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. 2019 Apr 1;26(4):368–377. doi: 10.5551/jat.45708

Table 4. Mean and median percentage changes in secondary endpoint lipid parameters from Phase 3 study–derived baseline to Week 60 LOCF of extension study.

Variable Statistic Week 60 LOCF
P-Valuea
Observed Value Observed Change Percent Change
Total Cholesterol (mg/dL), N 5 5 5
    Mean (SD) 203.6 (58.46) −71.2 (36.28) −26.53 (13.967)
    Median 178.0 −77.5 −33.18
    (Min., Max.) (142, 269) (−102, −11) (−38.1, −3.8)
    [95% CI] [131.0, 276.2] [−116.2, −26.2] [−43.88, −9.19] 0.012
apoB (mg/dL) N 2 2 2
    Mean (SD) 98.5 (38.89) −39.5 (28.28) −29.50 (22.763)
    Median 98.5 −39.5 −29.50
    (Min., Max.) (71, 126) (−60, −20) (−45.6, −13.4)
    [95% CI] [−250.9, 447.9] [−293.6, 214.6] [−234.02, 175.02] NS
Triglycerides (mg/dL), N 5 5 5
    Mean (SD) 41.2 (13.92) −50.1 (18.48) −54.75 (12.248)
    Median 41.0 −49.5 −50.24
    (Min., Max.) (19, 54) (−79, −28) (−68.9, −40.6)
    [95% CI] [23.9, 58.5] [−73.1, −27.1] [−69.96, −39.54] 0.004
Non-HDL-C (mg/dL), N 5 5 5
    Mean (SD) 140.4 (53.98) −80.6 (34.92) −37.45 (17.114)
    Median 112.0 −85.0 −40.83
    (Min., Max.) (92, 201) (−112, −27) (−54.9, −11.8)
    [95% CI] [73.4, 207.4] [−124.0, −37.2] [−58.70, −16.20] 0.007
Lp(a) (nmol/L), N 2 2 2
    Mean (SD) 25.2 (0.21) −36.9 (4.74) −59.32 (2.906)
    Median 25.2 −36.9 −59.32
    (Min., Max.) (25, 25) (−40, −34) (−61.4, −57.3)
    [95% CI] [23.2, 27.1] [−79.4, 5.7] [−85.42, −33.21] NS
HDL-C (mg/dL), N 5 5 5
    Mean (SD) 63.2 (12.30) 9.4 (7.06) 17.04 (14.036)
    Median 66.0 10.0 15.63
    (Min., Max.) (42, 74) (−2, 17) (−3.4, 32.0)
    [95% CI] [47.9, 78.5] [0.6, 18.2] [−0.39, 34.47] 0.041
apoA1 (mg/dL), N 2 2 2
    Mean (SD) 131.0 (26.87) −1.5 (32.53) −0.61 (24.523)
    Median 131.0 −1.5 −0.61
    (Min., Max.) (112, 150) (−25, 22) (−17.9, 16.7)
    [95% CI] [−110.4, 372.4] [−293.7, 290.7] [−220.94, 219.72] NS

apoA1, apolipoprotein A1; apoB, apolipoprotein B; CI, confidence interval; HDL-C, high-density lipoprotein cholesterol; LOCF, last observation carried forward; Lp(a), lipoprotein(a); non-HDL-C, non-high-density lipoprotein cholesterol; SD, standard deviation; NS, not significant

a

P-value from paired t-test