In October 2018, an FDA advisory committee voted 10-9 in favor of supporting continued agency-recommended cardiovascular outcomes trials to demonstrate safety for all type 2 diabetes drugs. In this Ƶ video, , chair of cardiovascular medicine at the Cleveland Clinic, talks about why this was so important.
The following is a transcript of his remarks:
I was greatly relieved that an FDA advisory panel voted, although narrowly, to continue the guidance to require outcome trials for diabetes drugs. Many of us were very concerned that this would be abandoned. We have learned more about the cardiovascular effects of diabetes drugs in the last 10 years than in the previous 40 years combined. We've learned that some drugs like DPP-4 inhibitors have no cardiovascular benefit. We've learned that the SGLT2 inhibitors reduce both major adverse cardiovascular events and heart failure, and we've learned that the GLP-1 agonists, some of them, also reduce cardiovascular disease. None of those findings would have been possible if the trials had not been required.
The prior approach to approval of diabetes drugs was to approve them if they lowered blood sugar, and we now know that some drugs that lower blood sugar are effective at preventing complications of diabetes and some are less effective. That's what we learned by doing these randomized, controlled clinical trials.
We've also learned about some harms associated with diabetes drugs from the trials. Canagliflozin showed an increased risk of amputations. Some of the SGLT2 inhibitors have been shown to increase the risk of diabetic ketoacidosis, and one of the DPP-4 inhibitors, saxagliptin, has been shown to increase the risk of heart failure. None of this information would have come to light if we hadn't required the outcome trials.
Fortunately, at least the recommendation to the FDA is to continue to do these trials. We cannot move forward in the treatment of diabetes in the absence of scientific evidence. I would encourage the FDA to follow the guidance of its panel and continue to require outcome trials.