但同时以22 - 1的投票结果认为文迪雅应该继续上市。
目的探讨马来酸罗格列酮(文迪雅)对2型糖尿病的临床疗效。
Objective To investigate clinical curative effect of rosiglitazone maleate (Avandia) in treating type 2 diabetes.
上周,由于担心造成心肌梗塞及其他的心血管风险,欧洲禁止了文迪雅的上市。
Last week, Europe banned Avandia because of the concern about the risk of myocardial infarction and other cardiovascular risk.
研究人员指出,文迪雅的使用不是随意规定,而是由医生自行决定。
The researchers noted that Avandia was not randomly prescribed but left to the discretion of individual physicians.
FDA忠告医保提供者,对服用文迪雅的病人,严密监测心血管的危险。
FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.
一些专家力促文迪雅标注“黑框警告”——处方药标识中最严重的一种警告。
Some urged a "black box" warning on Avandia, the strongest type of warning for prescription drugs.
全球数百万的糖尿病患者服用文迪雅,文迪雅是葛兰素史克第二大畅销药物。
Millions of diabetics around the world take avandia, glaxo 's second - best - selling drug.
疯狂的反文迪雅媒体恐吓病人离开这些药物,而没有确切证明其潜在的危险。
Because it kicks off just the kind of anti-Avandia media frenzy that frightens patients off their meds, without real substantiation of the potential danger.
全球数百万的糖尿病患者服用文迪雅,文迪雅是葛兰素史克第二大畅销药物。
Millions of diabetics around the world take Avandia, Glaxo's second-best-selling drug.
对尼森2007年的研究结果,FDA还要求文迪雅增加标签警语,但并没有要求其撤市。
After Nissen's 2007 study, the FDA added a warning label to Avandia, but decided to leave it on the market.
该研究由美国国立卫生研究院以及葛兰素史克公司—文迪雅制造商提供资助资金。
The study was funded by the U. S. National Institutes of Health as well as GlaxoSmithKline, which makes Avandia.
本研究的目的是CSII联合文迪雅强化治疗初诊2型糖尿病以评价其临床疗效。
The purpose of this study was to evaluate the effect of short-term continuously subcutaneous insulin infusion (CSII) combined with Rosiglitazone on newly diagnosed type 2 diabetic patients.
尽管委员会没有发布文迪雅的召回令,为了保护消费者,FDA仍然可能决定召回。
Although the committee did not call for a recall of Avandia, the FDA may still decide to do so despite to protect consumers.
FDA顾问上个月说,这个危险确实出现,但是将文迪雅撤出市场,证据还不充足。
FDA advisers said last month the risk appeared real but that the evidence wasn't conclusive enough to merit pulling Avandia from the market.
如果没有首先与您的医生商量此新的安全信息,不要停止服用文迪雅,文迪锐或文迪美。
Do not stop taking Avandia, Avandaryl or Avandamet without first talking to your doctor about this new information.
大多数美国食品药物管理局专家建议有争议的治疗糖尿病药“文迪雅”(商品名:文迪雅;
The majority of advisers to the Food and Drug Administration are recommending the controversial diabetes drug of Avandia stay on the market.
他们建议文迪雅的最新的标签,要包括这一危险信息,FDA称,他们将继续关注这一事件。
They did recommend Avandia's label be updated to include information on that risk. The FDA said it was continuing its review of the issue.
文迪雅在动脉斑块的第二个检测项目中的确表现出了明显的优势,但这并不是测试的主要结果。
Avandia did show a significant advantage in a second measure of artery plaque, but this was not the main result being tested.
此次会议后五天,新英格兰医学杂志发表了一项研究结果,发现文迪雅使心脏病风险升高43%。
The meeting came five days before a study was printed in the New England Journal of Medicine that found that Avandia carried a 43% increased risk of heart attack.
上月,新英格兰医学杂志发表文章认为文迪雅增加了心肌梗死的风险,GSK公司股票旋即大跌。
The company's stock fell sharply last month, after the New England Journal of Medicine published an analysis suggesting that Avandia increases the risk of heart attack.
FDA声明,医疗服务提供者和患者必须纳入文迪雅-罗格列酮药品方问计划,以处方和接收罗格列酮。
"Healthcare providers and patients must be enrolled in the Avandia-Rosiglitazone medicines Access Program in order to prescribe and receive rosiglitazone medicines," the FDA statement says.
现在-当委员会因葛兰素史克药物文迪雅的辩论分开他们的投票发生时-就到了茶叶阅读开始行动时间了!
And now - as happened when the panel split its vote on GlaxoSmithKline's diabetes drug Avandia - it's time for the tea leaf reading to commence!
《美国医学会杂志》的研究减缓了上述总量的恐惧,因为研究结果认为爱妥糖较之文迪雅在有效降低血糖方面更安全。
The JAMA study could ease these fears because it suggests that Actos is safer than Avandia but just as effective at lowering blood sugar.
该机构批准该药物上市的其他官员告诉顾问团他们当时不确定文迪雅的风险有多大并寻求专家顾问团的建议。
Other officials in the division that approves drugs for sale told the panel they were unsure how risky Avandia was and were seeking the panel's advice.
葛兰素史克面临的是13,000件关于文迪雅的法律诉讼,起诉该公司未履行该药的心脏病风险警示义务。
GlaxoSmithKline faced about 13,000 Avandia lawsuits filed by plaintiffs who accuse the company of failing to warn patients that of Avandia heart attack risks.
目的观察马来酸罗格列酮(商品名文迪雅)与胰岛素合用治疗2型糖尿病(T 2DM)的临床疗效和安全性。
OBJECTIVE To observe the clinical therapeutic effects and safety in the treatment of type 2 diabetes mellitus(T2DM) with Avandia and Insulin.
欧洲药物安全机构也表示,在其决定文迪雅最新标志前,该药不能用于有心脏事件或有类似心绞痛情况的人群。
The European Medicines Agency also said in its decision to update Avandia's label that the drug must not be used by people having a heart attack or with conditions such as angina.
拉响糖尿病治疗药物-文迪雅风险警报的知名心脏病学家声称,FDA高层发言人针对其策划了一场诋毁活动。
The prominent cardiologist sounding alarms about the diabetes drug Avandia claims he is the target of a smear campaign organized by a top Food and Drug Administration (FDA) spokesman.
我们希望这些研究公开发表在同行公认的期刊上,这样医生和病人就可以得到文迪雅的全部心血管安全性的信息。
We would like to see those analyses published in peer-reviewed journals so that the totality of information on the cardiovascular safety of Avandia is available to doctors and patients.
我们希望这些研究公开发表在同行公认的期刊上,这样医生和病人就可以得到文迪雅的全部心血管安全性的信息。
We would like to see those analyses published in peer-reviewed journals so that the totality of information on the cardiovascular safety of Avandia is available to doctors and patients.
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