Effect of combination therapy of ezetimibe and rosuvastatin on regression of coronary atherosclerosis in patients with coronary artery disease.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 25902885 · doi:10.1536/ihj.14-311
What was done
A prospective, randomized, open-label trial enrolled 51 patients with stable coronary artery disease undergoing percutaneous coronary intervention (PCI). Participants were allocated to combination therapy (rosuvastatin 5 mg/day plus ezetimibe 10 mg/day, n = 26) or monotherapy (rosuvastatin 5 mg/day, n = 25). Volumetric intravascular ultrasound (IVUS) analyses were performed at baseline and after 6 months of treatment at a non-PCI target site.
What was found
Combination therapy resulted in a significantly greater reduction in LDL-C than monotherapy (-55.8% vs -36.8%, P = 0.004). For the primary endpoint, the percent change in plaque volume was -13.2% in the combination group versus -3.1% in the monotherapy group (P = 0.050), with a statistically significant group-by-time interaction (P = 0.021). Percent change in plaque volume correlated positively with percent change in LDL-C (r = 0.384, P = 0.015).
Why it matters
The study provides imaging-level evidence that adding ezetimibe to low-to-moderate dose rosuvastatin provides greater coronary plaque regression within 6 months than statin monotherapy, driven by incremental LDL-C lowering.
Limits
The sample size was very small (n = 51) and the follow-up duration was limited to 6 months. The trial used an open-label design and evaluated surrogate IVUS imaging endpoints rather than clinical cardiovascular events. Statin dosing was fixed at rosuvastatin 5 mg/day, which is lower than standard high-intensity doses used in western practice.
Cited by
- supports Japanese studies have demonstrated that combining very low-dose rosuvastatin (2.5 mg or 5 mg) with ezetimibe leads to arterial plaque regression.