. 2022 Feb 3;24(5):868–880. doi: 10.1111/dom.14645

TABLE 2.

Percentage change from baseline at week 12 in lipid variables

	LDL‐C	TC	Non‐HDL‐C	Apo B	TG	hsCRP
ASCVD/HeFH on statins pool
Diabetes ^a
BA	Baseline	105.3 (30.3) (n = 642)	183.4 (36.8) (n = 642)	136.6 (35.4) (n = 642)	95.5 (26.2) (n = 641)	163.4 (85.4) (n = 642)	1.9 (0.9, 4.3) (n = 642)
% change	−18.5 (0.8) (n = 614)	−11.3 (0.6) (n = 616)	−12.9 (0.7) (n = 616)	−9.0 (0.8) (n = 605)	12.4 (1.7) (n = 616)	−25.4 (−50.0, 21.5) (n = 606)
Placebo	Baseline	105.5 (32.4) (n = 324)	183.7 (39.7) (n = 324)	136.7 (39.0) (n = 324)	96.5 (29.3) (n = 322)	161.2 (75.9) (n = 324)	1.9 (0.9, 4.6) (n = 322)
% change	0.6 (1.3) (n = 317)	0.1 (0.9) (n = 318)	0.6 (1.2) (n = 318)	3.4 (1.1) (n = 312)	4.3 (1.8) (n = 318)	−3.1 (−36.8, 57.6) (n = 313)
Difference (95% CI)	−19.1 (−22.1, −16.1) ^b	−11.4 (−13.5, −9.4) ^b	−13.5 (−16.2, −10.8) ^b	−12.3 (−15.0, −9.7) ^b	8.2 (3.3, 13.0) ^b	−18.9 (−27.1, −10.8) ^b
Prediabetes ^c
BA	Baseline	107.5 (31.9) (n = 1037)	184.9 (38.3) (n = 1037)	135.1 (37.1) (n = 1037)	95.1 (26.9) (n = 1034)	142.8 (67.4) (n = 1037)	1.5 (0.8, 3.2) (n = 1036)
% change	−16.4 (0.7) (n = 994)	−10.6 (0.5) (n = 996)	−11.7 (0.6) (n = 995)	−9.6 (0.6) (n = 980)	10.1 (1.5) (n = 996)	−20.4 (−49.1, 21.3) (n = 971)
Placebo	Baseline	108.6 (34.3) (n = 515)	186.4 (40.7) (n = 515)	135.9 (38.3) (n = 515)	95.5 (27.6) (n = 512)	140.3 (65.7) (n = 515)	1.6 (0.8, 3.3) (n = 514)
% change	2.1 (1.0) (n = 504)	1.4 (0.7) (n = 504)	2.2 (0.9) (n = 504)	3.3 (0.8) (n = 497)	6.8 (1.5) (n = 504)	−1.9 (−32.2, 48.0) (n = 496)
Difference (95% CI)	−18.6 (−20.9, −16.2) ^b	−12.0 (−13.6, −10.3) ^b	−14.0 (−16.1, −11.8) ^b	−12.9 (−14.9, −10.9) ^b	3.2 (−0.9, 7.4)	−17.7 (−24.0, −11.5) ^b
Normoglycaemia ^d
BA	Baseline	112.9 (36.7) (n = 331)	191.2 (41.8) (n = 331)	137.9 (41.0) (n = 331)	95.7 (27.6) (n = 329)	129.2 (65.3) (n = 331)	1.2 (0.6, 2.3) (n = 329)
% change	−14.0 (1.0) (n = 314)	−9.2 (0.7) (n = 314)	−11.0 (0.9) (n = 314)	−8.5 (0.9) (n = 309)	5.0 (2.2) (n = 314)	−15.9 (−46.4, 34.4) (n = 311)
Placebo	Baseline	107.6 (33.4) (n = 160)	185.5 (40.0) (n = 160)	132.5 (37.2) (n = 160)	90.7 (26.6) (n = 159)	127.3 (56.8) (n = 160)	1.3 (0.7, 2.5) (n = 160)
% change	3.2 (1.8) (n = 157)	1.1 (1.2) (n = 157)	2.2 (1.6) (n = 157)	4.7 (1.7) (n = 154)	1.3 (2.1) (n = 157)	4.2 (−32.5, 57.5) (n = 155)
