Angiotensin-receptor blockers as therapy for mild-to-moderate hypertension-associated non-alcoholic steatohepatitis

doi:10.3748/wjg.15.942

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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World J Gastroenterol. Feb 28, 2009; 15(8): 942-954
Published online Feb 28, 2009. doi: 10.3748/wjg.15.942

Table 1 Demographics and baseline data at inclusion (mean ± SE)

	Units	Overall patients	Group		P
	Units	Overall patients	T	V
No. of patients		54	28	26	P	NS
Gender	Male/female	28/26	14/14	12/14	NS
Age	yr	48.89 ± 1.41	48 ± 1.98	49.85 ± 2.05	NS
BMI (V1)	kg/m²	27.42 ± 0.36	27.21 ± 0.51	27.65 ± 0.53	NS
dBP (V1)	mmHg	101.65 ± 1.05	101.43 ± 1.17	101.89 ± 1.8
sBP (V1)	mmHg	156.53 ± 1.28	155.71 ± 1.61	157.42 ± 2.04
ALT (V1)	IU/L	67.65 ± 2.01	66.96 ± 2.95	68.38 ± 2.75	NS
AST (V1)	IU/L	70.31 ± 2.34	72.78 ± 3.53	67.65 ± 3.02
GGT (V1)	IU/L	23.85 ± 1.62	22.60 ± 2.37	25.19 ± 2.22
B (V1)	mg/dL	0.89 ± 0.02	0.9 ± 0.03	0.88 ± 0.04
HOMA IR (V1)	units	7.7 ± 0.24	7.81 ± 0.40	7.58 ± 0.25
IRI (V1)	&mgr;U/mL	27.64 ± 0.86	27.78 ± 1.14	27.50 ± 1.32
FPG (V1)	mg/dL	113.83 ± 1.98	113.60 ± 2.77	114.07 ± 2.88
HDL-C (V1)	mg/dL	42.44 ± 1.2	42.34 ± 1.68	42.54 ± 1.77	NS¹
		M: 37.8 ± 1.38	M: 37.45 ± 1.86	M: 38.16 ± 2.11
		F: 47.42 ± 1.5	F: 47.23 ± 2.13	F: 47.66 ± 2.19
TC (V1)	mg/dL	196.46 ± 1.13	196.07 ± 1.5	196.88 ± 1.73	NS¹
		M: 200.82 ± 1.2	M: 200.57 ± 1.29	M: 201.07 ± 2.07
		F: 191.77 ± 1.5	F: 191.57 ± 2.13	F: 192 ± 2.19
TG (V1)	mg/dL	161.51 ± 4.91	165.64 ± 6.95	157.08 ± 7.18
NAS (V1)	points	5.89 ± 0.14	6 ± 0.18	5.77 ± 0.22	NS
Steatosis (V1)		2.16 ± 0.09	2.21 ± 0.12	2.11 ± 0.16
Lobular inflammation (V1)		1.70 ± 0.06	1.68 ± 0.09	1.73 ± 0.09
Ballooning (V1)		2.02 ± 0.1	2.11 ± 0.13	1.92 ± 0.16
Fibrosis (V1)	points	2.11 ± 0.11	2.07 ± 0.16	2.15 ± 0.15	NS

BMI: Body mass index; dBP: Diastolic blood pressure; sBP: Systolic blood pressure; ALT: Alanine-aminotransferase; AST: Aspartate-aminotransferase; GGT: Gamma-glutamyl transpeptidase; B: Bilirubin; HOMA-IR: Homeostasis model assessment index for insulin-resistance; IRI: Plasma immunoreactive insulin; FPG: Fasting plasma glucose; TC: Total cholesterol; HDL-C: High density lypoprotein-cholesterol; TG: Triglycerides; NAS: NASH activity score; M: Male patients; F: female patients; V1: index data at visit 1;

¹Statistics performed depending on gender and also in overall patients.

