Table 2. Main outcomes at baseline and up to 6-week follow-up.
|
Alirocumab N=38 |
Sham control N=30 |
Between-group difference (95% CI) | p-value | |||||
|---|---|---|---|---|---|---|---|---|
| Baseline | Follow-up</p> | Percent change | Baseline | Follow-up</p> | Percent change | |||
| LDL cholesterol (mean [SD], mmol/L) |
2.97 (1.09) |
0.75 (0.46) |
−72.9% (17.5) |
2.87 (0.90) |
1.30 (0.45) |
−48.1% (29.5) |
−22.3% (−31.1 to −13.5) |
<0.001 |
| Apo B (mean [SD], g/L) |
0.88 (0.33) |
0.40 (0.11) |
−51.4 (17.2) |
0.83 (0.25) |
0.49 (0.13) |
−36.3 (24.4) |
−11.5% (−17.8 to −5.3)* |
<0.001 |
| Non-HDL cholesterol (mean [SD], mmol/L) |
3.68 (1.37) |
1.13 (0.62) |
−67.3% (18.8) |
3.46 (1.01) |
1.79 (0.50) |
−48.2% (20.0) |
−19.1% (−29.4 to −8.7) |
0.001 |
| Total cholesterol (mean [SD], mmol/L) |
4.73 (1.35) |
2.22 (0.65) |
−50.9% (18.0) |
4.51 (1.01) |
2.84 (0.65) |
−38.0% (18.4) |
−13.0% (−22.7 to −3.3) |
0.010 |
| Triglycerides (median [IQR], mmol/L) |
1.20 (0.68, 1.89) |
1.01 (0.82, 1.40) |
−8.9% (−41.1, 50.6) |
0.85 (0.55, 1.32) |
1.19 (0.88, 1.62) |
25.9% (−8.9, 61.0)† |
– | 0.044† |
| HDL cholesterol (median [IQR], mmol/L) | 0.97 (0.82, 1.28) |
1.09 (0.92, 1.23) |
5.8% (−12.0, 21.1) |
1.06 (0.83, 1.26) |
0.98 (0.86, 1.23) |
−1.7% (−15.6, 8.3) |
– | 0.29† |
| Lp(a) (median [IQR], mg/L) |
68 (34, 431) |
87 (34, 489) |
5.3% (0, 40.2) |
101 (50, 414) |
171 (43, 482) |
34.8% (14.7, 68.6) |
– | 0.023† |
| NT-proBNP (mean [SD], pmol/L) | – |
83.33 (99.43) |
− | − |
75.02 (79.47) |
− |
8.31 pmol/L (−40.50 to 57.13) |
0.71† |
| CRP (median [IQR], mg/L) |
2.70 (1.14, 5.53) |
1.84 (0.69, 5.97) |
−34.5% (−67.7, 17.86) |
1.86 (0.43, 4.88) |
0.99 (0.56, 2.54) |
−33.3% (−57.9, 30.0) |
1.02% (0.57 to 1.60) |
0.93‡ |
| CKMB area under the curve (mean [SD], units) | – |
4,436 (3,512) |
− | − |
4,416 (3,079) |
− |
−180 units (−1,803 to 1,443) |
0.67† |
| *68.4% of patients in the alirocumab group versus 26.7% in the sham-control group had Apo B levels ≤the assay lower detection limit of 0.35 mmol/L (p=0.001). All of these patients were assigned an Apo B level of 0.35 mmol/L. †Wilcoxon rank-sum test. ‡Comparison made on log-transformed data. CKMB: creatine kinase myocardial band; CRP: C-reactive protein; HDL: high-density lipoprotein; IQR: interquartile range; LDL: low-density lipoprotein; Lp(a): lipoprotein(a); NT-proBNP: N-terminal pro-brain natriuretic peptide; SD: standard deviation | ||||||||