Difference (95% CI)	−17.2 (−21.3, −13.0) ^b	−10.3 (−13.0, −7.6) ^b	−13.2 (−16.9, −9.5) ^b	−13.2 (−16.9, −9.5) ^b	3.8 (−2.2, 9.7)	−17.1 (−29.3, −5.0) ^e
Statin‐intolerant pool
Diabetes ^a
BA	Baseline	137.0 (38.5) (n = 113)	224.5 (46.9) (n = 113)	175.3 (45.0) (n = 113)	130.9 (31.1) (n = 112)	198.4 (91.0) (n = 113)	3.2 (1.6, 6.2) (n = 112)
% change	−21.1 (2.3) (n = 109)	−13.4 (1.6) (n = 109)	−15.3 (2.0) (n = 109)	−11.8 (1.9) (n = 109)	9.8 (3.8) (n = 109)	−36.3 (−54.8, 5.6) (n = 109)
Placebo	Baseline	133.0 (31.5) (n = 56)	215.6 (36.4) (n = 56)	168.0 (36.7) (n = 56)	129.2 (24.9) (n = 56)	183.6 (86.3) (n = 56)	4.0 (1.7, 6.7) (n = 55)
% change	−2.0 (1.8) (n = 52)	−0.7 (1.3) (n = 52)	0.0 (1.6) (n = 52)	−0.2 (1.4) (n = 52)	9.6 (4.9) (n = 52)	−4.7 (−26.6, 19.5) (n = 51)
Difference (95% CI)	−19.1 (−24.9, −13.3) ^b	−12.7 (−16.7, −8.6) ^b	−15.4 (−20.4, −10.3) ^b	−11.6 (−16.3, −6.9) ^b	0.2 (−12.1, 12.5)	−27.5 (−41.0, −13.0) ^b
Prediabetes ^c
BA	Baseline	150.8 (39.2) (n = 223)	238.9 (43.6) (n = 223)	184.9 (43.1) (n = 223)	136.5 (30.1) (n = 220)	173.8 (79.3) (n = 223)	2.4 (1.1, 4.4) (n = 220)
% change	−24.9 (1.5) (n = 214)	−16.9 (1.0) (n = 215)	−20.2 (1.2) (n = 214)	−16.2 (1.1) (n = 209)	5.3 (2.9) (n = 215)	−22.3 (−52.3, 11.8) (n = 210)
Placebo	Baseline	149.7 (41.5) (n = 94)	237.4 (46.6) (n = 94)	183.2 (47.3) (n = 94)	135.9 (33.5) (n = 90)	175.7 (89.8) (n = 94)	2.4 (1.1, 4.5) (n = 90)
% change	4.7 (2.1) (n = 91)	2.8 (1.3) (n = 91)	4.4 (1.8) (n = 91)	4.3 (1.5) (n = 88)	8.4 (3.7) (n = 91)	0.2 (−35.2, 39.8) (n = 88)
Difference (95% CI)	−29.6 (−34.5, −24.6) ^b	−19.7 (−22.8, −16.5) ^b	−24.6 (−28.9, −20.4) ^b	−20.5 (−24.3, −16.8) ^b	−3.1 (−12.4, 6.1)	−20.7 (−34.0, −8.0) ^e
Normoglycaemia ^d
BA	Baseline	145.1 (38.2) (n = 79)	232.3 (43.1) (n = 79)	172.5 (43.4) (n = 79)	127.7 (31.3) (n = 79)	138.1 (66.0) (n = 79)	2.1 (1.0, 3.7) (n = 79)
% change	−25.2 (2.2) (n = 76)	−16.4 (1.6) (n = 76)	−21.1 (2.1) (n = 76)	−18.3 (1.9) (n = 74)	3.1 (3.9) (n = 76)	−32.1 (−53.6, 25.8) (n = 74)
Placebo	Baseline	134.2 (33.6) (n = 49)	219.0 (41.6) (n = 49)	160.7 (40.3) (n = 49)	120.8 (28.1) (n = 47)	133.3 (65.4) (n = 49)	1.4 (0.8, 3.5) (n = 47)
% change	−1.6 (2.1) (n = 46)	−1.7 (1.7) (n = 46)	−0.8 (2.2) (n = 46)	0.7 (1.9) (n = 45)	6.2 (5.8) (n = 46)	10.0 (−19.0, 78.1) (n = 45)
Difference (95% CI)	−23.6 (−29.7, −17.4) ^b	−14.7 (−19.4, −10.1) ^b	−20.4 (−26.5, −14.3) ^b	−19.0 (−24.4, −13.5) ^b	−3.1 (−17.1, 10.8)	−43.7 (−65.2, −22.8) ^b

