Table 3.

Summary of clinical trials evaluating niacin, alone and in combination with other agents

Clinical trial	Agent	Compared to	Study population	Clinical outcomes	Reference
CDP	Niacin	Placebo	Men with EKG‐documented prior MI	27%↓ in nonfatal reinfarction at 6 years (3)	[29, 30]
				11%↓ in overall mortality at 15 years (4)
Stockholm	Clofibrate + niacin	Placebo	Patients with prior MI	13%↓ in serum cholesterol	[31]
				19%↓ in serum triglyceride levels
				36%↓ in ischemic heart disease mortality
				26%↓ in total mortality
HATS	Simvastatin + niacin	Placebo	Men and women with CAD and low HDL levels	↓ LDL 42%	[32]
				↑ HDL 26%
				90%↓ in cardiovascular events, including stroke
				Regression of coronary artery stenosis by angiogram
AFREGS	Gemfibrozil, cholestyramine, and niacin (mean dose: 2.5 g)	Placebo	Military retirees <76 years old with CAD and low HDL levels	20%↓ in total cholesterol	[33]
				36%↑ in HDL
				26%↓ in LDL
				50%↓ in triglyceride levels
				↓ in coronary artery stenosis by angiography
				13.7%↓ in clinical events, and a 2.8%↓ in CVA or TIA specifically (P‐value >0.2)
CLAS	Colestipol + niacin	Placebo	Nonsmoking men ages 40–59 with previous coronary bypass surgery	Atherosclerosis regression measured by carotid IMT, which correlated with ↑ HDL levels	[57]
ARBITER 2	Simvastatin + ER‐niacin	Simvastatin + placebo	Patients with CAD and low HDL levels	Slowed atherosclerosis progression by 68%, measured by carotid IMT	[17]
				↑ HDL 21%
ARBITER	Simvastatin + ER‐niacin	Simvastatin + placebo	Same subjects as above	↑ HDL 23%	[38]
3				Significant atherosclerosis regression

CDP = Coronary Drug Project; HATS = HDL‐Atherosclerosis Treatment Study; AFREGS = Armed Forces Regression Study; CLAS = Cholesterol Lowering Atherosclerosis Study; ARBITER = Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol.