美国FDA警告：降糖药可能会增加心脏衰竭的风险
药事网——最专业的药事服务平台，独家可以“听”的药学科普网站，各大三甲医院最富经验的临床医生及临床药师为您答疑解惑，同时与权威媒体合作撰写发表最权威、最靠谱的科普文章！欢迎点击标题下蓝字“药事网”或长按下方二维码免费订阅关注。
药事网的中美合作项目现已正式开启，除了图中的中美药师交流，我们和美国药师一起为您定期推送最新的美国药学资讯，第一时间了解大洋彼岸的"药事"。
DiabetesMedications May Increase Heart Failure Risk, FDA Warns
Ryan Marotta, Assistant Editor
The FDA has announced that it is updating the labels ofseveral type 2 diabetes (T2D) medications to warn patients and providers of anincreased heart failure risk associated with the drugs’ use.
The warning advises prescribers to consider discontinuing dipeptidylpeptidase-4 (DPP-4) inhibitors containing saxagliptin or alogliptin in patientswho develop heart failure.
In April 2015, an FDA advisory committee thatsuch warnings be added to the labels of saxagliptin (Onglyza), saxagliptin andmetformin (Kombiglyze), and alogliptin (Nesina) after studies suggested a linkbetween the use of these drugs and heart failure.
The agency ultimately based its decision on the results of 2 clinical trials inwhich patients who were treated with T2D medications containing eithersaxagliptin or alogliptin were found to be more likely to experience heartfailure than those who received placebo.
In addition to Onglyza, Kombiglyze, and Nesina, other DPP-4 inhibitors, such asalogliptin and metformin (Kazano) and alogliptin and pioglitazone (Oseni), willalso receive a label update.
Patients taking these medications are encouraged to contact their health careproviders immediately if they experience symptoms such as unusual shortness ofbreath, difficulty breathing while lying down, weakness, fatigue, or weightgain with swelling in the ankles, feet, legs, or stomach.
The FDA that the use of DPP-4 inhibitors may also cause severe and disabling joint pain.
美国食品药品监督管理局警告，降糖药可能会增加心脏衰竭的风险
美国食品药品监督管理局（FDA）宣布更新一些2型糖尿病（T2D）的药物标签，以警告医生和患者使用这些药物会使心衰风险增加。
警告建议医生，对于那些有可能心脏衰竭的患者，考虑停止使用包含沙格列汀或阿格列汀的二肽基肽酶-4（DPP-4）抑制剂。
2015年4月，一项研究表明心衰与沙格列汀（商品名：Onglyza），沙格列汀二甲双胍（商品名：kombiglyze）和阿格列汀（商品名：nesina）使用有关，FDA咨询委员会建议将这些警告添加到上述药物的标签中。
个临床试验，这两个试验发现，服用含有沙格列汀或阿格列汀的2型糖尿病患者比服用安慰剂治疗的患者更容易出现心衰。
除了以上三种药物，其他的DPP-4抑制剂，如阿格列汀二甲双胍（商品名：Kazano）和阿格列汀吡格列酮（商品名：Oseni），同样要更新标签。
鼓励服用这些药物的患者如果出现不寻常的呼吸急促、躺下时呼吸困难、虚弱、疲劳或体重增加伴随脚踝、脚、腿或腹部肿胀等症状，则应立即联系他们的医生。
此前FDA曾警告说，DPP-4抑制剂的使用也会造成严重的致残性关节疼痛。
本文翻译：
欢迎在药事网公众号文本框中输入数字
1~30 查阅权威辟谣及精选原创科普
最新咨询请点击