Dabigatran ‘still effective in obese’

Aug 9 2012

By Piriya Mahendra, MedWire Reporter

The oral direct thrombin inhibitor dabigatran is an effective thromboprophylactic therapy for patients undergoing total hip or knee replacement regardless of their body mass index (BMI), researchers assert.

Bengt Eriksson (University of Gothenburg, Mölndal, Sweden) and team conducted a post-hoc analysis of three large phase III trials and found dabigatran 220 mg once daily was of similar efficacy to enoxaparin 40 mg once daily for venous thromboembolism (VTE) prevention, with no increased bleeding risk, in overweight and obese people.

Of the study participants, 1417 (24.9%) had a normal BMI (20-25 kg/m²), 2373 (41.7%) were pre-obese (BMI=25-30 kg/m²), and 1826 (32.1%) were obese(BMI >30 kg/m²).

The rate of major VTE and VTE-related mortality was significantly lower in patients with a normal BMI who received treatment with dabigatran than those who received enoxaparin, at 2.1% versus 4.3% (p=0.037).

Indeed, patients with a normal BMI who received dabigatran had a significant 52% lower relative risk for major VTE or VTE-related mortality than those who received enoxaparin.

Pre-obese patients who received dabigatran had a 33% lower risk for this endpoint than those who received enoxaparin, but this was not significant. Obese patients had a nonsignificant 0.08% lower risk for this endpoint with dabigatran than with enoxaparin.

As reported in Thrombosis Research, there was also no significant difference in bleeding rate between patients who received dabigatran and enoxaparin in any of the BMI subgroups.

Eriksson and team say that, together with previous findings showing the volume of dabigatran distribution is not affected by body weight, the results of their study indicate that the "pharmacokinetic profile of dabigatran is unaffected by body weight."

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