Pharmacy & Therapeutics - September 2008 - (Page CB3)

Study Highlights TITLE Enoxaparin Versus Unfractionated Heparin with Fibrinolysis for ST-elevation Myocardial Infarction (ExTRACT-TIMI 25). N Engl J Med. 2006;354:1477-1488. OBJECTIVE Anticoagulation therapy with unfractionated heparin (UFH) often is used as an adjunct to ﬁbrinolysis in patients with ST-elevation myocardial infarction (STEMI). This study compared Lovenox® (enoxaparin sodium injection), a low-molecular-weight heparin (LMWH), with UFH for this purpose. STUDY PARAMETERS This was a randomized, double-blind, double-dummy study that enrolled patients (n=20,506) with STEMI to be treated with ﬁbrinolysis. Patients were randomly assigned to receive Lovenox throughout the index hospitalization, or weight-based UFH for at least 48 hours. Death or nonfatal MI through 30 days was the primary efﬁcacy endpoint of the study. RESULTS Lovenox reduced the incidence of the primary efﬁcacy endpoint compared with UFH (9.9% vs. 12.0%, respectively; relative risk reduction [RRR]=17%; P<.001). Nonfatal reinfarction occurred in 4.5% of patients in the UFH group and 3.0% in the Lovenox group (RRR=33%; P<.001). The composite of death, nonfatal reinfarction, or urgent revascularization occurred less often with Lovenox than UFH (11.7% vs. 14.5%; P<.001). Major bleeding (nonfatal, nonintracranial) occurred more often with Lovenox than UFH (2.1% vs. 1.4%; P<.001), but the composite of death, nonfatal reinfarction, or nonfatal intracranial hemorrhage (ICH), occurred less often with Lovenox than UFH (10.1% vs. 12.2%; P<.001), indicating a net clinical beneﬁt in favor of Lovenox. CONCLUSION For patients being treated with ﬁbrinolysis for STEMI, Lovenox throughout the index hospitalization is superior to treatment with UFH for at least 48 hours, and although it is associated with an increase in major bleeding episodes, the net clinical beneﬁt of Lovenox compared to UFH is positive. Clinical Insights Charles V. Pollack, Jr., MD Professor of Emergency Medicine University of Pennsylvania School of Medicine Fibrinolytic therapy represents foundation reperfusion therapy for patients with STEMI. This large study looked at Lovenox versus UFH as adjuvant anticoagulation for patients with STEMI receiving ﬁbrinolysis. The results of the study show that regardless of the ﬁbrinolytic used, regardless of patient age or infarct location, patients who received Lovenox experienced a reduction in ischemic outcomes as measured by a wide variety of endpoints. On the primary endpoint of death or recurrent MI, those treated with Lovenox had a 17% RRR. Although major bleeding (nonfatal, non-hemorrhagic stroke) was more common with Lovenox, the absolute numbers of bleeding complications were small, and there was no increase in ICH. Importantly, net clinical beneﬁt—which balances both efﬁcacy and safety results—favored Lovenox. On balance, if 1,000 STEMI patients are treated with Lovenox when receiving lytic therapy, there will be 15 fewer nonfatal infarctions, a reduction of 7 episodes of urgent revascularization, and 6 fewer deaths, albeit at the expense of 4 more episodes of major bleeding. The results of the ExTRACT study showed that for patients with STEMI treated with a ﬁbrinolytic, Lovenox was superior to UFH. Please see important safety information on back page. Please see accompanying full prescribing information for LOVENOX, including boxed WARNING. 3

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Pharmacy & Therapeutics - September 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Effect of Prescription Copays on Adherence and Treatment Failure with Oral Antidiabetic Medications Vaccine Declinations Present New Challenges for Public Health Universal Health Care in America Digestive Disease Week and American Diabetes Association Pharmaceutical Approval Update

Pharmacy & Therapeutics - September 2008

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