The direct thrombin inhibitor, which is taken orally, is currently licensed for primary prevention of VTE after hip or knee surgery. Earlier this year data showed that it was safer and more effective than warfarin at preventing stroke in patients with AF (GP, 4 September).
Patients treated with dabigatran, which does not interact with foods and is not thought to have any drug interactions, do not need their coagulation levels monitored studies have shown.
For the latest study, Dr Sam Schulman of Karolinska University Hospital, Stockholm, and colleagues compared dabigatran with warfarin in 2,539 patients with acute VTE.
Patients were initially treated with parenteral anticoagulation. They were then given either warfarin, titrated to achieve an international normalised ratio of 2.0-3.0, or twice-daily dabigatran 150mg.
In total, 57 patients experienced recurrent, symptomatic and objectively confirmed VTE.
The proportion of patients who experienced these events did not differ significantly across the two treatment groups.
The safety profile of the two drugs was similar, although bleeding episodes occurred less frequently in patients given dabigatran.
Commenting on the latest findings, the researchers said: 'Our trial provides data to support dabigatran as a fixed-dose oral treatment for acute deep-vein thrombosis and pulmonary embolism.
'For patients and healthcare providers, dabigatran is a far more convenient drug than warfarin because it has no known interactions with foods and minimal interactions with other drugs.'
However, the researchers stressed that the drug was tested on a restricted sample of patients who were predominately white.
Additional studies will need to be performed in patients whose baseline characteristics differ markedly from this population, they said.
In addition, they pointed out that dabigatran was only given after initial parenteral anticoagulation therapy. There are therefore no data yet to support the use of dabigatran monotherapy for VTE, they said.
- N Engl J Med 2009; 361: 2342-52