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- Title
A multicentre randomised clinical endpoint study ofparma 5 computer-assisted oral anticoagulant dosage.
- Authors
Poller, Leon; Keown, Michelle; Ibrahim, Saied; Lowe, Gordon; Moia, Marco; Turpie, Alexander G.; Roberts, Christopher; van den Besselaar, Aton M. H. P.; van der Meer, Felix J. M.; Tripodi, Armando; Palareti, Gualtiero; Jespersen, Jørgen
- Abstract
To meet growing demand for oral anticoagulation worldwide there has been increased dependence on computer-assistance in dosage although the safety and effectiveness of any of the individual computer-assisted dosage programs has not previously been established. This randomised multicentre clinical end-point study assessed a new version of theparma 5 program. It comparedparma 5 safety and effectiveness with manual dosage by experienced medical staff at 19 centres with a known interest in oral anticoagulation. Target recruitment was 8000 patient-years, randomised to medical staff orparma-5 assisted dosage. Safety and effectiveness of theparma 5 program was compared with manual dosage. A total of 10 421 patients were recruited (15 369 patient-years) in the 5-year study. International normalised ratio (INR) tests numbered 167 791 with manual and 160 078 withparma 5 dosage. Withparma 5 there was overall a non-significant reduction in clinical events but in the 2542 patients with deep vein thrombosis/pulmonary embolism, clinical events were significantly reduced ( P = 0·005). Success in achieving ‘time in target INR range’ was also significantly greater withparma 5 compared with the dosage by experienced medical staff. This study demonstrated the safety and effectiveness ofparma 5-assisted dosage.
- Subjects
ANTICOAGULANTS; DRUG dosage; THROMBOSIS; PULMONARY embolism; SAFETY
- Publication
British Journal of Haematology, 2008, Vol 143, Issue 2, p274
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/j.1365-2141.2008.07337.x