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Table of Contents
Vol. 33, No. 2, 2003
Issue release date: March–April 2003 (November 2003)
Pathophysiol Haemost Thromb 2003;33:59–63
(DOI:10.1159/000073847)

A Prospective Controlled Study of a Computer-Assisted Acenocoumarol Dosage Program

Marco F.b · Sedano C.a · Bermúdez A.a · López-Duarte M.a · Fernández-Fontecha E.a · Zubizarreta A.a
aServicio de Hematología del Hospital Universitario ‘Marqués de Valdecilla’, Universidad de Cantabria, Santander, bServicio de Hematología, Hospital de Basurto, Bilbao, Spain
email Corresponding Author

Abstract

The increase in oral anticoagulant (OA) treatment has led to development of new strategies for its control. We tested the efficacy of the GAO software (Dade Behring) in providing adequate acenocoumarol dosages for patients whose international normalised ratios (INRs) were no more than 0.5 points out of range. From December 1998 to August 1999, all outpatients in this setting were randomly assigned to receive computer-generated or traditionally fixed OA doses. Patients in their first 4 weeks of treatment were excluded. Overall, 8,352 dosages were calculated by the computer and 7,586 by the medical staff. The main endpoint of the study was the time spent in target INR range. The computer matched the traditional dosing, achieving a small but statistically significant greater efficacy in maintaining patients within the INR target range. The percentage of INR determinations over 5.5 was very low in both groups. Our results validate the computerised acenocoumarol dosing in our centre, achieving at least similar levels of effectiveness and safety compared with traditional dosage by medical staff.


 goto top of outline Key Words

  • Oral anticoagulants
  • Computer-assisted dosage
  • Therapeutic quality
  • Acenocoumarol
  • International normalised ratio

 goto top of outline Abstract

The increase in oral anticoagulant (OA) treatment has led to development of new strategies for its control. We tested the efficacy of the GAO software (Dade Behring) in providing adequate acenocoumarol dosages for patients whose international normalised ratios (INRs) were no more than 0.5 points out of range. From December 1998 to August 1999, all outpatients in this setting were randomly assigned to receive computer-generated or traditionally fixed OA doses. Patients in their first 4 weeks of treatment were excluded. Overall, 8,352 dosages were calculated by the computer and 7,586 by the medical staff. The main endpoint of the study was the time spent in target INR range. The computer matched the traditional dosing, achieving a small but statistically significant greater efficacy in maintaining patients within the INR target range. The percentage of INR determinations over 5.5 was very low in both groups. Our results validate the computerised acenocoumarol dosing in our centre, achieving at least similar levels of effectiveness and safety compared with traditional dosage by medical staff.

