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 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。 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。 使用限制: •NIASPAN应在睡前用低脂肪的零食。 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。
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. |
烟酸缓释片Niaspan(Niacin Extended Release Tablets)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 ... 责任编辑:admin |
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