title: A multicentre randomised assessment of the DAWN AC computer-assisted oral anticoagulant dosage program.
abstract: Computer-assisted oral anticoagulant dosage is being increasingly used to meet growing demands for oral anticoagulation. The DAWN AC is one of the most widely used computer-dosage programs. Evidence of its value and that of other computer programs has been based previously only on laboratory evidence of "time in target INR range" (TIR) not on clinical safety in practice. A five-year international randomised clinical study of computer assistance with the DAWN AC program compared with manual dosage in 2,631 patients has been performed at 13 centres with established expertise in oral anticoagulation mainly in the EU. Safety assessment have been based on the comparison of bleeding or thrombotic events with DAWN AC compared with manual dosage in a randomised study. Safety of the DAWN AC program has been demonstrated. Clinical events of bleeding and thrombosis were almost identical with the experienced manual dosage group. Therapeutic control improved with DAWN AC to 66.8% from 63.4% TIR. The program failed to provide a dosage recommendation on only 5.7% of occasions. At a group of experienced centres with a special interest in oral anticoagulation, the DAWN AC computer-dosage program proved as safe clinically as manual dosage by experienced medical staff. With DAWN AC, laboratory control was improved, the difference being highly significant. The results should reassure hospitals and community clinics that the DAWN AC program is safe and facilitate greater and longer provision of warfarin treatment where required.
authors.affiliation: EAA Central Facility, The University of Manchester Faculty of Life Sciences 3.614 Stopford Building, Oxford Road, Manchester M13 9PT, UK. leon.poller@manchester.ac.uk
authors.forename: Leon
authors.initials: L
authors.lastname: Poller
authors.forename: Michelle
authors.initials: M
authors.lastname: Keown
authors.forename: Saied
authors.initials: S
authors.lastname: Ibrahim
authors.forename: Gordon
authors.initials: G
authors.lastname: Lowe
authors.forename: Marco
authors.initials: M
authors.lastname: Moia
authors.forename: Alexander G
authors.initials: AG
authors.lastname: Turpie
authors.forename: Christopher
authors.initials: C
authors.lastname: Roberts
authors.forename: Anton M H P
authors.initials: AM
authors.lastname: van den Besselaar
authors.forename: Felix J M
authors.initials: FJ
authors.lastname: van der Meer
authors.forename: Armando
authors.initials: A
authors.lastname: Tripodi
authors.forename: Gualtiero
authors.initials: G
authors.lastname: Palareti
authors.forename: Caroline
authors.initials: C
authors.lastname: Shiach
authors.forename: Stirling
authors.initials: S
authors.lastname: Bryan
authors.forename: Meyer
authors.initials: M
authors.lastname: Samama
authors.forename: Michael
authors.initials: M
authors.lastname: Burgess-Wilson
authors.forename: Anthony
authors.initials: A
authors.lastname: Heagerty
authors.forename: Peter
authors.initials: P
authors.lastname: Maccallum
authors.forename: David
authors.initials: D
authors.lastname: Wright
authors.forename: Jørgen
authors.initials: J
authors.lastname: Jespersen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage*; D002138:Calibration; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D012984:Software; D014859:Warfarin / Q000008:administration & dosage*
chemical_list: D000925:Anticoagulants; D014859:Warfarin