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Comparison of 10-mg and 5-mg Warfarin Initiation Nomograms Together with Low-Molecular-Weight Heparin for Outpatient Treatment of Acute Venous Thromboembolism: A Randomized, Double-Blind, Controlled Trial

Michael J. Kovacs, MD, FRCPC; Marc Rodger, MD, FRCPC, MSc; David R. Anderson, MD, FRCPC, MSc; Beverly Morrow, RN; Gertrude Kells, BScN, RN; Judy Kovacs, RN; Eleanor Boyle, BSc; and Philip S. Wells, MD, FRCPC, MSc
[+] Article and Author Information

From London Health Science Centre, London, and Ottawa Health Research Institute, Ottawa, Ontario, Canada; and Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada.


Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Michael J. Kovacs, MD, FRCPC, Department of Hematology, London Health Sciences Centre, 800 Commissioners Road East, London, Ontario N6A 4G5, Canada; e-mail, michael.kovacs@lhsc.on.ca.

Current Author Addresses: Dr. Kovacs, Ms. Morrow, Ms. Kovacs, and Ms. Boyle: Department of Hematology, London Health Sciences Centre, 800 Commissioners Road East, London, Ontario N6A 4G5, Canada.

Drs. Rodger and Wells: Ottawa Hospital—Civic Campus, 1053 Carling Avenue, Ottawa, Ontario K1Y 4E9, Canada.

Dr. Anderson and Ms. Kells: Queen Elizabeth II Health Sciences Centre, 1278 Tower Road, Halifax, Nova Scotia B3H 2Y9, Canada.

Author Contributions: Conception and design: M.J. Kovacs, M. Rodger, D.R. Anderson, E. Boyle, P.S. Wells.

Analysis and interpretation of the data: M.J. Kovacs, M. Rodger, D.R. Anderson, P.S. Wells.

Drafting of the article: M.J. Kovacs, M. Rodger, P.S. Wells.

Critical revision of the article for important intellectual content: M.J. Kovacs, M. Rodger, D.R. Anderson, P.S. Wells.

Final approval of the article: M.J. Kovacs, M. Rodger, D.R. Anderson, B. Morrow, J. Kovacs, E. Boyle, P.S. Wells.

Provision of study materials or patients: M.J. Kovacs, M. Rodger, D.R. Anderson, G. Kells, P.S. Wells.

Statistical expertise: M. Rodger, E. Boyle, P.S. Wells.

Obtaining of funding: M. Rodger.

Administrative, technical, or logistic support: M.J. Kovacs, M. Rodger, D.R. Anderson, P.S. Wells.

Collection and assembly of data: M.J. Kovacs, M. Rodger, D.R. Anderson, B. Morrow, G. Kells, J. Kovacs, P.S. Wells.

A detailed description of the study methodology and patient flow is available in a trials bank at http://rctbank.ucsf.edu/Presenter?518. Annals does not maintain the trials bank.


Ann Intern Med. 2003;138(9):714-719. doi:10.7326/0003-4819-138-9-200305060-00007
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Between August 1999 and June 2000, 210 patients were approached for participation in the study. Two patients were excluded because they had a baseline INR greater than 1.4, 2 were excluded because they required hospitalization, and 5 were excluded because they had received warfarin in the previous 2 weeks. The last patient completed follow-up in September 2000. A total of 201 eligible, consenting patients were enrolled and randomly assigned to treatment (Table 2). One hundred four patients were assigned to the 10-mg group, and 97 were assigned to the 5-mg group. The baseline characteristics of both groups were similar, although the 10-mg group included more men. The overall age range was 18 to 98 years, and 32 patients (16%) were older than 75 years of age. All patients were followed for 90 days.

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Figures

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Figure 1.
10-mg warfarin initiation nomogram.

All patients receive 10 mg on day 1 and day 2. INR = international normalized ratio.

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Figure 2.
Time to therapeutic international normalized ratio (INR) in each study group.
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Summary for Patients

A Comparison of Two Methods of Starting the Anticoagulant Drug Warfarin

The summary below is from the full report titled “Comparison of 10-mg and 5-mg Warfarin Initiation Nomograms Together with Low-Molecular- Weight Heparin for Outpatient Treatment of Acute Venous Thromboembolism. A Randomized, Double-Blind, Controlled Trial.” It is in the 6 May 2003 issue of Annals of Internal Medicine (volume 138, pages 714-719). The authors are M.J. Kovacs, M. Rodger, D.R. Anderson, B. Morrow, G. Kells, J. Kovacs, E. Boyle, and P.S. Wells.

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