TABLE 3.
Mean Metabolic Parameters and Changes During 48 Weeks in P1010 Study Population
| Analyte | Mean Value ± SD (n) | Change From Week 0 to Week 48 | % With Abnormal Values | |||||
|---|---|---|---|---|---|---|---|---|
| Week 0 | Week 48 | Mean±SD (n) | 95% CI | P | Week 0 | Week 48 | Pa | |
| HDL cholesterol, mg/dL | 40.6±10.9 (90) | 48.0±14.3 (85) | 8.3±15.(78) | 14.9 to 11.7 | <.001b | 31 (28/90) | 16 (14/85) | .004b |
| LDL cholesterol, mg/dL | 88.4±32.2 (90) | 102.6±34.8 (85) | 14.0±37.0 (78) | 5.6 to 22.3 | .001b | 13 (12/90) | 21 (18/85) | .110 |
| Total cholesterol, mg/dL | 145.7±35.5 (90) | 172.7±44.1 (86) | 28.1±47.9 (79) | 17.4 to 38.8 | <.001b | 6 (5/90) | 21 (18/86) | .001b |
| Total-HDL cholesterol ratio | 3.8±1.1 (90) | 3.9±1.5 (85) | 0.1±1.5 (78) | −0.3 to 0.4 | .630 | 38 (34/90) | 32 (27/85) | .130 |
| Triglycerides, mg/dL | 93.0±55.5 (90) | 117.7±90.0 (86) | 21.2±86.0 (79) | 2.0 to 40.5 | .031b | 26 (23/90) | 34 (29/86) | .530 |
| Insulin, µ IU/mL | 4.5±3.8 (84) | 6.6±5.0 (79) | 2.1±5.2 (66) | 0.9 to 3.4 | .001b | 1 (1/84) | 3 (2/79) | 1.000 |
| Glucose, mg/dL | 70.3±16.4 (90) | 75.2±17.6 (85) | 4.3±19.9 (78) | −0.2 to 8.7 | .062 | 2 (2/90) | 4 (3/85) | 1.000 |
| HOMA-IR, µ IU/mL per mmol/L | 0.8±0.8 (84) | 1.3±1.2 (78) | 0.5±1.1 (65) | 0.2 to 0.8 | .001b | 1 (1/84) | 8 (7/78) | .480 |
| Apolipoprotein Al, mg/dL | 124.9±25.8 (78) | 137.2±29.6 (72) | 14.4±29.6 (58) | 6.6 to 22.2 | .001b | 29 (16/56) | 15 (8/53) | .058 |
| Apolipoprotein B, mg/dL | 77.9±24.6 (78) | 88.0±29.8 (72) | 10.8±24.4 (58) | 4.4 to 17.3 | .001b | 27 (15/56) | 36 (19/53) | .059 |
n is the number of observations included in the analyses. CI indicates confidence interval.
a
McNemar’s test was used to assess whether the change in the proportion of children with abnormal values differed from 0.
b
Significant (P<.05).