Results for the cardiovascular outcomes trial on the SGLT2 inhibitor mark the first time one of the newer diabetes drugs has produced benefits since the FDA began looking closely at these effects. Full data will be presented next month at the European Association for the Study of Diabetes.
The SGLT2 inhibitor empagliflozin, marketed as Jardiance, today became the first of the newer diabetes drugs to reduce the risk of heart attacks and stroke deaths in a clinical trial, an achievement that a leading researcher recently said would be the “holy grail” of such drugs.
Drugmakers Eli Lilly and Boehringer Ingelheim released topline results this morning. This marked the first time that one of the newer class of anti-diabetes drugs has been shown to not only have no adverse cardiovascular effects while producing glycemic control, but the drug also helped reduce the likelihood of bad outcomes.
Empagliflozin was approved by FDA a year ago; today’s results raise the possibility that other drugs in the SGLT2 class, including Johnson and Johnson’s Invokana (canagliflozin), would produce similar benefits.
In a statement, the companies said full results will be presented September 17, 2015, at European Association for the Study of Diabetes in Stockholm, Sweden.
The class, the sodium glucose cotransporter-2 inhibitors, work by blocking the SGLT2 protein, which would typically reabsorb glucose. Thus, sugar is expelled through the urine, lowering blood sugar levels in the body. The drug class is known to have benefits for hypertension, and patients have seen modest weight loss.
Drugmakers Lilly and Boehringer reported the results of a study of 7000 patients with type 2 diabetes mellitus (T2DM) who were considered at high risk for heart attacks or strokes. Those taking the therapy saw significantly fewer cardiac deaths, non-fatal heart attacks, and non-fatal strokes when taking empagliflozin, in combination with standard therapy, than those patients taking standard therapy alone, which included statins and drugs for blood pressure.
Patients were followed for an average of 3.1 years.
Since the mid-2000s, the FDA has required newer diabetes therapies to be studied after approval through longer term cardiovascular outcomes trials. This is done to ensure that there are no repeats of the Avandia saga; FDA had to highly restrict sales after a study in the New England Journal of Medicine indicated it increased heart attack risk.
Two such trials cardiovascular outcomes trials were presented during the 75th Scientific Sessions of the American Diabetes Association in Boston in June. At the presentation of the ELIXA trial on lixisenatide—which found no CV risk or benefit—Yale Diabetes Center’s Silvio E. Inzucchi, MD, said that if a therapy were ever developed that actually improved CV outcomes, “then we would have achieved the holy grail.”