主题：【转帖】FDA解除GSK降糖药文迪雅（Avandia）限制

2型糖尿病是一种可导致严重并发症及过早死亡的疾病，对于某些患者而言，罗格列酮（rosiglitazone）是一种治疗选择，能够改善血糖控制。2型糖尿病患者应继续与其医疗保健专家密切合作，以确定最适合的治疗方案。

在药品上市之后 ，FDA会继续对药物的安全性和疗效进行评估。FDA称，对于含罗格列酮的一类药物而言，此前对有关罗格列酮的一些临床试验（多为短期随机试验）的大型综合性分析数据表明，罗格列酮与心脏病发作风险升高相关。因此，FDA要求了一个名为罗格列酮REMS计划（Rosiglitazone REMS Program）的风险评估和减灾战略（REMS），这一计划限制了罗格列酮药物的使用，以帮助确保这类药物的临床利益大于其风险。

尽管关于罗格列酮药物心血管安全性的一些科学不确定性仍然存在，鉴于对RECORD（Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes）临床试验数据新的再评估结果，FDA的担忧已大大降低，因此，现在需要对罗格列酮REMS计划进行修改。此外，FDA还将需要修改罗格列酮处方信息和患者用药指南，以包含这些新的信息。

根据FDA对罗格列酮REMS计划的修改建议：

--含罗格列酮药物的分销将不再受限制。罗格列酮可结合饮食和锻炼来改善2型糖尿病患者的血糖控制。

--医疗保健专业人员、药店、患者将不再需要加入罗格列酮REMS计划才能开立处方、配药、或获得罗格列酮药物。

--作为REMS的一部分，主办方将确保向有可能处方罗格列酮药物的卫生保健专业人士，提供基于当前关于罗格列酮药物心血管风险科学知识的培训。制造商也将向医疗保健提供者和专业协会发送信件，对开处方人员进行这些新信息的教育。

关于文迪雅（Avandia）：

文迪雅（Avandia）是葛兰素史克（GSK）开发的糖尿病口服药物，其化学通用名称为马来酸罗格列酮片，有效化学成份为马来酸罗格列酮，属噻唑烷二酮类口服抗糖尿病药，为高选择性过氧化物酶体增殖激活受体g(PPARg)的激动剂，通过提高胰岛素敏感性而控制血糖水平，用于治疗2型糖尿病。

关于文迪雅事件：

文迪雅曾是GSK畅销全球的糖尿病口服药物，于2006年上市，在美国的销售额达220亿美元，上市当年全球服用人数超过600万。但该药因罗格列酮潜在的风险存在巨大争议，被撤出欧洲市场，同时FDA于2010年限制了该药在美国的应用

英文原文：FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines

Safety Announcement

[11-25-2013]  The U.S. Food and Drug Administration (FDA) has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea.  As a result, we are requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010.  This decision is based on our review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI). 

Type 2 diabetes is a disease that can lead to serious complications and premature death.  Rosiglitazone is a treatment option that can improve blood sugar control in some patients with the disease. Patients with type 2 diabetes should continue to work closely with their health care professionals to determine treatment options that are most appropriate.

FDA continues to evaluate the safety and effectiveness of drugs after they go on the market.  In the case of rosiglitazone medicines, previous data from a large, combined analysis of mostly short-term, randomized clinical trials of rosiglitazone had suggested an elevated risk of heart attack, so we required a Risk Evaluation and Mitigation Strategy (REMS), called the Rosiglitazone REMS program.  The Rosiglitazone REMS program restricted the use of rosiglitazone medicines to help ensure that their benefits outweighed the risks. 

Although some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines still remains, in light of the new re-evaluation of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, our concern is substantially reduced and the rosiglitazone REMS program requirements will be modified (see Data Summary).  We are also requiring revisions to the rosiglitazone prescribing information and the patient Medication Guide to include this new information.

Under FDA’s proposed modifications to the rosiglitazone REMS program:

Distribution of the medicines will no longer be restricted.  Rosiglitazone may be used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus.

Health care professionals, pharmacies, and patients will no longer be required to enroll in the rosiglitazone REMS program to be able to prescribe, dispense, or receive rosiglitazone medicines.

As part of the REMS, sponsors will ensure that health care professionals who are likely to prescribe rosiglitazone medicines are provided training based on the current state of knowledge concerning the cardiovascular risk of rosiglitazone medicines. Manufacturers will also send Dear Healthcare Provider and Dear Professional Society letters to educate prescribers about the new information.