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Randomized Controlled Trial Multicenter Study
Effectiveness of low-intensity atorvastatin 5 mg and ezetimibe 10 mg combination therapy compared with moderate-intensity atorvastatin 10 mg monotherapy: A randomized, double-blinded, multi-center, phase III study.
- Seung-Ah Lee, Soon Jun Hong, Jung-Hoon Sung, Kyung-Soo Kim, Seong Hwan Kim, Jin Man Cho, Sung Wan Chun, Sang Rok Lee, Chul Sik Kim, Tae Nyun Kim, Dae Hyeok Kim, Hwan-Cheol Park, Byung Jin Kim, Hyun-Sook Kim, Ji-Yong Choi, Young Joon Hong, Joong Wha Chung, Seong Bo Yoon, Sang-Hak Lee, and Cheol Whan Lee.
- Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
- Medicine (Baltimore). 2023 Nov 24; 102 (47): e36122e36122.
BackgroundWe compared the efficacy and safety of low-intensity atorvastatin and ezetimibe combination therapy with moderate-intensity atorvastatin monotherapy in patients requiring cholesterol-lowering therapy.MethodsAt 19 centers in Korea, 290 patients were randomized to 4 groups: atorvastatin 5 mg and ezetimibe 10 mg (A5E), ezetimibe 10 mg (E), atorvastatin 5 mg (A5), and atorvastatin 10 mg (A10). Clinical and laboratory examinations were performed at baseline, and at 4-week and 8-week follow-ups. The primary endpoint was percentage change from baseline in low-density lipoprotein (LDL) cholesterol levels at the 8-week follow-up. Secondary endpoints included percentage changes from baseline in additional lipid parameters.ResultsBaseline characteristics were similar among the study groups. At the 8-week follow-up, percentage changes in LDL cholesterol levels were significantly greater in the A5E group (49.2%) than in the E (18.7%), A5 (27.9%), and A10 (36.4%) groups. Similar findings were observed regarding the percentage changes in total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B levels. Triglyceride levels were also significantly decreased in the A5E group than in the E group, whereas high-density lipoprotein levels substantially increased in the A5E group than in the E group. In patients with low- and intermediate-cardiovascular risk, 93.3% achieved the target LDL cholesterol levels in the A5E group, 40.0% in the E group, 66.7% in the A5 group, and 92.9% in the A10 group. In addition, 31.4% of patients in the A5E group, 8.1% in E, 9.7% in A5, and 7.3% in the A10 group reached the target levels of both LDL cholesterol < 70 mg/dL and reduction of LDL ≥ 50% from baseline.ConclusionsThe addition of ezetimibe to low-intensity atorvastatin had a greater effect on lowering LDL cholesterol than moderate-intensity atorvastatin alone, offering an effective treatment option for cholesterol management, especially in patients with low and intermediate risks.Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.
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