LDL‐C

Non‐HDL‐C

Apo B

hsCRP

ASCVD/HeFH on statins pool

Diabetes ^a

Baseline

105.3 (30.3)

(n = 642)

183.4 (36.8)

(n = 642)

136.6 (35.4)

(n = 642)

95.5 (26.2)

(n = 641)

163.4 (85.4)

(n = 642)

1.9 (0.9, 4.3)

(n = 642)

% change

−18.5 (0.8)

(n = 614)

−11.3 (0.6)

(n = 616)

−12.9 (0.7)

(n = 616)

−9.0 (0.8)

(n = 605)

12.4 (1.7)

(n = 616)

−25.4 (−50.0, 21.5)

(n = 606)

Placebo

Baseline

105.5 (32.4)

(n = 324)

183.7 (39.7)

(n = 324)

136.7 (39.0)

(n = 324)

96.5 (29.3)

(n = 322)

161.2 (75.9)

(n = 324)

1.9 (0.9, 4.6)

(n = 322)

% change

0.6 (1.3)

(n = 317)

0.1 (0.9)

(n = 318)

0.6 (1.2)

(n = 318)

3.4 (1.1)

(n = 312)

4.3 (1.8)

(n = 318)

−3.1 (−36.8, 57.6)

(n = 313)

Difference (95% CI)

−19.1 (−22.1, −16.1) ^b

−11.4 (−13.5, −9.4) ^b

−13.5 (−16.2, −10.8) ^b

−12.3 (−15.0, −9.7) ^b

8.2 (3.3, 13.0) ^b

−18.9 (−27.1, −10.8) ^b

Prediabetes ^c

Baseline

107.5 (31.9)

(n = 1037)

184.9 (38.3)

(n = 1037)

135.1 (37.1)

(n = 1037)

95.1 (26.9)

(n = 1034)

142.8 (67.4)

(n = 1037)

1.5 (0.8, 3.2)

(n = 1036)

% change

−16.4 (0.7)

(n = 994)

−10.6 (0.5)

(n = 996)

−11.7 (0.6)

(n = 995)

−9.6 (0.6)

(n = 980)

10.1 (1.5)

(n = 996)

−20.4 (−49.1, 21.3)

(n = 971)

Placebo

Baseline

108.6 (34.3)

(n = 515)

186.4 (40.7)

(n = 515)

135.9 (38.3)

(n = 515)

95.5 (27.6)

(n = 512)

140.3 (65.7)

(n = 515)

1.6 (0.8, 3.3)

(n = 514)

% change

2.1 (1.0)

(n = 504)

1.4 (0.7)

(n = 504)

2.2 (0.9)

(n = 504)

3.3 (0.8)

(n = 497)

6.8 (1.5)

(n = 504)

−1.9 (−32.2, 48.0)

(n = 496)

Difference (95% CI)

