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Randomized Controlled Trial
. 2023 Apr 11;81(14):1339-1349.
doi: 10.1016/j.jacc.2023.02.007.

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

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Free article
Randomized Controlled Trial

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

Sang-Hyup Lee et al. J Am Coll Cardiol. .
Free article

Abstract

Background: The routine use of high-intensity statins should be considered carefully in elderly patients because of their higher risk of intolerance or adverse events.

Objectives: We evaluated the impact of moderate-intensity statin with ezetimibe combination therapy compared with high-intensity statin monotherapy in elderly patients with atherosclerotic cardiovascular disease (ASCVD).

Methods: In this post hoc analysis of the RACING (RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases) trial, patients were stratified by age (≥75 years and <75 years). The primary endpoint was a 3-year composite of cardiovascular death, major cardiovascular events, or nonfatal stroke.

Results: Among the 3,780 enrolled patients, 574 (15.2%) were aged ≥75 years. The rates of the primary endpoint were not different between the moderate-intensity statin with ezetimibe combination therapy group and the high-intensity statin monotherapy group among patients aged ≥75 years (10.6% vs 12.3%; HR: 0.87; 95% CI: 0.54-1.42; P = 0.581) and those <75 years (8.8% vs 9.4%; HR: 0.94; 95% CI: 0.74-1.18; P = 0.570) (P for interaction = 0.797). Moderate-intensity statin with ezetimibe combination therapy was associated with lower rates of intolerance-related drug discontinuation or dose reduction among patients aged ≥75 years (2.3% vs 7.2%; P = 0.010) and those <75 years (5.2% vs 8.4%; P < 0.001) (P for interaction = 0.159).

Conclusions: Moderate-intensity statin with ezetimibe combination therapy showed similar cardiovascular benefits to those of high-intensity statin monotherapy with lower intolerance-related drug discontinuation or dose reduction in elderly patients with ASCVD having a higher risk of intolerance, nonadherence, and discontinuation with high-intensity statin therapy. (RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases [RACING Trial]; NCT03044665).

Keywords: atherosclerotic cardiovascular disease; elderly; ezetimibe; statin.

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Conflict of interest statement

Funding Support and Author Disclosures Hanmi Pharmaceutical, Seoul, Korea, has provided funding for this paper. Dr Byeong-Keuk Kim has received speaker fees from Medtronic and Abbott Vascular. Dr Myeong-Ki Hong has received speaker fees from Medtronic, Abbott Vascular, and Pfizer. Dr Yangsoo Jang has received institutional research grants from Biotronik and Hanmi. Dr Jung-Sun Kim has received proctoring fees from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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