FDA committee urges tight restrictions on rosiglitazone

Bob Roehr

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FDA committee urges tight restrictions on rosiglitazone

机译：食品和药品管理局委员会敦促严格限制罗格列酮

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An advisory committee to the US Food and Drug Administration has recommended further restrictions on the drug rosiglitazone (Avandia), used to control type 2 diabetes. The decision came after two days of intense hearings on 13-14 July, outside Washington, DC.There was no question about the effectiveness of the widely prescribed drug, but a trail of evidence indicated that long term use increased the risk of cardiovascular disease. The meeting focused on the quality of that evidence and the comparative merits of randomised controlled trials, observational studies, and a meta-analysis. A consensus emerged that the data probably did indicate that rosiglitazone increased the risk of cardiovascular disease, possibly more so than did use of pioglitazone, a drug in the same class, the thiazolidinediones. But others at the meeting expressed concern that they might be seeing a long term class effect that showed up with rosiglitazone because it was first to come on the market and that there are several more years of data on pioglitazone that are not yet available.

机译：美国食品和药物的咨询委员会政府建议进一步限制药物罗格列酮(文迪雅),用于控制2型糖尿病。13 - 14日之后两天的听证会7月,在华盛顿特区。关于广泛的有效性问题处方药物,但是证据的踪迹表明,长期使用增加了风险的心血管疾病。证据的质量和比较的随机对照试验,观察性研究和荟萃分析。的共识是可能的数据表明罗格列酮增加的风险心血管疾病,可能比使用吡格列酮,一种药物在同一类中,thiazolidinediones。表示担心,他们可能会看到长期类效果显示罗格列酮,因为它是第一个来的市场,有好几年吡格列酮的数据尚未公布。

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《BMJ: British medical journal》 |2010年第7765期|171-171|共1页
作者
Bob Roehr;
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正文语种英语
中图分类医药、卫生;
关键词
Advisory Committees; rosiglitazone; Drug PrescribingUnited States Food and Drug Administrationpioglitazonetrail;

机译：咨询委员会,罗格列酮;药物PrescribingUnited国家食品和药物Administrationpioglitazonetrail;

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FDA committee urges tight restrictions on rosiglitazone

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