Table 2 Comparative overview of the primary parameters at inclusion versus end-of-treatment in study groups and in overall patients

	Units	Overall		Group T		Group V
	Units	mean ± SE	P	mean ± SE	P	mean ± SE	P
sBP (V1)	mmHg	156.54 ± 1.28	< 0.0001	155.71 ± 1.61	< 0.0001	157.42 ± 2.04	< 0.0001
sBP (V6)	mmHg	134.24 ± 1.28	< 0.0001	133.21 ± 1.23	< 0.0001	135.35 ± 2.31	< 0.0001
dBP (V1)	mmHg	101.65 ± 1.05	< 0.0001	101.43 ± 1.17	< 0.0001	101.89 ± 1.8	< 0.0001
dBP (V6)	mmHg	77.8 ± 1.04	< 0.0001	77.14 ± 1.25	< 0.0001	78.5 ± 1.7	< 0.0001
ALT (V1)	IU/L	67.65 ± 2.01	< 0.001	66.96 ± 2.95	< 0.001	68.38 ± 2.75	< 0.001
ALT (V6)	IU/L	49.48 ± 1.16	< 0.001	46.68 ± 1.42	< 0.001	52.50 ± 1.70	< 0.001
AST (V1)	IU/L	70.31 ± 2.34	< 0.001	72.78 ± 3.53	< 0.001	67.65 ± 3.02	< 0.001
AST (V6)	IU/L	51.11 ± 1.83	< 0.001	47.57 ± 2.08	< 0.001	54.92 ± 2.95	< 0.001
GGT (V1)	IU/L	23.85 ± 1.62	NS	22.60 ± 2.37	NS	25.19 ± 2.22	NS
GGT (V6)	IU/L	21.02 ± 1.98	NS	21.96 ± 3.55	NS	20 ± 1.58	NS
B (V1)	mg/dL	0.89 ± 0.02	NS	0.9 ± 0.03	NS	0.88 ± 0.04	NS
B (V6)	mg/dL	0.94 ± 0.02	NS	0.94 ± 0.03	NS	0.93 ± 0.03	NS
BMI (V1)	kg/m²	27.42 ± 0.36	NS	27.21 ± 0.51	NS	27.65 ± 0.53	NS
BMI (V6)	kg/m²	26.96 ± 0.36	NS	26.93 ± 0.49	NS	27.00 ± 0.54	NS
HOMA-IR (V1)	mg ×&mgr;IU	7.7 ± 0.24	< 0.001	7.81 ± 0.40	< 0.001	7.57 ± 0.25	< 0.05
HOMA-IR (V6)	/dL × 10^-2	5.19 ± 0.18	< 0.001	4.48 ± 0.21	< 0.001	5.95 ± 0.22	< 0.05
TG (V1)	mg/dL	161.51 ± 4.98	< 0.05¹	165.64 ± 6.95	< 0.031¹	157.08 ± 7.18	NS¹
		F: 168.42 ± 8.28		F: 169.85 ± 11.2		F: 166.75 ± 12.82
		M: 155.10 ± 5.63		M:161.42 ± 8.49		M: 148.78 ± 7.31
TG (V6)		153.96 ± 4.8		154.14 ± 6.79		153.77 ± 6.93
		F: 160 ± 8.29		F: 156.78 ± 11.33		F: 163.75 ± 12.61
		M: 148.35 ± 5.09		M: 151.5 ± 7.88		M: 145.21 ± 6.65
TC (V1)	mg/dL	196.46 ± 1.13	< 0.008¹	196.07 ± 1.5	< 0.024¹	196.88 ± 1.73	NS¹
		F: 191.77 ± 1.5		M: 200.57 ± 1.29		M: 201.07 ± 2.07
		M: 200.82 ± 1.2		F: 191.57 ± 2.13		F: 192 ± 2.19
TC (V6)		194.04 ± 1.19		191.89 ± 1.64		196.35 ± 1.64
		F: 189.73 ± 1.58		F: 188 ± 2.23		F: 191.75 ± 2.19
		M: 198.04 ± 1.39		M: 195.79 ± 1.96		M: 200.29 ± 1.87
NAS (V1)	Point	5.89 ± 0.14	< 0.001¹	6 ± 0.18	< 0.045¹	5.77 ± 0.22	NS¹
Steatosis		2.16 ± 0.09	²Excepting inflammation (V1) vs (V6)	2.21 ± 0.12		2.11 ± 0.16	²Excepting steatosis (V1) vs (V6) P = 0.027
Inflammation		1.70 ± 0.06	NS	1.68 ± 0.09		1.73 ± 0.09
Balooning		2.02 ± 0.1		2.11 ± 0.13		1.92 ± 0.16
NAS (V6)		4.96 ± 0.14		4.57 ± 0.18		5.38 ± 0.2
Steatosis		1.74 ± 0.09		1.71 ± 0.11		1.77 ± 0.15
Inflammation		1.55 ± 0.10		1.32 ± 0.12		1.81 ± 0.14
Balooning		1.67 ± 0.08		1.53 ± 0.11		1.81 ± 0.13
Fibrosis (V1)	Point	2.11 ± 0.11	< 0.001	2.07 ± 0.16	< 0.001	2.15 ± 0.15	NS
Fibrosis (V6)	Point	1.57 ± 0.09	< 0.001	1.32 ± 0.13	< 0.001	1.84 ± 0.11	NS

