David H. Fitchett, MD and Cardiologist at St. Michael’s Hospital at the University of Toronto discusses the effect of empagliflozin on mortality and causes of death in patients with type 2 diabetes at high cardiovascular risk at the American College of Cardiology 65th Annual Scientific Session & Expo (ACC.16).
The emperor egg outcomes study was a study design to assess primarily the safety of emperor flow seen in patients at high risk of cardiovascular disease so the study had a goal of showing that emperor closen was safe and did not increase cardiovascular risk but at the same time it was designed to look at whether there would be any benefit of giving this drug to
Patients with cardiovascular disease did it reduce mortality and cardiovascular events such as myocardial infarction stroke and heart failure patient population where patients to diabetes who had a hemoglobin a1c of greater than 7% who also had cardiovascular disease and that was defined as a a prior heart attack triple vessel coronary disease or single vessel
Coronary disease with evidence of revocable ischemia or they had a prior stroke or they had peripheral vascular disease they had to have a creatinine clearance sorry an estimated glomerular filtration rate of greater than 30 and they couldn’t have a body mass index of greater than 45 amplify osen is a sodium-glucose cotransport er inhibitor and it blocks the uptake
Of glucose by the proximal tubules in the kidney so it blocks both glucose and sodium uptake there so it increases glucose it causes glycosuria so the patient passes glucose in their urine and it’s the glucose urea which the excretion of glucose which results in glucose lowering and glycemic control it they’re quite powerful agents they in fact they lurk blood
Glucose more than the dpp-4 inhibitors for example so the use of these agents is in all patients with type 2 diabetes who have renal fact adequate renal function and so they have quite a wide application primary results looked at the primary endpoint was what we call triple mace which is a major adverse cardiac events which included cardiovascular mortality my
Cardin non-fatal myocardial infarction and non-fatal stroke and there was a 14% reduction in this primary endpoint which was it was statistically significant this is the first glucose lowering trial which has shown a definite primary endpoint reductions that this is significant the primary endpoint of the code of the triple mace was driven by a 38 percent reduction
In cardiovascular mortality and that cardiovascular mortality was one component of all cause mortality but all cause mortality was reduced by 32% with no reduction of non cardiovascular mortality well the take-home message is that now have a glucose lowering agent which in patients who have cardiovascular disease saves lives in addition to saving lives it reduces
Hospitalization with heart failure both in patients who had a prior history of heart failure but also in individuals who had no prior history of heart failure and heart failure is a very common event in patients with diabetes firstly forty percent of patients with heart failure have diabetes and up to 20 percent particularly in populations of patients over the age
Of 65 will have some degree of heart failure and then abnormal cardiac function particularly diastolic function is very common and there are studies suggesting that up to 50% of patients with diabetes have abnormal relaxation of their hearts adverse effects of are very few then the most common adverse effect is genital infections with yeast species glucose around
The gentles is often associated with yeast infections however this can be minimized by good gentle hygiene but in addition to that in the emperor egg study there was about a 6% excess of genital infections but only 1% of patients had to stop the drug because of this so it was a very low and and no other side effects so for example there was concern about fractures
We did not see in excess of fractures we did not see an excess of urinary tract infections we did not see an excess of diabetic ketoacidosis so a very safe agent with a relatively minor side effect which can be minimized
Transcribed from video
Empagliflozin reduces CV death in patients with type 2 diabetes at high CV risk By MDLinx