Comment Summary

The Vytorin controversy has created debate as to whether reduction of cholestrol and LDL cholesterol is a valid endpoint 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, or the drugs first have to be shown to reduce or stabilize carotid artery plaque before being approved by the FDA?
#	Response Date	Other (please specify)
1.	4/22/2008 4:56:00 PM	I think reduction in cardiovascular events and mortality is the most valid criterion.
2.	4/22/2008 6:15:00 PM	should demonstrate decreased clinically significant endpoints of MI, Stroke, CV death
3.	4/22/2008 6:50:00 PM	Hard end-points- MACE
4.	4/22/2008 8:56:00 PM	the carotid surrogate endpoint is acceptable for drugs within a class. Studying normal carotid arteries makes no sense.
5.	4/22/2008 9:54:00 PM	Outcomes data is what is important. EVENTS!
6.	4/22/2008 9:58:00 PM	Lowering LDL and reduced events.
7.	4/22/2008 10:03:00 PM	Need better outcome meassures
8.	4/22/2008 10:48:00 PM	Ideally, the drugs should be shown to reduce hard endpoints, such as stroke, MI and death.
9.	4/22/2008 11:33:00 PM	Then get outcomes data, not stabilization or reduction or carotid artery plaque, that's not why we prescribe them.
10.	4/23/2008 2:37:00 PM	Should show decreased MI/Stroke or CV death in treatment group
11.	4/23/2008 2:58:00 PM	The issue is far more complex than a simple number; too many people with big cholesterol drops have problems, and others with high have no problems. Too simplistic
12.	4/24/2008 1:31:00 AM	demonstrate reduction in cardiovascular events
13.	4/25/2008 12:18:00 AM	How about MACE impact?
14.	4/25/2008 2:59:00 PM	The AHA has developed the cholesteral treatement guidelines for patients with CAD, DM. CVD, and PVD based on the evidence that LDL levels less than 70 are correlated with the best clinical outcomes. If we need to use Vytorin to get to that goal because the patients are on a max dose of a statin or can't tolerate that medication, we should continue to use Vytorin and Zetia as well as other medications that can help us get patients to that goal.
15.	5/5/2008 10:15:00 PM	We need a clinical end point study--carotid or cardiac