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烟酸缓释片Niaspan(Niacin Extended Release Tablets)

2012-12-26 18:56:55  作者:新特药房  来源:互联网  浏览次数:518  文字大小:【】【】【
简介: 英文药名: Niaspan(Niacin Extended Release Tablets) 中文药名: 烟酸缓释片 生产厂家: Sepracor Inc. 药品介绍烟酸是B属维生素之一,与烟酰胺统称为“维生素PP”,多存于肝脏、肉类、米糖、酵母、番 ...

英文药名: Niaspan(Niacin Extended Release Tablets)

中文药名: 烟酸缓释片

生产厂家: Sepracor Inc.

药品介绍
烟酸是B属维生素之一,与烟酰胺统称为“维生素PP”,多存于肝脏、肉类、米糖、酵母、番茄、鱼等中,现多用其人工合成品。烟酸在体内变为烟酰胺,后者是 辅酶I和辅酶II的组成部分,参与体内生物氧化过程,缺乏时产生糙皮病,其症状包括皮炎、舌炎、食欲不振、烦躁失眠、感觉异常等。烟酸在临床上可用于治疗糙皮病。
烟酸还有较强的周围血管扩张作用,口服后数分钟即见效,可维持数分钟至1小时,用于治疗血管性偏头痛、头痛、脑动脉血栓形成、肺栓塞、内耳眩晕症、冻伤、中心性视网膜脉络膜炎等。
大剂量可降低血脂(主要是甘油三酯),适用于II、III、IV、V型高脂血症患者。
烟酸是最早上市的一种降血脂药,它能够显著改善所有的主要血脂成分,包括高密度脂蛋白(HDL),使它们恢复正常。烟酸用于减少各种脂质成分,包括对初期血胆固醇过高和混合型脂血障碍(IIa型和IIb型)、成年患者偏高的总胆固醇、脱辅基蛋白B和甘油三酯,并可作为饮食的辅助药物以降低脂类。
但烟酸由于它的两个常见副作用,即潮红和肝毒性,现已几乎没有用在血脂控制上。避免或降低烟酸副作用的方法是采用缓释制剂,药物的缓慢释放降低并延长了血药浓度因而最大限度地减少了副作用。

目前国外已研制开发几种缓释制剂,如;美国Kos制药公司研制的烟酸缓释片(Niaspan),Innovite公司的烟酸缓释片(Enduraic),以及Roche-Poulenc Rorer公司的烟酸胶囊(Nicobid)。 其中KOS公司研制的烟酸缓释片,应在低脂肪小吃后睡前服用,剂量根据个人情况而定。开始服药采用NITE系统(即烟酸在傍晚)选择剂量的起始包装,内装21天药量,推荐维持剂量为每天1000mg至2000mg,睡前服用。因人体内大部分胆固醇的合成是在夜间,特别是在人属于睡眠状态时。饭后给药并一天三次的给药方案将造成当体内胆固醇和甘油三脂达到峰值时被释放并提供有效的降血脂量。因而选择晚间给药比日间给药能起到更有效的降血脂作用,并且晚间给药只需要服用更少量的烟酸。能最大限度减少面部潮红以及肝毒性副反应,Niaspan能降低有心肌梗塞和高胆固醇血症病史的患者非致命心肌梗塞复民的风险。在与胆汁结合树脂共用时,能延缓动脉粥样硬化过程或促进其缓解软化。烟酸能减少心脏病的复发,并能减缓或改善动脉粥样硬化的作用可作为长期服用烟酸的副疗效,并且心肌梗塞列为Niaspan适应症之一已得到了FDA的认可。
与他汀类相比,烟酸降低总胆固醇和低密度脂蛋白(LDL)效力是他汀类的一半,但烟酸升高高密度脂蛋白(HDL)的效力是他汀类的近3倍,降低甘油三酯为1.5倍。烟酸还显示能够降低Lp(a)水平,近期已被列为“确实有害的胆固醇”。
因此烟酸是非常有吸引力的起始药物,尤其对于护理保健,用他汀类药对病人开始治疗太昂贵了。

