Risk/Benefit Analysis for the Use and Approval of Thrombolytic, Antiarrhythmic, and Hypolipidemic Agents

I. Thrombolytic Agents: Clinical Trials ISSUES.- 1. Measurement of infarct size: effect of reperfusion with arterial blood.- 2. Pitfalls in the design and evaluation of clinical trials of intravenously administered cardiovascular drugs.- 3. The relative benefit and risks of intravenous streptokinase and tissue plasminogen activator in acute myocardial infarction.- 4. New agents and new insights for thrombolytic therapy in acute myocardial infarction: focus on anistreplase, urokinase, and prourokinase.- 5. Myocardial reperfusion: Role of adjunctive agents to improve reperfusion and prevent reperfusion injury.- Panel Discussion.- II. Thrombolytic Agents: Adjunctive Issues.- 6. Interactions between thrombolysis and sudden cardiac death.- 7. What are the overall strategies for post-thrombolytic care that include use of angioplasty?.- 8. Thrombolytic agents: biologic properties and issues regarding products derived by recombinant DNA technology.- Panel Discussion.- III. Risk vs. Benefit for Antiarrhythmic Drugs.- 9. What do new anti-arrhythmic agents have to show to establish a favorable risk versus benefit ratio?.- 10. 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.- 11. Is it practical to develop a class III antiarrhythmic agent?.- Panel Discussion.- IV. Hypolipidemic Agents: Clinical & Regulatory Issues.- 12. What are the recommendations to the medical community to institute hypolipidemic therapy?.- 13. What are the comparative risks versus benefits for bile acid sequestrants, HMG CO-A reductase inhibitors, nicotinic acid, probucol, and fibric acid derivatives?.- 14. What levels of cholesterol should be studied and what should be the study designs?.- 15. Should a change in the atherosclerotic process be required for approval of new hypolipidemic agents?.- 16. How and when should long-term safety data be obtained for hypolipidemic agents?.- 17. What is required to gain approval of lipid altering drugs?.- Panel Discussion.- Participant List.