Application of a warfarin dosing calculator to guide individualized dosing versus empirical adjustment after fixed dosing: a pilot study

Background: Warfarin has a narrow therapeutic window and individual variation, and patients require regular follow-up and monitoring of the International Normalized Ratio (INR) for dose adjustment. The calculation method of Warfarin Dosing Calculator (WDC) software is based on the European and Ameri...

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Main Authors: Xiaofang Cai, Jiana Chen, Maohua Chen, Xiaotong Xia, Guanhua Fang, Jinhua Zhang
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-08-01
Series:Frontiers in Pharmacology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2023.1235331/full
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author Xiaofang Cai
Xiaofang Cai
Xiaofang Cai
Jiana Chen
Jiana Chen
Maohua Chen
Maohua Chen
Maohua Chen
Xiaotong Xia
Xiaotong Xia
Guanhua Fang
Jinhua Zhang
author_facet Xiaofang Cai
Xiaofang Cai
Xiaofang Cai
Jiana Chen
Jiana Chen
Maohua Chen
Maohua Chen
Maohua Chen
Xiaotong Xia
Xiaotong Xia
Guanhua Fang
Jinhua Zhang
author_sort Xiaofang Cai
collection DOAJ
description Background: Warfarin has a narrow therapeutic window and individual variation, and patients require regular follow-up and monitoring of the International Normalized Ratio (INR) for dose adjustment. The calculation method of Warfarin Dosing Calculator (WDC) software is based on the European and American populations, and its accuracy in the Chinese population is yet to be verified.Objective: This study was to evaluate the feasibility of applying Warfarin Dosing Calculator software intervention in a real-world clinical research setting in China.Methods: The pilot study divided the included patients after valve replacement into an experimental group and a control group, with 38 cases in each group. In the control group, the initial dose was fixed at 2.5 mg/d and the dose was adjusted empirically during the study period; in the experimental group, the Warfarin Dosing Calculator software was applied to guide the dosing, and patients in both groups were followed up for 3 months. Analysis of the incidence anticoagulation outcomes and excessive anticoagulation events in both groups. Kaplan-Meier survival curves were used to analyze the correlation between different dosing regimens and first International Normalized Ratio attainment, and Logrank tests were performed.Results: The mean time required for first International Normalized Ratio compliance in the experimental group was 4.38 days less than in the control group, and the mean number of tests was 1.43 less (p < 05). Time in therapeutic range (TTR) was significantly higher in the experimental group than in the control group (p < 05). Kaplan-Meier survival curve analysis showed that the first International Normalized Ratio attainment rate was significantly higher in the experimental group than in the control group (p = 01). No major bleeding events occurred in either group, but other excessive anticoagulation events (INR>3.5 and minor bleeding) were significantly reduced in the experimental group compared with the control group (p < 05).Conclusion: Application of Warfarin Dosing Calculator software to guide individualized warfarin dosing may be better than a fixed dose of 2.5 mg/d. It may be shorten the time to first International Normalized Ratio attainment, and the attainment rate in the same time, and can better improve the mean Time in therapeutic range level value and reduce excessive anticoagulation events, which improves the safety of warfarin anticoagulation therapy in clinical practice.Clinical Trial Registration:https://www.chictr.org.cn/showproj.html?proj=52793, ChiCTR2000032393.
