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A pharmacogenetic versus a clinical algorithm for warfarin dosing
- Source :
- The New England journal of medicine, vol 369, iss 24
- Publication Year :
- 2013
- Publisher :
- eScholarship, University of California, 2013.
-
Abstract
- BackgroundThe clinical utility of genotype-guided (pharmacogenetically based) dosing of warfarin has been tested only in small clinical trials or observational studies, with equivocal results.MethodsWe randomly assigned 1015 patients to receive doses of warfarin during the first 5 days of therapy that were determined according to a dosing algorithm that included both clinical variables and genotype data or to one that included clinical variables only. All patients and clinicians were unaware of the dose of warfarin during the first 4 weeks of therapy. The primary outcome was the percentage of time that the international normalized ratio (INR) was in the therapeutic range from day 4 or 5 through day 28 of therapy.ResultsAt 4 weeks, the mean percentage of time in the therapeutic range was 45.2% in the genotype-guided group and 45.4% in the clinically guided group (adjusted mean difference, [genotype-guided group minus clinically guided group], -0.2; 95% confidence interval, -3.4 to 3.1; P=0.91). There also was no significant between-group difference among patients with a predicted dose difference between the two algorithms of 1 mg per day or more. There was, however, a significant interaction between dosing strategy and race (P=0.003). Among black patients, the mean percentage of time in the therapeutic range was less in the genotype-guided group than in the clinically guided group. The rates of the combined outcome of any INR of 4 or more, major bleeding, or thromboembolism did not differ significantly according to dosing strategy.ConclusionsGenotype-guided dosing of warfarin did not improve anticoagulation control during the first 4 weeks of therapy. (Funded by the National Heart, Lung, and Blood Institute and others; COAG ClinicalTrials.gov number, NCT00839657.).
- Subjects :
- Adult
Male
Genotype
Clinical Trials and Supportive Activities
COAG Investigators
Hemorrhage
Medical and Health Sciences
Double-Blind Method
Clinical Research
Thromboembolism
Vitamin K Epoxide Reductases
General & Internal Medicine
Genetics
Humans
International Normalized Ratio
Treatment Failure
Aged
Cytochrome P-450 CYP2C9
Anticoagulants
Evaluation of treatments and therapeutic interventions
Hematology
Pharmacogenetics
5.1 Pharmaceuticals
6.1 Pharmaceuticals
Female
Warfarin
Aryl Hydrocarbon Hydroxylases
Development of treatments and therapeutic interventions
Algorithms
Follow-Up Studies
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- The New England journal of medicine, vol 369, iss 24
- Accession number :
- edsair.od.......325..72892bcfa39d5258ca31083ca3c87b39