Effectiveness of once-nightly dosing of extended-release niacin alone and in combination for hypercholesterolemia
Effectiveness of once-nightly dosing of extended-release niacin alone and in combination for hypercholesterolemia
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DOI：
10.1016/s0002-9149(98)00448-2
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发表时间：
1998-09-15
影响因子：
2.8
通讯作者：
O'Connor, CM
中科院分区：
文献类型：
--
作者：
Guyton, JR;Goldberg, AC;O'Connor, CM
我们进行了一项多中心、开放标签研究，以确定一种新的缓释烟酸制剂Niaspan治疗高胆固醇血症的长期安全性和有效性。Niaspan，0.5至3.0 g，每晚睡前一次，单独使用或与他汀类药物（羟甲基戊二酰辅酶A还原酶抑制剂）、胆汁酸螯合剂或两者联合使用。患者包括参加96周研究的269名高胆固醇血症男性和女性成人，以及230名可获得短期安全性数据的其他成人。269例患者获得的Niaspan剂量为1，000 mg（95%的患者）、1，500 mg（86%）和2，000 mg（65%）。治疗48周后，Niaspan单药（中位剂量2，000 mg）可降低低密度脂蛋白（LDL）胆固醇（18%）、载脂蛋白B（15%）、总胆固醇（11%）、甘油三酯（24%）和脂蛋白（a）（36%），并升高高密度脂蛋白（HDL）胆固醇（29%）。Niaspan加他汀类药物降低LDL胆固醇（32%）、载脂蛋白B（26%）、总胆固醇（23%）、甘油三酯（30%）和脂蛋白（a）（19%），并增加HDL胆固醇（26%）。2.6%的患者出现天冬氨酸转氨酶或丙氨酸转氨酶可逆性升高，超过正常范围的两倍。1例患者因转氨酶升高而停用Niaspan。4.8%的患者发生潮红不耐受，导致停用Niaspan。本研究结合2项既往随机试验中因潮红而停药的总体发生率为7.3%。在高胆固醇血症的长期治疗中，Niaspan使LDL和HDL胆固醇、甘油三酯和脂蛋白（a）产生了有利的变化。肝脏不良反应轻微，发生率与他汀类药物治疗报告的发生率相似。(C)1998年由Excerpta Medico，Inc.
We performed a multicenter, open-label study to determine the long-term safety and efficacy of a new extended-release once-a-night niacin preparation, Niaspan, in the treatment of hypercholesterolemia. Niaspan, 0.5 to 3.0 g once a night at bedtime, was used alone or in combination with a statin (inhibitor of hydroxymethyl-glutaryl coenzyme A reductase), a bile acid sequestrant, or both. Patients included 269 hypercholesterolemic male and female adults enrolled in a 96-week study, and 230 additional adults for whom short-term safety data were available. The dosages of Niaspan attained by 269 patients were 1,000 mg (95% of patients), 1,500 mg (86%), and 2,000 mg (65%). After 48 weeks of treatment, Niaspan alone (median dose 2,000 mg) reduced low-density lipoprotein (LDL) cholesterol (18%), apolipoprotein B (15%), total cholesterol (11%), triglycerides (24%), and lipoprotein(a) (36%), and increased high-density lipoprotein (HDL) cholesterol (29%). Niaspan plus a statin lowered LDL cholesterol (32%), apolipoprotein B (26%), total cholesterol (23%), triglycerides (30%), and lipoprotein(a) (19%), and increased HDL cholesterol (26%). Reversible elevations of aspartate aminotransferase or alanine aminotransferase more than twice the normal range occurred in 2.6% of patients. One patient discontinued Niaspan because of transaminase elevations. Intolerance to flushing, leading to dis continuation of Niaspan, occurred in 4.8% of patients. The overall rate of discontinuance due to flushing in this study combined with 2 previous randomized trials was 7.3%. In the long-term treatment of hypercholesterolemia, Niaspan produced favorable changes in LDL and HDL cholesterol, triglycerides, and lipoprotein(a). Adverse hepatic effects were minor and occurred at rates similar to those reported for statin therapy. (C) 1998 by Excerpta Medico, Inc.