J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website http://www.jocmr.org

Original Article

Volume 9, Number 6, June 2017, pages 476-481

Effect of Ezetimibe Monotherapy on Low-Density Lipoprotein Cholesterol and on Markers of Cholesterol Synthesis and Absorption in Japanese Patients With Hypercholesterolemia

Figure 1. Changes of the lipid profile in the E group and C group. Data are shown as the mean ± SE. BL: baseline. *P < 0.05, **P < 0.01. E group: ezetimibe treated group. C group: ezetimibe non-treated control group.

Figure 2. (a, b) Correlation between changing rate of LDL-C and changing rate of cholesterol absorption markers from baseline to 12 weeks in the E group. (c, d) Correlation between changing rate of LDL-C from baseline to 12 weeks and the baseline levels of cholesterol absorption markers in the E group.

**Table 1.** Baseline Characteristics of the Patients
	E group	C group	P-value
Results are expressed as the mean ± SE. E group: ezetimibe treated group. C group: ezetimibe non-treated control group. BMI: body mass index; FPG: fasting plasma glucose; HbA1c: hemoglobin A1c; GA: glycated albumin; HDL-C: high-density lipoprotein cholesterol; LDL-C: low-density lipoprotein cholesterol; TG: triglycerides; RLP-C: remnant-like particles cholesterol.
Gender (male/female)	44 (18:26)	32 (17:15)	0.35
Age (years)	59.3 ± 2.1	62.6 ± 2.2	0.28
BMI (kg/m²)	28.1 ± 1.1	27.4 ± 0.6	0.59
FPG (mg/dL)	105 ± 3	108 ± 4	0.53
HbA1c (%)	5.5 ± 0.1	5.6 ± 0.1	0.68
AST (mg/dL)	24.6 ± 1.5	22.3 ± 1.1	0.25
ALT (mg/dL)	27.8 ± 3.4	24.8 ± 2.8	0.53
Creatinine (mg/dL)	0.7 ± 0.0	0.7 ± 0.0	0.58
TG (mg/dL)	150.7 ± 10.8	141.3 ± 11.2	0.55
HDL-C (mg/dL)	52.8 ± 1.3	54.1 ± 2.3	0.60
LDL-C (mg/dL)	154.6 ± 3.9	152.5 ± 3.7	0.71
RLP-C (mg/dL)	7.3 ± 0.6	6.4 ± 0.5	0.28
Lathosterol (μg/mL)	4.2 ± 0.3	4.2 ± 0.3	0.95
Campesterol (μg/mL)	5.7 ± 0.4	5.6 ± 0.4	0.88
Sitosterol (μg/mL)	3.2 ± 0.2	3.1 ± 0.2	0.65

Table 1. Baseline Characteristics of the Patients

E group

C group

P-value

Results are expressed as the mean ± SE. E group: ezetimibe treated group. C group: ezetimibe non-treated control group. BMI: body mass index; FPG: fasting plasma glucose; HbA1c: hemoglobin A1c; GA: glycated albumin; HDL-C: high-density lipoprotein cholesterol; LDL-C: low-density lipoprotein cholesterol; TG: triglycerides; RLP-C: remnant-like particles cholesterol.

Gender (male/female)

44 (18:26)

32 (17:15)

0.35

Age (years)

59.3 ± 2.1

62.6 ± 2.2

0.28

BMI (kg/m²)

28.1 ± 1.1

27.4 ± 0.6

0.59

FPG (mg/dL)

105 ± 3

108 ± 4

0.53

HbA1c (%)

5.5 ± 0.1

5.6 ± 0.1

0.68

AST (mg/dL)

24.6 ± 1.5

22.3 ± 1.1

0.25

ALT (mg/dL)

27.8 ± 3.4

24.8 ± 2.8

0.53

Creatinine (mg/dL)

0.7 ± 0.0

0.58

TG (mg/dL)

150.7 ± 10.8

141.3 ± 11.2

0.55

HDL-C (mg/dL)

52.8 ± 1.3

54.1 ± 2.3

0.60

LDL-C (mg/dL)

154.6 ± 3.9

152.5 ± 3.7

0.71

RLP-C (mg/dL)

7.3 ± 0.6

6.4 ± 0.5

0.28

Lathosterol (μg/mL)

4.2 ± 0.3

0.95

Campesterol (μg/mL)

5.7 ± 0.4

5.6 ± 0.4

0.88

Sitosterol (μg/mL)

