这份来自信息公司AdverseEvents的报告分析了11款新药的数据，然后对于哪些药物最安全及哪些药物会经得起考验得出一些结论。在备受关注的GLP-1受体激动剂与DPP-4抑制剂药物类别中，发现结果最好的是艾塞那肽，最有问题的是阿格列汀。
AdverseEvents通过最初分析FDA不良事件报告系统(FAERS)的数据得出这些结论。该公司然后着眼于疑似病例的数量，计算那些危及生命事件及导致住院、残疾及死亡事件的百分数。根据这些，该公司推导出相应结果。
报告显示GLP-1受体激动剂与DPP-4抑制剂（特别是西格列汀）与胰腺炎与胰腺癌的增加具有相关性，但两类药物似乎与推测中的肾脏及肝脏并发症均无强烈的相关性。该报告承认这两类药物与胰腺癌与胰腺炎相关性的研究结果一直莫衷一是。事实上，2月份来自FDA与欧洲药品管理局的一份报告称，这些药物可能会引起胰腺疾病的说法“不符合当前的数据。”
AdverseEvents争论称，在GLP-1受体激动剂中得到评价的三款药物（阿斯利康与百时美施贵宝的艾塞那肽和百泌达及诺和诺德的利拉鲁肽）中，艾塞那肽似乎最安全。
此外，DPP-4抑制剂可能与更严重的副作用有关，这些药物包括默沙东的二甲双胍复方制剂（Janumet）和西格列汀，勃林格殷格翰与礼来的利拉利汀。报告发现阿格列汀引起最多的担忧。
报告还称SLGT2抑制剂正如预料的那样与尿路感染升高有关。这类药物可能也与更严重的事件有关联。该类药物包括阿斯利康和百时美施贵宝的达格列净（Farxiga）及强生的卡格列净（Invokana）。
FDA重点观察了GLP-1受体激动剂和DPP-4抑制剂的心脏病风险。2月份，FDA宣布将评价阿斯利康糖尿病药物沙格列汀（Onglyza）的风险，这是一款DPP-4抑制剂，一项最近的研究显示其可能与心脏风险有关联。
在发现葛兰素史克的文迪雅与心血管风险有关并引发公众争议之后，FDA加强了对糖尿病药物及其心脏安全性的审查。公众争议导致FDA为糖尿病新药的批准设置了一个更高的心脏安全性门槛。
FDA在这方面的行动，我们在去年已看到证据，当时FDA拒绝批准诺华诺德新糖尿病治疗药物德谷胰岛素（Tresiba），要求该丹麦制药商对这款药物进行一项新的心血管安全性研究。
考虑到糖尿病是一个日益严重的问题，对那些可能成功治疗糖尿病药物的投资在日益增长，更多的产品将会冲击市场，对其安全性可能需要持续的关注。就在近日，FDA批准了阿必鲁泰，这是葛兰素史克一款一周使用一次的GLP-1受体激动剂。礼来大肆宣传的Dulaglutide，也是一款GLP-1受体激动剂，目前正由FDA进行审评。
New report finds Bydureon safest of new class of diabetes drugs
Analysis of FDA adverse event data tries to pull together risks of three new classes of drugs
With big money to be made, drugmakers have responded to the global rise in Type 2 diabetes with a host of new classes of treatments that work in different ways. And while that is generally a good thing, the full range of adverse effects of all of these new drugs can't be known until they have been on the market for awhile, and some will fare better than others, a new report states. The report from informatics firm AdverseEvents analyzes data on 11 of the newer drugs, and then comes to some conclusions ab0ut which are the safest and which may bear more watching. In the closely watched categories of GLP-1 receptor agonists and DPP-4 inhibitors, the best results were found for Bydureon, and the least favorable for Nesina.
AdverseEvents reached those conclusions by first analyzing data from FDA's Adverse Event Reporting System (FAERS). It then looked at the number of suspect cases and figured up the percentages of those events that were life threatening, as well as those that resulted in hospitalizations, disabilities and death. From that it derived a score.
The bottom line from the report is that both GLP-1 receptor agonists and DPP-4 inhibitors (especially sitagliptin) have elevated associations with pancreatitis and pancreatic cancer, but neither class appears to have strong 1inks to presumed renal and hepatic complications. The report acknowledges that there has been conflicting studies on the associations to pancreatic cancer and pancreatitis. In fact, a report from the FDA and the European Medicines Agency in February said that suggestions that the drugs could cause pancreatic disease are "inconsistent with current data."
dverseEvents contends that of the three drugs eva1uated in the GLP-1 receptor agonist class--Bydureon and Byetta from AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY) and Victoza from Novo Nordisk ($NVO)--Bydureon appeared to be the safest.
Other findings were that DPP-4 inhibitors, which include drugs like Janumet and Januvia from Merck ($MRK), Tradjenta from Boehringer Ingelheim and Eli Lilly ($LLY), and Nesina from Takeda, may be 1inked to more serious side effects than has generally been believed. It found that Nesina raised the most concern.
It also said that the SLGT2 inhibitors are, as expected, associated with elevated urinary infection risks. It said they may also be 1inked to more serious events. Drugs in that class include Farxiga from AstraZeneca and Bristol-Myers Squibb and Invokana from Johnson & Johnson ($JNJ).
It is not as if the FDA and other agencies are not keeping tabs on studies that suggest here-to-for unknown risks. The agency took its closer look at the heart risks of the GLP-1 agonists and DPP-4 inhibitors. And in February the agency announced it would eva1uate the risks of AstraZeneca's diabetes drug Onglyza, one of the DPP-4 inhibitors for possible heart risks after a recent study suggested 1inks.
The FDA heightened its scrutiny of diabetes drugs and their heart safety after cardiovascular risks were associated with GlaxoSmithKline's ($GSK) Avandia, touching off a public controversy. That controversy also led the FDA to set a higher heart-safety bar for approving new diabetes drugs. Evidence of that was seen last year when it denied approval to Novo Nordisk's new diabetes treatment Tresiba, asking the Danish drugmaker for a new study of its cardiovascular safety.
But given diabetes is a growing problem with growing financial potential for the drugs that can successfully treat it, more products will hitting the market and may need ongoing attention. Just yesterday, the FDA approved Tanzeum (albiglutide), a once weekly GLP-1 agonist from GSK. Eli Lilly's has its much-hyped dulaglutide, also a GLP-1 agonist, being considered now by the FDA。
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