Table 2.
Primary endpoint: change ratea of LDL-C from baseline
| Statistic | Rosuvastatin | Rosuvastatin/Ezetimibe | LS mean difference (SE) | 95% CI | P value | |
|---|---|---|---|---|---|---|
| PPS | ||||||
| Number | 45 | 41 | ||||
| Mean±SD | –51.35±17.24 | –60.71±19.62 | ||||
| P value | <0.0001b | <0.0001b | ||||
| LS mean (SE)c | –55.44 (6.85) | –63.90 (6.89) | –8.47 (4.01) | –16.44 to 0.49 | 0.0378 | |
| FAS | ||||||
| Number | 51 | 48 | ||||
| Mean±SD | –50.90±20.42 | –57.08±22.35 | ||||
| P value | <0.0001b | <0.0001b | ||||
| LS mean (SE)c | –45.58 (5.53) | –50.11 (5.93) | –4.52 (4.22) | –12.91 to 3.86 | 0.2868 | |
LDL-C, low-density lipoprotein cholesterol; LS, least square; SE, standard error; CI, confidence interval; PPS, per-protocol set; SD, standard deviation; FAS, full analysis set.
a
Change rate (%)=[(LDL-C at 24 weeks)–(baseline LDL-C)]/(baseline LDL-C)×100,
b
Difference between baseline and post-baseline in each group: Wilcoxon signed rank test,
c
Difference between control and treatment group (analysis of covariance [ANCOVA] using baseline value and glycosylated hemoglobin level [<9%, ≥9%] as covariate).