title: [Oral administration of intravenous preparation of Vitamin K for excessive anticoagulation due to warfarin].
abstract: Anticoagulation therapy with warfarin, a common clinical practice, needs to be monitored using protombine time expressed as the International Normalized Ratio (INR); when safety range is exceeded, Vitamin K (Vit-K) could be administered with preference orally. In Venezuela the specific oral preparation for Vit-K is not available. This is a double blinded, randomized, placebo controlled, clinical trial; 20 patients, age 18-60 year with initial INR ≥ 6, ≤ 10, were randomized to oral Vit-K 1.25mg (prepared from intravenous presentation) or placebo plus withholding warfarin. INR < 3.5 at 24 hours of treatment (the primary end point) was achieved by 70% among Vit-K, and 20% among placebo patients; given an absolute risk reduction (ARR), of 50% (CI95%: 14.4-85.6) p = 0.028, NNT 2 (CI95%: 1.3 - 6.9). No adverse events were recorded including INR < 2 at 24 hours of treatment administration. Our results are consistent with studies where specific oral presentation of Vit-K was used. The results indicate that oral administration of Vit-K, prepared from an intravenous Vit-K preparation, is safe and more effective to revert excessive anticoagulation than simply withholding warfarin, in places where specific preparation of oral Vit-K is not available or too expensive.
authors.affiliation: Asociación Cardiovascular Centro Occidental (ASCARDIO), Barquisimeto, Estado Lara, Venezuela.
authors.forename: Yoleima
authors.initials: Y
authors.lastname: Lozada
authors.forename: Marinela
authors.initials: M
authors.lastname: Falcone
authors.forename: Ricardo
authors.initials: R
authors.lastname: Granero
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000925:Anticoagulants / Q000009:adverse effects*; D001777:Blood Coagulation / Q000187:drug effects; D003029:Coagulants / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019934:International Normalized Ratio / Q000592:standards*; D008297:Male; D008875:Middle Aged; D011517:Prothrombin Time; D013923:Thromboembolism / Q000517:prevention & control; D014812:Vitamin K / Q000008:administration & dosage*; D014859:Warfarin / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D003029:Coagulants; D014812:Vitamin K; D014859:Warfarin