Vitamin K1 in oral solution or tablets: a crossover trial and two randomized controlled trials to compare effects

• Published in: Journal of thrombosis and haemostasis 2014-12, Vol.12 (12), p.2017-2023
• Main Authors: Rein, N., Gebuis, E. P. A., Lijfering, W. M., Groeneveld, J. J. E., Horst, F. A. L., Cessie, S., Rosendaal, F. R., Meer, F. J. M.
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adult; Aged; anticoagulants; Antifibrinolytic Agents - administration & dosage; Atrial Fibrillation - drug therapy; Biological Availability; Cross-Over Studies; Female; Healthy Volunteers; Humans; International Normalized Ratio; Likelihood Functions; Male; Middle Aged; pharmacokinetics; pharmacology; Phenprocoumon - administration & dosage; randomized controlled trial; Tablets; Venous Thrombosis - drug therapy; Vitamin K 1 - administration & dosage; Vitamin K 1 - blood; vitamin K1
• ISSN: 1538-7933; 1538-7836; 1538-7836
• DOI: 10.1111/jth.12753

Summary Background Vitamin K1 (VK1) reverses the effects of vitamin K antagonists (VKAs). The literature shows that the bioavailability from solutions might be higher than that from tablets, possibly resulting in different effects. Objectives To compare the bioavailability and effect on the International Normalized Ratio (INR) of 5‐mg VK1 tablets and solution in three randomized clinical trials. Methods and results The bioavailability was determined in a crossover trial with 25 healthy volunteers. VK1 plasma concentrations were assessed at 0, 2, 4, 5, 6, 8, 10 and 24 h, and the area under the curve was higher in the solution group than in the tablet group (mean difference 365 μg L−1 h, 95% confidence interval [CI] 230–501, P