Title | Use and Approval of Antihypertensive Agents and Surrogate Endpoints for the Approval of Drugs Affecting Antiarrhythmic Heart Failure and Hypolipidemia [electronic resource] : Proceedings of the Tenth Annual Symposium on New Drugs & Devices, October 31 - November 1, 1989 / edited by Joel Morganroth, E. Neil Moore |
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Imprint | Boston, MA : Springer US, 1990 |
Connect to | http://dx.doi.org/10.1007/978-1-4613-1505-6 |
Descript | X, 230 p. online resource |
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 -- 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 -- III. Surrogate Endpoints to Define Risk VS. Benefits -- 11. What should be required for FDA approvability of a new antihypertensive drug? What is the FDAโs viewpoint? -- 12. Are there valid surrogate endpoints for mortality that can be used to evaluate the effects of antiarrhythmic drug therapy? -- 13. How to demonstrate the efficacy of a new drug for the treatment of chronic heart failure -- 14. Testing the relationship between cholesterol lowering and cardiovascular disease โ past, present, and prospects -- Participant List