Table 2.

Baseline Values and Outcomes After 6 Mo of Treatment

	Baseline		6 Mo		Change Over 6 Mo
	Pitavastatin	Placebo	Pitavastatin	Placebo	Pitavastatin (n = 24)	Placebo (n = 23)	Effect Size (95% CI)	P
Body composition
Weight, kg	108.6 ± 3.6	116.4 ± 4.8	107.6 ± 3.6	117.4 ± 4.6	−1.0 ± 0.8	1.0 ± 0.8	−2.0 (−4.4, 0.3)	0.09
BMI, kg/m2	35.6 ± 1.0	36.1 ± 1.4	35.4 ± 1.0	36.4 ± 1.3	−0.3 ± 0.3	0.3 ± 0.3	−0.6 (−1.4, 0.1)	0.10
Waist circumference, cm	118 ± 2	122 ± 3	117 ± 2	123 ± 3	−0 ± 1	1 ± 1	−1 (−4, 2)	0.40
VAT area, cm2	272 ± 16	271 ± 24	267 ± 16	287 ± 25	−6 ± 15	16 ± 13	−22 (−62, 19)	0.29
SAT area, cm2	393 ± 25	425 ± 36	405 ± 35	424 ± 33	11 ± 14	−1 ± 12	13 (−25, 51)	0.50
VAT/SAT ratio	0.75 ± 0.08	0.70 ± 0.08	0.78 ± 0.10	0.73 ± 0.08	0.02 ± 0.08	0.04 ± 0.05	−0.01 (−0.20, 0.17)	0.88
Body fat, %	35.8 ± 1.0	36.7 ± 1.2	35.8 ± 0.9	37.2 ± 1.1	0.1 ± 0.4	0.4 ± 0.3	−0.4 (−1.4, 0.6)	0.47
Lipid profile
Total cholesterol, mg/dL	183 ± 4	199 ± 6	137 ± 4	197 ± 6	−46 ± 4	−2 ± 5	−44 (−57, −32)	<0.0001
LDL-C, mg/dL	116 ± 4	125 ± 5	75 ± 3	126 ± 4	−49 ± 3	−1 ± 4	−48 (−58, −37)	<0.0001
HDL-C, mg/dL	41 ± 2	43 ± 2	39 ± 1	43 ± 2	−2 ± 1	−0 ± 1	−1 (−4, 2)	0.38
Triglycerides, mg/dL	133 ± 12	153 ± 15	123 ± 19	144 ± 12	−10 ± 10	−9 ± 11	−1 (−31, 29)	0.95
Metabolic parameters
HbA1c, %	5.7 ± 0.1	5.7 ± 0.1	5.7 ± 0.1	5.7 ± 0.1	0.0 ± 0.1	−0.0 ± 0.0	0.1 (−0.1, 0.2)	0.24
Fasting glucose, mg/dL	98 ± 2	97 ± 2	96 ± 3	99 ± 2	−2 ± 2	2 ± 2	−4 (−10, 1)	0.13
2-hr OGTT glucose, mg/dLa	139 ± 6	132 ± 8	141 ± 9	138 ± 8	3 ± 6	7 ± 6	−3 (−20, 14)	0.71
HOMA-IR	2.1 ± 0.4	1.6 ± 0.2	1.6 ± 0.3	2.0 ± 0.3	−0.5 ± 0.3	0.3 ± 0.2	−0.8 (−1.6, -0.1)	0.03
Fasting insulin, μU/mL	8.5 ± 1.5	6.7 ± 0.8	7.0 ± 1.0	7.9 ± 1.2	−1.9 ± 1.1	1.1 ± 1.0	−3.1 (−6.1, -0.0)	0.05
Low-dose clamp M, mg/kg/min	1.4 ± 0.2	1.9 ± 0.2	1.5 ± 0.2	1.6 ± 0.2	0.1 ± 0.1	−0.3 ± 0.2	0.4 (−0.1, 0.8)	0.11
High-dose clamp M, mg/kg/min	6.4 ± 0.4	6.6 ± 0.5	5.9 ± 0.4	5.9 ± 0.3	−0.5 ± 0.3	−0.7 ± 0.4	0.2 (−0.9, 1.3)	0.70
Ra glucose, mg/kg/minb	1.57 ± 0.06	1.55 ± 0.05	1.66 ± 0.08	1.58 ± 0.07	0.07 ± 0.07	0.04 ± 0.07	0.03 (−0.17, 0.23)	0.76
CPK, U/L	135 ± 18	197 ± 37	137 ± 14	194 ± 34	2 ± 13	−3 ± 24	5 (−50, 59)	0.87
CoQ10, μg/mL	1.0 ± 0.1	1.1 ± 0.1	0.6 ± 0.0	1.0 ± 0.1	−0.4 ± 0.1	−0.1 ± 0.1	−0.4 (−0.7, −0.1)	0.01
Liver parameters
ALT, IU/L	29 ± 3	25 ± 3	37 ± 8	27 ± 3	8 ± 8	3 ± 2	6 (−11, 22)	0.49
AST, IU/L	24 ± 2	24 ± 2	31 ± 5	26 ± 3	7 ± 5	2 ± 2	5 (−5, 15)	0.35
Liver fat content, %c	17 ± 2	14 ± 3	17 ± 2	14 ± 2	−1 ± 1	−0 ± 1	−1 (−5, 3)	0.56

Data reported as mean ± SEM. P for Student two sample t test (two-tailed) comparing changes between groups. Data shown are for patients who had both baseline and follow-up data available.

^aOGTT performed at screen visit and not repeated at baseline. Screen values shown for baseline. Change in 2-h glucose between screen visit and 6 mo.

^b10 participants (5 pitavastatin, 5 placebo) did not have data for stable isotope procedure because of inability to obtain venous access (N = 1) or temporary unavailability of glucose isotope (N = 9).

^c7 participants (2 pitavastatin, 5 placebo) were unable to complete MRI at baseline because of inability to fit in the scanner or unanticipated claustrophobia.