The new data published in the New England Journal of Medicine demonstrate that antiarrhythmic medication Cordarone I.V. (amiodarone HCl) is almost twice as effective as lidocaine in improving survival-to-hospital admission in cardiac arrest patients with shock-refractory ventricular fibrillation (VF)/pulseless ventricular tachycardia (VT), Wyeth reported.
Cordarone I.V. (amiodarone HCl) was approved by the Food and Drug Administration (FDA) in August 1995 for the treatment and prophylaxis of frequently recurring VF and hemodynamically unstable VT in patients refractory to other therapy. 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
The Alive (Amiodarone vs. Lidocaine In Ventricular fibrillation Evaluation) trial found 22.8 percent of patients with VF/pulseless VT resistant to defibrillation survived to hospital admission after the administration of Cordarone I.V., vs. 12 percent who received lidocaine (p=.008).
At least 250,000 people die each year of cardiac arrest within one hour of onset of symptoms and before they reach the hospital. Cardiac arrest particularly in theprehospital setting has a very poor survival rate. These sudden deaths are often caused by VF.
Prior to the publication of Alive, the ACLS guidelines published in the August 2000 issue of Circulation positioned Cordarone I.V. within the standard of care for the management of cardiac arrest due to shock-refractory VF/pulseless ventricular tachycardia (VT). Cordarone I.V. received the highest recommendation given to any antiarrhythmic agent for cardiac arrest (class IIb - acceptable and useful). Lidocaine, without adequate evidence to support a recommendation, was rated "indeterminate". The data supporting Cordarone I.V. challenges the long-standing practice of administering lidocaine in shock refractory VF/pulseless VT.
"This study, coupled with the ACLS recommendation provides overwhelming evidence to support the position of Cordarone I.V. (amiodarone HCl) as a first-line antiarrhythmic agent for cardiac arrest due to shock refractory VF/pulseless VT patients in emergency cardiac care settings," said Bramah N. Singh, M.D., Professor of Medicine at the UCLA School of Medicine. "While many professionals in the medical community continue to use lidocaine, these findings provide provocative evidence to use Cordarone I.V. instead of lidocaine in this patient population."
The Alive trial, which was a double blind, randomized trial evaluated approximately 350 patients with shock refractory VF/pulseless VT, also found that among patients who received drug treatment in 24 minutes or less, survival to hospital admission was 28 percent after administration of Cordarone(r) I.V. (amiodarone HCl) vs. 15 percent after lidocaine (P=0.005). Survival to hospital discharge was evaluated as a secondary endpoint.
A total of 9 patients treated with Cordarone I.V. survived to hospital discharge vs. 5 patients treated with lidocaine (p=NS). In this study, Cordarone I.V. (amiodarone HCl) was administered as a bolus dose of 5 mg/kg, and IV lidocaine was administered at 1.5 mg/kg. When necessary, a second bolus dose of study drug was administered (2.5 mg/kg of IV amiodarone or 1.5 mg/kg of lidocaine). The study was conducted by Toronto Emergency System paramedics. The Alive trial received recognition at AHA Scientific Sessions from the Council on Cardiopulmonary and Critical Care as the "2001 Critical Care Best Abstract."
"This groundbreaking study comes on the heels of the landmark Arrest trial, which found that Cordarone I.V. increased survival-to-hospital admission rates by 29 percent vs. placebo in patients with cardiac arrest due to VF/pulseless VT," says Harold Marder, M.D., senior vice president medical affairs and medical director, Wyeth Pharmaceuticals. "Supporting trials such as Alive is integral to our core values at Wyeth. Studies such as this establish the utility of our product and help establish goals for future studies. We are pleased with the results of the Alive trial."