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

The Symposium on New Drugs provides for an annual forum for academic investigators, research and development personnel from the pharmaceutical and related health care industries, and members of the Food and Drug Administration to discuss important clinical research issues. The Tenth Annual Symposium on New Drugs addressed the problem of whether it was still appropriate to approve antihypertensive agents soley on the endpoint of lowering cuff blood pressure. The initial discussions at this symposium related to the approaches and methods to studying antihypertensive agents. Dr. William Frishman provided a detailed list of the new approaches to the treatment of hypertension and pointed out the many new concepts that are currently active in the development of many new antihypertensive agents. Dr. William White detailed the growing importance of ambulatory blood pressure monitoring to define hypertension and to determine the change in blood pressure due to pharmacologically active agents. Dr. Jay Cohn pointed out the flaws in using cuff blood pressure and detailed the potential virtues of using vascular compliance to identify patients requiring treatment for hypertension. Dr. Thomas Pickering also discussed the potential value of evaluating changes in left ventricular hypertrophy a finding which identifies high risk patients who need to be included in clinical trials. Dr. Michael Weber detailed the issues and suggested refinements in the approaches to clinical trial designs for antihypertensive agents and Dr. Raymond Lipicky discussed the definition of dose-duration and the role of non-Mem and Peak/Through measurements in defining an antihypertensive drug effect.

Inhalt

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.