Migdalis I, Efthimiadis A, Pappas St, Alexopoulos D, Vlasserou F, Mikhailidis D P
2nd Department of Internal Medicine, NIMTS General Hospital, Monis Petraki 10, 10675, Athens, Greece.
Curr Med Res Opin. 2009 Oct;25(10):2571-6. doi: 10.1185/03007990903169031.
This study aimed to describe the clinical experience of the ezetimibe (EZE)/simvastatin (SIMVA) combination in a hypercholesterolaemic Greek population who did not attain the cholesterol goals on statin treatment alone.
Patients already treated with a statin, at any dose, for at least 8 weeks, with LDL-C levels above the goal, (>100, >130 or >160 mg/dl according to their risk category), where the physician chose EZE/SIMVA as appropriate treatment, entered the study. Medical history, demographics and laboratory values were recorded at baseline and 2 months later.
The study included 1514 patients (male 53.4%) of mean age 60.1 + or - 10.5 years. Diabetes mellitus was reported in 29.9% of the patients, 61.2% had hypertension, 39% were obese, 10.5% had a history of myocardial infarction and 6.8% had a history of stroke or peripheral arterial disease. Current and ex-smoking was reported in 46.8%. Atorvastatin (33%) and SIMVA (27.2%) were the most frequently used statins prior to using the EZE/SIMVA regimen. After 2 months of EZE/SIMVA therapy mean LDL-C was reduced by 33%, mean total cholesterol by 26%, mean triglycerides by 15%, while HDL-C was increased by 10%. The percentage of patients who achieved the LDL-C goal with EZE/SIMVA was 73.8%. One serious adverse event, not related to study treatment and 23 adverse events in total were recorded. There was a significant decrease in serum creatinine levels in patients with baseline values greater than 1.0 mg/dl (88 micromol/L).
Treatment with the EZE/SIMVA combination appears an effective and safe therapeutic option for patients who do not achieve the LDL-C goals on statin therapy alone.
本研究旨在描述依折麦布（EZE）/辛伐他汀（SIMVA）联合用药在希腊高胆固醇血症患者中的临床经验，这些患者仅接受他汀类药物治疗时未达到胆固醇目标。
已接受任何剂量他汀类药物治疗至少8周、低密度脂蛋白胆固醇（LDL-C）水平高于目标值（根据风险类别，分别为>100、>130或>160mg/dl）且医生选择EZE/SIMVA作为适当治疗方案的患者进入本研究。在基线和2个月后记录病史、人口统计学和实验室值。
该研究纳入了1514例患者（男性占53.4%），平均年龄为60.1±10.5岁。29.9%的患者报告患有糖尿病，61.2%患有高血压，39%肥胖，10.5%有心肌梗死病史，6.8%有中风或外周动脉疾病病史。46.8%的患者报告目前吸烟或曾吸烟。在使用EZE/SIMVA方案之前，阿托伐他汀（33%）和SIMVA（27.2%）是最常用的他汀类药物。EZE/SIMVA治疗2个月后，平均LDL-C降低了33%，平均总胆固醇降低了26%，平均甘油三酯降低了15%，而高密度脂蛋白胆固醇（HDL-C）升高了10%。使用EZE/SIMVA达到LDL-C目标的患者百分比为73.8%。记录到1例与研究治疗无关的严重不良事件和总共23例不良事件。基线值大于1.0mg/dl（88微摩尔/升）的患者血清肌酐水平显著下降。
对于仅接受他汀类治疗未达到LDL-C目标的患者，EZE/SIMVA联合治疗似乎是一种有效且安全的治疗选择。
