Source:Clinical Therapeutics
Author(s): Young-June Yang, Sang-Hak Lee, Byung Soo Kim, Yun-Kyeong Cho, Hyun-Jai Cho, Kyoung Im Cho, Seok-Yeon Kim, Jae Kean Ryu, Jin-Man Cho, Joong-Il Park, Jong-Seon Park, Chang Gyu Park, Woo Jung Chun, Myung-A Kim, Dong-Kyu Jin, Namho Lee, Byung Jin Kim, Kwang Kon Koh, Jon Suh, Seung-Hwan Lee, Byoung-Kwon Lee, Seung-Jin Oh, Han-Young Jin, Youngkeun Ahn, Sang-Gon Lee, Jang-Ho Bae, Woo Jung Park, Sang-Chol Lee, Han Cheol Lee, Jaewon Lee, Cheolwon Park, Backhwan Lee, Yangsoo Jang
PurposeThe aim of this study was to evaluate the efficacy and tolerability of rosuvastatin/ezetimibe combination therapy in Korean patients with high cardiovascular risk.MethodsThis was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 337 patients were screened. After a 4-week run-in period, 245 of these patients with high or moderately high risk as defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines were randomly assigned. Patients received 1 of 6 regimens for 8 weeks as follows: (1) rosuvastatin 5 mg, (2) rosuvastatin 5 mg/ezetimibe 10 mg, (3) rosuvastatin 10 mg, (4) rosuvastatin 10 mg/ezetimibe 10 mg, (5) rosuvastatin 20 mg, or (6) rosuvastatin 20 mg/ezetimibe 10 mg. The primary outcome variable was percentage change in the level of LDL-C at week 8 of drug treatment. Secondary outcome variables included percentage changes of other lipid variables and achievement rates of LDL-C targets. Tolerability analyses were also performed.FindingsThe percentage change of LDL-C ranged from –45% to –56% (mean, –51%) in the monotherapy groups and from –58% to –63% (mean, –60%) in the combination therapy groups. The percentage change was greater in the pooled combination therapy group than in the counterpart (P < 0.001 for the pooled groups); this difference was more obvious for regimens with a lower statin dose. The percentage reductions of total cholesterol and triglycerides were greater in the combination groups than in the monotherapy groups. The LDL-C target achievement rates were 64% to 87% (mean, 73%) in the monotherapy groups and 87% to 95% (mean, 91%) in the combination groups (P = 0.01 for the pooled groups). The rates were significantly greater in patients receiving the combination therapy than in the monotherapy at lower doses of rosuvastatin. The proportions of patients with various adverse events were not significantly different between the groups.ImplicationsRosuvastatin/ezetimibe combination therapy has better efficacy and target achievement rates than rosuvastatin monotherapy in patients with high cardiovascular risk.
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