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 7, Number 6, June 2015, pages 446-452

Efficacy of Statin Monotherapy or in Combination With Coenzyme A Capsule in Patients With Metabolic Syndrome and Mixed Dyslipidemia

Figure 1. Mean percent change in triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and non-HDL-C from baseline to the end of study. CoA: coenzyme A. *P < 0.05; **P < 0.01.

**Table 1.** Demographics and Baseline Characteristics
Characteristic	Statin + CoA (n = 118)	Statin + placebo (n = 94)	P value
CoA: coenzyme A; BMI: body mass index; SBP: systolic blood pressure; DBP: diastolic blood pressure; ACEI: angiotensin-converting enzyme inhibitor; ARB: angiotensin receptor blocker; MetS: metabolic syndrome; FPG: fasting plasma glucose; BP: blood pressure.
Age (years)	55.6 ± 11.6	53.6 ± 13.1	0.25
Male gender (n, %)	65 (55.1)	59 (62.8)	0.27
Current smokers (n, %)	38 (32.2)	36 (38.3)	0.39
BMI (kg/m²)	26.0 ± 2.7	25.8 ± 2.7	0.52
Waist circumference (cm)	91.4 ± 10.6	90.9 ± 10.1	0.72
SBP (mm Hg)	134.8 ± 12.5	131.4 ± 14.5	0.07
DBP (mm Hg)	81.6 ± 9.7	81.6 ± 8.7	0.96
Hypertension (n, %)	56 (47.5)	40 (42.6)	0.49
Diabetes mellitus (n, %)	21 (17.8)	23 (24.5)	0.24
ACEIs/ARBs (n, %)	35 (29.7)	24 (25.5)	0.54
β-blockers (n, %)	25 (21.2)	17 (18.1)	0.61
Calcium channel blockers (n, %)	34 (28.8)	18 (19.1)	0.11
Diuretics (%, n)	7 (5.9)	1 (1.1)	0.079
Platelet aggregation inhibitors (n, %)	18 (15.3)	14 (14.9)	1.00
Statins			0.70
Atorvastatin (n, %)	74 (62.7)	63 (67.0)
Rosuvastatin (n, %)	12 (10.2)	5 (5.3)
Simvastatin (n, %)	22 (18.6)	17 (18.1)
Fluvastatin (n, %)	9 (7.6)	7 (7.4)
Lovastatin (n, %)	1 (0.8)	0 (0.0)
MetS components (n)	3 (3 - 5)	3 (3 - 5)	0.37
Waist criterion (n, %)	79 (66.9)	63 (67.0)	1.00
FPG criterion (n, %)	82 (69.5)	68 (72.3)	0.76
TG criterion (n, %)	118 (100.0)	94 (100.0)	1.00
HDL-C criterion (n, %)	41 (34.7)	43 (45.7)	0.12
BP criterion (n, %)	93 (78.8)	69 (73.4)	0.42

Table 1. Demographics and Baseline Characteristics

Characteristic

Statin + CoA (n = 118)

Statin + placebo (n = 94)

P value

CoA: coenzyme A; BMI: body mass index; SBP: systolic blood pressure; DBP: diastolic blood pressure; ACEI: angiotensin-converting enzyme inhibitor; ARB: angiotensin receptor blocker; MetS: metabolic syndrome; FPG: fasting plasma glucose; BP: blood pressure.

Age (years)

55.6 ± 11.6

53.6 ± 13.1

0.25

Male gender (n, %)

65 (55.1)

59 (62.8)

0.27

Current smokers (n, %)

38 (32.2)

36 (38.3)

0.39

BMI (kg/m²)

26.0 ± 2.7

25.8 ± 2.7

0.52

Waist circumference (cm)

91.4 ± 10.6

90.9 ± 10.1

0.72

SBP (mm Hg)

134.8 ± 12.5

131.4 ± 14.5

0.07

DBP (mm Hg)

81.6 ± 9.7

81.6 ± 8.7

0.96

Hypertension (n, %)

56 (47.5)

40 (42.6)

0.49

Diabetes mellitus (n, %)

21 (17.8)

23 (24.5)

0.24

ACEIs/ARBs (n, %)

35 (29.7)

24 (25.5)

0.54

β-blockers (n, %)

25 (21.2)

17 (18.1)

0.61

Calcium channel blockers (n, %)

34 (28.8)

18 (19.1)

0.11

Diuretics (%, n)

7 (5.9)

1 (1.1)

0.079

Platelet aggregation inhibitors (n, %)

18 (15.3)

14 (14.9)

1.00

Statins

0.70

Atorvastatin (n, %)

74 (62.7)

63 (67.0)

Rosuvastatin (n, %)

12 (10.2)

5 (5.3)

Simvastatin (n, %)

22 (18.6)

17 (18.1)

Fluvastatin (n, %)

9 (7.6)

7 (7.4)

Lovastatin (n, %)

1 (0.8)

0 (0.0)

MetS components (n)

3 (3 - 5)

0.37

Waist criterion (n, %)

79 (66.9)

63 (67.0)

1.00

FPG criterion (n, %)

82 (69.5)

68 (72.3)

