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NASPE: Intravenous Cordarone (Amiodarone HCl) Appears Superior to Lidocaine for Treatment of Ventricular Fibrillation MADISON, NJ -- May 8, 2001 -- American Home Products Corporation announced today that new data clearly demonstrated that its antiarrhythmic medication Cordarone® I.V (amiodarone HCl) improved survival-to-hospital admission at twice the rate of lidocaine. Although lidocaine remains an acceptable treatment according to the 2000 ACLS guidelines, the guidelines state that the evidence to support its use as a first-line antiarrhythmic in the acute treatment of ventricular fibrillation (VF) remains poor and methodologically weak. This first head-to-head, randomized, controlled study comparing amiodarone HCl and lidocaine was presented on Saturday, May 5, 2001 at the North American Society of Pacing and Electrophysiology (NASPE) 22nd Annual Scientific Sessions. More specifically, the ALIVE (Amiodarone vs. Lidocaine In Ventricular fibrillation Evaluation) trial, which evaluated approximately 350 patients, found that following the administration of Cordarone I.V., 22.7 percent of patients with shock resistant ventricular fibrillation survived to hospital admission vs. 11 percent who received lidocaine, representing a 52 percent risk reduction (p<0.0043). Among patients who received drug treatment in less than or equal to 24 minutes (earlier than the median time to study drug), survival to hospital admission was 29.1 percent after administration of Cordarone I.V. vs. 15 percent after lidocaine (p<0.02). In this study, Cordarone I.V. was administered as a bolus dose of 5mg/kg, with a maximum dose of 600 mgs per patient. The study was assessed through the Metropolitan Toronto EMS System in Toronto, Ontario. "This groundbreaking study provides us with further evidence of the importance of Cordarone I.V. as a first-line antiarrhythmic for individuals who experience out-of-hospital cardiac arrest due to shock-resistant VF/pulseless ventricular tachycardia (VT)," says Harold Marder, M.D., Senior Vice President Medical Affairs and Medical Director, Wyeth-Ayerst Laboratories. "This is the second study to demonstrate a significant improvement in survival to hospital admission for Cordarone IV - confirming the results seen in the landmark ARREST (Amiodarone in out-of-hospital Resuscitation of REfractory Sustained ventricular Tachyarrhythmias) trial, which was published in the New England Journal of Medicine. More than one million Americans suffer from heart attack each year, and Cordarone I.V. offers hope for those patients who need an antiarrhythmic agent." A critical appraisal of the scientific literature supports the administration of Cordarone I.V. before lidocaine in the management of cardiac arrest due to VF/pulseless VT. This represents a significant change to the long-standing practice of administering lidocaine as the first antiarrhythmic to virtually everyone suffering cardiac arrest. In fact, in the ACLS guidelines published in the August 2000 issue of Circulation, Cordarone I.V. received the highest classification (IIb) given to any antiarrhythmic agent for VF/pulseless VT -- whereas lidocaine was classified as "indeterminate." The inclusion of Cordarone I.V. within the guidelines was based on an exhaustive review of the worldwide body of scientific data by the AHA Emergency Cardiovascular Committee. The most notable study is the ARREST trial, which demonstrated an increase in survival-to-hospital admission rates by 29 percent when Cordarone I.V. was administered in the first critical minutes of cardiac arrest due to persistent VF/pulseless VT. At least 250,000 people die each year of a cardiac arrest within one hour of onset of symptoms and before they reach the hospital. Cardiac arrest particularly in the prehospital setting has a very poor survival rate. These sudden deaths are often caused by VF. Cordarone I.V. was approved by the Food and Drug Administration (FDA) in September 1995 for the treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT). Benefits of Cordarone I.V. include rapid onset of action, convenient transition to oral therapy, and a manageable side-effect profile. Cordarone I.V. is the most widely studied antiarrhythmic agent among those included in the 2000 ACLS guidelines and is the only ACLS antiarrhythmic drug to be studied in randomized, placebo-controlled trials. Cordarone I.V. is marketed by Wyeth-Ayerst Laboratories (AHP's pharmaceutical division). Cordarone I.V. is contraindicated in patients with cardiogenic shock, marked sinus bradycardia, and second- or third degree AV block in the absence of a functioning pacemaker. Hypotension is the most common adverse effect seen with Cordarone I.V. and may be related to the rate of infusion. The most important treatment-emergent adverse effects are hypotension (16 percent), bradycardia (4.9 percent), liver function test abnormalities (3.4 percent), cardiac arrest (2.9 percent), VT (2.4 percent), congestive heart failure (2.1 percent), cardiogenic shock (1.3 percent), and AV block (0.5 percent). SOURCE: American Home Products Corporation Related Link: American Home Products Corporation. 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