A	B	C	D	E	F	G	H	I	J	K
1	Main
2		Brand Name	MK-524A, MK-524B (fixed combo of 524A with Zocor)
3		Generic Name	laropiprant
4		Mechanism	MK-524A: fixed combo of niacin XR with inhibitor of niacin flush pathway (prostaglandin D2 blocker). DP-1 selective inhibitor.
5		Economics	100%
6		Clinical Trials
7			HPS2-THRIVE: 20,000 patient study to begin in 2006 - 6/7/2006 - Completed Enrollment 5/2010 outcome study. Expect 20% increase in HDL.
8				Niaspan 1g	Niaspan 2g	Tricor 145mg	MK-524A	Lipitor/CTEP
9			LDL	0.07	0.16	0.21		41-60%			10/2008 - >15k
10			HDL	0.14	0.22	0.11	20-25%	53-66%
11			Tg	0.16	0.38	0.29	25-30%	18-31%
12
13
14			1% of statin patients are on niacin because of flushing. Patients still flush with -0524, just less.
15			58% of patients on niacin are already on a statin
16			7.4% discontinued due to flushing vs 12.4% for extended-release niacin, p=0.002.
17
18			Phase II ERN+0524 vs ERN alone.
19			n=272 vs 72 vs 68 placebo.
20			10% had flushing days vs 35% for ERN alone and 1% for placebo. This decreased to 1%, 15% and 1% in week 8.
21			CK (creatine kinase) elevation of 10x ULN was 2.6% vs 1.4% for ERN alone and 1.5% for placebo. This is a biomarker of muscle injury.