Table 2.

Biochemical Biomarkers and Lipid Profile at Baseline (Before Randomization) and After 8 Weeks of Treatment

	Baseline	8 Weeks	Change (%)
ALP (IU/L)
Fenofibrate plus UDCA	195±73	132±70	-32.6†,¶
UDCA	232±74	245±81	+5.6
AST (IU/L)
Fenofibrate plus UDCA	42±15	41±19	-3.0
UDCA	38±10	37±11	-2.0
ALT (IU/L)
Fenofibrate plus UDCA	49±25	41±27	-16.9 †,¶
UDCA	41±13	39±14	-5.0
γGT (IU/L)
Fenofibrate plus UDCA	96 (38-479)	54 (19-348)	-44.0 †,¶
UDCA	112 (56-419)	120 (62-430)	+1.0
Total bilirubin (mg/dL)
Fenofibrate plus UDCA	0.70±0.14	0.64±0.29	-8.5
UDCA	0.73±0.18	0.65±0.24	-11.0
Conjugated bilirubin (mg/dL)
Fenofibrate plus UDCA	0.16±0.04	0.14±0.09	-12.5
UDCA	0.17±0.07	0.15±0.08	-12.0
Uric acid (mg/dL)
Fenofibrate plus UDCA	4.3±1.3	4.0±1.5	-7.0
UDCA	4.1±1.2	4.0±1.3	-2.0
Creatinine (mg/dL)
Fenofibrate plus UDCA	0.74±0.15	0.82±0.13	+6.0
UDCA	0.76±0.12	0.79±0.12	+4.0
Amylase (IU/L)
Fenofibrate plus UDCA	63±15	62±10	-1.0
UDCA	68±16	62±13	-9.0
Total cholesterol (mg/dL)
Fenofibrate plus UDCA	283±40	257±39	-9.5 †,¶
UDCA	302±45	297±39	-2.0
Triglycerides (mg/dL)
Fenofibrate plus UDCA	145±67	108±35	-25.6 †,¶
UDCA	136±68	122±28	-10.0
HDL-C (mg/dL)
Fenofibrate plus UDCA	68±17	68±14	0.0
UDCA	71±18	70±16	-1.5
LDL-C (mg/dL)
Fenofibrate plus UDCA	189±29	167±22	-10.0
UDCA	198±24	201± 26	+1.0
non HDL-C (mg/dL)
Fenofibrate plus UDCA	215±27	188±29	-12.5 †,¶
UDCA	221±29	209±32	-5.0
Glucose (mg/dL)
Fenofibrate plus UDCA	96±19	85±11	-1.0
UDCA	92±16	94±15	+2.0

For abbreviations and conversions to SI units see Table 1

^†p<0.049 vs baseline

^¶p<0.03 vs UDCA monotherapy

Values are expressed as mean ± SD, except for γGT which is expressed as median (range).