Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX 75230 , USA.
Postgrad Med. 2012 Jul;124(4):14-20. doi: 10.3810/pgm.2012.07.2564.
To evaluate the efficacy and safety of colesevelam in Hispanic subjects with primary hyperlipidemia and prediabetes.
A 16-week, randomized, double-blind, placebo-controlled, multinational study evaluating colesevelam in participants with primary hyperlipidemia (low-density lipoprotein cholesterol [LDL-C] level ≥ 100 mg/dL) and prediabetes (fasting plasma glucose level ≥ 110 to ≤ 125 mg/dL, or 2-hour postload glucose level ≥ 140 to < 200 mg/dL during an oral glucose tolerance test) was conducted between January 14, 2008 and April 3, 2009. Participants were randomized 1:1 to colesevelam 3.75 g/day or placebo. The primary efficacy endpoint was mean change from baseline in LDL-C level with colesevelam compared with placebo. Participants who self-identified as Hispanic during enrollment were included in this exploratory analysis evaluating the efficacy of colesevelam in Hispanics with primary hyperlipidemia and prediabetes.
From a total of 216 subjects with primary hyperlipidemia and prediabetes, 153 Hispanics were included in this post hoc analysis; 77 subjects were randomized to colesevelam and 76 subjects were randomized to placebo. At week 16, LDL-C levels were significantly reduced with colesevelam compared with placebo (mean treatment difference, -19.4%; P < 0.0001). Achievement of LDL-C level < 100 mg/dL was more frequent with colesevelam than with placebo (27% vs 11%; P = 0.002). In addition, significant mean reductions in non-high-density lipoprotein cholesterol, total cholesterol, and apolipoprotein B levels (P ≤ 0.0002 for all), and a significant median increase in triglyceride levels (P = 0.003), were seen with colesevelam compared with placebo. At study end, there was a significant mean reduction in glycated hemoglobin levels and median reduction in fasting plasma glucose levels with colesevelam compared with placebo (P ≤ 0.02 for both). A fasting plasma glucose level < 100 mg/dL was achieved in 44% of colesevelam recipients compared with 23% of placebo recipients (P < 0.05). Overall, colesevelam was well tolerated.
Colesevelam may be a treatment option for Hispanic subjects with primary hyperlipidemia and prediabetes, mainly to reduce LDL-C levels, with added beneficial effect on glucose levels.
www.ClinicalTrials.gov identifier NCT00570739.
评估考来维仑在伴有前驱糖尿病的西班牙裔原发性高脂血症患者中的疗效和安全性。
这是一项 16 周、随机、双盲、安慰剂对照、多国研究，评估了考来维仑在伴有原发性高脂血症（低密度脂蛋白胆固醇[LDL-C]水平≥100mg/dL）和前驱糖尿病（空腹血糖水平≥110 至≤125mg/dL，或口服葡萄糖耐量试验中 2 小时餐后血糖水平≥140 至<200mg/dL）的参与者中的疗效。该研究于 2008 年 1 月 14 日至 2009 年 4 月 3 日进行。参与者按 1:1 随机分配至考来维仑 3.75g/天或安慰剂组。主要疗效终点是与安慰剂相比，考来维仑治疗后 LDL-C 水平的平均变化。在入组期间自认为是西班牙裔的参与者被纳入这项探索性分析中，评估考来维仑在伴有原发性高脂血症和前驱糖尿病的西班牙裔患者中的疗效。
在总计 216 例伴有原发性高脂血症和前驱糖尿病的患者中，共有 153 例西班牙裔患者被纳入本事后分析；77 例随机分配至考来维仑组，76 例随机分配至安慰剂组。在第 16 周时，与安慰剂相比，考来维仑显著降低 LDL-C 水平（平均治疗差异，-19.4%；P<0.0001）。与安慰剂相比，考来维仑组达到 LDL-C 水平<100mg/dL 的比例更高（27%比 11%；P=0.002）。此外，与安慰剂相比，非高密度脂蛋白胆固醇、总胆固醇和载脂蛋白 B 水平也显著降低（所有 P 值均≤0.0002），且考来维仑组的甘油三酯水平中位数显著升高（P=0.003）。与安慰剂相比，考来维仑组在研究结束时，糖化血红蛋白水平的平均降低和空腹血糖水平的中位数降低均具有统计学意义（两者 P 值均≤0.02）。与安慰剂组相比，考来维仑组有 44%的患者空腹血糖水平<100mg/dL，而安慰剂组仅有 23%（P<0.05）。总的来说，考来维仑耐受性良好。
考来维仑可能是伴有前驱糖尿病的西班牙裔原发性高脂血症患者的一种治疗选择，主要用于降低 LDL-C 水平，同时对血糖水平也有有益影响。
www.ClinicalTrials.gov 标识符 NCT00570739。
