Table 4.

Changes in Liver Histology in Colesevelam- Versus Placebo-Treated Patients

	Colesevelam (n=17)			Placebo (n=14)			Difference
	Baseline	Posttreatment	P-Value	Baseline	Posttreatment	P-Value	(P-Value)
Steatosis
Mean ± SE	2.00 (0.7)	1.53 (0.8)	0.021	1.86 (0.8)	1.50 (0.8)	0.096	0.598
Median ± IQR	2.0 (1.5-2.5)	1.0 (1.0-2.0)		2.0 (1.0-2.25)	1.5 (1.0-2.0)
N grade 0/1/2/3	0/4/9/4	0/11/3/3		0/5/6/3	1/6/6/1
Lobular inflammation
Mean ± SE	1.82 (0.7)	1.59 (0.7)	0.248	1.43 (0.7)	1.71 (0.7)	0.102	0.069
Median ± IQR	2.0 (1.0-2.0)	1.0 (1.0-2.0)		1.0 (1.0-2.0)	2.0 (1.0-2.0)
N grade 0/1/2/3	0/6/8/3	0/9/6/2		0/9/4/1	0/6/6/2
Ballooning
Mean ± SE	1.12 (0.8)	1.06 (0.7)	0.782	1.07 (0.7)	1.14 (0.7)	0.655	0.488
Median ± IQR	1.0 (0.5-2.0)	1.0 (0.5-2.0)		1.0 (0.75-2.0)	1.0 (1.0-2.0)
N grade 0/1/2	4/7/6	4/8/5		3/7/4	2/8/4
Fibrosis
Mean ± SE	1.12 (1.5)	1.06 (1.3)	0.660	1.36 (1.6)	1.50 (1.4)	0.480	0.229
Median ± IQR	0 (0.0-3.0)	1.0 (0.0-2.0)		1.0 (0.0-3.0)	1.0 (0.0-2.25)
Stage 0/1/2/3/4	9/3/0/4/1	8/4/2/2/1		6/3/1/2/2	4/4/3/1/2
NAS
Mean ± SE	4.89 (1.3)	4.18 (1.8)	0.151	4.36 (1.3)	4.36 (1.8)	0.927	0.136
Median ± IQR	5.0 (4.0-6.0)	3.0 (3.0-6.0)		4.0 (3.75-5.0)	4.0 (3.0-5.25)

Data are expressed as means with standard error in parentheses or as median with interquartile range in parentheses.

SE, standard error; IQR, interquartile range.

Nonparametric tests (Wilcoxon-rank sum test) for related samples and independent samples were performed on all variables for histologic comparisons within groups and between groups respectively. Mean differences reflect comparison between baseline averages minus posttreatment values.