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

Proceedings of the Ninth Annual Symposium on New Drugs & Devices, October 27 & 28, 1988

Häftad, Engelska, 2011

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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.

Produktinformation

Utgivningsdatum2011-10-10
Mått155 x 235 x 18 mm
Vikt487 g
FormatHäftad
SpråkEngelska
SerieDevelopments in Cardiovascular Medicine
Antal sidor298
FörlagSpringer-Verlag New York Inc.
ISBN9781461288886

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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 studydesigns?.- 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.