Risk/Benefit Analysis for the Use and Approval of Thrombolytic, Antiarrhythmic, and Hypolipidemic Agents: Proceedings of the Ninth Annual Symposium on New Drugs and Devices, October 27 And 28 1988

The Symposium on New Drugs provides a forum for academic investigators, research and development personnel from the pharmaceutical industry and members of the Food and Drug Administration to discuss important clinical research issues. The Ninth Annual symposium on New Drugs addressed the problem of determining the risk versus benefit for use of three important classes of cardiovascular agents: thrombolytic, antiarrhythmic, and hypolipidemic agents. The use of thrombolytic agents has become one of the major advances in clinical intensive cardiologic care in the 1980s. While the lysis of clot(s) obstructing a major coronary artery should reverse or prevent the damage of acute myocardial ischemia and infarction, one must carefully consider the potential risks of such agents in regards to their potential benefits. The time when a thrombolytic agent should be administered to maximize benefit as well as how one defines a dose response relationship using intravenous critical care medicines were discussed as important clinical trial issues. The benefit versus risk data on currently available thrombolytic agents was reviewed and the potential roles for adjunctive agents addressed. Overall strategies regarding post- x thrombolytic care and relationships to sudden cardiac death were also detailed. The panel discussion sections provided a comprehensive view of the current thinking of the various participating groups in this symposium. Sudden cardiac death remains the number one cause of mortality in western industrialized societies. Front Matter....Pages i-xvi Front Matter....Pages 1-1 Measurement of Infarct Size: Effect of Reperfusion with Arterial Blood....Pages 3-13 Pitfalls in the Design and Evaluation of Clinical Trials of Intravenously Administered Cardiovascular Drugs....Pages 15-22 The Relative Benefit and Risks of Intravenous Streptokinase and Tissue Plasminogen Activator in Acute Myocardial Infarction....Pages 23-28 New Agents and New Insights for Thrombolytic Therapy in Acute Myocardial Infarction: Focus on Anistreplase, Urokinase, and Prourokinase....Pages 29-46 Myocardial Reperfusion: Role of Adjunctive Agents to Improve Reperfusion and Prevent Reperfusion Injury....Pages 47-58 Back Matter....Pages 59-89 Front Matter....Pages 91-91 Interactions between Thrombolysis and Sudden Cardiac Death....Pages 93-98 What are the Overall Strategies for Post-Thrombolytic Care That Include Use of Angioplasty?....Pages 99-108 Thrombolytic Agents: Biologic Properties and Issues Regarding Products Derived by Recombinant DNA Technology....Pages 109-116 Back Matter....Pages 117-142 Front Matter....Pages 143-143 What do New Anti-Arrhythmic Agents Have to Show to Establish a Favorable Risk versus Benefit Ratio....Pages 145-151 What do New Cardiovascular Agents (e.g. Antiarrhythmic Drugs) Have to Show to Establish a Favorable Risk versus Benefit Ratio to Obtain Approvability? — Clinical Viewpoint....Pages 153-156 Is It Practical to Develop a Class III Antiarrhythmic Agent?....Pages 157-166 Back Matter....Pages 167-198 Front Matter....Pages 199-199 What are the Recommendations to the Medical Community to Institute Hypolipidemic Therapy?....Pages 201-214 What are the Comparative Risks versus Benefits for Bile Acid Sequestrants, HMG Co-A Reductase Inhibitors, Nicotinic Acid, Probucol, and Fibric Acid Derivatives?....Pages 215-223 What Levels of Cholesterol should be Studied and What Should be the Study Designs?....Pages 225-231 Should a Change in the Atherosclerotic Process be Required for Approval of New Hypolipidemic Agents?....Pages 233-239 How and When Should Long-Term Safety Data be Obtained for Hypolipidemic Agents?....Pages 241-248 What is Required to Gain Approval of Lipid Altering Drugs?....Pages 249-251 Back Matter....Pages 253-278 Back Matter....Pages 279-301 Proceedings of the Ninth Annual Symposium on New Drugs & Devices, October 27 and 28, 1988