome was the proportion of patients achieving an INR of < 2 for all indications of warfarin reversal, except in patients with intracranial hemorrhage, where the goal was an INR of < 1.5.

Results

A total of 44 patients met the inclusion criteria; 25 patients in the weight-based dosing group and 19 patients in the fixed-dose group. The median baseline INR was similar in both groups (weight-based dosing group 3.2 [interquartile range {IQR} 2.8–3.7] vs fixed-dose group 3.0 [IQR 2.7–4.9], p = 1). The median post-treatment INR was significantly lower in the weight-based dosing group compared to the fixed-dose group (1.3 [IQR 1.2–1.5] vs 1.6 [IQR 1.5–1.9], p < 0.01). However, there was no significant difference in the primary outcome between both groups (weight-based dosing strategy 84% vs fixed dose strategy 90%, p = 0.68).

Conclusion

Our findings suggest that a fixed-dose regimen of 2000 units in obese patients weighing ≥ 100 kg is adequate to achieve these INR goals.

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Authors and Affiliations

  1. Department of Pharmacy, Beth Israel Deaconess Medical Center, 1 Deaconess Rd, Boston, MA, 02215, USA

    Pansy Elsamadisi, Mark A. G. Cepeda, Tuyen Yankama, Adrian Wong, Qua Tran & Ifeoma Mary Eche

  2. Department of Pharmacy Practice, MCPHS University, 179 Longwood Avenue, Boston, MA, 02215, USA

    Adrian Wong

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  1. Pansy Elsamadisi
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Correspondence to Pansy Elsamadisi.

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No external funding was used in the preparation of this article.

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Pansy Elsamadisi, Mark AG Cepeda, Tuyen Yankama, Adrain Wong, Qua Tran, and Ifeoma Mary Eche declare that they have no potential conflicts of interest that might be relevant to the contents of this article.

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This study was approved by the Beth Israel Deaconess Medical Center IRB.

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Elsamadisi, P., Cepeda, M.A.G., Yankama, T. et al. Weight-Based Dosing Versus a Fixed-Dose Regimen of 4-Factor Prothrombin Complex Concentrate in Obese Patients Requiring Vitamin K Antagonist Reversal. Am J Cardiovasc Drugs 21, 355–361 (2021). https://doi.org/10.1007/s40256-020-00442-w

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