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Biotech / Medical : Biotech success, 2002 -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (103)	10/29/2002 2:00:22 PM
From: Biomaven	Read Replies (1) \| Respond to of 117

<Exanta> Those are quite some p values! This is particularly instructive, because an earlier trial against warfarin didn't reach significance, allegedly because the warfarin dosing in the trial was too well controlled: AAOS: Ximelagatran Fails to Demonstrate Statistically Significant Superiority Over Warfarin in Pivotal Trial By Peggy Peck Special to DG News DALLAS, TX -- February 18, 2002 -- In a pivotal North American trial comparing the investigational oral direct thrombin inhibitor, ximelagatran, to warfarin for prevention of venous thromboembolism (VTE) following total knee arthroplasty, the overall VTE rate for ximelagatran was less than the rate in the warfarin group but the investigational drug failed to demonstrate significant superiority. The study was presented Sunday at the 69th Annual Meeting of the American Academy of Orthopaedic Surgeons. But lead investigator, Dr. Clifford W. Colwell, Jr. of Scripps Clinic, La Jolla, California, said that the outcome was due to an unforeseen aspect of the trials design -- exceptionally good warfarin control. "Warfarin can prevent DTE if it is tightly controlled and carefully monitored. That is exactly what happened in this study. In the warfarin arm the VTE rate was 25.7 percent, which is much, much better than the 40 percent to 45 percent rate in other warfarin trials." Dr. Colwell said that although 74 centers participated in the study, which randomized 680 patients to ximelagatran or warfarin, "all of the warfarin was run out of a central area. So this high quality warfarin dosing got very, very good results." The study is being run again, and "we’ll have results of this new trial by the end of March. I fully expect the new study to demonstrate statistically significant superiority", Dr. Colwell said. In the study the average age of patients was 68 years, and 63 percent were women. Patients were randomized to receive either ximelagatran 24 mg bid or oral warfarin qid for seven to 12 days. In the warfarin arm dosing was initiated the evening prior to surgery while ximelagatran was started the morning after surgery. Of the 680 patients randomized, 675 received at least one dose of the study drug and 537 had adequate venography or symptomatic VTE. The proximal VTE/PE rate was 3.3 percent for ximelagatran and 5.0 percent for warfarin. Dr. Richard E. Jones of Dallas, Texas, who served as a moderator of the session at which Dr. Colwell presented the findings, noted that low-molecular weight heparin (enoxaparin) is still being widely promoted for VTE prophylaxis yet many orthopedic surgeons are reluctant to use it, relying instead on warfarin. "In light of that experience, is ximelagatran the 'Holy Grail' of VTE prevention?" Dr. Jones asked Dr. Colwell. Dr. Colwell replied that he does not like terms such as "Holy Grail" but he said that most orthopedic surgeons are eager to have an easy, reliable, oral agent to prevent VTE. He illustrated the point by asking orthopedic surgeons in the audience for a show of hands if they wanted an easy dosing oral agent for VTE prevention. Every hand shot up in response. AstraZeneca Pharmaceuticals funded the study. pslgroup.com So here we see one big difference between pharma and biotech - pharma can afford multiple, simultaneous large trials, so if one fails they have a backup. Peter