Table 2.
Evidence from selected randomized controlled trials supporting the use of add-on ezetimibe to reach LDL-C targets [22, 24–26]
| Study name | N | Patients | Intervention | Control | Duration (weeks) | LDL-C goal < 2.6 mmol/L (100 mg/dL); intervention vs. control | LDL-C goal of < 1.8 mmol/L (70 mg/dL); intervention vs. control |
|---|---|---|---|---|---|---|---|
| Strategy: adding ezetimibe vs. maintaining monotherapy dose | |||||||
| EXPLORER [22] | 469 | Hypercholesterolemia + high risk of CHD | Ezetimibe/rosuvastatin 10/40 mg | Rosuvastatin 40 mg | 6 | 94.0 vs. 79.1%; p < 0.001 | NA |
| EXPLORER [22] | 393 | Hypercholesterolemia + very high risk of CHD | Ezetimibe/rosuvastatin 10/40 mg | Rosuvastatin 40 mg | 6 | NA | 79.6 vs. 35.0%; p < 0.001 |
| I-ROSETTE [24] | 325 | Hypercholesterolemia + CHD/CHD risk equivalents | Ezetimibe/rosuvastatin 10/5, 10/10, or 10/20 mg | Rosuvastatin 5, 10, or 20 mg | 8 | 92.0 vs. 77.8%; p < 0.001 | NA |
| Ran et al. [25] | 84 | Non-ST-elevation ACS | Ezetimibe/ rosuvastatin 10/10 mg | Rosuvastatin 10 mg | 6 | NA | 81.0 vs. 33.3%; p < 0.05 |
| Strategy: adding ezetimibe vs. doubling monotherapy dose | |||||||
| ACTE [28] | 440 | Hypercholesterolemia + moderate-high CHD risk | Ezetimibe/ rosuvastatin 10/5 or 10/10 mg | Rosuvastatin 20 mg | 6 | 59.4 vs. 30.9%; p < 0.001 | 43.8 vs. 17.5%; p < 0.001 |
| PACE [26] (period I) | 603 | Hypercholesterolemia + high ASCVD risk | Ezetimibe/atorvastatin 10/10 mg | Atorvastatin 20 mg | 6 | 56.3 vs. 37.4%; p < 0.01 | 19.3 vs. 3.0%; p < 0.01 |
| PACE [26] (period II) | 250 | Uncontrolled on atorvastatin 20 mg during phase 1 | Ezetimibe/atorvastatin 10/20 mg | Atorvastatin 40 mg | 6 | 55.8 vs. 34.1%; p < 0.01 | 18.3 vs. 0.8%; p < 0.01 |
| Ran et al. [25] | 83 | Non-ST-elevation ACS | Ezetimibe/rosuvastatin 10/10 mg | Rosuvastatin 20 mg | 6 | NA | 81.0 vs. 68.3%; p < 0.05 |
ACS acute coronary syndrome, ASCVD atherosclerotic cardiovascular disease, CHD coronary heart disease, LDL-C low-density lipoprotein cholesterol, NA not available