长效烟酸治疗混合型脂质紊乱病人也是有价值的,也可用作吉非贝齐的替代品,因它对所有脂质都有广泛作用而且较少胃肠道副作用。 心血管疾病是一类严重危害人类身体健康的疾病,目前心血管疾病已成为第一死亡原因。随着肥胖人口剧增,高脂血症也成为突出的一种心血管疾病,烟酸缓释征的出现将为患者提供一种价格低廉、副作用少的降血脂药。

药理特点:作用平缓,降低普通制剂的副作用。

NIASPAN(烟酸缓释)片剂,薄膜包衣,缓释口服使用。

美国首次批准:1997   公司:雅培公司

NIASPAN包含延长释放烟酸(烟碱酸)

•为降低升高的TC,LDL-C,载脂蛋白B和甘油三酯,增加HDL-C在原发性高脂血症和混合性高血脂患者。
•在与辛伐他汀或洛伐他汀的组合。治疗原发性高脂血症和混合性高血脂NIASPAN,辛伐他汀,洛伐他汀单药治疗被认为是治疗不足。
为了减少风险复发性的非致命性心肌梗死患者心肌梗死和高脂血症的历史。
•在与胆汁酸结合树脂的组合:
◦减缓恶化或,促进回归与冠状动脉疾病(CAD)和高脂血症病史的患者的动脉粥样硬化性疾病。
◦作为一种辅助手段在成人原发性高脂血症患者的饮食,以降低升高的TC和LDL-C。
•为降低TG严重的高甘油三酯血症的成年患者。

使用限制:
没有增量利益并用NIASPAN与辛伐他汀或洛伐他汀对心血管疾病的发病率和死亡率及以上的证明烟酸,辛伐他汀和洛伐他汀单药治疗,已建立。

•NIASPAN应在睡前用低脂肪的零食。
•剂量范围:500毫克至2000毫克,每天一次。
•治疗与NIASPAN必须在500 mg发起在就寝时间,以减少副作用的发生率和严重程度的早期治疗的过程中可能发生的,并且不应该被增加超过500毫克在任何4周期间。
维持剂量:1000〜2000毫克,每天一次。
•剂量大于2000毫克,每日不推荐
合并治疗与洛伐他汀洛伐他汀的初始剂量为20毫克,每日一次; NIASPAN和洛伐他汀联合治疗不应超过每天2000毫克和40毫克的剂量,分别为;
•同时与辛伐他汀治疗:辛伐他汀的起始剂量是20毫克,每日一次; NIASPAN与辛伐他汀联合治疗不应超过每天2000毫克和40毫克的剂量,分别为;
薄膜包衣片Unscored口服:500,750和1000毫克烟酸缓释型。

活动性肝脏疾病,其中可能包括不明原因的肝转氨酶水平持续升高。
•活动性消化性溃疡病。
•动脉出血。
•已知过敏的产品组件。
•严重的肝毒性发生在患者立即释放在同等剂量的烟酸缓释烟酸代。
•肌病患者服用NIASPAN,洛伐他汀或辛伐他汀与NIASPAN并用的,特别是在老年患者及患有糖尿病,肾功能​​衰竭,或无法控制的甲状腺功能减退症,肌病和横纹肌溶解症的风险增加。
•肝酶异常和监控:在肝转氨酶持续升高可发生前和在治疗过程中监测肝酶。
请谨慎使用,在不稳定型心绞痛患者在急性期的MI。
•NIASPAN可以提高血糖水平,糖尿病或潜在的糖尿病患者进行密切监测血糖水平,尤其是在最初几个月的使用或调整剂量。
最常见的不良反应(发生率> 5%和大于安慰剂)冲洗,腹泻,恶心,呕吐,咳嗽加重,皮肤瘙痒症。
皮肤潮红,可降低频率和严重程度与阿司匹林预处理(NIASPAN剂量前30分钟服用325毫克的推荐剂量)。
报告疑似不良反应,请联系雅培公司在1-800-633-9110或FDA在1-800-FDA-1088或www.fda.gov / medwatch。
•他汀类药物的注意事项。处方时,应使用烟酸与他汀类药物,因为这些药物可以增加肌病/横纹肌溶解症的风险。
胆汁酸螯合剂。胆汁酸螯合剂具有较高的烟酸结合的能力,并应采取至少4-6小时前NIASPAN管理。
•肾功能损害:肾功能不全的患者应谨慎使用NIASPAN。
肝功能损害。NIASPAN是禁忌的活动性肝病或的重大或原因不明的肝功能障碍或无法解释的血清转氨酶升高。

