>>CAMBRIDGE, Mass.--(BW HealthWire)--Feb. 12, 2002--The Medicines Company (NASDAQ: MDCO - news) announced today that an analysis of the TIMI-8 trial, a Phase 3 clinical trial conducted in 1994 comparing ANGIOMAX® (bivalirudin) to heparin in patients with unstable angina or non-ST-elevation myocardial infarction has been published in the American Heart Journal. The article, titled ``Bivalirudin as a replacement for unfractionated heparin in unstable angina/non-ST-elevation myocardial infarction: Observations from the TIMI-8 trial'' was written by Dr. Elliott Antman et al and reports data from the Phase 3 trial, which was a randomized, double-blind trial in 133 patients. In the trial, major events consisting of death, MI and major hemorrhage were studied.
Through 14 days or hospital discharge (whichever came first) the rate of any major event was 13.8% in the heparin arm and 2.9% in the ANGIOMAX arm (p = .03 by the Fisher exact test). When examined through 30 days, the difference in the results between the two agents increased, with a rate of major events of 16.9% in the heparin arm and 4.4% in the ANGIOMAX arm (p = .024 by the Fisher exact test). The authors also noted that the results of the trial demonstrated a significantly greater number of ANGIOMAX-treated patients achieving target anticoagulation (measured by aPTT) in the first 72 hours after dosing as compared to the heparin-treated patients (p less than .001). At the time interval between 48 and 72 hours, 42.4% of the heparin treated patients and 81.1% of the Angiomax treated patients were in the aPPT target range of between 55 and 85 seconds.
In an accompanying editorial, Professor Harvey White stated, ``Bivalirudin is the first anticoagulant approved by the US Food and Drug Administration for use in patients undergoing percutaneous coronary intervention, where it has been shown to be superior to heparin. Although there is clearly a need for more data regarding bivalirudin use in patients with other indications, the evidence is mounting that this agent provides an unprecedented net clinical benefit by uncoupling efficacy and bleeding. Bivalirudin may well become the foundation anticoagulant for use in patients with acute coronary syndromes.''
In the TIMI-8 trial, 133 unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI) patients out of the planned 5,320 were enrolled, with 65 receiving heparin and 68 receiving ANGIOMAX. The primary efficacy endpoint was a composite of all-cause mortality or nonfatal recurrent myocardial infarction (MI) through hospital discharge or 14 days, whichever came first, with a safety endpoint of major hemorrhage. The primary endpoint of death or recurrent MI was 9.2% in the heparin arm and 2.9% in the ANGIOMAX arm through 14 days (p = .16 using the Fisher exact test), while major hemorrhage occurred in 2.9% of patients in the heparin arm and no patients in the ANGIOMAX arm (p = .11 using the Fisher exact test). This 1994 study conducted by Biogen, Inc. was terminated early for business reasons and was not reported until the Antman article was published this week. The Medicines Company licensed ANGIOMAX in 1997 and successfully developed the product for commercialization.
``This study confirms the predictable nature of anticoagulation with ANGIOMAX beyond the cardiac cath lab,'' said Clive Meanwell, M.D., Ph.D., Executive Chairman of The Medicines Company. ``We continue to be encouraged by the growing evidence of potential benefit of ANGIOMAX in a broad range of hospital uses.''
ANGIOMAX is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA) and is not approved as a therapy for patients with acute coronary syndromes not undergoing angioplasty. ANGIOMAX is intended for use with aspirin. The most common (greater than or equal to 10%) adverse events for ANGIOMAX were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the ANGIOMAX and heparin groups. ANGIOMAX is contraindicated in patients with active major bleeding or hypersensitivity to ANGIOMAX or its components. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of ANGIOMAX administration.<<
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Cheers, Tuck |
