Table 3.

Cardiovascular risk reduction with fibrate therapy or extended release niacin (± statin) in patients with and without diabetes or features of the metabolic syndrome (MS)

Study	Treatment (mg/day)	Patients	End point	Absolute risk reduction (%)	Relative	p-value
Primary prevention
Helsinki Heart Study [105]	Gemfibrozil 1200 mg vs placebo	4081 men with no prior CVD	Nonfatal MI + CAD death	13.8	34	<0.02
		−1146 (28% with MS)	Nonfatal MI + CAD death	27.2	71	<0.0005
		292*	Nonfatal MI + CAD death	9.1	71	0.004
FIELD [106]	Fenofibrate 200 mg vs placebo	9795 men and women with type 2 diabetes (some with CAD)	Nonfatal MI + CAD death	0.7	11	NS
			Total CVD events	3.2	11	0.035
		7664 without CHD	Nonfatal MI + CAD death	1.9	19	0.004
		8183 with MS	Total CVD events	1.4	11	0.052
		314 with MS and marked dyslipidemia**	Total CVD events	4.3	27	0.005
ACCORD [109]	Simvastatin + fenofibrate 160 mg vs simvastatin + placebo	5518 men and women with type 2 diabetes	Fatal CVD, nonfatal MI or nonfatal stroke	0.2	8	0.32
		Subset with TG > 2.3 mmol/L (204 mg/dL) and HDL ≤ 0.88 mmol/L (34 mg/dL)	Fatal CVD, nonfatal MI or nonfatal stroke	4.9	28	0.057
Secondary prevention
VA-HIT [107]	Gemfibrozil 1200 mg vs placebo	2531 men with CAD	Nonfatal MI, CAD death + stroke	5.6	24	<0.001
		769 (30%) with diabetes	Nonfatal MI, CAD death + stroke	10.0	32	0.004
Bezafibrate Infarction Prevention Study (BIP) [108]	Bezafibrate 400 mg vs placebo	3090 men and women with Previous MI	Nonfatal MI + CAD Death	1.4	9.4	NS
		1470 (48%) with MS***		4.3	25	0.03
AIM- HIGH [110] Stopped early after 3 years due to lack of benefit	Niacin extended release 1.5–2g vs placebo; all received simvastatin 40–80 mg + Ezetimibe 10 mg if needed	3414 men and women with CAD	Fatal CVD, nonfatal MI, ischemic stroke, hospitalization for acute coronary syndrome, coronary or cerebral revascularization	+0.2	+2	0.79

BIP = Bezafibrate Infarction Prevention; CAD = coronary artery disease; CVD = cardiovascular disease; FIELD = Fenofibrate Intervention and Event Lowering in Diabetes; HHS = Helsinki Heart Study; MI = myocardial infarction; NS = not significant; VA-HIT = Veterans Affairs HDL Intervention Trial.

^*Patients with TG >204 mg/dL and an LDL/HDL >5 (may or may not have had DM or the MS); ACCORD = Action to Control Cardiovascular Risk in Diabetes;

AIM-HIGH: Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes

^**Defined as elevated triglycerides (>204 mg/dL [≥2.3 mmol/L]) and HDL <1.03 mmol/L for men and <1.29 mmol/L for women

^***Defined as elevated triglycerides (>204 mg/dL [1 mg/dL = 0.0113 mmol/L]), low high-density lipoprotein cholesterol (<42 mg/dL [1 mg/dL = 0.02586 mmol/L]), body mass index >26, and blood glucose ≥ 5.5 mmol/L