Copyright © 2003 S. Karger AG, Basel


 goto top of outline References
  1. British Society for Haematology: Guidelines on Oral Anticoagulation, ed 3. Br J Haematol 1998;101:374–387.
  2. Hirsh J, Dalen JE, Anderson DR, Poller L, Bussey H, Ansell J, Deykin D: Oral anticoagulants. Mechanisms of action, clinical effectiveness and optimal therapeutic range (review). Chest 2001;119(suppl):8S-21S.
  3. Fihn SD, McDonell M, Martin D, Henikoff J, Vermes D, Kent D, White RH: Risk factors for complications of chronic anticoagulation. A multicenter study. Warfarin Optimised Outpatient Follow-up Study Group. Ann Intern Med 1993;118:511–520.
  4. Galloway MJ, Foggin JJ, Dixon S: Introduction of computer-assisted control of oral anticoagulation in general practice. J Clin Pathol 1995;48:1144–1146.
  5. Barbui T, Finazzi G, Remuzzi A: Clinical anticoagulation laboratory and oral anticoagulant therapy treatment. Instrumental and methodology. Thromb Haemost 1995;74:511–514.
  6. Taylor F, Ramsay M, Covell B, Gaminara L, Thomson D, Cohen H, et al: Management of expanding anticoagulant clinics: A role for general practitioners? Br J Haematol 1994;86:68.
  7. Poller L, Wright D, Rowlands M: Prospective comparative study of computer programs used for management of warfarin. J Clin Pathol 1993;46:299–303.
  8. Vadher B, Patterson DLH, Leaning M: Evaluation of a decision support system for initiation and control of oral anticoagulation in a randomised trial. BMJ 1997;314:1252–1256.
  9. Fitzmaurice DA, Hobbs FDR, Delaney BC, Wilson S, MacManus R: Review of computerised decision support systems for oral anticoagulation management. Br J Haematol 1998;102:907–909.
  10. Fitzmaurice DA, Hobbs FD, Murray ET, Holder RL, Allan TF, Rose PE: Oral anticoagulation management in primary care with the use of computerized decision support and near-patient testing: A randomized, controlled trial. Arch Intern Med 2000;160:2343–2348.
  11. Poller L, Shiach CR, MacCallum PK, Johansen AM, Magalhaes A, Jespersen J: Multicentre randomised study of computerised anticoagulant dosage. Lancet 1998;352:1505–1509.
  12. Palareti G: A guide to oral anticoagulant therapy. Italian Federation of Anticoagulation Clinics. Haemostasis 1998;28(suppl 1):1–46.
  13. Rosendaal FR, Cannegieter SC, van der Meer FJM, Briët E: A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 1993;69:236–239.
  14. Hutten BA, Prins MH, Redekop WK, Tijssen JGP, Heisterkamp SH, Büller HR: Comparison of three methods to assess therapeutic quality control of treatment with vitamin K antagonists. Thromb Haemost 1999;82:1260–1263.
  15. Palareti G, Leali N, Coccheri S, Poggi M, Manotti C, D’Angelo A, Pengo V, Erba N, Moia M, Ciavarella N, Devoto G, Berrettini M, Musolesi S, on behalf of the Italian Study on Complications of Oral Anticoagulant Therapy: Bleeding complications of oral anticoagulant treatment: An inception-cohort, prospective collaborative study (ISCOAT). Lancet 1996;348:423–428.
  16. Palareti G, Manotti C, D’Angelo A, Pengo V, Erba N, Moia M, Ciavarella N, Devoto G, Berrettini M, Leali N, Poggi M, Legnani C, Musolesi S, Coccheri S, on behalf of the ISCOAT Study Group (Italian Study on Complications of Oral Anticoagulant Therapy): Thrombotic events during oral anticoagulant treatment: Results of the inception-cohort, prospective, collaborative ISCOAT study. Thromb Haemost 1997;78:1438–1443.
  17. Kumar S, Haigh JRM, Rhodes LE, Peaker S, Davies JA, Roberts BE, Feely MP: Poor compliance is a major factor in unstable outpatient control of anticoagulant therapy. Thromb Haemost 1989;62:729–732.
  18. Wells PS, Holbrook AM, Crowther NR, Hirsh J: Interaction of warfarin with drugs and food. Ann Intern Med 1994;121:676–683.
  19. Sorano GG, Biondi G, Conti M, Mameli G, Licheri D, Marongiu F: Controlled vitamin K content in diet for improving the management of poorly controlled anticoagulated patients: A clinical practice proposal. Haemostasis 1993;23:77–82.
  20. Manotti C, Quintavalla R, Pattacini C, Tagliaferri A, Pini M: Evaluation of a computer-assisted dosage prediction method for oral anticoagulant therapy. Thromb Haemost 1997;Suppl 699.
  21. Azar AJ, Deckers JW, Rosendaal FR, van Bergen PF, van der Meer FJM, Jonker JJC, Briëf E: Assessment of therapeutic quality control in a long-term anticoagulant trial in post-myocardial infarction patients. Thromb Haemost 1994;72:347–351.
  22. Cortelazzo S, Finazzi G, Viero P, Galli M, Remuzzi A, Parenzan L, Barbui T: Thrombotic and hemorrhagic complications in patients with mechanical heart valve prosthesis attending an anticoagulation clinic. Thromb Haemost 1993;69:316–320.
  23. Fitzmaurice DA, Hobbs FD, Murray ET: Primary care anticoagulant clinic management using computerised decision support and near patient International Normalised Ratio (INR) testing: Routine data from a practice nurse-led clinic. Fam Pract 1998;15:144–146.
  24. Eriksson H, Eriksson UG, Frison L, Hansson PO, Held P, Holmström M, Hägg A, Jonsson T, Lapidus L, Leijd B, Stockelberg D, Säfwenberg U, Taghavi A, Thorsen M: Pharmacokinetics and pharmacodynamics of melagatran, a novel synthetic LMW thrombin inhibitor, in patients with acute DVT. Thromb Haemost 1999;81:358–363.

 goto top of outline Author Contacts

Fernando Marco
Servicio de Hematología, Hospital de Basurto
Avenida Montevideo s/n. 48008 Bilbao (Spain)
Tel. +34 944006001, Fax +34 944006188
E-Mail fmarco@telefonica.net


 goto top of outline Article Information

Received: April 25, 2002
Accepted after revision: April 7, 2003
Number of Print Pages : 5
Number of Figures : 2, Number of Tables : 3, Number of References : 24


 goto top of outline Publication Details

Pathophysiology of Haemostasis and Thrombosis
(Formely: Haemostasis)
Official Journal of the ‘Mediterranean League against Thromboembolic Diseases’

Vol. 33, No. 2, Year 2003 (Cover Date: March-April 2003 (Released November 2003))

Journal Editor: J. Rosing, Maastricht
ISSN: 1424–8832 (print), 1424–8840 (Online)

For additional information: http://www.karger.com/pht


Copyright / Drug Dosage / Disclaimer

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

Abstract

The increase in oral anticoagulant (OA) treatment has led to development of new strategies for its control. We tested the efficacy of the GAO software (Dade Behring) in providing adequate acenocoumarol dosages for patients whose international normalised ratios (INRs) were no more than 0.5 points out of range. From December 1998 to August 1999, all outpatients in this setting were randomly assigned to receive computer-generated or traditionally fixed OA doses. Patients in their first 4 weeks of treatment were excluded. Overall, 8,352 dosages were calculated by the computer and 7,586 by the medical staff. The main endpoint of the study was the time spent in target INR range. The computer matched the traditional dosing, achieving a small but statistically significant greater efficacy in maintaining patients within the INR target range. The percentage of INR determinations over 5.5 was very low in both groups. Our results validate the computerised acenocoumarol dosing in our centre, achieving at least similar levels of effectiveness and safety compared with traditional dosage by medical staff.



 goto top of outline Author Contacts

Fernando Marco
Servicio de Hematología, Hospital de Basurto
Avenida Montevideo s/n. 48008 Bilbao (Spain)
Tel. +34 944006001, Fax +34 944006188
E-Mail fmarco@telefonica.net


 goto top of outline Article Information

Received: April 25, 2002
Accepted after revision: April 7, 2003
Number of Print Pages : 5
Number of Figures : 2, Number of Tables : 3, Number of References : 24


 goto top of outline Publication Details

Pathophysiology of Haemostasis and Thrombosis
(Formely: Haemostasis)
Official Journal of the ‘Mediterranean League against Thromboembolic Diseases’

Vol. 33, No. 2, Year 2003 (Cover Date: March-April 2003 (Released November 2003))

Journal Editor: J. Rosing, Maastricht
ISSN: 1424–8832 (print), 1424–8840 (Online)

