Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993-0002, USA.
Rev Endocr Metab Disord. 2010 Mar;11(1):21-30. doi: 10.1007/s11154-010-9130-8.
All medications currently approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes mellitus are indicated to improve glycemic control. Since 1995, FDA has used HbA1c as the primary basis for approval of these therapies because a reduction in blood glucose lessens the symptoms of hyperglycemia and lowering of HbA1c has been shown to reduce the risk for some of the chronic complications of diabetes. Despite evidence of clinical benefit with therapies that reduce HbA1c, concerns have been raised that some diabetes medications may increase cardiovascular risk in a patient population that is already vulnerable to cardiovascular disease. Therefore, FDA convened a public advisory committee meeting to discuss the role of cardiovascular assessment in the pre-approval and post-approval settings for medications developed for the treatment of type 2 diabetes. After considering the advisory panel's recommendations and other data, FDA published a guidance document requesting evidence showing that new treatments for type 2 diabetes do not result in an unacceptable increase in cardiovascular risk. This review article begins by summarizing the events leading up to publication of this guidance. Subsequent sections discuss the guidance itself as well as general considerations for implementing the new cardiovascular recommendations. The new approach to developing medications for the treatment of type 2 diabetes will lead to evaluation in patients more representative of those who will use these therapies, if approved, and will help healthcare providers make informed decisions when choosing a medication within the growing treatment armamentarium for type 2 diabetes.
所有目前获得美国食品和药物管理局（FDA）批准用于治疗 2 型糖尿病的药物均被指示可改善血糖控制。自 1995 年以来，FDA 一直将 HbA1c 作为批准这些疗法的主要依据，因为降低血糖可以减轻高血糖的症状，并且降低 HbA1c 已被证明可以降低某些糖尿病慢性并发症的风险。尽管有证据表明降低 HbA1c 的疗法具有临床益处，但有人担心某些糖尿病药物可能会增加已经易患心血管疾病的患者群体的心血管风险。因此，FDA 召集了一次公开咨询委员会会议，讨论心血管评估在用于治疗 2 型糖尿病的药物的批准前和批准后环境中的作用。在考虑了咨询小组的建议和其他数据后，FDA 发布了一份指导文件，要求提供证据表明，用于治疗 2 型糖尿病的新治疗方法不会导致不可接受的心血管风险增加。本文首先总结了导致发布该指南的事件。随后的部分讨论了指南本身以及实施新的心血管建议的一般考虑因素。用于治疗 2 型糖尿病的药物的新开发方法将导致在更能代表那些将使用这些疗法的患者中进行评估，如果获得批准，这将有助于医疗保健提供者在选择治疗 2 型糖尿病的不断增长的治疗武器库中的药物时做出明智的决策。
