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TitleRisk/Benefit Analysis for the Use and Approval of Thrombolytic, Antiarrhythmic, and Hypolipidemic Agents [electronic resource] : Proceedings of the Ninth Annual Symposium on New Drugs & Devices, October 27 & 28, 1988 / edited by Joel Morganroth, E. Neil Moore
ImprintBoston, MA : Springer US, 1989
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Descript XVIII, 298 p. online resource


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


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? โ{128}{148} 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

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