−18.6 (−20.9, −16.2) ^b

−12.0 (−13.6, −10.3) ^b

−14.0 (−16.1, −11.8) ^b

−12.9 (−14.9, −10.9) ^b

3.2 (−0.9, 7.4)

−17.7 (−24.0, −11.5) ^b

Normoglycaemia ^d

Baseline

112.9 (36.7)

(n = 331)

191.2 (41.8)

(n = 331)

137.9 (41.0)

(n = 331)

95.7 (27.6)

(n = 329)

129.2 (65.3)

(n = 331)

1.2 (0.6, 2.3)

(n = 329)

% change

−14.0 (1.0)

(n = 314)

−9.2 (0.7)

(n = 314)

−11.0 (0.9)

(n = 314)

−8.5 (0.9)

(n = 309)

5.0 (2.2)

(n = 314)

−15.9 (−46.4, 34.4)

(n = 311)

Placebo

Baseline

107.6 (33.4)

(n = 160)

185.5 (40.0)

(n = 160)

132.5 (37.2)

(n = 160)

90.7 (26.6)

(n = 159)

127.3 (56.8)

(n = 160)

1.3 (0.7, 2.5)

(n = 160)

% change

3.2 (1.8)

(n = 157)

1.1 (1.2)

(n = 157)

2.2 (1.6)

(n = 157)

4.7 (1.7)

(n = 154)

1.3 (2.1)

(n = 157)

4.2 (−32.5, 57.5)

(n = 155)

Difference (95% CI)

−17.2 (−21.3, −13.0) ^b

−10.3 (−13.0, −7.6) ^b

−13.2 (−16.9, −9.5) ^b

3.8 (−2.2, 9.7)

−17.1 (−29.3, −5.0) ^e

Statin‐intolerant pool

Diabetes ^a

Baseline

137.0 (38.5)

(n = 113)

224.5 (46.9)

(n = 113)

175.3 (45.0)

(n = 113)

130.9 (31.1)

(n = 112)

198.4 (91.0)

(n = 113)

3.2 (1.6, 6.2)

(n = 112)

% change

−21.1 (2.3)

(n = 109)

−13.4 (1.6)

(n = 109)

−15.3 (2.0)

(n = 109)

−11.8 (1.9)

(n = 109)

9.8 (3.8)

(n = 109)

−36.3 (−54.8, 5.6)

(n = 109)

Placebo

Baseline

133.0 (31.5)

(n = 56)

215.6 (36.4)

(n = 56)

168.0 (36.7)

(n = 56)

129.2 (24.9)

(n = 56)

183.6 (86.3)

(n = 56)

4.0 (1.7, 6.7)

(n = 55)

% change

−2.0 (1.8)

(n = 52)

−0.7 (1.3)

(n = 52)

0.0 (1.6)

(n = 52)

−0.2 (1.4)

(n = 52)

9.6 (4.9)

(n = 52)

−4.7 (−26.6, 19.5)

(n = 51)

Difference (95% CI)

−19.1 (−24.9, −13.3) ^b

−12.7 (−16.7, −8.6) ^b

−15.4 (−20.4, −10.3) ^b

−11.6 (−16.3, −6.9) ^b

0.2 (−12.1, 12.5)

−27.5 (−41.0, −13.0) ^b

Prediabetes ^c

Baseline

150.8 (39.2)

(n = 223)

238.9 (43.6)

(n = 223)

184.9 (43.1)

(n = 223)

136.5 (30.1)

(n = 220)

173.8 (79.3)

(n = 223)

2.4 (1.1, 4.4)

(n = 220)

% change

−24.9 (1.5)

(n = 214)

−16.9 (1.0)

(n = 215)

−20.2 (1.2)

(n = 214)

−16.2 (1.1)

(n = 209)

5.3 (2.9)

(n = 215)

−22.3 (−52.3, 11.8)

(n = 210)

Placebo

Baseline

149.7 (41.5)

(n = 94)

237.4 (46.6)

(n = 94)

183.2 (47.3)

