Meet Jardiance: the First Antidiabetic Drug To Reduce Cardiovascular Risk
August 25, 2015
The obesity epidemic and a progressively more sedentary lifestyle have contributed to type 2 diabetes (T2D) becoming increasingly more common. Cardiovascular (CV) disease is the major cause of mortality among patients with T2D, accounting for 60–80% of deaths in these patients. Despite recent studies demonstrating the benefit of a proper glycemic control in decreasing cardiovascular risk in T2D, there have been lingering concerns about potential adverse cardiovascular effects of some anti-diabetes medications. Eli Lilly and Boehringer Ingelheim have announced that their diabetes medication Jardiance is the first of its kind to reduce the risk of heart attacks, strokes and other cardiovascular damage.
A staggering 30 million of Americans, which corresponds to almost 10% of the population, have diabetes and it is estimated that 86 million more have prediabetes, and will develop diabetes at some point in their life unless major measures are taken.
Although a clear cut correlation between lower blood glucose and decreased risk of mortality for CV complications in T2D patients is still missing, several large-scale studies, including the United Kingdom Prospective Diabetes Study (UKPDS), suggest that a good glycemic control does decrease the risk of developing CV complications in patients with T2D. In the UKPDS, a regimen of more aggressive glycemic control was associated with a 16% reduction in risk for fatal and nonfatal myocardial infarction (MI) or sudden death. A more recent analysis of the UKPDS results showed that, for each 1% reduction in glycated hemoglobin (HbA1c), used as a surrogate biomarker of glycemic control, there was a 14% reduction in MI risk. Based on this correlation, most clinical development programs for anti-diabetes drugs have focused on glucose lowering medications, such as the DPP-IV inhibitor class, which control blood sugar by increasing the body's insulin production. However, after reviewing the outcome of the SAVOR study on two DPP-IV inhibitors, an FDA Advisory Committee found that the risk of heart failure in patients treated with one of them (Onglyza) was significantly increased and warned that this could be a DPP-IV class effect.
Since then significant efforts have been made to assess the CV safety of new and existing antidiabetic medications until the EMPA-REG OUTCOME trial results, which potentially have imposed a paradigm shift to the market. Full details on the trials have yet to be published but Ely Lilly and partner Boehringer Ingelheim have disclosed their top-line results, announcing their drug Jardiance is capable of delaying the time until patients die of CV disease of suffer a heart attack or a stroke.
Jardiance is part of a newer class of diabetes drugs called SGLT-2 inhibitors, which work by making the kidneys extract sugar from the blood to be excreted in urine. Jardiance is a once-a-day pill that was approved in the U.S. last August for patients T2D. In the Jardiance study 7,000 patients who had an history of being on several standard medication to control blood sugar, blood pressure, and cholesterol levels were given either Jardiance or dummy pills and were followed just over three years. According to the manufacturers, this closely watched study met its main goal and full disclosure of the trial results will be given in September during the EASD meeting. If, as expected, these big announcements will be sustained by the trial data Jardiance will be the first diabetes drug to demonstrate CV benefits and will have a great impact on patients whose glycemic index has not been sufficiently controlled by current medications and in need of additional drugs.
Crown Bioscience will be attending EASD and looks forward to hearing about the Jardiance trial results. Crown Bioscience promotes diabetes drug discovery research through the use of non-human primate (NHP) models, the most clinically translatable animal models in the diabetes field. Crown has the world’s largest collection of well characterized, naturally diabetic NHPs (DPrime™) and has established the first ever tissue bank of samples from spontaneously diabetic NHPs (DBank™), currently containing over 40 tissue sets with full details on the background history, physiological profile, and individual disease information.
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