Am J Cardiol. 1993 Jun 15;71(16):1408-14. doi: 10.1016/0002-9149(93)90601-8.
The efficacy and safety profile of simvastatin and pravastatin across their most commonly recommended dosage ranges were compared in a double-blind, parallel, multicenter study in 550 patients with primary hypercholesterolemia. The study consisted of a 6-week placebo period followed by 18 weeks of active treatment. Patients were randomized to 10 mg of simvastatin or pravastatin once in the evening; doses were titrated at 6-week intervals to a maximum of 40 mg/day if the low-density lipoprotein (LDL) cholesterol remained > or = 130 mg/dl (3.4 mmol/liter). Baseline characteristics were similar in both groups. At the end of the study with simvastatin and pravastatin, respectively, 30 and 14% continued to take the 10 mg dose and 48 and 66% were titrated to the maximal dose. After 18 weeks of treatment with simvastatin and pravastatin the mean percent decreases from baseline were, respectively, for total plasma cholesterol 27 and 19% (p < 0.01 between groups), for LDL cholesterol 38 and 26% (p < 0.01 between groups), for very low density lipoprotein cholesterol 30 and 16% (p < 0.01 between groups), and for triglycerides 18 and 14% (p < 0.05 between groups). The mean percent increase from baseline in high-density lipoprotein cholesterol was 15% with simvastatin compared to 12% with pravastatin (p < 0.05 between groups). The efficacy goal of LDL cholesterol < 130 mg/dl was achieved in 65% of the patients treated with simvastatin versus 39% of those treated with pravastatin (p < 0.001). There was no significant difference between groups in the frequency of drug-related adverse experiences.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项针对550例原发性高胆固醇血症患者的双盲、平行、多中心研究中，比较了辛伐他汀和普伐他汀在其最常推荐剂量范围内的疗效和安全性。该研究包括为期6周的安慰剂期，随后是18周的积极治疗期。患者被随机分为每晚服用10毫克辛伐他汀或普伐他汀；如果低密度脂蛋白（LDL）胆固醇仍≥130毫克/分升（3.4毫摩尔/升），则每隔6周将剂量滴定至最大40毫克/天。两组的基线特征相似。在分别使用辛伐他汀和普伐他汀的研究结束时，分别有30%和14%的患者继续服用10毫克剂量，48%和66%的患者被滴定至最大剂量。在使用辛伐他汀和普伐他汀治疗18周后，总血浆胆固醇较基线的平均百分比下降分别为27%和19%（组间p<0.01），LDL胆固醇为38%和26%（组间p<0.01），极低密度脂蛋白胆固醇为30%和16%（组间p<0.01），甘油三酯为18%和14%（组间p<0.05）。与普伐他汀相比，辛伐他汀使高密度脂蛋白胆固醇较基线的平均百分比增加为15%，而普伐他汀为12%（组间p<0.05）。接受辛伐他汀治疗的患者中有65%达到了LDL胆固醇<130毫克/分升的疗效目标，而接受普伐他汀治疗的患者中这一比例为39%（p<0.001）。两组药物相关不良事件的发生频率无显著差异。（摘要截短于250字）
