FDA解除对文迪雅的使用及处方限制
出自识林
FDA解除对文迪雅的使用及处方限制
笔记 2013-11-27 FDA FDA解除对文迪雅的使用及处方限制 11月25日，FDA官网发布声明，宣布解除对罗格列酮（商品名：文迪雅）使用及处方的某些限制。这一行动与专家咨询委员会的建议一致，反映了对这种药品心血管风险的最新信息。 FDA在声明中指出，来自于旨在评价罗格列酮心血管病结果和糖尿病中糖血症的RECORD临床试验显示，与多种糖尿病标准疗法治疗药品相比，使用罗格列酮治疗的患者心脏病发作和死亡并未增加。从该临床试验中得出的数据，并未确认2007年首次报道的对多个临床试验的荟萃分析显示的心脏病发作风险增加的迹象。 FDA药品审评与中心主任Janet Woodcock博士表示，FDA采取的行动反映了对罗格列酮风险与获益的最新科学认识。 FDA采取的行动包括修改标签说明中有关心血管病安全性的内容，对风险评价与降低策略（REMS）计划的变更，放松上市后研究要求。 这些修改最终落实之后，罗格列酮的使用将不再限制于某些患者。FDA希望，新的适应症将声明，配合饮食和运动使用罗格列酮,可改善2型糖尿病患者的血糖控制。要求罗格列酮的生产厂家，依据现有的与这类药品心血管风险的相关知识，确保对可能处方罗格列酮的医护人员开展培训。 FDA还取消了要求开展评价维生素D联用的噻唑烷二酮药品的临床试验（TIDE），对比文迪雅与Actos（吡格列酮）的要求。FDA得出结论认为，不再需要该临床试验。 除文迪雅之外，目前市场上还有罗格列酮与二甲双胍（商品名文达敏，Avandamet）和与格列美脲（Avandaryl）的复方制剂销售。 GSK公司表述将与FDA合作修改标签说明。 纽约西奈山糖尿病中心主任 Robert Tamler博士表示，FDA的决定对临床实践无关紧要。2007年以来，患者就一直接触到文迪雅增加心血管风险的信息，尽管FDA作出决定，但患者对文迪雅安全性的忧虑难以立刻消除。 识林-Kapok 2013-11-27 FDA requires removal of certain restrictions on the diabetes drug Avandia The U.S. Food and Drug Administration today announced it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine. Today’s actions are consistent with the recommendations of expert advisory committees. Results from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) clinical trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared to standard-of-care diabetes drugs. These data do not confirm the signal of increased risk of heart attacks that was found in a meta-analysis of clinical trials first reported in 2007. “Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions.” The FDA's actions include requiring modifications to labeling about cardiovascular safety, requiring changes to the Risk Evaluation and Mitigation Strategy (REMS) program, and releasing a postmarket study requirement. Once the changes are final, rosiglitazone's indication for use will no longer be limited to certain patients. The FDA anticipates that the new indication will state that the drug may be used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus, an indication similar to other diabetes drugs currently available. Once the changes to the REMS are finalized, health care professionals, pharmacists, and patients will no longer be required to enroll in the rosiglitazone REMS program to prescribe, dispense, or receive rosiglitazone medicines. Patients will also be able to receive rosiglitazone through regular retail pharmacies and mail order pharmacies. The manufacturers of rosiglitazone drugs will be required to ensure that health care providers who are likely to prescribe rosiglitazone-containing medicines are provided training based on the current state of knowledge concerning the cardiovascular risk of these medicines. The FDA is also releasing GlaxoSmithKline (GSK) from the postmarket requirement to conduct a clinical trial, known as Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE), comparing Avandia to Actos (pioglitazone), the only other approved drug in the thiazolidinedione class, and to standard diabetes drugs. The FDA has concluded that this trial is no longer necessary or feasible. In 2010, in response to data from a meta-analysis of placebo-controlled randomized trials that suggested an elevated risk of cardiovascular events in association with rosiglitazone use, the FDA announced it would restrict the drug to use in patients with type 2 diabetes who could not control their diabetes on other medications. The FDA also required GSK to convene an independent group of scientists to readjudicate key aspects of RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs to provide clarity about the integrity of the study findings. On June 5 and 6, 2013, the readjudicated results of RECORD, which were consistent with the original findings of the trial, were discussed at a joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Committee members generally agreed that the readjudication was well conducted and provided reassurance that the original study findings were accurate. A majority of the committee members voted to recommend that the REMS for rosiglitazone be eliminated or modified to lessen restrictions to use. In addition to Avandia, rosiglitazone is available in combination with other diabetes medications, including metformin under the brand name Avandamet and glimepiride under the brand name Avandaryl. For more information:
原文请见 FDA requires removal of certain restrictions on the diabetes drug Avandia |