3.2 ± 0.2

3.1 ± 0.2

0.65

**Table 2.** Comparison of the Changes in Serum Lipids and Cholesterol Absorption and Synthesis Markers
	E group	P-value (vs. baseline)	C group	P-value (vs. baseline)	P-value (E group vs. C group at 12 weeks)
Results are expressed as the mean ± SE. E group: ezetimibe treated group. C group: ezetimibe non-treated control group.
HDL-C (mg/dL)	52.8 ± 1.3	54.7 ± 1.5	< 0.05	54.1 ± 2.3	55.0 ± 2.7	0.44	0.93
LDL-C (mg/dL)	154.6 ± 3.9	131.7 ± 3.9	< 0.01	152.5 ± 3.7	147.2 ± 3.2	0.18	< 0.01
TG (mg/dL)	150.7 ± 10.8	139.0 ± 7.4	0.20	141.3 ± 11.2	146.4 ± 12.5	0.61	0.60
RLP-C (mg/dL)	7.3 ± 0.6	5.3 ± 0.3	< 0.01	6.4 ± 0.5	6.5 ± 0.6	0.95	0.08
Lathosterol (μg/mL)	4.2 ± 0.3	4.6 ± 0.2	< 0.01	4.2 ± 0.3	4.5 ± 0.5	0.41	0.79
Campesterol (μg/mL)	5.7 ± 0.4	3.1 ± 0.2	< 0.01	5.6 ± 0.4	5.9 ± 0.4	0.36	< 0.01
Sitosterol (μg/mL)	3.2 ± 0.2	1.8 ± 0.1	< 0.01	3.1 ± 0.2	3.3 ± 0.2	0.26	< 0.01

Table 2. Comparison of the Changes in Serum Lipids and Cholesterol Absorption and Synthesis Markers

E group

P-value (vs. baseline)

C group

P-value (vs. baseline)

P-value (E group vs. C group at 12 weeks)

Baseline

12 weeks

Baseline

12 weeks

Results are expressed as the mean ± SE. E group: ezetimibe treated group. C group: ezetimibe non-treated control group.

HDL-C (mg/dL)

52.8 ± 1.3

54.7 ± 1.5

< 0.05

54.1 ± 2.3

55.0 ± 2.7

0.44

0.93

LDL-C (mg/dL)

154.6 ± 3.9

131.7 ± 3.9

< 0.01

152.5 ± 3.7

147.2 ± 3.2

0.18

< 0.01

TG (mg/dL)

150.7 ± 10.8

139.0 ± 7.4

0.20

141.3 ± 11.2

146.4 ± 12.5

0.61

0.60

RLP-C (mg/dL)

7.3 ± 0.6

5.3 ± 0.3

< 0.01

6.4 ± 0.5

6.5 ± 0.6

0.95

0.08

Lathosterol (μg/mL)

4.2 ± 0.3

4.6 ± 0.2

< 0.01

4.2 ± 0.3

4.5 ± 0.5

0.41

0.79

Campesterol (μg/mL)

5.7 ± 0.4

3.1 ± 0.2

< 0.01

5.6 ± 0.4

5.9 ± 0.4

0.36

< 0.01

Sitosterol (μg/mL)

3.2 ± 0.2

1.8 ± 0.1

< 0.01

3.1 ± 0.2

3.3 ± 0.2

0.26

< 0.01

**Table 3.** Comparison of Baseline Parameters Between the Ezetimibe High Responder Group and the Low Responder Group
	High responder group	Low responder group	P-value
Results are expressed as the mean ± SE. High responder group: equal or more than 20 mg/dL LDL-C reduction. Low responder group: less than 20 mg/dL LDL-C reduction.
n	18	26
Age (years)	61.8 ± 2.7	57.8 ± 2.9	0.36
BMI (kg/m²)	27.0 ± 1.9	28.1 ± 1.5	0.41
FPG (mg/dL)	102 ± 5	106 ± 4	0.49
HDL-C (mg/dL)	53.4 ± 2.0	52.3 ± 1.7	0.69
LDL-C (mg/dL)	163.1 ± 4.0	148.7 ± 5.7	0.07
RLP-C (mg/dL)	6.8 ± 0.8	7.6 ± 0.8	0.49
Lathosterol (μg/mL)	4.2 ± 0.3	4.2 ± 0.4	0.98
Campesterol (μg/mL)	6.6 ± 0.7	5.1 ± 0.4	0.04
Sitosterol (μg/mL)	3.8 ± 0.5	2.8 ± 0.2	0.04

Table 3. Comparison of Baseline Parameters Between the Ezetimibe High Responder Group and the Low Responder Group

High responder group

Low responder group

P-value

Results are expressed as the mean ± SE. High responder group: equal or more than 20 mg/dL LDL-C reduction. Low responder group: less than 20 mg/dL LDL-C reduction.

Age (years)

61.8 ± 2.7

57.8 ± 2.9

0.36

BMI (kg/m²)

27.0 ± 1.9

28.1 ± 1.5

0.41

FPG (mg/dL)

102 ± 5

106 ± 4

0.49

HDL-C (mg/dL)

53.4 ± 2.0

52.3 ± 1.7

0.69

LDL-C (mg/dL)

163.1 ± 4.0

148.7 ± 5.7

0.07

RLP-C (mg/dL)

6.8 ± 0.8

7.6 ± 0.8

0.49

Lathosterol (μg/mL)

4.2 ± 0.3

4.2 ± 0.4

0.98

Campesterol (μg/mL)

6.6 ± 0.7

5.1 ± 0.4

0.04

Sitosterol (μg/mL)

3.8 ± 0.5

2.8 ± 0.2

0.04