LONG-TERM EFFICACY AND TOLERABILITY OF SIMVASTATIN IN A LARGE COHORT OF ELDERLY HYPERCHOLESTEROLEMIC PATIENTS
LONG-TERM EFFICACY AND TOLERABILITY OF SIMVASTATIN IN A LARGE COHORT OF ELDERLY HYPERCHOLESTEROLEMIC PATIENTS
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DOI：
10.1016/0021-9150(95)05523-y
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发表时间：
1995-08-01
期刊：
影响因子：
5.3
通讯作者：
HAYDEN, MR
中科院分区：
文献类型：
--
作者：
LANSBERG, PJ;MITCHEL, YB;HAYDEN, MR
辛伐他汀是一种3-羟基-3-甲基戊二酰辅酶A（HMG-CoA）还原酶抑制剂，在168例老年高胆固醇血症患者中进行了为期24个月的随访，评估了其长期疗效和耐受性。在完成一项为期4周的辛伐他汀双盲剂量范围研究后，本扩展研究纳入了47名男性和122名女性，年龄超过62岁，患有II型高脂血症、总胆固醇水平高于6.5 mmol/l和临床表现的心血管疾病。共有159名患者完成了12个月的随访期，141名患者在整个24个月内接受了监测。所有患者均开始接受10 mg辛伐他汀每日一次治疗，并增加剂量，直至达到2.3 mmol/l（90 mg/dl）至3.6 mmol/l（140 mg/dl）的低密度脂蛋白（LDL）胆固醇目标水平。在研究期间，50%的患者达到了LDL胆固醇< 3.6 mmol/l（140 mg/dl）的目标。研究完成时，65例患者（39%）每天服用40 mg辛伐他汀，56例患者（33%）每天服用20 mg辛伐他汀，42例患者（25%）每天服用10 mg辛伐他汀，5例患者（3%）每天仅服用5 mg辛伐他汀。16例患者（9%）接受了伴随降脂治疗。2年内，LDL胆固醇平均降低36%至38%，甘油三酯平均降低12%至19%，高密度脂蛋白（HDL）胆固醇平均增加9%至10%。7例患者因不良临床或实验室事件而停用辛伐他汀，但仅2例（1.1%）被认为与药物相关。副作用轻微，最常见的是胃肠道。丙氨酸氨基转移酶（AST）的平均变化与零无显著差异，丙氨酸氨基转移酶（ALT）和肌酸磷酸激酶（CPK）的平均变化显示小幅增加。我们的结论是，辛伐他汀是一种有效的和耐受性良好的治疗高胆固醇血症的老年人的延长期。
The long-term efficacy and tolerability of simvastatin, a 3-hydroxy-3-methylglutaryl-co-enzyme A (HMG-CoA) reductase inhibitor, was assessed during a 24-month follow-up period in 168 elderly hypercholesterolemic patients. After completing a 4 week double blind dose ranging study with simvastatin, 47 males and 122 females over 62 years of age with type II hyperlipidemia, a total cholesterol level above 6.5 mmol/l and clinically manifest cardiovascular disease were included in this extended study. A total of 159 patients completed the 12-month follow-up period and 141 patients were monitored over the full 24 months. All patients were started on 10 mg simvastatin once daily and the dosage was increased until the target levels of low density lipoprotein (LDL) cholesterol between 2.3 mmol/l (90 mg/dl) and 3.6 mmol/l (140 mg/dl) were reached. Fifty percent of patients reached the targeted LDL cholesterol goal of < 3.6 mmol/l (140 mg/dl) during the study. At study completion, 65 patients (39%) were taking 40 mg simvastatin per day, 56 patients (33%) 20 mg, 42 patients (25%) 10 mg and 5 patients (3%) only used 5 mg per day. Sixteen patients (9%) received concomitant lipid lowering therapy. Over 2 years, the mean decrease in LDL cholesterol ranged from 36% to 38%, the median decrease in triglycerides was 12% to 19% and the mean increase in high density lipoprotein (HDL) cholesterol ranged from 9% to 10%, respectively. Seven patients discontinued simvastatin because of adverse clinical or laboratory events, but only in two (1.1%) was this considered to be drug-related. Side-effects were mild and most frequently gastrointestinal in nature. Mean changes in asparate aminotransferase (AST) were not significantly different from zero and mean changes in alanine aminotransferase (ALT) and creatine phosphokinase (CPK) showed a small increase. We conclude that simvastatin is an efficacious and well-tolerated treatment for hypercholesterolemia in elderly individuals for extended periods.