Ezetimibe Lipid-Lowering Trial on Prevention of Atherosclerotic Cardiovascular Disease in 75 or Older (EWTOPIA 75): A Randomized, Controlled Trial.

Autor:	Ouchi Y; Toranomon Hospital, Tokyo, Japan (Y. Ouchi, M.K.)., Sasaki J; International University of Health and Welfare, Fukuoka, Japan (J.S.)., Arai H; National Center for Geriatrics and Gerontology, Obu, Japan (H.A.)., Yokote K; Chiba University, Chiba, Japan (K.Y.)., Harada K; Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan (K.H., H.I.)., Katayama Y; General Tokyo Hospital, Tokyo, Japan (Y.K.)., Urabe T; Juntendo University Urayasu Hospital, Urayasu, Japan (T.U.)., Uchida Y; Saga Memorial Hospital, Saga, Japan (Y.U.)., Hayashi M; Nagahama City Hospital, Nagahama, Japan (M.H.)., Yokota N; Yokota Clinic, Miyazaki, Japan (N.Y.)., Nishida H; Nishida Clinic, Neyagawa, Japan (H.N.)., Otonari T; Otonari Clinic, Chikushino, Japan (T.O.)., Arai T; Arai Clinic, Yamagata, Japan (T.A.)., Sakuma I; Caress Sapporo Hokko Memorial Clinic, Sapporo, Japan (I.S.)., Sakabe K; Sakabe Clinic, Kyoto, Japan (K.S.)., Yamamoto M; Yamamoto Clinic, Shimoniikawa, Japan (M.Y.)., Kobayashi T; Jyuzen General Hospital, Niihama, Japan (T.K.)., Oikawa S; Fukujuji Hospital, Tokyo, Japan (S.O.)., Yamashita S; Rinku General Medical Center, Izumisano, Japan (S.Y.)., Rakugi H; Osaka University, Suita, Japan (H.R.)., Imai T; Kyoto University, Japan (T.I., S.T.)., Tanaka S; Kyoto University, Japan (T.I., S.T.)., Ohashi Y; Chuo University, Tokyo, Japan (Y. Osachi)., Kuwabara M; Toranomon Hospital, Tokyo, Japan (Y. Ouchi, M.K.)., Ito H; Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan (K.H., H.I.).
Jazyk:	angličtina
Zdroj:	Circulation [Circulation] 2019 Sep 17; Vol. 140 (12), pp. 992-1003. Date of Electronic Publication: 2019 Aug 22.
DOI:	10.1161/CIRCULATIONAHA.118.039415
Abstrakt:	Background: Evidence regarding the primary prevention of coronary artery disease events by low-density lipoprotein cholesterol (LDL-C) lowering therapy in older individuals, aged ≥75 years, is insufficient. This trial tested whether LDL-C-lowering therapy with ezetimibe is useful for the primary prevention of cardiovascular events in older patients. Methods: This multicenter, prospective, randomized, open-label, blinded end-point evaluation conducted at 363 medical institutions in Japan examined the preventive efficacy of ezetimibe for patients aged ≥75 years, with elevated LDL-C without history of coronary artery disease. Patients, who all received dietary counseling, were randomly assigned (1:1) to receive ezetimibe (10 mg once daily) versus usual care with randomization stratified by site, age, sex, and baseline LDL-C. The primary outcome was a composite of sudden cardiac death, myocardial infarction, coronary revascularization, or stroke. Results: Overall, 3796 patients were enrolled between May 2009 and December 2014, and 1898 each were randomly assigned to ezetimibe versus control. Median follow-up was 4.1 years. After exclusion of 182 ezetimibe patients and 203 control patients because of lack of appropriate informed consent and other protocol violations, 1716 (90.4%) and 1695 (89.3%) patients were included in the primary analysis, respectively. Ezetimibe reduced the incidence of the primary outcome (hazard ratio [HR], 0.66; 95% CI, 0.50-0.86; P =0.002). Regarding the secondary outcomes, the incidences of composite cardiac events (HR, 0.60; 95% CI, 0.37-0.98; P =0.039) and coronary revascularization (HR, 0.38; 95% CI, 0.18-0.79; P =0.007) were lower in the ezetimibe group than in the control group; however, there was no difference in the incidence of stroke, all-cause mortality, or adverse events between trial groups. Conclusions: LDL-C-lowering therapy with ezetimibe prevented cardiovascular events, suggesting the importance of LDL-C lowering for primary prevention in individuals aged ≥75 years with elevated LDL-C. Given the open-label nature of the trial, its premature termination and issues with follow-up, the magnitude of benefit observed should be interpreted with caution. Clinical Registration: URL: https://www.umin.ac.jp. Unique identifier: UMIN000001988.
Databáze:	MEDLINE
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