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美国FDA批准雅培公司的烟酸＋辛伐他汀复方缓释片（niacin extended-release＋simvastatin，Simcor）上市，结合控制饮食降低单独采用烟酸缓释制剂或辛伐他汀片治疗混合型脂质代谢疾病无效患者的总胆固醇、“坏”胆固醇LDL和甘油三酯，而升高“好”胆固醇HDL。本品薄膜包衣片剂量规格：缓释烟酸/辛伐他汀500mg/20mg/片，750mg/20mg/片，1000 mg/20mg/片。
在临床研究中，患者通常对本品耐受性好。6％的患者因发生潮红不良反应中止治疗。肝病、胃溃疡或严重出血患者、孕妇或哺乳期妇女以及对本制剂中任一成分过敏者禁用。
优点
不良反应发生降低，更加安全；
使用方便，一日一次；
双作用靶点，疗效更佳。
SIMCOR, a combination of simvastatin, an HMG-CoA reductase inhibitor and niacin extended-release (Niaspan),is indicated as adjunct to diet for patients requiring
modifications of lipid profiles.1 SIMCOR was approved by the FDA on Feb 15, 2008 and is indicated to reduce elevated total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C),apolipoprotein B (Apo B), and triglycerides(TG), and to increase high-density lipoprotein cholesterol (HDL-C)
in patients with primary hypercholesterolemia,mixed dyslipidemia, and hypertriglyceridemia when treatment with simvastatin or Niaspan monotherapies areconsidered inadequate.
SIMCOR is administered as a single daily dose at bedtime, with a low fat snack. The SIMCOR (niacin extendedrelease/simvastatin) tablet is available in strengths of 500/20 mg, 750/20 mg, and 1000/20 mg. The dosage range is500/20 mg/day to 2000/40 mg/day with a recommended initial dose of 500/20 mg/day for patients not previously taking niacin extended-release.
The dose should be increased based upon desired lipid effects and individual tolerability.
SIMCOR CLINICAL EFFICACY AND SAFETY
SIMCOR reduces non-HDL-C, LDL-C, TC, TG, and Apo B and increases HDL-C in patients with primary hypercholesterolemia, mixed dyslipidemia, and hypertriglyceridemia.1 The SEACOAST (The Safety and Efficacy of A COmbination of NiAcin ER and Simvastatin in PaTients With Dyslipidemia) study, a pivotal phase III, double-blind, randomized, multicenter, multi-national, active-controlled,24 week study, compared the efficacy and safety of SIMCOR with low-dose and high-dose simvastatin in adult patients (N=641) with type II hyperlipidemia or mixed dyslipidemia.1,2,3 Significantly greater reductions in
non-HDL-C levels were observed in subjects treated with SIMCOR
2000/20 mg (p<0.05) and SIMCOR
1000/20 mg (p<0.05) compared with subjects treated with simvastatin 20 mg. Reductions in non-HDL-C observed in subjects treated with SIMCOR 2000/40 mg and 1000/40 mg were
non-inferior to the reduction observed in subjects treated with simvastatin 80 mg.
SIMCOR 1000/20
Manufacturer
Abbott Laboratories
Legal Classification
Rx
Pharmacological Class
Nicotinic acid deriv. + HMG-CoA reductase inhibitor
Generic Name
Niacin ext-rel 1000mg, simvastatin 20mg; tabs.
Also
SIMCOR 500/20
SIMCOR 750/20
Indications
Adjunct to diet in primary hypercholesterolemia, mixed dyslipidemia, and hypertriglyceridemia if monotherapy is inadequate.
Children
Not recommended.
Adults
Take once daily at bedtime with low-fat snack. Swallow whole. Naive to or switching from immediate-release niacin: initially one 500/20 tab. May increase at 4-wk intervals by up to 500mg/day (ext-rel niacin component); maintenance: 1000/20 to 2000/40 once daily. May
substitute for previously-titrated ext-rel niacin at equivalent doses. Re-titrate if therapy interrupted ≥7 days. To reduce flushing, pretreat with aspirin or an NSAID.
Contraindications
Active liver or peptic ulcer disease. Unexplained persistent elevated transaminases. Arterial bleeding. Pregnancy (Cat.X).
Nursing mothers.
Precautions
Do not substitute for equivalent doses of immediate-release niacin.
