Use and Approval of Antihypertensive Agents and Surrogate Endpoints for the Approval of Drugs Affecting Antiarrhythmic Heart Failure and Hypolipidemia

I. Approaches and Methods to Studying Antihypertensive Drugs.- 1. New concepts in antihypertensive drug therapy.- 2. Is ambulatory blood pressure monitoring required to define the hypertensive patient and to detect efficacy?.- 3. What vascular effects should be measured in antihypertensive drug research?.- 4. Is it necessary to demonstrate changes in left ventricular hypertrophy in the evaluation of antihypertensive drugs?.- 5. Clinical trials of antihypertensive agents.- 6. How does one define dose-duration of an antihypertensive drug? What is the role of non-Mem and the Peak/Through measurement.- Panel Discussion on Hypertension Methodology.- II. What Should be Required for FDA Approvability of a New Antihypertensive Drug?.- 7. What have we learned from prior clinical trials of antihypertensive drug therapy?.- 8. Are specific studies in elderly patients required for FDA approvability of a new antihypertensive drug?.- 9. Do we need any more antihypertensive drugs: The validity of a change in blood pressure as the only endpoint for approvability?.- 10. The cost and time to develop a new antihypertensive drug depending upon the endpoint.- Panel Discussion on Hypertensive Trial Design Issues.- III. Surrogate Endpoints to Define Risk VS. Benefits.- 11. What should be required for FDA approvability of a new antihypertensive drug? What is the FDA's viewpoint?.- 12. Are there valid surrogate endpoints for mortality that can be used to evaluate the effects of antiarrhythmic drug therapy?.- Panel Discussion on Surrogate Endpoints: Antiarrhythmic Agents.- 13. How to demonstrate the efficacy of a new drug for the treatment of chronic heart failure.- Panel Discussion on Surrogate Endpoints: Congestive Heart Failure Agents.- 14. Testing the relationship between cholesterol lowering and cardiovascular disease - past, present, and prospects.- Panel Discussion on Surrogate Endpoints: Hypolipidemic Agents.- Participant List.