Dabigatran etexilate (DE) is as successful in lowering the risk of VTE (venous thromboembolism) following total hip replacement surgery as enoxaparin, according to a report in The Lancet, published this week.
Dr Bengt Eriksson, Sahlgrenska University Hospital, Gothenburg, Sweden, and team carried out the RE-NOVATE study, a double blind study involving 3,494 patients who underwent total hip replacement. They received 28-35 days’ treatment of either oral DE @@) mg once a day, or DE 250 mg one a day, or a subcutaneous enoxaparin 40 mg injection once a day – all the patients were randomly selected to receive these treatments. The primary treatment outcome was judged by venographic or symptomatic blood clot and death from all causes during treatment.
The researchers reported the following outcomes:
— For the 220mg DE patients: The outcome happened in 6% (53) patients out of a total of 880
— For the 1150 mg DE patients: The outcome happened in 8.6% (75) patients out of a total of 874
— For the enoxaparin patients: The outcome happened in 6.7% (60) patients out of a total of 897
The researchers did not observe any significant variations in major bleeding rates among the DE dose or enoxaparin patients. Neither were there any differences in either acute coronary events or rises in liver enzyme concentrations.
“Our results show that oral dabigatran etexilate, 220 mg or 150 mg once daily, given for a median of 33 days, was non-inferior to enoxaparin for reducing the risk of total venous thromboembolism and all-cause mortality after total hip replacement surgery. These findings, in conjunction with other results from the large, phase III development programmed in total hip and knee replacement surgery, will help define the optimum dosage regimen for dabigatran etexilate,” the writers concluded.
An accompanying Comment explains that the study was faulty as some data was not there. Dr John Norrie, Centre for Healthcare Randomized Trials, University of Aberdeen, Scotland, UK says that there was no data in the VTE trials with venographically determined primary outcomes in approximately one third of the patients. He said that either the venography was not done or the results are illegible. “The bottom line is that the effect of these missing data is unknown.”
Dr. Norrie concluded “Even in a mature research area such as treatments for venous thromboembolism, there is still important methodological work to be done to improve design and so ensure the highest quality of evidence to inform the management of these conditions.”
Written by: Christian Nordqvist