Table 1.
Parameter | Pooled across treatment groups
|
ERN/LRPT
|
Pooled SIMVA
|
Pooled ERN/LRPT + SIMVA
|
||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Overall population (N=1,233) | Baseline TG subgroup
|
Overall population (N=155) | Baseline TG subgroup
|
Overall population (N=561) | Baseline TG subgroup
|
Overall population (N=517) | Baseline TG subgroup
|
|||||
<2.26 mmol/L (n=983) | ≥2.26 mmol/L (n=250) | <2.26 mmol/L (n=121) | ≥2.26 mmol/L (n=34) | <2.26 mmol/L (n=444) | ≥2.26 mmol/L (n=117) | <2.26 mmol/L (n=418) | ≥2.26 mmol/L (n=99) | |||||
Age, mean ± SD, years | 56.6±10.8 | 57.3±10.9 | 53.7±10.3 | 56.7±10.6 | 57.6±10.6 | 53.5±10.1 | 56.0±10.9 | 56.6±11.0 | 53.6±10.3 | 57.2±10.8 | 57.9±10.8 | 53.9±10.3 |
Age, no (%) | ||||||||||||
<65 years | 921 (74.7) | 716 (72.8) | 205 (82.0) | 116 (74.8) | 87 (71.9) | 29 (85.3) | 426 (75.9) | 330 (74.3) | 96 (82.1) | 379 (73.3) | 299 (71.5) | 80 (80.8) |
≥65 years | 312 (25.3) | 267 (27.2) | 45 (18.0) | 39 (25.2) | 34 (28.1) | 5 (14.7) | 135 (24.1) | 114 (25.7) | 21 (18.0) | 138 (26.7) | 119 (28.5) | 19 (19.2) |
Sex, no (%) | ||||||||||||
Male | 560 (45.4) | 441 (44.9) | 119 (47.6) | 68 (43.9) | 51 (42.2) | 17 (50.0) | 259 (46.2) | 196 (44.1) | 63 (53.9) | 233 (45.1) | 194 (46.4) | 39 (39.4) |
Female | 673 (54.6) | 542 (55.1) | 131 (52.4) | 87 (56.1) | 70 (57.9) | 17 (50.0) | 302 (53.8) | 248 (55.9) | 54 (46.2) | 284 (54.9) | 224 (53.6) | 60 (60.6) |
Race, no (%) | ||||||||||||
White | 974 (79.0) | 784 (79.8) | 190 (76.0) | 123 (79.4) | 94 (77.7) | 29 (85.3) | 447 (79.7) | 354 (79.7) | 93 (79.5) | 404 (78.1) | 336 (80.4) | 68 (68.7) |
Black | 49 (4.0) | 45 (4.6) | 4 (1.6) | 5 (3.2) | 5 (4.1) | 0 (0.0) | 23 (4.1) | 21 (4.7) | 2 (1.7) | 21 (4.1) | 19 (4.6) | 2 (2.0) |
Hispanic | 52 (4.2) | 38 (3.9) | 14 (5.6) | 9 (5.8) | 8 (6.6) | 1 (2.9) | 21 (3.7) | 16 (3.6) | 5 (4.3) | 22 (4.3) | 14 (3.4) | 8 (8.1) |
Other | 158 (12.8) | 116 (11.8) | 42 (16.8) | 18 (11.6) | 14 (11.6) | 4 (11.8) | 70 (12.5) | 53 (11.9) | 17 (14.5) | 70 (13.5) | 49 (11.7) | 21 (21.2) |
BMI, mean ± SD, kg/m2 | 28.1±5.1 | 27.7±5.0 | 30.0±5.3 | 27.8±4.7 | 27.4±4.2 | 29.4±5.9 | 28.0±4.8 | 27.4±4.5 | 30.2±5.0 | 28.4±5.5 | 28.0±5.5 | 29.9±5.3 |
Weight, mean ± SD, kg | 79.1±16.5 | 77.8±16.1 | 84.5±17.1 | 78.6±16.3 | 76.9±15.4 | 84.5±15.6 | 79.2±16.0 | 77.3±15.4 | 86.1±16.2 | 79.3±17.2 | 78.5±17.0 | 82.5±17.6 |
Height, mean ± SD, cm | 167.6±10.2 | 167.5±10.1 | 167.7±10.6 | 167.7±10.4 | 167.2±10.6 | 169.4±9.4 | 168.0±9.9 | 167.8±9.7 | 168.9±10.6 | 167.1±10.4 | 167.4±10.4 | 165.8±10.7 |
CHD risk category, no (%) | ||||||||||||
I | 861 (69.9) | 708 (72.2) | 153 (61.2) | 118 (76.6) | 97 (80.8) | 21 (61.8) | 384 (68.6) | 317 (71.6) | 67 (57.3) | 359 (69.4) | 294 (70.3) | 65 (65.7) |
II | 360 (29.2) | 265 (27.0) | 95 (38.0) | 33 (21.4) | 22 (18.3) | 11 (32.4) | 172 (30.7) | 122 (27.5) | 50 (42.7) | 155 (30.0) | 121 (29.0) | 34 (34.3) |
III | 10 (0.8) | 8 (0.8) | 2 (0.8) | 3 (2.0) | 1 (0.8) | 2 (5.9) | 4 (0.7) | 4 (0.9) | 0 (0.0) | 3 (0.6) | 3 (0.7) | 0 (0.0) |
Baseline lipid/lipoprotein values, mean (SD) | ||||||||||||
ApoB, g/L | 1.46±0.21 | 1.41±0.19 | 1.64±0.21 | 1.44±0.20 | 1.39±0.18 | 1.61±0.18 | 1.46±0.22 | 1.41±0.19 | 1.63±0.22 | 1.46±0.21 | 1.42±0.18 | 1.66±0.20 |
TC, mmol/L | 6.05±0.58 | 5.97±0.57 | 6.36±0.55 | 5.99±0.56 | 5.91±0.56 | 6.27±0.45 | 6.04±0.61 | 5.96±0.58 | 6.37±0.58 | 6.07±0.57 | 6.00±0.55 | 6.39±0.53 |
Non-HDL-C, mmol/L | 4.68±0.55 | 4.55±0.47 | 5.22±0.49 | 4.64±0.51 | 4.51±0.45 | 5.12±0.39 | 4.68±0.57 | 4.54±0.49 | 5.24±0.49 | 4.69±0.53 | 4.56±0.45 | 5.23±0.50 |
HDL-C, mmol/L | 1.37±0.34 | 1.42±0.34 | 1.15±0.22 | 1.34±0.31 | 1.40±0.31 | 1.15±0.27 | 1.36±0.34 | 1.42±0.34 | 1.13±0.22 | 1.38±0.35 | 1.44±0.36 | 1.16±0.20 |
LDL-C, mmol/L | 3.92±0.42 | 3.91±0.41 | 3.93±0.45 | 3.86±0.38 | 3.87±0.37 | 3.81±0.4 | 3.92±0.44 | 3.91±0.43 | 3.95±0.45 | 3.93±0.42 | 3.93±0.40 | 3.94±0.46 |
TGs, mmol/La | 1.51 | 1.36 | 2.68 | 1.54 | 1.40 | 2.82 | 1.51 | 1.33 | 2.65 | 1.51 | 1.37 | 2.67 |
Note:
Median.
Abbreviations: apoB, apolipoprotein B; BMI, body mass index; CHD, coronary heart disease; ERN, extended-release niacin; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; LRPT, laropiprant; SD, standard deviation; SIMVA, simvastatin; TC, total cholesterol; TG, triglyceride.