Giannini S D, de Góes J M, Dereviack B E, Machado C, Forti N, Diament J
Instituto do Coração do Hospital das Clínicas, FMUSP.
Arq Bras Cardiol. 1990 Jun;54(6):407-14.
To evaluate the efficacy and tolerability of simvastatin, a new and potent HMG-CoA reductase inhibitor, in the treatment of hypercholesterolemia in elderly patients.
Twenty patients, 14 female and 6 male, aged 65 to 72 years (x = 69 +/- 3), with total cholesterol (TC) above 260 mg/dl and triglycerides below 350 mg/dl were studied. All patients presented clinical evidences of atherosclerotic disease and were followed up for 6 months. Monthly visits were required for clinical and laboratory evaluation. The initial dosage of simvastatin was 10 mg/day; dosage was titrated up to 10 mg/day or to a minimum of 5 mg/day in intervals of at least 4 weeks, in order to maintain LDL-cholesterol below 140 mg/dl. To evaluate the changes on plasma lipid levels, the mean value of determinations during the placebo baseline period was compared to the mean value of determinations during the active treatment period.
There were significant reductions of total cholesterol (-26.4%), triglycerides (-16.0%), LDL-cholesterol (-35.2%), VLDL-cholesterol (-15.4%), TC/HDL-C (-30.7%), and LDL/HDL-C (-39.5%). There was significant elevation of HDL-cholesterol (+5.2%), although this response was not uniform. The drug was well tolerated: only five patients reported transient clinical adverse experiences that subsided spontaneously. Two patients had elevation of CPK and one of TGP. The drug did not have to be discontinued in any case. Ophthalmological examinations performed before treatment compared to examinations at the end of the study showed no signficant alterations.
Simvastatin in elderly patients appeared to be a potent TC and LDL-C lowering drug and presented mild but significant effect on the elevation of HDL-C. There was good tolerability, with low incidence of adverse experiences. This fact is important when one considers drug therapy for hypercholesterolemia in this age group.
评估新型强效HMG-CoA还原酶抑制剂辛伐他汀治疗老年患者高胆固醇血症的疗效和耐受性。
研究对象为20例患者，其中女性14例，男性6例，年龄65至72岁（平均年龄69±3岁），总胆固醇（TC）高于260mg/dl且甘油三酯低于350mg/dl。所有患者均有动脉粥样硬化疾病的临床证据，并接受了6个月的随访。每月需进行临床和实验室评估。辛伐他汀初始剂量为10mg/天；剂量以至少4周的间隔逐步增至10mg/天或最低至5mg/天，以使低密度脂蛋白胆固醇（LDL-C）维持在140mg/dl以下。为评估血脂水平变化，将安慰剂基线期测定的平均值与积极治疗期测定的平均值进行比较。
总胆固醇（-26.4%）、甘油三酯（-16.0%）、LDL-C（-35.2%）、极低密度脂蛋白胆固醇（VLDL-C）（-15.4%）、TC/高密度脂蛋白胆固醇（HDL-C）（-30.7%）和LDL/HDL-C（-39.5%）均显著降低。HDL-C显著升高（+5.2%），尽管这种反应并不一致。该药物耐受性良好：只有5例患者报告了短暂的临床不良经历，且这些经历自行消退。2例患者肌酸磷酸激酶（CPK）升高，1例患者谷草转氨酶（TGP）升高。在任何情况下均无需停用该药物。治疗前进行的眼科检查与研究结束时的检查相比，未发现明显改变。
辛伐他汀对老年患者似乎是一种强效降低TC和LDL-C的药物，对HDL-C升高有轻微但显著的作用。耐受性良好，不良经历发生率低。在考虑该年龄组高胆固醇血症的药物治疗时，这一事实很重要。
