In Harch of 1980, we organized the first symposium on how to evaluate new antiarrhythmic agents in which the participants included members of the Cardio-Renal Division of the Food and Drug Administration, academic investigators from the United States and Abroad and directors and imple- mentors of pharmacological research representing the pharmaceutical industry. By bringing together all three elements, it was hoped that better communication and under- standing would ensue to more rapidly bring new cardiac agents to the American public. This goal was important since a rather limited number of antiarrhythmic agents were and are currently available to treat patients with such disorders in the United States. These agents are needed not only for the treatment of patients with sustained ventricular tachyarrhythmias which produce life-threatening hemodynamic consequences but also and in fact more potentially important as a prophylactic measure in the high risk patient subject to sudden cardiac death.
This book represents the proceedings of the third of these Symposiums whose purpose was to evaluate the clinical research methodology and models used in the evaluation of ne" antiarrhythmic agents for not only acute therapeutic inter- vention but also for the prophylaxis of sudden cardiac death. In addition, new devices have evolved over the past few years that can detect and treat life-threatening cardiac arrhythmias and the evaluation of efficacy and safety of these devices is detailed.
New Antiarrhythmic Agents: Basic Considerations.- Do animal models predict results in man?.- Application of pharmacologic principles in the evaluation of new antiarrhythmic agents.- Characterization of antiarrhythmic drugs.- Panel Discussion: New antiarrhythmic agents: basic considerations.- Efficacy Models For Patients With Chronic Ventricular Arrhythmias.- How should ventricular arrhythmias be classified and which patients should be treated?.- Study design for patients with chronic ventricular ectopy: determination of efficacy and tolerance.- Chronic tolerance to antiarrhythmic therapy How to handle emergency drug requests.- Panel Discussion: Efficacy models for patients with chronic ventricular arrhythmias.- Efficacy Models: Acute Ventricular Arrhythmias.- The value of electrophysiologic testing in predicting long-term efficacy of antiarrhythmic drugs in patients with life-threatening ventricular arrhythmias.- Efficacy models: acute ventricular arrhythmias.- A look to the future: outpatient placebo controlled trials of antiarrhythmic drug efficacy in patients with life-threatening ventricular arrhythmias.- Panel Discussion: Efficacy models: acute ventricular arrhythmias.- Sudden Death: Can it Now be Used as an Endpoint?.- Protocol design for sudden death prevention.- Do beta blockers prevent sudden cardiac death?.- Does non beta-blocking antiarrhythmic therapy prevent sudden cardiac death?.- Current problems in the evaluation and approval of new antiarrhythmic agents.- Panel Discussion: Sudden death: can it now be used as an endpoint?.- New Devices: Pacemakers in the Treatment of Arrhythmias and Prevention of Sudden Cardiac Death.- New devices: pacemakers in the treatment of arrhythmias and prevention of sudden cardiac death.- Transvenous cardioversion to treat tachyarrhythmias.- The role of permanently implanted pacemakers in the therapy of recurrent tachyarrhythmias.- Clinical evaluation of an implantable automatic cardioverter defibrillator.- Evaluation of devices for the prevention of sudden death: study design for safety and efficacy of the devices.- New device approval by the Food and Drug Administration.- Panel Discussion: New devices: pacemakers in the treatment of arrhythmias and prevention of sudden cardiac death.- New Cardiac Inotropic Agents.- Pharmacologic principles in the use of new inotropic agents.- The clinical assessment of A inotropic drugs.- Panel Discussion: New cardiac inotropic agents.- Conclusion: Remarks by Arthur Hull Hayes, Jr., Commissioner of Food and Drugs.- List of Participants.
Series: Developments in Cardiovascular Medicine
Number Of Pages: 302
Published: December 2009
Publisher: Kluwer Academic Publishers
Country of Publication: US
Dimensions (cm): 23.5 x 15.5
Weight (kg): 1.39