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Table 2 Main efficacy endpoints at week 12 assessed by on-treatment estimand

From: Efficacy and safety of tafolecimab in Chinese patients with heterozygous familial hypercholesterolemia: a randomized, double-blind, placebo-controlled phase 3 trial (CREDIT-2)

 

150 mg Q2W

450 mg Q4W

Tafolecimab (n = 52)

Placebo (n = 23)

ETD versus placebo

Tafolecimab (n = 48)

Placebo (n = 25)

ETD versus placebo

LDL-C

 Percent CFB (%)a

−58.4 (4.6)

−1.0 (5.3)

−57.4 (−69.2, −45.5); P <0.0001

−58.7 (5.5)

3.2 (6.4)

−61.9 (−73.4, −50.4) ; P <0.0001

 CFB (mmol/L)

−2.42 (0.22)

0.05 (0.25)

−2.47 (−2.96, −1.99) ; P <0.0001

−2.38 (0.25)

0.10 (0.29)

−2.48 (−2.93, −2.03) ; P <0.0001

 ≥50% reductiona

31 (59.6)

0

58.5 (42.2, 74.8) ; P <0.0001

36 (75.0)

0

73.4 (58.5, 88.4) ; P <0.0001

 <1.8 mmol/La

27 (51.9)

1 (4.3)

47.9 (29.2, 66.7) ; P <0.0001

30 (62.5)

0

59.9 (43.2, 76.5) ; P <0.0001

Non-HDL-C

 Percent CFB (%)

−60.6 (4.9)

−2.8 (5.6)

−57.8 (−68.6, −47.0) ; P <0.0001

−60.3 (5.5)

0.4 (6.5)

−60.7 (−70.7, −50.6) ; P <0.0001

 CFB (mmol/L)

−2.74 (0.25)

0.01 (0.29)

−2.75 (−3.30, −2.20) ; P <0.0001

−2.61 (0.29)

0.04 (0.34)

−2.65 (−3.17, −2.12) ; P <0.0001

Apolipoprotein B

 Percent CFB (%)

−56.7 (6.2)

5.0 (8.0)

−61.7 (−79.1, −44.3) ; P <0.0001

−56.8 (4.9)

−1.0 (5.8)

−55.8 (−64.5, −47.0) ; P <0.0001

 CFB (g/L)

−0.66 (0.08)

0.07 (0.09)

−0.74 (−0.94, −0.54) ; P <0.0001

−0.65 (0.07)

−0.02 (0.08)

−0.63 (−0.75, −0.51) ; P <0.0001

Lipoprotein(a)

 Percent CFB (%)

−47.6 (7.2)

−4.3 (8.2)

−43.3 (−58.9, −27.6) ; P <0.0001

−30.0 (7.1)

4.1 (8.2)

−34.1 (−47.1, −21.1) ; P <0.0001

 CFB (g/L)

−0.17 (0.02)

−0.04 (0.03)

−0.13 (−0.18, −0.08) ; P <0.0001

−0.13 (0.02)

−0.01 (0.03)

−0.12 (−0.17, −0.08) ; P <0.0001

 ≥50% reduction

16 (30.8)

1 (4.3)

27.6 (11.2, 43.9) ; P =0.0010

20 (41.7)

0

42.2 (27.8, 56.5) ; P <0.0001

  1. Data are least squares mean (standard error) for CFB and percent CFB; n (%) for LDL-C and lipoprotein(a) target attainment rates; least squares mean (97.5% CI) for ETD of percent CFB in LDL-C; mean (97.5% CI) for ETD of LDL-C target attainment rates; least squares mean (95% CI) for ETD of CFB in LDL-C, as well as ETD of CFB and percent CFB in other lipid parameters; mean (95% CI) for ETD of lipoprotein(a) target attainment rates.
  2. CFB change from baseline, CI confidence interval, ETD estimated treatment difference, LDL-C low density lipoprotein cholesterol, non-HDL-C non-high density lipoprotein cholesterol, Q2W every 2 weeks, Q4W every 4 weeks
  3. aControlled for type I error (pairwise α = 0.025).
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