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Domingo 16 de Diciembre de 2007
Oral Agent Rivals Subcutaneous Enoxaparin for Thromboprophylaxis After Total Hip Replacement: Presented at ASH
The investigational drug rivaroxaban, given once daily in a fixed oral dose for 4 weeks, was significantly more effective than the current standard of care -- subcutaneous enoxaparin -- in preventing venous thromboembolism after total hip replacement surgery, according to research presented here at the 49th American Society of Hematology (ASH) Annual Meeting and Exposition.
This superior efficacy was achieved with a similar safety profile as enoxaparin and the convenience of once-daily oral dosing without the need for cumbersome coagulation monitoring, said lead investigator Bengt I. Eriksson, MD, PhD, Sahlgrenska University Hospital/Östra, Goteborg, Sweden.
"It's very exciting to be here today to present very positive results, because we showed the superiority of rivaroxaban over the low-molecular-weight heparin -- enoxaparin -- and in spite of this increased superiority it was possible to maintain safety regarding the risk of bleeding," Dr. Eriksson said at a press briefing on December 8.
Dr. Eriksson presented the results from the Regulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE (RECORD1) trial, which randomized 4,541 patients to rivaroxaban 10 mg beginning 6 to 8 hours after surgery and then once a day thereafter, or to enoxaparin 40 mg once daily, beginning the evening before surgery and restarting 6 to 8 hours after surgery, for 5 weeks after total hip replacement.
The trial's primary efficacy endpoint was a composite of any deep vein thrombosis (DVT), nonfatal pulmonary embolism (PE), and all-cause mortality. The rate of any DVT, PE, or death was 1.1% with rivaroxaban compared with 3.7% with enoxaparin. This difference was highly statistically significant (P <.001). Rates of major venous thromboembolism were 0.2% with rivaroxaban and 2% with enoxaparin (P <.001).
There was no significant difference in rates of major bleeding, the trial's main safety endpoint. Rivaroxaban was associated with a 0.27% rate of major bleeding, compared with 0.09% for enoxaparin (P =.178) Rates of nonmajor bleeding were the same for both drugs (5.8%).
Dr. Eriksson said he was astonished by the superiority results, given the well-established effectiveness of low-molecular-weight heparin against thromboembolic events.
He added there were no adverse cardiovascular events or hepatotoxicity associated with rivaroxaban treatment.
Dr. Eriksson predicted that rivaroxaban will be a boon to his orthopedic surgeon colleagues, enabling them to provide thromboprophylaxis more conveniently. "What we have had until now has been very cumbersome, what with the injections and the monitoring, and I think this will really help both physicians and patients."
Dr. Eriksson disclosed that he is a consultant and receives research funding from Bayer HealthCare AG, which is developing rivaroxaban with Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Presentation title: Oral Rivaroxaban Compared With Subcutaneous Enoxaparin for Extended Thromboprophylaxis After Total Hip Arthroplasty: The RECORD1 Trial. Abstract 6
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