The Evaluation of Beta Blocker and Calcium Antagonist Drugs

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. Front Matter....Pages I-IX Introduction....Pages 1-6 Beta-Adrenoceptor Blocking Agents: Historical Perspectives....Pages 7-20 The Clinical Relevance of Beta-Receptor Blockade, Intrinsic Sympathomimetic Activity and Membrane Depressant Action....Pages 21-40 Pharmacokinetics and Pharmacodynamics of Beta-Blockers....Pages 41-61 Importance of Alpha Blocking and Vasodilator Effects of Beta Blocking Agents....Pages 63-71 Are Animal Models Useful in Determining if All Beta-Blocking Agents are the Same?....Pages 73-85 Moderator’s Comments on Beta Blocking Drugs....Pages 87-88 General Group Discussion — are All Beta-Blocking Agents the Same?....Pages 89-107 How to Define Beta-Blocker Usefulness in Hypertension: Is Ambulatory Monitoring Necessary?....Pages 109-124 Evaluation of Beta Blocking Agents in the Treatment of Angina Pectoris Due to Coronary Artery Disease....Pages 125-128 Beta Blocking Agents in the Treatment of Ventricular Arrhythmias....Pages 129-140 How to Define Beta Blocker Usefulness in Supraventricular Arrhythmias.....Pages 141-149 How to Define Beta-Blocker Usefulness in Hypertension, Angina and Arrhythmias: An Overview....Pages 151-156 General Group Discussion — How to Define Beta-Blocker Usefulness In:....Pages 157-182 Comparative Safety of Beta Blocking Drugs....Pages 183-188 Current Problems in the Evaluation of New Beta-Blocking Agents....Pages 189-196 General Group Discussion — Problems in Study Design....Pages 197-215 Remarks....Pages 217-230 Beta Blocker in Sudden Death Prevention....Pages 231-232 Do Beta-Blockers Prolong Life?....Pages 233-245 Clinical Trials to Prevent Sudden Death: What are the Problems in Study Design?....Pages 247-260 Who Should Fund Clinical Trials?....Pages 261-264 General Group Discussion — Beta Blockers in Sudden Death Prevention....Pages 265-287 Calcium Channel Blockers/Historical Perspectives....Pages 289-302 Comparative Clinical Pharmacology of Slow Channel Blocking Agents....Pages 303-311 The Electrophysiologic Differences of Calcium Antagonist Drugs....Pages 313-328 Clinical Differences Between The Calcium Channel Blocking Agents....Pages 329-340 General Group Discussion — Calcium Antagonists....Pages 341-352 How to Define Controlled Studies in Coronary Artery Spasm....Pages 353-366 Calcium Entry Blocking Agents: How to Define Controlled Studies in Patients With Arrhythmias....Pages 367-376 Evaluation of Beta Blockers and Calcium Antagonists in the Treatment of Hypertrophic Cardiomyopathy....Pages 377-379 Determination of the Safety of Calcium Antagonists in Combination with Beta-Adrenergic Blocking Agents — The Case for Circumscribed Clinical Trials....Pages 381-394 General Group Discussion — How to Define Controlled Studies In:....Pages 395-403 Back Matter....Pages 405-410