The Evaluation of New Antiarrhythmic Drugs [antikvár]

preface In March of 19 80, it was evident that a host of new antiarrhythmic agents were being evaluated in the United States and that most were proceeding down very different pathways in their process of evaluation. In part, this was due to a lack of preciseness of the Food and Drug Administration's guidelines for the evaluation of new antiarrhythmic agents and in larger part, to the different approaches of investigators who were usually infatuated with a particular model of study. Thus, the setting was ripe for similar antiarrhythmic agents to be studied using markedly different methods causing confusion and possible delay in their approval by the Federal Government for marketing. Pre-clinical animal models of a variety of types were utilized in different ways by different scientists as was the primary thrust of clinical evaluation with some centers being limited to invasive electrophysiologic studies while others used primarily noninvasive ambulatory monitoring and exercise testing models. Since the United States' physicians have a rather limited drug armamentarium to treat patients with cardiac arrhythmias, we feel, as do others, that a concerted effort should be made to speed the process of obtaining approval of new antiarrhythmic agents. Such agents are needed not only for the treatment of patients with life-threatening ventricular arrhythmias but also, potentially most important, for the prophylaxis of sudden cardiac death in a high-risk population with electrical instability.