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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Reduction of LDL cholesterol in patients with primary hypercholesterolemia by SCH 48461: results of a multicenter dose-ranging study.
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Reduction of LDL cholesterol in patients with primary hypercholesterolemia by SCH 48461: results of a multicenter dose-ranging study.

机译：SCH 48461降低原发性高胆固醇血症患者的LDL胆固醇：一项多中心剂量范围研究的结果。

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摘要

SCH 48461, an inhibitor of gastrointestinal absorption of cholesterol, was evaluated for its effects on lipid parameters in patients with primary hypercholesterolemia in a multicenter, double-blind, randomized, parallel-group study. Following the baseline phase, which consisted of a 2- to 10-week drug washout and dietary stabilization phase and a 4-week placebo lead-in (placebo baseline phase), 190 patients were randomized to an 8-week double-blind active drug (SCH 48461 1, 6.25, 25, 100, 200, or 400 mg) or 40 mg lovastatin once daily each morning or placebo treatment phase. By week 2, patients who received SCH 48461 6.25 to 400 mg or lovastatin demonstrated greater reduction from baseline in directly measured low-density lipoprotein cholesterol (LDL-C) levels than patients in the placebo group (p < or = 0.03). Overall, the percent reductions in LDL-C from baseline increased as the dose of SCH 48461 increased, with 0.6% to 15.5% reductions from the minimum dose of 1 mg to the maximum dose of 400 mg. Lovastatin 40 mg/day reduced LDL-C by 30.7% (p < 0.01). Statistically significant decreases were also seen for total cholesterol and apolipoprotein B (apo B) with doses of 25 mg to 400 mg of SCH 48461 and lovastatin. SCH 48461 was well tolerated. There was a similar incidence of adverse events in each SCH 48461- or lovastatin-treated group compared to placebo. This study demonstrated a clinically and statistically significant cholesterol-lowering effect of SCH 48461 in patients with primary hypercholesterolemia.
机译：SCH 48461是胃肠道吸收胆固醇的抑制剂，在多中心，双盲，随机，平行分组研究中评估了其对原发性高胆固醇血症患者血脂参数的影响。在基线阶段（包括2到10周的药物洗脱和饮食稳定阶段以及4周的安慰剂导入（安慰剂基线阶段））之后，将190名患者随机分配为8周的双盲活性药物（SCH 48461 1、6.25、25、100、200或400 mg）或每天40 mg洛伐他汀每天早晨或安慰剂治疗阶段一次。到第2周时，接受SCH 48461 6.25至400 mg或洛伐他汀治疗的患者，与安慰剂组相比，直接测量的低密度脂蛋白胆固醇（LDL-C）水平较基线水平有更大降低（p <或= 0.03）。总体而言，随着SCH 48461剂量的增加，LDL-C从基线减少的百分比增加，从最低剂量1 mg到最大剂量400 mg减少0.6％至15.5％。洛伐他汀40 mg /天可使LDL-C降低30.7％（p <0.01）。 SCH 48461和洛伐他汀的剂量范围为25 mg至400 mg，总胆固醇和载脂蛋白B（载脂蛋白B）也有统计学意义的下降。 SCH 48461的耐受性良好。与安慰剂相比，每个SCH 48461或洛伐他汀治疗组的不良事件发生率相似。这项研究表明，SCH 48461在原发性高胆固醇血症患者中具有降低胆固醇的临床和统计学意义。

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