Gastroenterol Res

Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access

Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc

Journal website http://www.gastrores.org

Original Article

Volume 13, Number 2, April 2020, pages 73-80

Benefits of the Therapy With Abexol in Patients With Non-Alcoholic Fatty Liver Disease

Figure 1. Effects on secondary efficacy outcomes. ^aP < 0.05 comparison with baseline (t-test for paired samples); ^bP < 0.05 comparison with placebo (t-test for independent samples).

Figure 2. Effects on laboratory variables. All comparisons were not significant. ALT: alanine aminotransferase; AST: aspartate aminotransferase; GGT: gamma glutamyl transferase.

**Table 1.** Baseline Characteristics of Study Patients
	Abexol (n = 50)	Placebo (n = 50)	Total (n = 100)
All comparisons were not significant. The table included CM consumed by ≥ two patients. BMI: body mass index; CM: concomitant medications; X: mean; SD: standard deviation; ACEI: angiotensin converting enzyme inhibitor.
Age (years) (X ± SD)	53 ± 9	53 ± 8	53 ± 9
BMI (kg/m²) (X ± SD)	29.7 ± 5.3	29.1 ± 4.1	29.4 ± 4.6
	n, %	n, %	n, %
Gender, n (%)
Female	28 (56.0%)	26 (52.0%)	54 (54.0%)
Male	22 (44.0%)	24 (48.0%)	46 (46.0%)
Personal history, n (%)
Hypertension	30 (60.0%)	27 (54.0%)	57 (57.0%)
Dyslipidemia	27 (54.0%)	26 (52.0%)	53 (53.0 %)
Overweight (BMI ≥ 25, < 30 kg/m²)	23 (46.0%)	24 (48.0%)	47 (47.0 %)
Obesity (BMI ≥ 30 kg/m²)	20 (40.0%)	19 (38.0%)	39 (39.0%)
Diabetes mellitus	12 (24.0%)	10 (20.0%)	22 (22.0%)
Smoking	11 (22.0%)	9 (18.0%)	20 (20.0%)
Coronary heart disease	4 (8.0%)	5 (10%)	9 (9.0%)
CM, n (%)
Patients consuming CM	48 (96.0%)	47 (94%)	95 (95.0%)
ACEI	20 (40.0%)	16 (32.0%)	36 (36.0%)
Lipid-lowering drugs	15 (30.0%)	16 (32.0%)	31 (31.0%)
Diuretics	14 (28.0%)	14 (28.0%)	28 (28.0%)
Oral hypoglycemic drugs	12 (24.0%)	10 (20.0%)	22 (22.0%)
β-blockers	6 (12.0%)	4 (8.0%)	10 (10.0%)
Antiplatelet drugs	4 (8.0%)	5 (10.0%)	9 (9.0%)
Calcium antagonists	2 (4.0%)	4 (8.0%)	6 (6.0%)
Nitrovasodilator	2 (4.0%)	2 (4.0%)	4 (4.0%)

Table 1. Baseline Characteristics of Study Patients

Abexol (n = 50)

Placebo (n = 50)

Total (n = 100)

All comparisons were not significant. The table included CM consumed by ≥ two patients. BMI: body mass index; CM: concomitant medications; X: mean; SD: standard deviation; ACEI: angiotensin converting enzyme inhibitor.

Age (years) (X ± SD)

53 ± 9

53 ± 8

53 ± 9

BMI (kg/m²) (X ± SD)

29.7 ± 5.3

29.1 ± 4.1

29.4 ± 4.6

n, %

Gender, n (%)

Female

28 (56.0%)

26 (52.0%)

54 (54.0%)

Male

22 (44.0%)

24 (48.0%)

46 (46.0%)

Personal history, n (%)

Hypertension

30 (60.0%)

27 (54.0%)

57 (57.0%)

Dyslipidemia

27 (54.0%)

26 (52.0%)

53 (53.0 %)

Overweight (BMI ≥ 25, < 30 kg/m²)

23 (46.0%)

24 (48.0%)

47 (47.0 %)

Obesity (BMI ≥ 30 kg/m²)

20 (40.0%)

19 (38.0%)

39 (39.0%)

Diabetes mellitus

12 (24.0%)

10 (20.0%)

22 (22.0%)

Smoking

11 (22.0%)

9 (18.0%)

20 (20.0%)

Coronary heart disease

4 (8.0%)

5 (10%)

9 (9.0%)

CM, n (%)

Patients consuming CM

48 (96.0%)

47 (94%)

95 (95.0%)

ACEI

20 (40.0%)

16 (32.0%)

36 (36.0%)

Lipid-lowering drugs

15 (30.0%)

16 (32.0%)

31 (31.0%)

Diuretics

14 (28.0%)

28 (28.0%)

Oral hypoglycemic drugs

12 (24.0%)

10 (20.0%)

22 (22.0%)

β-blockers

6 (12.0%)

4 (8.0%)

10 (10.0%)

Antiplatelet drugs

4 (8.0%)

5 (10.0%)

9 (9.0%)

