FDA审查有关糖尿病药物文迪雅心血管风险的最新资料，但未提出任何新建议

ST LOUIS (MD Consult) - On February 22, 2010, the US Food and Drug Administration (FDA) announced that it is reviewing the primary data from a large, long-term clinical study known as Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) in regard to possible cardiovascular risks associated with use of Avandia (rosiglitazone), a drug indicated for the treatment of diabetes. In addition, the FDA has been conducting an ongoing review of data from a number of published observational studies in regard to the cardiovascular safety of rosiglitazone. At this time, the FDA has drawn no new conclusions or made any new recommendations about the use of rosiglitazone in the treatment of type 2 diabetes.

The RECORD study findings were published in the June 20, 2009, issue of The Lancet (abstract).

The FDA previously communicated to the public about the possible association between rosiglitazone and increased cardiovascular risk. The agency also sought advice from external experts about this issue at a July 2007 joint meeting of the FDA Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. The RECORD study data represent the only new information from a completed randomized, controlled clinical trial of rosiglitazone received by the FDA since the 2007 announcements.

After the FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010.

When prescribing rosiglitazone, health care professionals are advised to adhere to the recommendations outlined in the drug label. The label includes a Boxed Warning that states that use of rosiglitazone in patients with established New York Heart Association class III or IV heart failure is contraindicated. Furthermore, rosiglitazone is not recommended for patients with symptomatic heart failure. In addition, rosiglitazone causes or exacerbates congestive heart failure in some patients, and prescribers are advised to monitor their patients for the signs and symptoms of heart failure after starting treatment with the drug and after dose increases.

Patients are being advised to continue taking rosiglitazone unless otherwise instructed and are being encouraged to discuss any concerns with their health care professional.

Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. It is also available in combination with other diabetes medications. Combined with metformin, it is sold under the brand name Avandamet, and combined with glimepiride, it is sold under the brand name Avandaryl.

圣路易斯(MD Consult)——2010年2月22日，美国食品药品管理局(FDA)宣布，其正对一项大规模长期临床研究(罗格列酮治疗糖尿病的心血管转归和血糖调节评价研究，RECORD)的初步数据进行审查，以分析与使用糖尿病治疗药物文迪雅(罗格列酮)相关的潜在心血管风险。此外，FDA一直在对诸多已发表的观察性研究中有关罗格列酮心血管安全性的数据进行持续评价。截至目前，FDA未对应用罗格列酮治疗2型糖尿病做出任何新的结论或建议。

RECORD研究结果已于2009年6月20日以摘要形式发表于《柳叶刀》。

FDA此前向公众通报，罗格列酮与心血管风险增加之间可能存在关联。在2007年7月举行的FDA内分泌和代谢药物咨询委员会与药品安全和风险管理咨询委员会联合会议上，FDA还向外部专家征求了意见。RECORD研究数据是FDA自2007年发布通知以来接收的来自已完成的随机对照临床试验的唯一最新资料。

FDA在完成对RECORD研究数据的分析后，将在2010年7月举行的内分泌和代谢药物咨询委员会与药品安全和风险管理咨询委员会联合会议上，公开报告所有有关罗格列酮心血管安全性的现有数据和最新数据。

医学专业人员应遵循药品标签上的建议，进行罗格列酮的处方。标签包含一个黑框警告，提醒禁止应用罗格列酮治疗确诊纽约心脏协会III或IV级心力衰竭的患者。此外，不推荐应用罗格列酮治疗症状性心力衰竭患者。在一些患者中，罗格列酮可引起或加重充血性心力衰竭，因此建议处方医生在治疗开始后及增加用药量后，对患者进行心力衰竭体征和症状方面的监测。

建议患者持续服用罗格列酮，除非医嘱变更。同时，鼓励患者与自己的诊疗医生就任何担忧的问题进行讨论。

商品名为文迪雅的罗格列酮是成分单一的单方制剂。 此外，还有罗格列酮与其他糖尿病药物联合的复方制剂销售。商品名为文达敏的制剂是罗格列酮与二甲双胍的复方制剂。商品名为Avandaryl的制剂是罗格列酮与格列美脲的复方制剂。