(n = 94)

135.9 (33.5)

(n = 90)

175.7 (89.8)

(n = 94)

2.4 (1.1, 4.5)

(n = 90)

% change

4.7 (2.1)

(n = 91)

2.8 (1.3)

(n = 91)

4.4 (1.8)

(n = 91)

4.3 (1.5)

(n = 88)

8.4 (3.7)

(n = 91)

0.2 (−35.2, 39.8)

(n = 88)

Difference (95% CI)

−29.6 (−34.5, −24.6) ^b

−19.7 (−22.8, −16.5) ^b

−24.6 (−28.9, −20.4) ^b

−20.5 (−24.3, −16.8) ^b

−3.1 (−12.4, 6.1)

−20.7 (−34.0, −8.0) ^e

Normoglycaemia ^d

Baseline

145.1 (38.2)

(n = 79)

232.3 (43.1)

(n = 79)

172.5 (43.4)

(n = 79)

127.7 (31.3)

(n = 79)

138.1 (66.0)

(n = 79)

2.1 (1.0, 3.7)

(n = 79)

% change

−25.2 (2.2)

(n = 76)

−16.4 (1.6)

(n = 76)

−21.1 (2.1)

(n = 76)

−18.3 (1.9)

(n = 74)

3.1 (3.9)

(n = 76)

−32.1 (−53.6, 25.8)

(n = 74)

Placebo

Baseline

134.2 (33.6)

(n = 49)

219.0 (41.6)

(n = 49)

160.7 (40.3)

(n = 49)

120.8 (28.1)

(n = 47)

133.3 (65.4)

(n = 49)

1.4 (0.8, 3.5)

(n = 47)

% change

−1.6 (2.1)

(n = 46)

−1.7 (1.7)

(n = 46)

−0.8 (2.2)

(n = 46)

0.7 (1.9)

(n = 45)

6.2 (5.8)

(n = 46)

10.0 (−19.0, 78.1)

(n = 45)

Difference (95% CI)

−23.6 (−29.7, −17.4) ^b

−14.7 (−19.4, −10.1) ^b

−20.4 (−26.5, −14.3) ^b

−19.0 (−24.4, −13.5) ^b

−3.1 (−17.1, 10.8)

−43.7 (−65.2, −22.8) ^b

Note: Baseline values are reported as mean (SD) mg/dl, except for hsCRP, which is reported as median (Q1, Q3) mg/L. Percentage change from baseline values for LDL‐C, TC, non‐HDL‐C, Apo B, and TG are reported as LS mean (SE). LS mean, standard error, placebo‐adjusted change from baseline, 95% confidence intervals, and P values are based on ANCOVA with percentage change from baseline as the dependent variable, study and treatment as fixed factors, and baseline as a covariate. Only observed data are included in the analysis. P values for median (IQR) are based on Wilcoxon 2 sample test.

Abbreviations: Apo B, apolipoprotein B; ASCVD, atherosclerotic cardiovascular disease; BA, bempedoic acid; HeFH, heterozygous familial hypercholesterolaemia; hsCRP, high‐sensitivity C‐reactive protein; IQR, interquartile range; LS, least squares; SE, standard error; TC, total cholesterol; TG, triglycerides.

^{^a}

Patients with one or more of the following: history of type 1 or type 2 diabetes; receiving antihyperglycaemic medication before baseline; and/or HbA1c ≥ 6.5% at baseline, or at least one fasting plasma glucose value of ≥100 mg/dl, but not more than one value of ≥126 mg/dl between screening and randomization.

^{^b}

P < .001.

^{^c}

Patients with all of the following: no medical history of diabetes; not receiving antihyperglycaemic medication before baseline; and HbA1c of 5.7% to 6.4% (inclusive) at baseline, or at least one fasting glucose value of ≥100 mg/dl, but not more than one value of ≥126 mg/dl between screening and randomization.

^{^d}

Patients not fulfilling the criteria for diabetes or prediabetes.

^{^e}

P < .01.