Presented herein are the results of oral administration of dabigatran etexilate for treatment and secondary prevention of lower-limb deep vein thrombosis (DVT) and pulmonary thromboembolism (PTE) in patients with established thrombophilia, studying its efficacy and safety in prolonged administration during a year as compared with warfarin. The study group included a total of fifty-seven 18-to-79-year-old patients (33 men and 24 women) with DVT and PTE, taking dabigatran etexilate. The comparison group was composed of a total of 126 patients (65 men and 61 women) with DVT and PTE, taking warfarin. Efficacy of the drugs was analysed in relation to the development of relapses thromboembolic complications, with the drugs' safety profile being evaluated in relation to the development of major and clinically significant haemorrhage. It was determined that prolonged administration of dabigatran etexilate taken at a fixed dose (150 mg twice daily) for 6-12 months in patients with DVT and PTE and with confirmed thrombophilia turned out to be effective for secondary prevention of relapsing venous thromboembolic complications and lethal outcomes, indirectly contributing to recanalization of the lower-limb venous bed, with the drug possessing a favourable profile of safety concerning the development of haemorrhagic complications as compared with warfarin and requiring no routine laboratory monitoring.

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