OBJECTIVE:To test the safety, tolerance, and efficacy of extended-release niacin monotherapy on dyslipidemia in persons with chronic tetraplegia. DESIGN:Placebo-controlled, blinded, multicenter, randomized controlled trial. SETTING:Three spinal cord injury research/rehabilitation centers. PARTICIPANTS:Persons with chronic tetraplegia (N=54) and low plasma high-density lipoprotein cholesterol (HDL-C) levels. INTERVENTION:Extended-release niacin monotherapy (48 weeks; n=31) on a dose-titration schedule versus matched placebo (n=23). MAIN OUTCOME MEASURES:Safety was assessed by using percentages of treatment-emergent adverse events and increased levels of hepatic transaminases, uric acid, glycosylated hemoglobin, and fasting glucose. Tolerance was assessed by using participant reports for frequency and intensity of adverse effects of extended-release niacin. Primary effectiveness outcomes were fasting HDL-C level and plasma total cholesterol (TC)/HDL-C ratio. Secondary outcomes included plasma low-density lipoprotein cholesterol (LDL-C) and TC levels and LDL-C/HDL-C ratio. RESULTS:Significant increases in fasting HDL-C levels (24.5%) were accompanied by decreases in TC/HDL-C and LDL-C/HDL-C ratios, LDL-C levels, and TC levels (all P<.05). No evidence of sustained hepatotoxicity or hyperglycemia was observed. Treatment-emergent withdrawals (12.9%) accompanied flushing (n=1), hypotension/presyncope (n=1), and diarrhea (n=2). One subject experienced transient hyperuricemia. Other drug-reported symptoms did not differ from those for placebo. CONCLUSIONS:Extended-release niacin monotherapy is safe, tolerated, and effective for most persons with chronic tetraplegia. Special precautions for changes in bowel habits and postadministration hypotension should be observed.

译文

目的:探讨烟酸缓释单药治疗慢性四肢瘫痪患者血脂异常的安全性,耐受性和疗效。
设计:安慰剂对照,双盲,多中心,随机对照试验。
地点:三个脊髓损伤研究/康复中心。
参与者:慢性四肢瘫痪(N = 54)和血浆高密度脂蛋白胆固醇(HDL-C)水平低的人。
干预:按剂量滴定方案延长烟酸单药治疗(48周; n = 31),而与之匹配的安慰剂(n = 23)。
主要观察指标:使用治疗紧急不良事件的百分比以及肝转氨酶,尿酸,糖基化血红蛋白和空腹血糖水平的增加来评估安全性。通过使用参与者报告评估缓释烟酸不良反应的发生频率和强度,以评估耐受性。主要疗效结果是禁食HDL-C水平和血浆总胆固醇(TC)/ HDL-C比值。次要结果包括血浆低密度脂蛋白胆固醇(LDL-C)和TC水平以及LDL-C / HDL-C比。
结果:空腹HDL-C水平显着增加(24.5%),同时TC / HDL-C和LDL-C / HDL-C比率,LDL-C水平和TC水平降低(均P <.05)。没有观察到持续的肝毒性或高血糖的证据。紧急治疗时停药(12.9%)伴有潮红(n = 1),低血压/晕厥(n = 1)和腹泻(n = 2)。一名受试者经历了短暂性高尿酸血症。其他药物报告的症状与安慰剂无差异。
结论:烟酸缓释单药对大多数慢性四肢瘫痪患者是安全,可耐受且有效的。应注意改变大便习惯和给药后低血压的特殊预防措施。

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