מתוך medicontext.co.il
NEW ORLEANS (Reuters Health) – Pentasaccharide, the first selective factor Xa inhibitor, is better than enoxaparin for prevention of venous thromboembolism (VTE) in patients who have undergone total hip replacement, according to the combined results of four phase III trials.
Principal investigator Dr. Paul Peters, Jr., of the University of Texas Southwestern Medical Center at Dallas, Texas, presented the results at the 87th Clinical Congress of the American College of Surgeons. Pentasaccharide, also known as fondaparinux sodium, has been assigned the trade name Arixtra by the manufacturer, Organon Sanofi-Synthelabo.
The four trials (Pentathlon 2000, PentaMaks, Penthifra, and Ephesus) were conducted at more than 300 centers worldwide and enrolled 7344 patients. All trials used the same study design, Dr. Peters said.
Patients were randomized to receive pentasaccharide 2.5 mg SC once daily postoperatively, enoxaparin 30 mg twice daily postoperatively, or enoxaparin 40 mg once daily starting preoperatively. The patients were continued on the therapy for an average of 7 days or until they underwent mandatory bilateral venogram at least 5 days postoperatively.
The primary efficacy endpoint of all the trials was a composite of symptomatic deep vein thrombosis and/or DVT and pulmonary embolism diagnosed by bilateral venography at day 11 or at discharge, but not earlier than 5 days postoperatively.
The incidence of VTE up to day 11 was reduced by pentasaccharide in each study, although compared to enoxaparin the reduction was not statistically significant in the Pentathlon 2000 study. The relative risk reduction for VTE was 55% in the PentaMaks trial and 56% in both Ephesus and Penthifra.
"As an orthopedic surgeon, I can tell you this is a good drug that is well tolerated," Dr. Peters said. "If you consider the combined results of the trials, this drug is 50% better than enoxaparin, which is considered superior to heparin."
Dr. William Haines, medical liaison for Organon, told Reuters Health that the company has an approvable letter for pentasaccharide from the US Food and Drug Administration and the drug is expected to receive final approval by late November.
Pentasaccharide is designed to bind to antithrombin with high affinity, producing a conformational change in antithrombin that allows antithrombin to bind to factor Xa.
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