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spelling doaj.art-f1656711aa434fcca3b11d6a43c0ff2e2023-08-17T19:40:51ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-08-011410.3389/fphar.2023.12353311235331Application of a warfarin dosing calculator to guide individualized dosing versus empirical adjustment after fixed dosing: a pilot studyXiaofang Cai0Xiaofang Cai1Xiaofang Cai2Jiana Chen3Jiana Chen4Maohua Chen5Maohua Chen6Maohua Chen7Xiaotong Xia8Xiaotong Xia9Guanhua Fang10Jinhua Zhang11Department of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics and Gynecology and Pediatrics, Fujian Medical University, Fuzhou, ChinaDepartment of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, ChinaZhangpu County Hospital, Zhangzhou, ChinaDepartment of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics and Gynecology and Pediatrics, Fujian Medical University, Fuzhou, ChinaDepartment of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, ChinaDepartment of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics and Gynecology and Pediatrics, Fujian Medical University, Fuzhou, ChinaDepartment of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, ChinaPingtan Comprehensive Experimental Area Hospital, Pingtan Comprehensive Experimental Area, Fuzhou, ChinaDepartment of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics and Gynecology and Pediatrics, Fujian Medical University, Fuzhou, ChinaDepartment of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, ChinaDepartment of Cardiac Surgery, Union Hospital, Fujian Medical University, Fuzhou, ChinaDepartment of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics and Gynecology and Pediatrics, Fujian Medical University, Fuzhou, ChinaBackground: Warfarin has a narrow therapeutic window and individual variation, and patients require regular follow-up and monitoring of the International Normalized Ratio (INR) for dose adjustment. The calculation method of Warfarin Dosing Calculator (WDC) software is based on the European and American populations, and its accuracy in the Chinese population is yet to be verified.Objective: This study was to evaluate the feasibility of applying Warfarin Dosing Calculator software intervention in a real-world clinical research setting in China.Methods: The pilot study divided the included patients after valve replacement into an experimental group and a control group, with 38 cases in each group. In the control group, the initial dose was fixed at 2.5 mg/d and the dose was adjusted empirically during the study period; in the experimental group, the Warfarin Dosing Calculator software was applied to guide the dosing, and patients in both groups were followed up for 3 months. Analysis of the incidence anticoagulation outcomes and excessive anticoagulation events in both groups. Kaplan-Meier survival curves were used to analyze the correlation between different dosing regimens and first International Normalized Ratio attainment, and Logrank tests were performed.Results: The mean time required for first International Normalized Ratio compliance in the experimental group was 4.38 days less than in the control group, and the mean number of tests was 1.43 less (p < 05). Time in therapeutic range (TTR) was significantly higher in the experimental group than in the control group (p < 05). Kaplan-Meier survival curve analysis showed that the first International Normalized Ratio attainment rate was significantly higher in the experimental group than in the control group (p = 01). No major bleeding events occurred in either group, but other excessive anticoagulation events (INR>3.5 and minor bleeding) were significantly reduced in the experimental group compared with the control group (p < 05).Conclusion: Application of Warfarin Dosing Calculator software to guide individualized warfarin dosing may be better than a fixed dose of 2.5 mg/d. It may be shorten the time to first International Normalized Ratio attainment, and the attainment rate in the same time, and can better improve the mean Time in therapeutic range level value and reduce excessive anticoagulation events, which improves the safety of warfarin anticoagulation therapy in clinical practice.Clinical Trial Registration:https://www.chictr.org.cn/showproj.html?proj=52793, ChiCTR2000032393.https://www.frontiersin.org/articles/10.3389/fphar.2023.1235331/fullthrombusdose calculatorwarfainINRTTRbleeding
spellingShingle Xiaofang Cai
Xiaofang Cai
Xiaofang Cai
Jiana Chen
Jiana Chen
Maohua Chen
Maohua Chen
Maohua Chen
Xiaotong Xia
Xiaotong Xia
Guanhua Fang
Jinhua Zhang
Application of a warfarin dosing calculator to guide individualized dosing versus empirical adjustment after fixed dosing: a pilot study
Frontiers in Pharmacology
thrombus
dose calculator
warfain
INR
TTR
bleeding
title Application of a warfarin dosing calculator to guide individualized dosing versus empirical adjustment after fixed dosing: a pilot study
title_full Application of a warfarin dosing calculator to guide individualized dosing versus empirical adjustment after fixed dosing: a pilot study
title_fullStr Application of a warfarin dosing calculator to guide individualized dosing versus empirical adjustment after fixed dosing: a pilot study
title_full_unstemmed Application of a warfarin dosing calculator to guide individualized dosing versus empirical adjustment after fixed dosing: a pilot study
title_short Application of a warfarin dosing calculator to guide individualized dosing versus empirical adjustment after fixed dosing: a pilot study
title_sort application of a warfarin dosing calculator to guide individualized dosing versus empirical adjustment after fixed dosing a pilot study
topic thrombus
dose calculator
warfain
INR
TTR
bleeding
url https://www.frontiersin.org/articles/10.3389/fphar.2023.1235331/full
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