sBP: Systolic blood pressure; dBP: Diastolic blood pressure; ALT: Alanine-aminotransferase; AST: Aspartate-aminotransferase; GGT: Gamma-glutamyl transpeptidase; B: Bilirubin; BMI: Body mass index; HOMA-IR: Homeostasis model assessment index for insulin-resistance; TG: Triglycerides; TC: Total cholesterol; NAS: NASH activity score; M: Male patients; F: Female patients; V1: Index data at visit 1; V6: End-of-treatment data;

¹For any comparation;

²Exception.

Table 3 Derivate study parameters in treatment groups and in overall patients (mean ± SE)

	Units	Overall	Group T	Group V
mMd*ALT	IU/dL per month	-0.57 ± 0.05	-0.63 ± 0.09	-0.52 ± 0.05
mMd*HOMA-IR	units/mo	-9.63 ± 0.94 × 10^-2	-13.7 ± 1.32 × 10^-2	-5.3 ± 0.64 × 10^-2
mMd*TG	mg/dL per month	-1.79 ± 0.10	-1.99 ± 0.16	-1.58 ± 0.11
mMd*TC	mg/dL per month	-0.03 ± 0.03	-0.12 ± 0.05	0.06 ± 0.02
md*BMI	units	0.03 ± 0.36	0.11 ± 0.47	-0.05 ± 0.57
md*sBP	mmHg	-21.13 ± 1.13	-21.35 ± 1.68	-20.90 ± 1.54
md*dBP	mmHg	-19.18 ± 1.43	-19.65 ± 2.15	-18.67 ± 1.91
md*NAS	point	-0.92 ± 0.14	-1.43 ± 0.19	-0.38 ± 0.17
md*Fibrosis	point	-0.46 ± 0.11	-0.75 ± 0.13	-0.15 ± 0.18

mMd*ALT: Mean monthly decrease of ALT; mMd*HOMA-IR: Mean monthly decreases for HOMA-IR; mMd*TG: Mean monthly decrease of plasma triglycerides; mMd*TC: Mean monthly decrease of total cholesterol; md*BMI: Mean decrease of BMI; md*sBP: Mean decrease of systolic blood pressure; md*dBP: Mean decrease of diastolic blood pressure; md*NAS: The mean decrease for NAS; md*Fibrosis: Mean decrease for fibrosis score.

Citation: Georgescu EF, Ionescu R, Niculescu M, Mogoanta L, Vancica L. Angiotensin-receptor blockers as therapy for mild-to-moderate hypertension-associated non-alcoholic steatohepatitis. World J Gastroenterol 2009; 15(8): 942-954
URL: https://www.wjgnet.com/1007-9327/full/v15/i8/942.htm
DOI: https://dx.doi.org/10.3748/wjg.15.942