0.76

TG criterion (n, %)

118 (100.0)

94 (100.0)

1.00

HDL-C criterion (n, %)

41 (34.7)

43 (45.7)

0.12

BP criterion (n, %)

93 (78.8)

69 (73.4)

0.42

**Table 2.** Percentage Change From Baseline to Follow-Up in Levels of Serum Lipoproteins
Variable	Statin + CoA (n = 118)	Statin + placebo (n = 94)	P value
CoA: coenzyme A; TG: triglyceride; TC: total cholesterol; HDL-C: high-density lipoprotein cholesterol; LDL-C: low-density lipoprotein cholesterol.
TG
Baseline mean (mg/dL)	318.8 ± 114.2	305.5 ± 99.2
Final mean (mg/dL)	215.2 ± 126.6	275.4 ± 172.7
Mean change, % ± SE (median)	-32.47 ± 28.30 (-36.81)	-8.69 ± 49.12 (-19.66)	0.0002
TC
Baseline mean (mg/dL)	204.2 ± 42.9	192.2 ± 42.5
Final mean (mg/dL)	181.7 ± 38.3	183.3 ± 44.9
Mean change, % ± SE (median)	-9.56 ± 17.85 (-9.86)	-3.58 ± 16.47 (-4.57)	0.013
HDL-C
Baseline mean (mg/dL)	45.2 ± 12.4	42.2 ± 11.6
Final mean (mg/dL)	48.3 ± 13.9	45.6 ± 14.7
Mean change, % ± SE (median)	10.07 ± 30.08 (5.93)	9.73 ± 27.12 (6.49)	0.93
LDL-C
Baseline mean (mg/dL)	111.0 ± 35.6	103.2 ± 35.2
Final mean (mg/dL)	99.4 ± 36.3	100.9 ± 35.2
Mean change, % ± SE (median)	-7.48 ± 31.40 (-11.36)	2.08 ± 33.09 (-2.84)	0.033
Non-HDL-C
Baseline mean (mg/dL)	159.3 ± 39.4	150.0 ± 41.0
Final mean (mg/dL)	133.4 ± 37.5	137.7 ± 43.3
Mean change, % ± SE (median)	-14.31 ± 22.20 (-15.84)	-6.38 ± 22.40 (-7.38)	0.011

Table 2. Percentage Change From Baseline to Follow-Up in Levels of Serum Lipoproteins

Variable

Statin + CoA (n = 118)

Statin + placebo (n = 94)

P value

CoA: coenzyme A; TG: triglyceride; TC: total cholesterol; HDL-C: high-density lipoprotein cholesterol; LDL-C: low-density lipoprotein cholesterol.

Baseline mean (mg/dL)

318.8 ± 114.2

305.5 ± 99.2

Final mean (mg/dL)

215.2 ± 126.6

275.4 ± 172.7

Mean change, % ± SE (median)

-32.47 ± 28.30 (-36.81)

-8.69 ± 49.12 (-19.66)

0.0002

Baseline mean (mg/dL)

204.2 ± 42.9

192.2 ± 42.5

Final mean (mg/dL)

181.7 ± 38.3

183.3 ± 44.9

Mean change, % ± SE (median)

-9.56 ± 17.85 (-9.86)

-3.58 ± 16.47 (-4.57)

0.013

HDL-C

Baseline mean (mg/dL)

45.2 ± 12.4

42.2 ± 11.6

Final mean (mg/dL)

48.3 ± 13.9

45.6 ± 14.7

Mean change, % ± SE (median)

10.07 ± 30.08 (5.93)

9.73 ± 27.12 (6.49)

0.93

LDL-C

Baseline mean (mg/dL)

111.0 ± 35.6

103.2 ± 35.2

Final mean (mg/dL)

99.4 ± 36.3

100.9 ± 35.2

Mean change, % ± SE (median)

-7.48 ± 31.40 (-11.36)

2.08 ± 33.09 (-2.84)

0.033

Non-HDL-C

Baseline mean (mg/dL)

159.3 ± 39.4

150.0 ± 41.0

Final mean (mg/dL)

133.4 ± 37.5

137.7 ± 43.3

Mean change, % ± SE (median)

-14.31 ± 22.20 (-15.84)

-6.38 ± 22.40 (-7.38)

0.011

**Table 3.** Incidence of Adverse Events
Variable	Total (n = 212)	Statin + CoA (n = 118)	Statin + placebo (n = 94)
CoA: coenzyme A; AE: adverse event.
Any AE	15	10	5
Patients who experienced any AE	15	10	5
Most common AEs
Abdominal distention	1	1	0
Nausea	1	1	0
Elevated liver enzymes	1	1	0
Elevated creatine phosphokinase	5	2	3
Upper respiratory tract infection	3	3	0

Table 3. Incidence of Adverse Events

Variable

Total (n = 212)

Statin + CoA (n = 118)

Statin + placebo (n = 94)

CoA: coenzyme A; AE: adverse event.

Any AE

Patients who experienced any AE

Most common AEs

Abdominal distention

Nausea

Elevated liver enzymes

Elevated creatine phosphokinase

Upper respiratory tract infection