Comment Summary

The Vytorin controversy has stirred debate as to whether reduction of cholestrol and LDL cholesterol and stabilization and/or reduction of carotid artery plaque are valid endpoints for clinical trials. Do you believe that cholesterol lowering drugs should be approved as long as they demonstrate safe reduction of cholesterol and LDL cholesterol and stabilization/reduction of carotid artery plaque, or must the drugs also have to demonstrate reduction of myocardial infarction incidence to be approved by the FDA?
#	Response Date	Other (please specify)
1.	4/22/2008 6:15:00 PM	should prove reduction in any of several CV endpoints, eg, cva, mi, death
2.	4/22/2008 8:56:00 PM	depends on the drug class and mechanism
3.	4/22/2008 9:45:00 PM	and stroke
4.	4/22/2008 10:03:00 PM	L;wer mortality
5.	4/23/2008 2:37:00 PM	Should show decreased MI/Stroke or CV death in treatment group
6.	5/2/2008 1:52:00 AM	LDL lowering is enough unless the mechanism is bad or there are real safety concerns