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. 2021 Sep 22;22(3):239–249. doi: 10.1007/s40256-021-00498-2

Table 2.

Evidence from selected randomized controlled trials supporting the use of add-on ezetimibe to reach LDL-C targets [22, 2426]

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