Lipid profile and safety of rosuvastatin monotherapy versus rosuvastatin plus ezetimibe in high risk coronary artery disease: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND

Combining lipid-lowering agents may enhance outcomes in patients with high-risk coronary artery disease. While rosuvastatin is known to reduce LDL-C and cardiovascular events, the additional benefit of ezetimibe remains under investigation. This meta-analysis evaluated the efficacy and safety of RSV combined with EZ compared to RSV monotherapy in high-risk coronary artery disease.

METHODS

A systematic review was conducted using PubMed, Scopus, and Google Scholar up to August 30, 2024. Data were analyzed using a random-effects model in Review Manager 5.4. Lipid profile and safety outcomes were assessed in accordance with PRISMA guidelines.

RESULTS

Combination therapy with rosuvastatin and ezetimibe significantly improved the lipid profile in high-risk coronary artery disease patients compared to rosuvastatin monotherapy, based on 11 studies with 1,963 subjects. Treatment with RSV plus EZ decreased total cholesterol by 0.50 units (SMD = -0.50; 95% CI: -0.80 to -0.19; p = 0.001), LDL-C by 0.57 units (SMD = -0.57; 95% CI: -0.80 to -0.33; p < 0.00001), and triglycerides by 0.85 units (SMD = -0.85; 95% CI: -1.81 to -0.11; p = 0.002). Meanwhile, HDL-C increased by 0.26 units (SMD = 0.26; 95% CI: 0.04 to 0.48; p = 0.02). RSV monotherapy showed a significant risk of elevated liver enzymes (RR 0.36; 95% CI 0.13-0.99; p = 0.05), while combination therapy increased the risk of myalgia (RR 2.17; 95% CI 1.04-4.54; p = 0.04) and gastrointestinal symptoms (RR 2.00; 95% CI 1.01-3.97; p = 0.05). No significant difference in angina pectoris was noted (RR 0.84; 95% CI: 0.39-1.80; p = 0.65).

CONCLUSION

Combination therapy with RSV and EZ effectively improves lipid profiles in high-risk coronary artery disease patients, particularly in reducing total cholesterol, LDL-C, and triglycerides. However, it is associated with a higher risk of gastrointestinal symptoms and myalgia. In contrast, RSV monotherapy is linked to a greater risk of elevated liver enzymes but was also associated with increased HDL-C compared to the combination therapy of RSV + EZ.