Table 3.
Changes in parameters after 24 weeks of treatment with ezetimibe plus rosuvastatin versus rosuvastatin monotherapy
| Ezetimibe + rosuvastatin (n=31) | Rosuvastatin alone (n=33) | Difference between groups | |||||
|---|---|---|---|---|---|---|---|
| Baseline | Post-treatment | p-value | Baseline | Post-treatment | p-value | p-value | |
| BMI, kg/m2 | 26.6 (6.4) | 26.2 (5.8) | 0.002 | 28.3 (3.6) | 27.9 (3.7) | 0.001 | 0.675 |
| Waist circumference, cm | 94.0 (15.0) | 91.0 (13.0) | <0.001 | 96.0 (12.5) | 93.5 (14.0) | <0.001 | 0.269 |
| Seated SBP, mmHg | 127.0 (10.4) | 127.2 (12.7) | 0.936 | 128.3 (13.0) | 126.2 (11.5) | 0.341 | 0.450 |
| Seated DBP, mmHg | 81.5 (7.3) | 80.0 (10.1) | 0.409 | 82.0 (9.8) | 78.2 (8.7) | 0.020 | 0.354 |
| ALT, IU/l | 40.0 (31.0) | 40.0 (24.0) | 0.459 | 31.0 (21.0) | 32.0 (26.0) | 0.563 | 0.471 |
| AST, IU/l | 25.0 (14.0) | 26.0 (15.0) | 0.681 | 24.0 (11.0) | 27.0 (18.0) | 0.727 | 0.462 |
| Platelets, ×103/μl | 265.0 (87.0) | 259.0 (82.0) | 0.175 | 255.0 (80.0) | 248.0 (75.5) | 0.003 | 0.357 |
| Alk Phos, U/l | 64.0 (21.0) | 63.0 (18.0) | 0.642 | 71.0 (36.0) | 70.0 (32.5) | 0.326 | 0.510 |
| GGT, U/l | 43.0 (35.0) | 32.0 (41.0) | 0.125 | 36.0 (33.5) | 33.0 (27.5) | 0.957 | 0.861 |
| Total bilirubin, mg/dl | 0.6 (0.3) | 0.6 (0.4) | 0.871 | 0.7 (0.4) | 0.7 (0.4) | 0.165 | 0.600 |
| Glucose, mg/dl | 116.0 (29.0) | 116.0 (40.0) | 0.378 | 115.0 (33.5) | 120.0 (25.0) | 0.957 | 0.345 |
| Insulin, uU/ml | 12.5 (9.3) | 12.7 (6.9) | 0.931 | 15.0 (8.0) | 15.5 (12.1) | 0.993 | 0.911 |
| HbA1c, % | 6.4 (0.6) | 6.5 (0.8) | 0.167 | 6.5 (1.1) | 6.5 (1.4) | 0.055 | 0.445 |
| FFA, mmol/l | 480.0 (314.0) | 506.0 (318.0) | 0.433 | 515.0 (279.5) | 403.0 (316.5) | 0.059 | 0.545 |
| HOMA-IR | 3.6 (3.7) | 3.5 (3.0) | 0.814 | 4.0 (3.5) | 4.7 (3.3) | 0.925 | 0.691 |
| HOMA-beta | 87.0 (65.6) | 91.7 (81.2) | 0.299 | 99.6 (59.6) | 94.0 (81.6) | 0.957 | 0.098 |
| Triglycerides, mg/dl | 177.0 (139.0) | 138.0 (77.0) | <0.001 | 217.0 (157.0) | 135.0 (71.0) | <0.001 | 0.175 |
| HDL, mg/dl | 45.0 (16.0) | 44.0 (10.0) | 0.045 | 42.0 (7.5) | 41.0 (11.0) | 0.948 | 0.109 |
| LDL, mg/dl | 116.0 (66.4) | 55.0 (37.2) | <0.001 | 109.8 (42.9) | 66.4 (28.3) | <0.001 | 0.111 |
| CRP, mg/l | 1.4 (1.7) | 0.8 (1.2) | 0.036 | 1.5 (1.4) | 0.8 (1.6) | 0.008 | 0.805 |
| tPAI-1, ng/ml | 17.8 (10.2) | 12.5 (17.3) | 0.116 | 21.7 (14.4) | 17.5 (12.2) | 0.016 | 0.217 |
| IL-1 β, pg/ml | 0.045 (0.085) | 0.077 (0.111) | 0.144 | 0.063 (0.082) | 0.076 (0.124) | 0.296 | 0.843 |
| IL-8, pg/ml | 3.3 (2.5) | 2.6 (2.1) | 0.122 | 3.7 (2.3) | 2.9 (2.1) | 0.088 | 0.866 |
| IL-18, pg/ml | 163.6 (73.8) | 146.2 (52.0) | 0.003 | 168.2 (73.8) | 162.6 (76.8) | 0.042 | 0.210 |
Data are expressed as median (IQR) with p-values from Wilcoxon signed-rank test. p-value difference was determined using per-protocol analysis
Abbreviations: BMI body mass index, SBP systolic blood pressure, DBP diastolic blood pressure, ALT alanine aminotransferase, AST aspartate aminotransferase, GGT gamma-glutamyl transferase, FFA free fatty acids, HOMA-IR homeostatic model assessment of insulin resistance, HDL high-density lipoprotein, LDL low-density lipoprotein, CRP C-reactive protein, tPAI total plasminogen activator inhibitor, IL interleukin