Empagliflozin- The emerging superstar for management of diabetes

Empagliflozin (trade name Jardiance) is a drug of the gliflozin class, approved for the treatment of type 2 diabetes in adults in 2014. It was developed by Boehringer Ingelheim and Eli Lilly and Company.

Empagliflozin is an inhibitor of the sodium glucose co-transporter-2 (SGLT-2), and causes sugar in the blood to be excreted by the kidneys and eliminated in urine.

Empagliflozin-An exciting new drug for the treatment of diabetes, is about to be introduced in India. Diabetologists all over the country are very eagerly awaiting the introduction of this drug in the armamentarium for the management of diabetes. Diabetes is a lifelong “lifestyle disease” affecting more than 380 million people all over the world, more than 65 million of these live in India. Only China has higher number of diabetic people [more than 95 million] than India. By the year 2030, India will have 109 million diabetic people.

The lifespan of diabetics is about 5-10 years shorter than that of general population. Average shorter life span is due to early cardio vascular mortality, particularly in those who are unable to control their blood sugar and associated conditions such as blood pressure and blood cholesterol. About 2/3rd of diabetics die due to macro vascular diseases [diseases of large blood vessels such as 1] coronary artery disease resulting in heart attacks and heart failure, 2] cerebro vascular disease resulting in paralytic stroke; and 3] peripheral vascular disease resulting in gangrene of leg and foot. Among those who die from macro vascular diseases, 2/3rds die due to coronary artery disease and remaining 1/3rd due to cerebro vascular disease and peripheral vascular disease.

Thus, while selecting the drugs to reduce blood sugar levels in their patients, the Diabetologists, are looking for the drugs which should not have any cardio vascular side effects besides having very effective, durable; and safe ability to reduce blood sugar. In addition, it would be an icing on the cake if the anti-diabetic drug works beyond the expectation of safety to heart and actually protects the heart from cardio vascular complications of diabetes. Alas some of the commonly used anti diabetic drugs, though very effective in their ability to reduce blood sugar, are not totally safe from cardio vascular point of view.

The issue of cardiovascular safety of anti-diabetic medications occupied the center court in 2008 following the publication of report linking excess cardio vascular mortality in those consuming Rosiglitazone as compared to other anti-diabetic agents. Subsequently Rosiglitazone was banned from most countries including India.

Rosiglitazone fiasco led to regulatory authorities across the globe issuing instructions to closely scrutinize existing anti diabetic medications and mandatory grueling cardio vascular outcome trials to prove cardio vascular safety before any anti diabetic drug is introduced in the market.

Use of some anti-diabetic agents leads to weight gain and tendency for occasional excessive dipping of blood sugar to sub normal levels. Both these side effects are postulated to have a strong link with cardio vascular side effects.

In this context, Empagliflozin offers outstanding benefits. Besides very efficient reduction in blood sugar level, long term use of Empagliflozin is associated with about 3-3.5 kg weight loss, a significant reduction in systolic blood pressure, and an absence of dangerous hypoglycemic episodes, which occur with some other anti-diabetic agents such as sulphonylurea compounds, the old war horses of anti-diabetic therapy. These properties lead to cardio vascular protection in those using Empagliflozin. Among the entire major anti-diabetic drugs, Empagliflozin is the only agent which has been proved to be superior to other anti-diabetic agents as regards cardio vascular outcomes, in a specially designed cardio vascular safety outcome trial.

In a well-designed, large scale, long term study which was recently published in prestigious New England Journal of Medicine on 17th September 2015, patients with diabetes at high risk for cardio vascular disease who received Empagliflozin as compared to placebo, had a significantly lower rate of a composite of sudden death from cardio vascular disease, non-fatal heart attacks and non fatal strokes when the drug was added to standard care. Thus Empagliflozin use offers superior cardio vascular protection besides efficient reduction in blood sugar, weight and blood pressure. Empagliflozin is expected to be launched in India in a few days and is eagerly awaited by the diabetologist and endocrinologist fraternity.