由雅培研发的抗胆固醇复方新药SIMCOR近日获得美国FDA批准上市。该药为缓释烟酸和辛伐他汀的复方药，可全面提高人体内的高密度脂蛋白水平，同时降低低密度脂蛋白水平。
据统计，美国有超过4400万人的高密度脂蛋白水平较低，8000万人有低密度脂蛋白水平过高的现象。
根据美国心脏协会、美国国家胆固醇教育规划(NCEP)以及美国心脏病学会的建议：因为低密度脂蛋白一旦过量，将在血管中积聚并导致血管堵塞，易引起心脏疾病。所以,可通过对高密度脂蛋白的干预来预防心脏疾病。根据NCEP指南，每提高1%的高密度脂蛋白水平，就能降低2%患心脏病的几率；同时每降低1%的低密度脂蛋白水平，也能降低1%患心脏病的几率。

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500 mg/20 mg/片，750 mg/20 mg/片，1 000 mg/20 mg/片。

美国FDA批准本品上市是基于纳入641例混合型脂质代谢障碍血症和Ⅱ型高脂血症的随机双盲国际多中心临床研究的安全性和有效性数据。在临床研究中，服用复方缓释烟酸/辛伐他汀1 000 mg/20 mg片的患者较单独服用辛伐他汀片20 mg的患者显著降低了血胆固醇。以复方缓释烟酸/辛伐他汀片1 000 mg/20 mg治疗的患者还较单独服用辛伐他汀片20 mg为基础治疗的患者改善了血脂：降低LDL分别为12％和7％；增加HDL分别为21％和8％；降低甘油三酯分别为27％和15％。

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。

1.药品名称：复方烟酸辛伐他汀缓释片
2.注册分类：化药3.2类
3. 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
4. 用法用量：口服。每日一次，每次一片。睡前服用。
5. 适 应 症：原发性高胆固醇血症和混合血脂异常。
6.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。

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 500/20

Indication(s):

Adjunct to diet in primary hypercholesterolemia, mixed dyslipidemia, and hypertriglyceridemia if monotherapy is inadequate.

Pharmacology:

Simcor combines the HMG-CoA reductase inhibitor, simvastatin, and the nicotinic acid derivative, extended-release niacin (Niaspan, also from Abbott).

Clinical Trials:

Simcor was compared to simvastatin 20mg and 80mg in 641 patients with type II hyperlipidemia or mixed dyslipidemia in a 24-week study. Group A included those with elevated non-HDL levels who had been taking simvastatin 20mg; these patients were randomized to either Simcor 1000/20, Simcor 2000/20, or simvastatin 20mg. The non-HDL-C lowering with Simcor 2000/20 and 1000/20 was significantly greater than that achieved with simvastatin 20mg.

Legal Classification:

Rx

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. Retitrate if therapy interrupted ≥7 days. To reduce flushing, pretreat with aspirin or an NSAID.

Children:

Not recommended.

Contraindication(s):

Active liver or peptic ulcer disease. Unexplained persistent elevated transaminases. Arterial bleeding. Pregnancy (Cat.X). Nursing mothers.

Warnings/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.

Interaction(s):

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 Reaction(s):

Flushing, headache, pruritus, GI upset, back pain; elevated ALT/AST, myopathy, rhabdomyolysis with renal failure.

How Supplied:

Tabs—90

Last Updated:

1/15/2009

Manufacturer:

Abbott Laboratories

Pharmacological Class:

Nicotinic acid deriv. + HMG-CoA reductase inhibitor

Active Ingredient(s):

Niacin ext-rel 500mg, simvastatin 20mg; tabs.

Also:

SIMCOR 750/20
Niacin ext-rel 750mg, simvastatin 20mg; tabs.

SIMCOR 1000/20
Niacin ext-rel 1000mg, simvastatin 20mg; tabs

原产地英文商品名:
SIMCOR (1000/40)mg/tab 90tabs/bottle
原产地英文药品名:
Niacin/Simvastatin
中文参考商品译名:
SIMCOR (1000/40)毫克/片 90片/瓶
中文参考药品译名:
复方烟酸/辛伐他汀缓释片
生产厂家中文参考译名:
美国雅培
生产厂家英文名:
abbott