Effect of moderate-intensity statin with ezetimibe combination vs. high-intensity statin therapy according to sex in patients with atherosclerosis

Byung Gyu Kim, Seung Jun Lee, Yong Joon Lee, Seng Chan You, Soon Jun Hong, Kyeong Ho Yun, Bum Kee Hong, Jung Ho Heo, Seung Woon Rha, Sung Jin Hong, Chul Min Ahn, Byeong Keuk Kim, Young Guk Ko, Donghoon Choi, Myeong Ki Hong, Yangsoo Jang, Yun Hyeong Cho, Jung Sun Kim

Research output: Contribution to journalArticlepeer-review

Abstract

We aimed to evaluate sex differences in the effects of moderate-intensity statin with ezetimibe combination therapy (rosuvastatin 10 mg plus ezetimibe) versus high-intensity statin (rosuvastatin 20 mg) monotherapy in patients with atherosclerotic cardiovascular disease (ASCVD). This was a sex-specific subgroup analysis of the RACING trial that evaluated the interaction between sex and treatment strategies for the primary outcome (composite of cardiovascular death, major cardiovascular events, or nonfatal stroke at 3 years). Of 3780 patients in the RACING trial, 954 (25.2%) were women. Regardless of sex, the effect of moderate-intensity statin with ezetimibe combination therapy on primary outcome compared with high-intensity statin monotherapy was similar (hazard ratio [HR] 0.98 [0.63–1.52] in women; HR 0.90 [0.71–1.14] in men). The rate of discontinuation or dose reduction of study drugs due to intolerance was lower in the ezetimibe combination group than in the high-intensity statin monotherapy group in both women (4.5% vs. 8.6%, P = 0.014) and men (4.8% vs. 8.0%, P < 0.001). LDL cholesterol levels of < 70 mg/dL at 1, 2, and 3 years were more frequently achieved in the ezetimibe combination group than in the high-intensity statin monotherapy group (all P < 0.001) in both sexes. There were no significant interactions between sex and treatment groups regarding the primary outcome, discontinuation, or dose reduction of study drugs, or the proportion of achievement of LDL cholesterol levels < 70 mg/dL. The effect of ezetimibe combination therapy for the 3-year composite outcomes was not different in both men and women. The benefits of ezetimibe combination therapy on LDL cholesterol lowering and drug tolerance were similarly observed regardless of sex. Trial registration: https://clinicaltrials.gov ; Unique identifier: NCT03044665.

Original languageEnglish
Article number20157
JournalScientific reports
Volume13
Issue number1
DOIs
Publication statusPublished - 2023 Dec
Externally publishedYes

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Publisher Copyright:
© 2023, The Author(s).

ASJC Scopus subject areas

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