商品名称：QSYMIA 通用名称：PHENTERMINE; TOPIRAMATE(苯丁胺+托吡酯) 生产厂家：VIVUS 规格：3.75MG/23MG;7.5MG/46MG ;11.25MG/69MG;15MG/92MG 剂型:缓释胶囊 Qsymia药物此前已经获得广大医师的推荐，被誉为最安全的减肥药物。 Manufacturer: Vivus, Inc. Pharmacological Class: Sympathomimetic amine + antiepileptic. Active Ingredient(s): Phentermine HCl/topiramate extended-release; 3.75mg/23mg, 7.5mg/46mg, 11.25mg/69mg, 15mg/92mg; caps. Indication(s): As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30kg/m2 or ≥27kg/m2 in the presence of at least one weight related co-morbidity (eg, hypertension, type 2 diabetes, or dyslipidemia. Pharmacology: The effect of phentermine on chronic weight management is likely mediated by release of catecholamines in the hypothalamus, resulting in reduced appetite and decreased food consumption, but other metabolic effects may also be involved. The effect of topiramate may be due to its effects on both appetite suppression and satiety enhancement, induced by a combination of pharmacologic effects including augmenting the activity of the neurotransmitter gamma-aminobutyrate, modulation of voltage-gated ion channels, inhibition of AMPA/kainite excitatory glutamate receptors, or inhibition of carbonic anhydrase. Clinical Trials: The effect of Qsymia was studied in two trials in obese patients (Study 1) and in obese and overweight patients with two or more significant co-morbidities (Study 2). After 1 year of Qsymia treatment, all dose levels resulted in statistically significant weight loss compared to placebo. A statistically significant greater proportion of the patients randomized to Qsymia than placebo achieved 5% and 10% weight loss. Legal Classification: CIV Adults: Take once daily in the AM. Initially 3.75mg/23mg for 14 days; then increase to 7.5mg/46mg and evaluate weight loss after 12 weeks on this dose. If patient has not lost ≥3% baseline body weight, discontinue or escalate dose. To escalate dose: increase to 11.25mg/69mg for 14 days, then increase to 15mg/92mg and evaluate weight loss after additional 12 weeks at this dose. If patient has not lost ≥5% baseline body weight, discontinue by taking a dose every other day for at least 1 week prior to stopping altogether. Qsymia 3.75mg/23mg and 11.25mg/69mg strengths are for titration purposes only. Renal (moderate or severe), hepatic (moderate) impairment: max 7.5mg/46mg once daily. Children: <18yrs: not established. Contraindication(s): Pregnancy (Cat. X). Glaucoma. Hyperthyroidism. Within 14 days of MAOIs. Warnings/Precautions: May cause fetal harm; obtain negative pregnancy test before starting and monthly thereafter; use effective contraception. ESRD on dialysis, severe hepatic impairment: avoid. Recent or unstable cardiac or cerebrovascular disease: not recommended. Measure resting heart rate regularly. History of suicidal attempts or active suicidal