For additional information: http://www.karger.com/pht


Copyright / Drug Dosage

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

References

  1. British Society for Haematology: Guidelines on Oral Anticoagulation, ed 3. Br J Haematol 1998;101:374–387.
  2. Hirsh J, Dalen JE, Anderson DR, Poller L, Bussey H, Ansell J, Deykin D: Oral anticoagulants. Mechanisms of action, clinical effectiveness and optimal therapeutic range (review). Chest 2001;119(suppl):8S-21S.
  3. Fihn SD, McDonell M, Martin D, Henikoff J, Vermes D, Kent D, White RH: Risk factors for complications of chronic anticoagulation. A multicenter study. Warfarin Optimised Outpatient Follow-up Study Group. Ann Intern Med 1993;118:511–520.
  4. Galloway MJ, Foggin JJ, Dixon S: Introduction of computer-assisted control of oral anticoagulation in general practice. J Clin Pathol 1995;48:1144–1146.
  5. Barbui T, Finazzi G, Remuzzi A: Clinical anticoagulation laboratory and oral anticoagulant therapy treatment. Instrumental and methodology. Thromb Haemost 1995;74:511–514.
  6. Taylor F, Ramsay M, Covell B, Gaminara L, Thomson D, Cohen H, et al: Management of expanding anticoagulant clinics: A role for general practitioners? Br J Haematol 1994;86:68.
  7. Poller L, Wright D, Rowlands M: Prospective comparative study of computer programs used for management of warfarin. J Clin Pathol 1993;46:299–303.
  8. Vadher B, Patterson DLH, Leaning M: Evaluation of a decision support system for initiation and control of oral anticoagulation in a randomised trial. BMJ 1997;314:1252–1256.
  9. Fitzmaurice DA, Hobbs FDR, Delaney BC, Wilson S, MacManus R: Review of computerised decision support systems for oral anticoagulation management. Br J Haematol 1998;102:907–909.
  10. Fitzmaurice DA, Hobbs FD, Murray ET, Holder RL, Allan TF, Rose PE: Oral anticoagulation management in primary care with the use of computerized decision support and near-patient testing: A randomized, controlled trial. Arch Intern Med 2000;160:2343–2348.
  11. Poller L, Shiach CR, MacCallum PK, Johansen AM, Magalhaes A, Jespersen J: Multicentre randomised study of computerised anticoagulant dosage. Lancet 1998;352:1505–1509.
  12. Palareti G: A guide to oral anticoagulant therapy. Italian Federation of Anticoagulation Clinics. Haemostasis 1998;28(suppl 1):1–46.
  13. Rosendaal FR, Cannegieter SC, van der Meer FJM, Briët E: A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 1993;69:236–239.
  14. Hutten BA, Prins MH, Redekop WK, Tijssen JGP, Heisterkamp SH, Büller HR: Comparison of three methods to assess therapeutic quality control of treatment with vitamin K antagonists. Thromb Haemost 1999;82:1260–1263.
  15. Palareti G, Leali N, Coccheri S, Poggi M, Manotti C, D’Angelo A, Pengo V, Erba N, Moia M, Ciavarella N, Devoto G, Berrettini M, Musolesi S, on behalf of the Italian Study on Complications of Oral Anticoagulant Therapy: Bleeding complications of oral anticoagulant treatment: An inception-cohort, prospective collaborative study (ISCOAT). Lancet 1996;348:423–428.
  16. Palareti G, Manotti C, D’Angelo A, Pengo V, Erba N, Moia M, Ciavarella N, Devoto G, Berrettini M, Leali N, Poggi M, Legnani C, Musolesi S, Coccheri S, on behalf of the ISCOAT Study Group (Italian Study on Complications of Oral Anticoagulant Therapy): Thrombotic events during oral anticoagulant treatment: Results of the inception-cohort, prospective, collaborative ISCOAT study. Thromb Haemost 1997;78:1438–1443.
  17. Kumar S, Haigh JRM, Rhodes LE, Peaker S, Davies JA, Roberts BE, Feely MP: Poor compliance is a major factor in unstable outpatient control of anticoagulant therapy. Thromb Haemost 1989;62:729–732.
  18. Wells PS, Holbrook AM, Crowther NR, Hirsh J: Interaction of warfarin with drugs and food. Ann Intern Med 1994;121:676–683.
  19. Sorano GG, Biondi G, Conti M, Mameli G, Licheri D, Marongiu F: Controlled vitamin K content in diet for improving the management of poorly controlled anticoagulated patients: A clinical practice proposal. Haemostasis 1993;23:77–82.
  20. Manotti C, Quintavalla R, Pattacini C, Tagliaferri A, Pini M: Evaluation of a computer-assisted dosage prediction method for oral anticoagulant therapy. Thromb Haemost 1997;Suppl 699.
  21. Azar AJ, Deckers JW, Rosendaal FR, van Bergen PF, van der Meer FJM, Jonker JJC, Briëf E: Assessment of therapeutic quality control in a long-term anticoagulant trial in post-myocardial infarction patients. Thromb Haemost 1994;72:347–351.
  22. Cortelazzo S, Finazzi G, Viero P, Galli M, Remuzzi A, Parenzan L, Barbui T: Thrombotic and hemorrhagic complications in patients with mechanical heart valve prosthesis attending an anticoagulation clinic. Thromb Haemost 1993;69:316–320.
  23. Fitzmaurice DA, Hobbs FD, Murray ET: Primary care anticoagulant clinic management using computerised decision support and near patient International Normalised Ratio (INR) testing: Routine data from a practice nurse-led clinic. Fam Pract 1998;15:144–146.
  24. Eriksson H, Eriksson UG, Frison L, Hansson PO, Held P, Holmström M, Hägg A, Jonsson T, Lapidus L, Leijd B, Stockelberg D, Säfwenberg U, Taghavi A, Thorsen M: Pharmacokinetics and pharmacodynamics of melagatran, a novel synthetic LMW thrombin inhibitor, in patients with acute DVT. Thromb Haemost 1999;81:358–363.