Abstract
Studies comparing efficacy and safety of moderate-intensity statin plus ezetimibe versus high-intensity statin in patients with atherosclerotic cardiovascular disease (ASCVD) and type 2 diabetes (T2DM) are scarce. In this multicenter non-inferiority randomized trial, 223 ASCVD patients with T2DM were randomly assigned to receive either rosuvastatin 20 mg once daily or single-pill combination of rosuvastatin 10 mg plus ezetimibe 10 mg once daily for 24 weeks. Laboratory parameters and clinical events were evaluated at 12 and 24 weeks. Primary efficacy endpoint was the least square mean percent (LSM %) change of low-density lipoprotein cholesterol (LDL-C) level at 24 weeks from baseline. At 24 weeks, the LDL-C LSM % change from baseline was - 13.5 in the high-intensity rosuvastatin group and - 20.5 in the combination group, with the between-group difference remaining within the predefined non-inferiority margin (p = 0.06). Decrease in apolipoprotein B level at 24 weeks from baseline was significantly greater in the combination group than in the high-intensity rosuvastatin group (-15.6% vs. -9.9%, p-value = 0.008). Rates of achieving LDL-C < 55 mg/dL were higher in the combination group than in the high-intensity rosuvastatin group, with a significant difference at 12 weeks (p = 0.01), though the difference at 24 weeks was not statistically significant (p = 0.09). Incidence of total adverse events was lower in the combination groups than in the high-intensity rosuvastatin group (p = 0.048). Single-pill combination of moderate-intensity rosuvastatin plus ezetimibe was non-inferior to high-intensity rosuvastatin in LDL-C lowering efficacy with good safety profile in ASCVD patients with T2DM.