Table 2.
Main Efficacy Endpoints at Week 12 (On-Treatment Estimand)
| 450 mg Q4W |
|||
|---|---|---|---|
| Tafolecimab (n = 201) | Placebo (n = 98) | ETD versus placebo | |
| LDL-C | |||
| Percent CFB to week 12 (%)a | −68.9 ± 1.4 | −5.8 ± 1.8 | −63.0 (−66.5 to −59.6) |
| CFB (mmol/L) | −2.10 ± 0.05 | −0.17 ± 0.06 | −1.93 (−2.05 to −1.81) |
| ≥50% LDL-C reduction at week 12a | 182 (90.5) | 2 (2.0) | 88.6 (83.7-93.5) |
| LDL-C <1.8 mmol/L at week 12a | 193 (96.0) | 3 (3.1) | 93.0 (88.6-97.3) |
| LDL-C <1.4 mmol/L at week 12a | 174 (86.6) | 1 (1.0) | 85.8 (80.7-90.8) |
| Non-HDL-C | |||
| Percent CFB to week 12 (%) | −70.5 ± 1.4 | −6.6 ± 1.8 | −63.9 (−67.5 to −60.3) |
| CFB (mmol/L) | −2.46 ± 0.06 | −0.24 ± 0.07 | −2.22 (−2.35 to −2.08) |
| Apolipoprotein B | |||
| Percent CFB to week 12 (%) | −61.4 ± 1.3 | −2.45 ± 1.6 | −59.0 (−62.1 to −55.8) |
| CFB (g/L) | −0.56 ± 0.01 | −0.04 ± 0.02 | −0.52 (−0.55 to −0.49) |
| Apolipoprotein B/apolipoprotein A1 | |||
| Percent CFB to week 12 (%) | −65.1 ± 1.2 | −5.25 ± 1.5 | −59.8 (−62.8 to −56.8) |
| CFB | −0.42 ± 0.01 | −0.04 ± 0.01 | −0.38 (−0.40 to −0.35) |
| Lipoprotein(a) | |||
| Percent CFB to week 12 (%) | −45.4 ± 3.1 | −11.5 ± 3.9 | −33.9 (−42.2 to −25.7) |
| CFB (g/L) | −0.11 ± 0.01 | −0.03 ± 0.01 | −0.08 (−0.10 to −0.06) |
Values are least squares mean ± SE for CFB, and least squares mean (95% CI) for ETD. n (%) for proportion of patients.
CFB = change from baseline; ETD = estimated treatment difference; HDL-C = high-density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol; Q4W = every 4 weeks.
a
Controlled for type I error (α = 0.05).