Trial | Active vs control daily therapies | Non-DM patients/total cohort (%) | N (without DM) on niacin/control | Description | Follow-up (months) | Method of DM diagnosis | Mean BMI (kg/m2) | Mean age (years) | Frequency of within-trial FPG measurement |
---|---|---|---|---|---|---|---|---|---|
Coronary drug project6 | Niacin 3 g vs placebo | 3436/3906 (88) | 988/2448 | Men with previous MI | 60 | I, II, III | 26.1 | 52.5 | Yearly |
FATS7 | Niacin 4 g/colestipol 30 mg vs placebo or placebo/colestipol 30 mg | 82/82 (100) | 36/46 | Men with high ApoB and family history of CHD | 32 | II | 26.7 | 46.7 | 6 monthly |
ADMIT8 | Niacin 3 g vs placebo | 343/468 (73) | 173/170 | Peripheral artery disease, with and without DM | 11 | II | 27 | 65 | 6 weekly |
ARBITER-213 | ERN 1 g vs placebo (background statin) | 121/167 (72) | 63/58 | CHD and HDL <1.16 mmol/L | 12 | II, III | 29.1* | 67* | At 12 months |
Moore et al15 | ERN 2 g/atorvastatin±colsevelam 3.8 g vs placebo/atorvastatin | 108/123 (88) | 70/38 | CHD or carotid atherosclerosis with high ApoB and LDL-c | 12 | I, II, III | 29.6* | 55* | At months 5 and 12 |
SEACOAST I9 | ERN 1 g/simvastatin 20 mg or 2 g/20 mg vs simvastatin 20 mg | 248/314 (79) | 150/98 | High CVD risk with mixed dyslipidaemia | 4 | Not stated | 28.2* | 56.6* | At week 24 |
Guyton et al10 | ERN 2 g/ezetimibe 10 mg/simvastatin 20 mg vs ezetimibe 10 mg/ simvastatin 20 mg | 798/942 (85) | 569/229 | Type IIa or Type IIIb hyperlipidaemia | 16 | I, II, III | 30.1* | 57.2* | 4 weekly |
Maccubbin et al11 | ERN 2 g/LRPT 40 mg or ERN 2 g vs placebo (with or without background statin) | 1356/1613 (84) | 1124/232 | Primary hypercholesterolaemia or mixed dyslipidaemia | 4 | I, II | 29* | – | At week 24 |
ARBITER-614 | ERN 2 g vs ezetimibe 10 mg (background statin) | 218/363 (60) | 114 /104 | CHD or high CHD-risk, with LDL <2.6 mmol/L and low HDL | 14 | II, III | 30.9* | 64.5* | At months 2, 8 and 14 |
AIM-HIGH1 | ERN 1.5–2 g/simvastatin 40–80 mg vs placebo/simvastatin 40–80 mg (with or without ezetimibe 10 mg) | 2256/3414 (66) | 1130/1126 | Atherosclerotic CVD and LDL <1.81 mmol/L | 36 | Not stated | – | 63.7* | 6 monthly |
HPS2-THRIVE2 | ERN 2 g/LRPT 40 mg/simvastatin 40 mg vs placebo/simvastatin 40 mg (with or without ezetimibe 10 mg) | 17 374/25 673 (68) | 8704/8670 | Patients with CVD | 47† | I, II | 27.7* | 64.9* | None |
Total | 26 340/37 065 (71) | 13 121/13 219 |
I=adverse event report or physician report; II=glucose lowering therapy; III=raised fasting plasma glucose (≥7.0 mmol/L) on two occasions.
*Data from total cohort (including diabetics at baseline).
‡Weighted mean follow-up.
AIM-HIGH, Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes; BMI, body mass index; CHD, coronary heart disease; CVD, cardiovascular disease; DM, diabetes mellitus; ERN, extended release niacin; FPG, fasting plasma glucose; HPS2-THRIVE, Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events; HDL,high-density lipoprotein; LDL, low-density lipoprotein; LRPT, laropiprant; MI, myocardial infarction.