 
Abbott Labs' cholesterol drug Niaspan is growing prescription share nicely after a clinical trial highlighted its potential as part of a one-two punch in reducing plaque. Now, the company says, it is considering how best to capitalize on the data.
The study, known as ARBITER 6-HALTS, looked at the effects of treatment with Niaspan plus a statin to reduce plaque build-up, or atherosclerosis. Niaspan, an extended-release form of niacin, is indicated to raise HDL cholesterol and lower LDL cholesterol and triglycerides, but is not approved to promote regression of atherosclerosis in combination with a statin.
That could mean Abbott's options for touting results to patients are limited at present. “Abbott is not promoting the HALTS data as these data are not in the Niaspan label,” said a spokesperson. “At this point, we're reviewing the data and determining what our next steps might be."
The ability to add a discussion of HALTS study results to Niaspan's label could boost US sales of the drug, which totaled $601 million through the first nine months of 2009, a 6% increase over the first nine months of 2008.
Niaspan, which is indicated to slow atherosclerosis in combination with an older class of lipid medications known as bile acid binding resins, is also one component of another Abbott drug, Simcor. This product combines extended-release niacin with the statin simvastatin, the active ingredient in Merck's off-patent drug Zocor and one of the statins given to subjects in the HALTS research.
On the professional side, drug company sales reps can distribute reprints of journal articles on off-label uses for drugs, as long as they refrain from discussing the findings during meetings with doctors, according to guidance issued by FDA in 2008. In response to a question about its sales-force activity, Abbott declined to comment.
While Abbott ponders whether to apply for formal approval to expand the Niaspan label, medical practice may already be changing. As previously reported in MM&M, new prescriptions for Niaspan (including those for new patients, switches and add-ons) rose by 31%, when comparing prescribing trends for the week ending Nov. 13 (just prior to appearance of the study in the New England Journal of Medicine) to Rx trends for the week ending Dec. 11, according to SDI.
Companies tend to initiate new clinical trials to evolve the profile of marketed drugs. Once cleared by regulators, labeling changes can prompt changes in strategy or even new marketing campaigns.
After it received approval to slow regression of atherosclerosis, based on a trial called METEOR, Abbott's competitor in the cardiovascular space AstraZeneca launched “Us Against Athero,” a campaign which used branded and unbranded advertising to communicate statin drug Crestor's ability to counter atherosclerosis and raise awareness of the disease. The claim was added to the brand's LDL-lowering, HDL-raising message.
And last year AstraZeneca applied for approval to broaden Crestor's label again, this time based on a study called JUPITER, to reduce the risk of cardiovascular events among patients with normal cholesterol levels and elevated C-reactive protein levels. In December, an FDA advisory panel voted 12 yes, four no, and one abstention to allow the new indication.
A supplemental new indication would bring Crestor's label more in line with that of rival statin Lipitor, Pfizer's best-selling drug, which is already approved to prevent heart attacks and strokes. In 2004, Pfizer honed its sales message to emphasize more aggressive cholesterol targets following the National Cholesterol Education Program's statement (not a guideline) that those at very high cardiovascular risk “consider” an LDL-C less than 70 mg./dl. Prior to that, the panel had recommended those with established vascular disease or type II diabetes to aim for below 100.
In the case of HALTS, the study found that Niaspan did a better job than Merck's ezetimibe at lessening atherosclerosis. Because atherosclerosis can heighten risk of heart attacks, the trial cast HDL-raising as a favorable strategy in the fight against cardiovascular disease.

责任编辑:admin


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