Calcium antagonists

2 (4.0%)

4 (8.0%)

6 (6.0%)

Nitrovasodilator

2 (4.0%)

4 (4.0%)

**Table 2.** Effects on Ultrasonographic Evaluation
Degree of severity	Abexol	Placebo	P value
P < 0.05 comparison with placebo (χ² test). ns: no significant.
Baseline
Normal	0	0	ns
Mild	17	18	ns
Moderate	23	24	ns
Severe	10	8	ns
Six months
Normal	14	6	P < 0.05
Mild	16	18	ns
Moderate	17	21	ns
Severe	3	5	ns

Table 2. Effects on Ultrasonographic Evaluation

Degree of severity

Abexol

Placebo

P value

P < 0.05 comparison with placebo (χ² test). ns: no significant.

Baseline

Normal

Mild

Moderate

Severe

Six months

Normal

P < 0.05

Mild

Moderate

Severe

**Table 3.** Effects on Secondary Efficacy Outcomes (X ± SD)
Treatment	Baseline	Six months	Changes (%)
^aP < 0.05 comparison with baseline (t-test for paired samples); ^bP < 0.05 comparison with placebo (t-test for independent samples). X: mean; SD: standard deviation.
Insulin levels (µUI/mL)
Placebo	70.6 ± 29.8	73.2 ± 30.1	+3.7
Abexol	71.4 ± 28.6	50.6 ± 31.2^{a, b}	-29.1
HOMA index
Placebo	11.5 ± 5.5	13.3 ± 8.6	+15.7
Abexol	12.2 ± 8.2	9.0 ± 5.1^{a, b}	-26.3

Table 3. Effects on Secondary Efficacy Outcomes (X ± SD)

Treatment

Baseline

Six months

Changes (%)

^aP < 0.05 comparison with baseline (t-test for paired samples); ^bP < 0.05 comparison with placebo (t-test for independent samples). X: mean; SD: standard deviation.

Insulin levels (µUI/mL)

Placebo

70.6 ± 29.8

73.2 ± 30.1

+3.7

Abexol

71.4 ± 28.6

50.6 ± 31.2^{a, b}

-29.1

HOMA index

Placebo

11.5 ± 5.5

13.3 ± 8.6

+15.7

Abexol

12.2 ± 8.2

9.0 ± 5.1^{a, b}

-26.3

**Table 4.** Effects on Laboratory Variables (X ± SD)
Treatment	Baseline	Three months	Six months
All comparisons were not significant. X: mean: SD standard deviation; ALT alanine aminotransferase; AST: aspartate aminotransferase; GGT: gamma glutamyl transferase.
AST (U/L)
Placebo	28.1 ± 10.2	28.9 ± 10.5	27.3 ± 11.1
Abexol	28.4 ± 11.3	27.3 ± 10.8	26.2 ± 10.7
ALT (U/L)
Placebo	32.6 ± 13.4	30.9 ± 12.5	31.4 ± 14.7
Abexol	31.9 ± 14.3	30.1 ± 11.9	29.6 ± 13.5
GGT (U/L)
Placebo	41.2 ± 28.6	39.9 ± 25.8	40.1 ± 26.7
Abexol	42.1 ± 26.5	40.3 ± 23.7	38.9 ± 24.5
Glucose (mmol/L)
Placebo	5.4 ± 1.6	5.5 ± 1.0	5.0 ± 1.7
Abexol	5.7 ± 1.4	5.5 ± 1.2	5.2 ± 1.1
Creatinine (μmol/L)
Placebo	75.9 ± 13.4	76.8 ± 14.2	75.3 ± 15.1
Abexol	80.6 ± 18.6	79.1 ± 14.4	78.6 ± 14.7

Table 4. Effects on Laboratory Variables (X ± SD)

Treatment

Baseline

Three months

Six months

All comparisons were not significant. X: mean: SD standard deviation; ALT alanine aminotransferase; AST: aspartate aminotransferase; GGT: gamma glutamyl transferase.

AST (U/L)

Placebo

28.1 ± 10.2

28.9 ± 10.5

27.3 ± 11.1

Abexol

28.4 ± 11.3

27.3 ± 10.8

26.2 ± 10.7

ALT (U/L)

Placebo

32.6 ± 13.4

30.9 ± 12.5

31.4 ± 14.7

Abexol

31.9 ± 14.3

30.1 ± 11.9

29.6 ± 13.5

GGT (U/L)

Placebo

41.2 ± 28.6

39.9 ± 25.8

40.1 ± 26.7

Abexol

42.1 ± 26.5

40.3 ± 23.7

38.9 ± 24.5

Glucose (mmol/L)

Placebo

5.4 ± 1.6

5.5 ± 1.0

5.0 ± 1.7

Abexol

5.7 ± 1.4

5.5 ± 1.2

5.2 ± 1.1

Creatinine (μmol/L)

Placebo

75.9 ± 13.4

76.8 ± 14.2

75.3 ± 15.1

Abexol

80.6 ± 18.6

79.1 ± 14.4

78.6 ± 14.7