Physicians' Academy for Cardiovascular Education

Moderate-intensity statin plus ezetimibe as an alternative to high-intensity statin in ASCVD patients ≥75 years

Combination Moderate-Intensity Statin and Ezetimibe Therapy for Elderly Patients With Atherosclerosis

Literature - Lee SH, Lee YJ, Heo JH, et al. - J Am Coll Cardiol. 2023 Apr 11;81(14):1339-1349. doi: 10.1016/j.jacc.2023.02.007

Background

While high-intensity statin therapy is recommended for patients with ASCVD [1-2], this is less likely to be used in elderly patients because of the increased risk of adverse events. In patients >75 years of age, moderate-intensity statins may therefore be preferable to high-intensity statins [2-3].

Recently, the RACING (Randomized Comparison of Efficacy and Safety of Lipid Lowering With Statin Monotherapy versus Statin-Ezetimibe Combination for High-Risk Cardiovascular Disease) trial showed that combination therapy consisting of a moderate-intensity statin plus ezetimibe was as effective as monotherapy with a high-intensity statin in preventing a composite of CV events and was associated with a lower rate of intolerance-related drug discontinuation or dose reduction [4].

Aim of the study

In a post-hoc analysis of the RACING trial, the authors evaluated the efficacy and safety of moderate-intensity statin with ezetimibe combination therapy compared with high-intensity statin monotherapy in elderly ASCVD patients, especially those aged ≥75 years.

Methods

The RACING trial was a multicenter, prospective, open-label, noninferiority RCT in which 3780 patients with documented ASCVD from South Korea were included. Patients were randomized to combination therapy with a moderate-intensity statin (rosuvastatin 10 mg) plus ezetimibe 10 mg once daily or high-intensity statin monotherapy (rosuvastatin 20 mg) once daily. 574 patients were ≥75 years and 3206 patients were <75 years.

Outcomes

The primary endpoint was a composite outcome of CV death, major CV events, or nonfatal stroke within 3 years. Secondary efficacy endpoints were a composite outcome of all-cause mortality, major CV events, or nonfatal stroke; individual components of the primary endpoint; and LDL-c levels at 1, 2, and 3 years.

Secondary safety endpoints included rates of discontinuation or dose reduction of the study drug caused by intolerance; clinical adverse events including new-onset DM; adverse events associated with muscles, liver, or gallbladder; cancer diagnosis; or cataract surgery. An independent clinical endpoint committee adjudicated all endpoints.

Main results

Primary endpoint and secondary efficacy endpoints

Secondary safety endpoints

Conclusion

In a post-hoc analysis of the RACING trial, combination therapy with a moderate-intensity statin plus ezetimibe showed similar CV benefits over 3 years as high-intensity statin monotherapy in elderly ASCVD patients, regardless of age group (<75 years vs. ≥75 years). Ezetimibe combination therapy was associated with a larger LDL-c reduction and lower intolerance-related drug discontinuation or dose reduction in the entire study population, and with a reduced rate of new-onset DM in patients aged ≥75 years.

References

Show references

Find this article online at - J Am Coll Cardiol.

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