With the beginning of the 1980's it was becoming increasingly evident that the lack of approval of new cardiovascular agents for use by clinicians in the United States for the treatment of cardiovascular disorders was becoming a problem. Patients requiring medical therapy for hypertension, angina pectoris, arrhythmias, congestive heart failure, and vasospastic disorders of the coronary arteries could receive in the United States only a small number of the drugs available to physicians in the rest of the world. In fact, as the 1980's began, there was only one available beta blocking agent released by The Food and Drug Administration; and even as of this writing, no oral calcium antagonist agent. This lag, in part, has been due to the confusion of proper and expeditious methods to define safety and efficacy of such agents so that the United States regulatory agency (Food and Drug Administration) could approve the use of such agents by clinicians. The vast number of new beta blocker and calcium antagonist agents being developed, as well as the long-term use abroad of many new drugs, has raised important questions as to how relative safety and efficacy of such agents can be determined to facilitate availability in the United States.
Table of ContentsBeta-Adrenoceptor Blocking Agents: Historical Perspectives.- The Clinical Relevance of Beta-Receptor Blockade, Intrinsic Sympathomimetic Activity and Membrane Depressant Action.- Pharmacokinetics and Pharmacodynamics of Beta Blockers.- Importance of Alpha Blocking and Vasodilator Effects of Beta Blocking Agents.- Are Animal Models Useful in Determining if All Beta-Blocking Agents Are the Same.- Moderator’s Comments on Beta Blocking Drugs.- General Group Discussion: Are All Beta Blocking Agents the same.- How to Define Beta Blocker Usefulness in Hypertension Is Ambulatory Monitoring Necessary.- Evaluation of Beta Blocking Agents in the Treatment of Angina Pectoris Due to Coronary Artery Disease.- Beta Blocking Agents in the Treatment of Ventricular Arrhythmias.- How to Define Beta Blocker Usefulness in Supraventricular Arrhythmias.- How to Define Beta Blocker Usefulness in Hypertension, Angina and Arrhythmias: An Overview.- General Group Discussion: How to Define Beta Blocker Usefulness.- Comparative Safety of Beta Blocking Drugs.- Current Problems in the Evaluation of New Beta Blocking Agents.- General Group Discussion: Problems in Study Design.- Remarks by Commissioner of Food and Drugs.- Beta Blocker in Sudden Death Prevention.- Do Beta-Blockers Prolong Life.- Clinical Trials to Prevent Sudden Death: what Are the Problems in Study Design.- Who Should Fund Clinical Trials.- General Group Discussion: Beta Blockers in Sudden Death Prevention.- Calcium Channel Blockers/Historical Perspectives.- Comparative Clinical Pharmacology of Slow Channel Blocking Agents.- The Electrophysiologic Differences of Calcium Antagonist Drugs.- Clinical Differences Between the Calcium Channel Blocking Agents.- General Group Discussion: Calcium Antagonists.- How to Define Controlled Studies in Coronary Artery Spasm.- Calcium Entry Blocking Agents: How to Define Controlled Studies in Patients with Arrhythmias.- Evaluation of Beta Blockers and Calcium Antagonists in the Treatment of Hypertrophic Cardiomyopathy.- Determination of the Safety of Calcium Antagonists in Combination with Beta-Adrenergic Blocking Agents the Case for Circumscribed Clinical Trials.- General Group Discussion: How to Define Controlled Studies.- List of Participants.