Substantial alcohol consumption. History of liver disease. Monitor transaminases (at baseline, every 12wks for 1st 6 mos, then periodically); discontinue if levels ≥3xULN persist or if signs/symptoms of liver disease occur. Discontinue if myopathy is diagnosed or suspected. Suspend therapy before surgery and if major medical event occurs. Renal dysfunction. Gout. Monitor blood glucose, PT, platelets.
Interactions
Avoid other niacin, potent CYP3A4 inhibitors (eg, azole antifungals, macrolides, HIV PIs, nefazodone, grapefruit juice >1qt/day), gemfibrozil, fenofibrate, cyclosporine, danazol. Potentiated by amiodarone and verapamil (limit simvastatin to 20mg/day). Separate dosing of bile acid sequestrants by 4–6hrs. Postural hypotension with ganglionic blockers, vasoactive drugs. Monitor warfarin, digoxin, antidiabetics.
Adverse Reactions
Flushing, headache, pruritus, GI upset, back pain; elevated ALT/AST, myopathy, rhabdomyolysis with renal failure.
How Supplied
Tabs—90
Additional Resources
Related Prescribing Note
Niacin ext-rel 750mg, simvastatin 20mg; tabs.
Niacin ext-rel 500mg, simvastatin 20mg; tabs.
Niacin ext-rel 1000mg, simvastatin 20mg; tabs.
规 格：烟酸500mg／辛伐他汀20mg；烟酸750mg／辛伐他汀20mg；烟酸1g／辛伐他汀20mg
用法用量：口服。每日一次，每次一片。睡前服用。
适 应 症：原发性高胆固醇血症和混合血脂异常。
作用特点
美国FDA于2008年2月15日批准了ABBOTT公司新的复方制剂“烟酸辛伐他汀缓释片”，商品名“SIMCOR”。该制剂是继“复方烟酸洛伐他汀缓释片”之后上市的新型的烟酸和他汀类复方制剂，也是治疗混合型脂质失调和降低总胆固醇的药物。辛伐他汀和烟酸两者合用，既能有效地降低低密度脂蛋白（LDL）和甘油三酯（TG）水平，又可以增加高密度脂蛋白（HDL）水平。同时烟酸制成缓释制剂后，降低了该药的峰谷波动，减少了烟酸不良反应的发生率，在安全性和使用方便性方面均优于现有降脂药。
烟酸和辛伐他汀合并用药不同于任何其他单一的降血脂药，可以总体改善血脂状况。辛伐他汀可降低LDL和总胆固醇，可用于原发性高胆固醇血症及动脉粥样硬化症。辛伐他汀对降低LDL具有显著效果，但对增加HDL作用较弱。烟酸的作用正相反，有很强的增加HDL作用，但降低LDL作用较弱。烟酸能有效增加HDL水平、降低甘油三酯与脂蛋白a的水平。两者都能降低血清甘油三酯水平。国外联合使用烟酸和辛伐他汀的III期临床研究显示，两药作用相加。治疗一年后，联合用药的降脂效果优于两种组成药物的任何一种，而副作用并未增加。
本品与普通制剂和单方相比，可最大限度的减少由烟酸引起的头痛、面部潮红等副作用，在增强降脂效果的同时，血液的各项生化指标无明显变化。服用缓释烟酸制剂的患者肝毒性和肌病发生率较低。
附件:
200951223093431.pdf
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注：以下产品不同规格和不同价格，购买时请以咨询为准！
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产地国家: 美国
原产地英文商品名:
SIMCOR (1000/20)mg/tab 90 Tabs/bottle
原产地英文药品名:
Niacin/Simvastatin
中文参考商品译名:
SIMCOR (1000/20)毫克/片 90片/瓶
中文参考药品译名:
烟酸/辛伐他汀
生产厂家中文参考译名:
美国雅培
生产厂家英文名:
abbott
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产地国家: 美国
原产地英文商品名:
SIMCOR (500/20)mg/tab 90 Tabs/bottle
原产地英文药品名:
Niacin/Simvastatin
中文参考商品译名:
SIMCOR (500/20)毫克/片 90片/瓶
中文参考药品译名:
烟酸/辛伐他汀
生产厂家中文参考译名:
美国雅培
生产厂家英文名:
abbott
-------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
SIMCOR (750/20)mg/tab 90 Tabs/bottle
原产地英文药品名:
Niacin/Simvastatin
中文参考商品译名:
SIMCOR (750/20)毫克/片 90片/瓶
中文参考药品译名:
烟酸/辛伐他汀
生产厂家中文参考译名:
美国雅培
生产厂家英文名:
abbott
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