Table 3.
Alirocumab efficacy on low-density lipoprotein cholesterol (LDL-C) levels according to patient subgroups (intention-to-treat [ITT] analysis)
| n a | Baseline mean (SD), mmol/L [mg/dL] |
n a | Week 24 mean (SD), mmol/L [mg/dL] |
Percentage change from baseline to week 24,b LS mean, % | Interaction p value | |
|---|---|---|---|---|---|---|
| FH | 299 | 5.1 (1.7) [195.8 (66.3)] | 254 | 2.5 (1.4) [97.4 (53.7)] | − 49.1 | 0.6500 |
| Non-FH | 34 | 4.1 (1.1) [157.5 (41.5)] | 28 | 2.1 (0.9) [79.3 (33.2)] | − 51.4 | |
| Unknown FH status | 261 | 4.3 (1.3) [166.0 (50.9)] | 224 | 2.1 (0.9) [82.6 (35.2)] | − 47.7 | |
| Type 1 DM | 10 | 3.7 (0.9) [144.0 (35.7)] | 7 | 1.9 (0.5) [73.9 (19.2)] | − 48.4 | 0.7930 |
| Type 2 DM | 150 | 4.5 (1.6) [175.4 (63.3)] | 130 | 2.3 (1.1) [87.2 (42.9)] | − 47.4 | |
| Non-DM | 424 | 4.8 (1.5) [184.4 (59.6)] | 363 | 2.4 (1.2) [91.6 (47.5)] | − 49.0 | |
| CHD | 434 | 4.5 (1.5) [172.3 (57.7)] | 384 | 2.2 (1.0) [83.7 (40.0)] | − 50.0 | 0.1542 |
| Non-CHD | 82 | 5.0 (1.4) [191.2 (54.4)] | 70 | 2.6 (1.2) [100.0 (45.2)] | − 45.6 | |
| Post-ACS | 194 | 4.3 (1.3) [166.0 (50.8)] | 186 | 2.1 (1.0) [80.5 (39.1)] | − 50.4 | 0.7891 |
| No ACS | 227 | 4.8 (1.5) [184.9 (57.9)] | 191 | 2.4 (1.1) [91.1 (43.0)] | − 49.8 | |
| Male | 383 | 4.4 (1.5) [171.2 (56.7)] | 332 | 2.2 (1.2) [84.1 (44.7)] | − 49.2 | 0.3595 |
| Female | 207 | 5.1 (1.7) [198.8 (63.9)] | 172 | 2.6 (1.2) [101.3 (46.5)] | − 47.2 | |
| Baseline LDL-C < 3.4 mmol/L (< 130 mg/dL) | 112 | 2.7 (0.5) [102.9 (20.8)] | 92 | 1.7 (0.9) [64.2 (35.1)] | − 38.1 | < 0.0001 |
| Baseline LDL-C ≥ 3.4 to ≤ 4.9 mmol/L (≥ 130 to ≤ 190 mg/dL) | 250 | 4.2 (0.4) [162.0 (17.1)] | 205 | 2.1 (0.8) [80.3 (31.1)] | − 50.1 | |
| Baseline LDL-C > 4.9 mmol/L (> 190 mg/dL) | 232 | 6.2 (1.2) [237.9 (48.3)] | 194 | 2.9 (1.4) [113.0 (53.0)] | − 52.0 | |
| Total statin intolerance | 267 | 5.0 (1.6) [193.1 (60.1)] | 227 | 2.6 (1.2) [99.3 (44.7)] | − 47.6 | 0.1302 |
| Partial statin intolerance | 150 | 4.3 (1.4) [167.8 (54.5)] | 132 | 2.0 (1.0) [77.2 (38.1)] | − 52.2 | |
| No statin intolerance | 154 | 4.4 (1.6) [170.5 (63.7)] | 131 | 2.2 (1.3) [85.6 (50.8)] | − 47.1 |
ACS acute coronary syndrome, CHD coronary heart disease, DM diabetes mellitus, FH familial hypercholesterolemia, LS least squares, SD standard deviation
aNumber of patients with available LDL-C levels
bData presented for the modified ITT population