University of Kansas Medical Center, Kansas City, KS 66160, USA.
Postgrad Med. 2011 Mar;123(2):70-83. doi: 10.3810/pgm.2011.03.2265.
Niacin is a water-soluble B vitamin (B3) known to have favorable effects on multiple lipid parameters, including raising high-density lipoprotein cholesterol (HDL-C) levels and lowering triglycerides (TGs), lipoprotein(a), and low-density lipoprotein cholesterol (LDL-C). Although LDL-C remains the primary target of lipid-altering therapy, current guidelines emphasize HDL-C and other modifiable lipid factors as key secondary targets. Thus, niacin is considered an important therapeutic option to help reduce the risk of cardiovascular disease in patients with mixed dyslipidemia who, in addition to high LDL-C, have elevated TGs and low HDL-C. Although available prescription niacin products, including immediate-release niacin (IR; Niacor) and an extended-release niacin formulation (Niaspan), have demonstrated safety and efficacy in randomized clinical trials, confusion remains among health care providers and their patients regarding the various commercially available nonprescription dietary supplement niacin products. These dietary supplements, which include IR, sustained-release (SR), and "no-flush" or "flush-free" niacin products, are not subject to the same stringent US Food and Drug Administration regulations as prescription drugs. In fact, both the American Heart Association and the American Pharmacists Association recommend against the use of dietary supplement niacin as a substitute for prescription niacin. Although some dietary supplement IR and SR niacin products have demonstrated a lipid response in clinical trials, products labeled as "no-flush" or "flush-free" that are intended to avoid the common niacin-associated adverse effect of flushing generally contain minimal or no free, pharmacologically active niacin and therefore lack beneficial lipid-modifying effects. To clarify important differences between available prescription and dietary supplement niacin products, this article contrasts current regulatory standards for dietary supplements and prescription drugs and provides an overview of available clinical data from key trials of niacin.
烟酸是一种水溶性 B 族维生素（B3），已知对多种脂质参数具有有利影响，包括提高高密度脂蛋白胆固醇（HDL-C）水平和降低甘油三酯（TGs）、脂蛋白（a）和低密度脂蛋白胆固醇（LDL-C）。尽管 LDL-C 仍然是脂质改变治疗的主要目标，但当前的指南强调 HDL-C 和其他可改变的脂质因素作为关键的次要目标。因此，烟酸被认为是一种重要的治疗选择，可以帮助降低患有混合性血脂异常的患者发生心血管疾病的风险，这些患者除了 LDL-C 升高外，还伴有 TG 升高和 HDL-C 降低。尽管现有的处方烟酸产品，包括即时释放烟酸（IR；Niacor）和延长释放烟酸制剂（Niaspan），在随机临床试验中已证明其安全性和有效性，但医疗保健提供者及其患者对各种市售非处方膳食补充烟酸产品仍存在混淆。这些膳食补充剂，包括 IR、缓释（SR）和“无潮红”或“无潮红”烟酸产品，不受与处方药相同的严格美国食品和药物管理局法规的限制。事实上，美国心脏协会和美国药剂师协会都建议不要将膳食补充烟酸用作处方烟酸的替代品。尽管一些膳食补充 IR 和 SR 烟酸产品在临床试验中显示出了脂质反应，但标签为“无潮红”或“无潮红”的产品旨在避免常见的烟酸相关潮红不良反应，通常含有最小或没有游离的、药理学上有效的烟酸，因此缺乏有益的脂质调节作用。为了澄清可用的处方和膳食补充烟酸产品之间的重要差异，本文对比了膳食补充剂和处方药的现行监管标准，并提供了烟酸关键试验的现有临床数据概述。
