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ȣ - 520532 382 |
| Effects of rosuvastatin and atorvastatin in Korean metabolic syndrome patients with increased LDL-C: results from the Rosuvastatin in Metabolic Syndrome (ROMEO) study |
| 보라매병원¹, 삼성의료원², 한림대 평촌성심병원³, 아산병원⁴, 고려대 안암병원 5, 순천향대학교병원 6, 아주대학교병원 7, 고려대 구로병원 8, 전남대병원9, 강남성모병원10, 인제대부산백병원11, 동아대학교병원12, 서울대학교병원12 |
| 김상현¹, 성지동², 최영진³, 한기훈⁴, 임도선 5, 현민수 6, 신준한 7, 박창규 8, 안영근 9, 백상홍10, 김두일11, 김영대12, 김효수12 |
Backgroud¦ The metabolic syndrome is a constellation of risk factors for cardiovascular disease. This study was designed to compare the effect of statin treatment in Korean patients with metabolic syndrome. Methods¦ ROMEO study was a randomized, multi-center, open-label study designed to compare the efficacy and tolerability of rosuvastatin 10mg with atorvastatin 10mg in metabolic syndrome subjects with increased low density lipoprotein cholesterol (LDL-C) level. The study was composed of two periods, 6-week run-in period and 6-week randomized treatment period. The primary objective of this study was to compare the effect on the apolipoprotein B/apolipoprotein A1 (ApoB/A1) ratio after treatment. The secondary objectives were the effects on achievement rate of NCEP ATP III LDL-C and non HDL-C goal, glucose and insulin resistance, change of LDL-C level, other lipoproteins, high sensitivity C-reactive protein (hsCRP). Results¦ Among 613 enrolled patients, 258 patients were randomized and 247 patients completed the study. With 6 weeks’treatment, rosuvastatin 10 mg significantly reduced ApoB/A1 ratio compared to atorvastatin 10 mg [-44.4% vs -36.5%, p<0.0001]. Significantly more patients on rosuvastatin achieved their LDL-C target goal than those with atorvastatin. (88.2% vs 75.4%, p=0.0067), but the insulin resistance (HOMA-R and QUICK index) were not significantly different between two groups. Rosuvastatin treatment significantly decreased LDL-C and total cholesterol compared to atorvastatin (-45.5% vs -37.9%, p<0.0001 and -34.1% vs –28.8%, p=0.0002, respectively). However, there was no significant difference between the two groups in HDL-C and triglyceride. Rosuvastatin treatment decreased hsCRP level more significantly than atorvastatin treatment(p=0.0478). Tolerability profiles were not significantly different between two groups. Conclusion¦ Rosuvastatin 10mg treatment showed significant benefits in the changes of ApoB/A1 ratio, LDL-C, total cholesterol, hsCRP levels and the achievement rate of NCEP ATP III LDL-C target goals, compared to atorvastatin 10 mg in the treatment of Korean metabolic syndrome subjects with increased LDL-C level.
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