Alsheikh-Ali Alawi A, Karas Richard H
Institute for Clinical Research and Health Policy Studies and Molecular Cardiology Research Institute, Department of Medicine, Tufts-New England Medical Center and Tufts University School of Medicine, Boston, Massachusetts 02111, USA.
Am J Cardiol. 2008 Apr 17;101(8A):9B-13B. doi: 10.1016/j.amjcard.2008.02.027.
Of currently approved drugs, niacin is the most effective in raising high-density lipoprotein cholesterol levels, either as monotherapy or in combination with other agents. The US Food and Drug Administration's (FDA) Adverse Event Reporting System provides 1 mechanism to evaluate the safety of niacin as it is used in common clinical practice. In this report, the authors review recent analyses of adverse events reported to the FDA demonstrating that the extended-release formulation of niacin (niacin-ER) has a significantly better safety profile compared with other niacin formulations and compares favorably with other commonly used lipid-altering drugs, including 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) and fibrates. In addition, analyses of FDA adverse event reports of the pill combining lovastatin and niacin-ER suggest that the safety of combination therapy with niacin-ER and a statin is comparable with the safety of each of the drugs alone. These analyses should encourage the use of niacin-ER in patients at high risk for cardiovascular disease, as recommended by current national guidelines for cardiovascular prevention.
在目前已获批的药物中，烟酸无论是作为单一疗法还是与其他药物联合使用，在提高高密度脂蛋白胆固醇水平方面都是最有效的。美国食品药品监督管理局（FDA）的不良事件报告系统提供了一种机制，用于评估烟酸在临床实践中的安全性。在本报告中，作者回顾了近期向FDA报告的不良事件分析，结果表明，与其他烟酸制剂相比，缓释型烟酸（niacin-ER）具有显著更好的安全性，并且与其他常用的调脂药物相比也具有优势，这些药物包括3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂（他汀类药物）和贝特类药物。此外，对FDA关于洛伐他汀与niacin-ER组合片剂的不良事件报告分析表明，niacin-ER与他汀类药物联合治疗的安全性与每种药物单独使用时相当。这些分析应鼓励按照当前国家心血管疾病预防指南的建议，在心血管疾病高危患者中使用niacin-ER。
