Kannel W B, D'Agostino R B, Stepanians M, D'Agostino L C
Boston University School of Medicine, Department of Preventive Medicine, Massachusetts.
Am J Cardiol. 1990 Sep 18;66(8):1B-10B. doi: 10.1016/0002-9149(90)90434-3.
This study reports the results of a 6-month, open-label multicenter study of the efficacy and tolerability of lovastatin, a 3-hydroxy-3-methylglutaryl co-enzyme A (HMG CoA) reductase inhibitor, in the management of nonfamilial primary hypercholesterolemia. The study enrolled 489 patients with elevated total serum cholesterol levels, whose lipids were not controlled sufficiently by diet. There was good representation of gender (48.3% women and 51.7% men), age (mean 57, range 25 to 83) and hypertension status (55.4% normotensive and 43.6% hypertensive) in the sample. Within 1 month of lovastatin therapy, total cholesterol was reduced 19% (from a mean of 269 to 217 mg/dl, low-density lipoprotein (LDL) cholesterol was reduced 27% (191 to 140 mg/dl), high-density lipoprotein (HDL) cholesterol increased 6% (42.6 to 45.1 mg/dl), the ratio of total cholesterol to HDL was reduced 24% (6.7 to 5.1) and the ratio of LDL to HDL was reduced 30% (4.7 to 3.3). These results were consistent across age group, gender and hypertension status, and were maintained for a period of 6 months of therapy. Lovastatin was generally well tolerated. Of the 489 patients enrolled, 449 (92%) completed 6 months of therapy. Only 21 (4%) withdrew because of adverse experience regardless of cause. None of the few serious adverse experiences (e.g., myocardial infarction) could be attributed to the drug. Abnormal laboratory values during the 6 months of therapy were within expectations. Seventy-four patients had at least 1 abnormal value during 6 months of treatment. Of these, 42 had at least 1 mild to moderate creatine phosphokinase elevation during this period. Only 1 patient had an adverse change on ophthalmologic examination: a posterior subcapsular opacity in both eyes just visible on 6-month examination.
本研究报告了一项为期6个月的开放标签多中心研究结果，该研究旨在评估3-羟基-3-甲基戊二酰辅酶A（HMG CoA）还原酶抑制剂洛伐他汀治疗非家族性原发性高胆固醇血症的疗效和耐受性。该研究纳入了489例总血清胆固醇水平升高且饮食控制后血脂仍未得到充分控制的患者。样本在性别（女性48.3%，男性51.7%）、年龄（平均57岁，范围25至83岁）和高血压状态（血压正常者55.4%，高血压患者43.6%）方面具有良好的代表性。在洛伐他汀治疗的1个月内，总胆固醇降低了19%（从平均269mg/dl降至217mg/dl），低密度脂蛋白（LDL）胆固醇降低了27%（从191mg/dl降至140mg/dl），高密度脂蛋白（HDL）胆固醇升高了6%（从42.6mg/dl升至45.1mg/dl），总胆固醇与HDL的比值降低了24%（从6.7降至5.1），LDL与HDL的比值降低了30%（从4.7降至3.3）。这些结果在各年龄组、性别和高血压状态中均一致，并在为期6个月的治疗期间保持稳定。洛伐他汀总体耐受性良好。在纳入的489例患者中，449例（92%）完成了6个月的治疗。仅有21例（4%）因不良事件（无论原因）退出治疗。少数严重不良事件（如心肌梗死）均不能归因于该药物。治疗6个月期间的实验室异常值在预期范围内。74例患者在6个月治疗期间至少有1次异常值。其中，42例在此期间至少有1次轻度至中度肌酸磷酸激酶升高。仅1例患者眼科检查出现不良变化：6个月检查时双眼可见后囊下混浊。