ideation: avoid. Monitor for worsening of depression, suicidal thoughts, unusual behaviors. Depression. Sleep disorders. Measure electrolytes including serum bicarbonate, potassium, creatinine, blood glucose (in diabetics), BP (in patients on antihypertensives) prior to starting and during therapy. Avoid abrupt withdrawal (seizure risk). Monitor for decreased sweating and increased body temperature during physical activity. Nursing mothers: not recommended. Interaction(s): See Contraindications. Avoid alcohol. May potentiate CNS depression with concomitant other CNS depressants (eg, barbiturates, benzodiazepines, hypnotics). Avoid other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, methazolamide). Increased risk of hypokalemia with concomitant non-K+-sparing diuretics (eg, furosemide, HCTZ). May be antagonized by phenytoin, carbamazepine. Hyperammonemia w/wo encephalopathy with concomitant valproic acid. May affect oral contraceptives (spotting may occur). Adverse Reaction(s): Paraesthesia, dizziness, dysgeusia, insomnia, constipation, dry mouth; acute myopia and secondary angle closure glaucoma (discontinue if occurs), cognitive dysfunction, metabolic acidosis, increased serum creatinine, kidney stones, oligohidrosis, hyperthermia. How Supplied: Caps 3.75mg/23mg—14, 30; 7.5mg/46mg, 11.25mg/69mg, 15mg/92mg—30 Last Updated: 10/1/2012 美国药监局在批准文书中指出，Qsymia药物适用于那些肥胖症成年人群，尤其是患有至少一种肥胖症综合症如高血压，糖尿病以及高胆固醇的患者。 药监局称，维福斯制药公司对该药物展开的两项临床试验中，患者在服用长达一年的Qsymia药物之后，分别减轻了6.7%和8.9%的体重，这比此前刚批准上市的两种减肥药效果更胜一筹。 尽管Qsymia药物的临床药效甚佳，但是却不算是医学界的创新突破，该药物的研发技术等方面依然没有任何创新之处。据维福斯制药公司表示，Qsymia药物只是两种老减肥药的结合，这两种老减肥药分别是芬特明(phentermine)以及topirimate。芬特明(phentermine)是一种可以抑制人体食欲的兴奋剂，适合短期内的迅速减肥。Topirimate药物则属于抗痉挛药，是由强生制药公司以Topamax作为商品名上市销售的，患者在服用这种药物之后，会产生很强的饱腹感。 研究人员表示，维福斯制药公司此次研发的Qsymia药物主要作用于人脑的多个信号中心，这些信号通常控制的是人的食欲。 　　 近期，已经有两种减肥药先后获批上市销售，六月份时，阿瑞娜制药公司的Belviq减肥药丸获批上市。据悉1999年起，美国食品和药物监管局就再也没有批准任何一种减肥药上市。 美国境内的肥胖症患者比率高达35%，而且依然保持稳步增长的趋势，因此很多医师向药监局提出申请，希望药监局尽快批准合格的减肥药上市销售，并称当前市场上的很多处方类减肥药会产生诸多不良副作用，尤其影响心脏健康。 1997年市场热销的芬—芬(节食药)在销售过程中被发现会导致心脏瓣膜损伤。当时，鸡尾酒疗法非常盛行，鸡尾酒疗法就是将苯丁胺(phentermine)同氟苯丙胺(fenfluramine)进行混合服用，但是该种疗法并未得到药监局批准，最终氟苯丙胺(fenfluramine)也被迫停止销售。 随后的数年里，陆续有数种减肥药被检查出可以导致各种副作用。2010年，雅培制药公司的减肥药诺美婷(Meridia)被叫停，主要是因为有研究表明该药物可增加心脏病的发病率以及中风。 2010年，维福斯制药公司首次向美国药监局提交该减肥新药的上市申请但是遭到拒绝，遭拒原因是孕妇在服用该药物之后，出生的婴儿会存在天生缺陷。本周二时，药监局特别制定了一个风险管理计划，主要针对的是孕妇群体，希望该计划可以将风险降低至最小值。药监局指出，育龄女性在服用该药物之前应该先进行怀孕测试，怀孕期间，每月都要进行孕期检查。 药监局还指出，由于该药物对心脏影响程度依然未知，因此那些近期患有心脏病或者是中风的患者不宜服用该药物，维福斯制药公司将会展开深层试验，审查该减肥新药对心脏的影响。 医药行业市场经济分析师表示，预计截止至2016年，该药物的市场销售总额或将高达10亿美元。维福斯制药公司表示，预计今年最后一个季度就将在市场上开售Qsymia药物，但是销售伊始，规模不会很大，公司的销售人员仅仅保持在150名左右，而且该药物最初的销售对象并不是一般的医师，而是肥胖症研究专家。 起初，维福斯制药公司计划以Qnexa为减肥新药的商品名，但是美国药监局拒绝了该申请，表示Qnexa的发音与另外一种药物发音十分相似，容易造成后期冲突。 据悉，总部位于圣地亚哥地区的阿瑞娜生物制药公司计划2013年早期开售减肥新药Belviq。加州Orexigen治疗剂公司的减肥新药Contrave已经进入到临床试验阶段，预计将于2014年提交药物上市申请。