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The quality of warfarin treatment may be improved if management is guided by the use of models based upon pharmacokinetic-pharmacodynamic theory. A prospective, two-armed, single-blind, randomized controlled trial compared management aided by a web-based dose calculator (NextDose) with standard clinical care. Participants were 240 adults receiving warfarin therapy following cardiac surgery, followed up until the first outpatient appointment at least 3 months after warfarin initiation. We compared the percentage of time spent in the international normalized ratio acceptable range (%TIR) during the first 28 days following warfarin initiation, and %TIR and count of bleeding events over the entire follow-up period. Two hundred thirty-four participants were followed up to day 28 (NextDose: 116 and standard of care: 118), and 228 participants (114 per arm) were followed up to the final study visit. Median %TIR tended to be higher for participants receiving NextDose guided warfarin management during the first 28 days (63 vs. 56%, P = 0.13) and over the entire follow-up period (74 vs. 71%, P = 0.04). The hazard of clinically relevant minor bleeding events was lower for participants in the NextDose arm (hazard ratio: 0.21, P = 0.041). In NextDose, there were 89.3% of proposed doses accepted by prescribers. NextDose guided dose management in cardiac surgery patients requiring warfarin was associated with an increase in %TIR across the full follow-up period and fewer hemorrhagic events. A theory-based, pharmacologically guided approach facilitates higher quality warfarin anticoagulation. An important practical benefit is a reduced requirement for clinical experience of warfarin management.

Titel:	A Randomized Trial Comparing Standard of Care to Bayesian Warfarin Dose Individualization.
Autor/in / Beteiligte Person:	Xue, L ; Ma, G ; Holford, N ; Qin, Q ; Ding, Y ; Hannam, JA ; Ding, X ; Fan, H ; Ji, Z ; Yang, B ; Shen, H ; Shen, Z ; Miao, L
Link:	Zum Volltext
Zeitschrift:	Clinical pharmacology and therapeutics, Jg. 115 (2024-06-01), Heft 6, S. 1316-1325
Veröffentlichung:	2015- : Hoboken, NJ : Wiley ; <i>Original Publication</i>: St. Louis : C.V. Mosby, 2024
Medientyp:	academicJournal
ISSN:	1532-6535 (electronic)
DOI:	10.1002/cpt.3207
Schlagwort:	Humans Female Male Aged Middle Aged Prospective Studies Single-Blind Method Standard of Care Cardiac Surgical Procedures Dose-Response Relationship, Drug Precision Medicine methods Drug Dosage Calculations Drug Monitoring methods Warfarin administration & dosage Warfarin adverse effects Anticoagulants administration & dosage Anticoagulants adverse effects Anticoagulants pharmacokinetics Bayes Theorem Hemorrhage chemically induced International Normalized Ratio
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article; Randomized Controlled Trial; Comparative Study; Research Support, Non-U.S. Gov't; Research Support, N.I.H., Extramural Language: English [Clin Pharmacol Ther] 2024 Jun; Vol. 115 (6), pp. 1316-1325. <i>Date of Electronic Publication: </i>2024 Mar 04. MeSH Terms: Warfarin* / administration & dosage ; Warfarin* / adverse effects ; Anticoagulants* / administration & dosage ; Anticoagulants* / adverse effects ; Anticoagulants* / pharmacokinetics ; Bayes Theorem* ; Hemorrhage* / chemically induced ; International Normalized Ratio* ; Humans ; Female ; Male ; Aged ; Middle Aged ; Prospective Studies ; Single-Blind Method ; Standard of Care ; Cardiac Surgical Procedures ; Dose-Response Relationship, Drug ; Precision Medicine / methods ; Drug Dosage Calculations ; Drug Monitoring / methods References: January, C.T. et al. 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines and the Heart Rhythm Society. J. Am. Coll. 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A Randomized Trial Comparing Standard of Care to Bayesian Warfarin Dose Individualization.