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    Aspirin and Glycoprotein IIb/IIIa Inhibitors Subjects of Clinical Trials

    Researchers presented results of late-breaking clinical trials (part 3) on Tuesday, March 14, at the ACC's 49th Annual Meeting. Highlights of several studies include the following:

    A study presented by Allan M. Ross M.D., George Washington University Medical Center, compared the conventional form of the anticoagulant heparin to a low-molecular weight heparin called enoxaparin, for supplemental use in MI patients on recombinant tissue-plasminogen activator (rt-PA) or "clot buster" therapy. The HART-II trial (Heparins and Aspirin Reperfusion Therapy) involved about 400 patients in a randomized, multicenter trial. Heparin and aspirin are given to prevent clots in 'high-risk' patients, such as those who have had a heart attack (MI) or stroke.

    Patients were given intravenous unfractionated heparin or the low-molecular weight heparin (enoxaparin) as an initial bolus, followed by subsequent injections at 15 minutes, and then every 12 hours for a minimum of 72 hours.

    Results showed that patients treated with enoxaparin in conjunction with a clot lysing agent, rt-PA, "achieved equivalent artery patency at 90 minutes as compared with patients who received rt-PA and standard unfractionated heparin" In other words, low- molecular weight heparin appears to offer the same level of benefit as conventional heparin and in about the same amount of time. However, there was a trend toward higher rates of restored artery patency with enoxaparin, indicating the enoxaparin may be effective in more people. In addition, "Reocclusion rates within one week also trended strongly in favor of the enoxaparin group"

    "The results of HART II demonstrate that enoxaparin can be effectively substituted for standard unfractionated heparin as an adjunct to thrombolytic therapy for the treatment of a heart attack," said Dr. Ross.

    Editorial Comment: Low molecular weight heparins offer many advantages to standard unfractionated heparins. They are easier to administer and don't have many of the side effects of regular heparins, such as a reduced platelet count or increased bleeding. Low molecular weight heparins are likely to become more widely used after administration of rt-PA clot busters.

    Aspirin was compared to the drug sibrafiban, an oral glycoprotein IIB/IIIA receptor antagonist, in a clot-prevention trial. Robert Califf M.D., Duke University Medical Center, presented the results of the 2nd SYMPHONY trial. This study compared aspirin to the antiplatelet agent, sibrafiban in blood clot prevention for patients at risk for a second heart attack. Results suggest that aspirin is as effective as sibrafiban and causes fewer bleeding complications.

    A halted trial, 2nd SYMPHONY, tested the drug in 6,671 patients out of the planned 8,400. Compared to the first trial, the second SYMPHONY study gave one group a combination of aspirin and low-dose sibrafiban; the other two groups were again given only aspirin or only high-dose sibrafiban.

    Results from at least 6,671 patients reinforced those of the first study: all three groups had similar rates of death, second heart attacks, or recurrent ischemia after 30 days, when measured as "events" together (9.3 percent for aspirin; 9.2 percent for low-dose sibrafiban; and 10.5 percent for high-dose sibrafiban). But the high-dose sibrafiban group had higher mortality rates compared to the aspirin group - 2.4 percent vs.1.3 percent. The same trend was observed when second heart attacks were measured alone. Aspirin caused fewer major bleeding events than high-dose sibrafiban, or low-dose sibrafiban plus aspirin.

    The results suggest that aspirin is as effective in preventing blood clots in these high-risk patients as sibrafiban in either low or high doses and does so with fewer bleeding problems.

    Editorial Comment: The platelet is an integral part of blood clots that form in heart attacks. We now have several antiplatelet drugs that have different mechanisms of action: Aspirin and sibrafiban are two examples, and this study suggests that we have not yet found anything superior to aspirin.

    Finally, Dr. James E. Tcheng, Duke Clinical Research Institute, presented results of the ESPRIT trial (Enhanced Suppression of the Platelet IIb/IIIA Receptor with Integrilin Therapy). The study was designed to determine the effects of a preventative approach that keeps platelets from building blood clots in patients undergoing coronary stenting. Traditionally, glycoprotein IIb/IIIa receptor blockers are administered only after a clot has formed and blocks the flow of blood in coronary arteries. Even then, only three-fourths of patients undergoing coronary stenting and angioplasty receive the drugs due to their high cost.

    Results of the double-blind, randomized, placebo-controlled trial of 2,064 patients showed that eptifibatide (Integrilin) reduced the number of deaths and heart attacks by 40 percent (after 48 hours) compared to placebo.

    Editorial Comment: Integrilin is a small peptide like sibrafiban but is more specific in its action. Earlier trials such as the IMPACT trial suggested the efficacy of this agent in reducing ischemic events. As we refine these drugs to increase their specificity, we may be able to reduce side effects, but this remains to be demonstrated. The benefit over aspirin needs to be clear, as the cost differential is huge. is not a comercial or official site. all opinions provided at drugsboat are personal opinions and should not be taken too seriously, but considered. drugsboat holds no responsibility for any negative consequences of it's contents. information is here free for taking, it's visitor's responsibility to use it in a proper way.