Resverlogix’s scientists were in attendance at the American Diabetes Association (ADA): 75th Scientific Sessions June 5-9 in Boston. At the meeting there were major announcements in regards to diabetes mellitus (DM) and cardiovascular disease (CVD) in the late breaking trials section. Most people who suffer from DM die of CVD (68% over the age of 65). These two diseases are closely linked and the medical community is recognizing the significance and complexity of this relationship. In line with this connection, in 2008, the FDA provided a document called: “Guidance for Industry, Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” The guidance requires that, since DM and CVD are so closely linked, any new drugs being developed for DM must undergo clinical trials to determine their effects in cardiovascular disease outcomes.
At the ADA there were two major sessions detailing recent clinical trials intended to ensure that new drugs on the market for treating DM were not raising CVD risks. Two trials called ELIXA and TECOS tested two members of the incretin class of drugs used to lower glucose in patients with DM. While ELIXA studied lixisenatide, an injected GLP-1 agonist being developed by Sanofi, the TECOS trial dealt with the actions of an oral dipeptidyl peptidase-4 inhibitor (DDP-IV) inhibitor saxagliptin from Merck. Both trials enrolled patients with DM and CVD to determine whether the addition of either of these agents on top of standard of care was better or worse in terms of CVD events.
The results of both trials were similar in that there was not an increase nor a decrease in major CVD events in response to lixisenatide or saxagliptin treatment on top of standard of care. This means that the treatments may be cardiovascular-safe in that they don’t increase the risk of cardiovascular events however they didn’t lower the rate of cardiac events either. The results point to the growing body of evidence revealing that drugs capable of effectively lowering glucose levels in patients with diabetes do not seem to be capable of lowering CVD risks.
