Summary: In a 223-patient multicentre randomised trial of adults with atherosclerotic cardiovascular disease and type 2 diabetes, a single-pill combination of rosuvastatin 10 mg plus ezetimibe 10 mg was non-inferior to rosuvastatin 20 mg for LDL-C lowering at 24 weeks (least-squares mean change -20.5% vs -13.5%; between-group difference within the non-inferiority margin, p=0.06). The combination produced a significantly greater apolipoprotein B reduction and fewer total adverse events.
PICO Summary
| Element | Detail |
|---|---|
| Population | 223 adults with established atherosclerotic cardiovascular disease (ASCVD) and type 2 diabetes; multicentre randomised non-inferiority trial conducted in the Republic of Korea. |
| Intervention | Single-pill combination of rosuvastatin 10 mg plus ezetimibe 10 mg once daily for 24 weeks (moderate-intensity statin plus ezetimibe). |
| Comparison | Rosuvastatin 20 mg once daily as high-intensity monotherapy for 24 weeks. |
| Outcome | Primary endpoint (LDL-C least-squares mean percent change at 24 weeks): -20.5% with the combination versus -13.5% with high-intensity monotherapy; the between-group difference remained within the predefined non-inferiority margin (p=0.06 for superiority, so not statistically superior). Apolipoprotein B fell more with the combination (-15.6% vs -9.9%, p=0.008). Attainment of LDL-C below 55 mg/dL favoured the combination at 12 weeks (p=0.01) but not at 24 weeks (p=0.09). Total adverse events were lower with the combination (p=0.048). No 95% confidence intervals, absolute risk reduction, or number-needed-to-treat were reported for the primary endpoint. |
Rosuvastatin + ezetimibe vs rosuvastatin 20 mg
RCT · ASCVD + type 2 diabetes · 24 weeks
The single-pill combination was non-inferior, not superior, to rosuvastatin 20 mg for LDL-C lowering, with a greater apoB reduction and fewer adverse events. A reasonable alternative when high-intensity monotherapy is not tolerated or not at goal.
Expert Commentary
This trial supports a familiar message: a single-pill combination of moderate-intensity rosuvastatin plus ezetimibe achieves LDL-C lowering that is non-inferior to high-intensity rosuvastatin monotherapy in patients with ASCVD and type 2 diabetes, with a numerically larger drop and a significant advantage in apolipoprotein B. The headline must be read carefully. The primary endpoint met the non-inferiority margin but did not reach statistical superiority (p=0.06), so the combination should be presented as an equally effective alternative rather than a clearly better one. The principal limitation is the design itself: with 223 participants and a surrogate lipid endpoint over 24 weeks, the study was neither powered nor long enough to demonstrate any reduction in cardiovascular events, and the discordant LDL-C target attainment at 12 versus 24 weeks suggests fragile secondary signals. Can I use this with my patients? Yes, for a person with ASCVD and type 2 diabetes who is not at goal on, or is intolerant of, high-intensity statin monotherapy, this combination is a reasonable and well-tolerated route to comparable LDL-C control, consistent with existing guideline support for adding ezetimibe. It should not be framed as outperforming high-intensity therapy. Larger, event-driven trials remain the appropriate basis for any claim of superior cardiovascular protection.
References
Choi HI, Oh SJ, Jo YH, Park YH, Park YH, Yang TH, et al. Comparison of rosuvastatin 10 mg plus ezetimibe versus rosuvastatin 20 mg in atherosclerotic cardiovascular disease and type 2 diabetes. Sci Rep. 2025;15(1):16012. doi:10.1038/s41598-025-00298-7