Empagliflozin Improves CV Risk Factors in T2DM

According to the results of four phase III clinical trials, twenty-four weeks of treatment achieved clinically meaningful improvements in cardiovascular risk factors as well as in glycemic control….

Empagliflozin is a sodium glucose cotransporter 2 (SGLT2) inhibitor which is an emerging class of oral diabetic medications that work by boosting urinary glucose excretion. Canagliflozin (Invokana), the first-in-class SGLT2 inhibitor, received FDA marketing approval in March for treatment of type 2 diabetes. Empagliflozin’s application for marketing approval is now under review by the FDA and the European Medicines Agency.

Dr. Thomas Hach, Boehringer Ingelheim Pharma in Ingelheim, Germany, presented an analysis of pooled data involving 2,477 patients with type 2 diabetes who participated in four separate randomized, placebo-controlled, phase III trials in which empagliflozin at 10 or 25 mg/day was given as monotherapy or as an add-on to either metformin, metformin plus a sulfonylurea, or pioglitazone with or without metformin.

Empagliflozin resulted in significant, clinically meaningful improvements in blood pressure, body weight, uric acid, HDL cholesterol, hemoglobin A_1c, and fasting plasma glucose, along with a modest increase in LDL cholesterol.

The improvement in blood pressure was particularly noteworthy. Among patients with uncontrolled blood pressure at baseline – that is, blood pressures of 130/80 mm Hg or higher – 33.3% of those who received empagliflozin at 10 mg/day and 32.2% on empagliflozin at 25 mg/day had controlled blood pressure at week 24. That was true of only 18.6% of placebo-treated controls, according to Dr. Hach.

The impact of empagliflozin on cardiovascular events in patients with type 2 diabetes is under study in the ongoing EMPA-REG OUTCOME cardiovascular outcomes trial.

Empagliflozin is being jointly developed by Boehringer Ingelheim and Eli Lilly.

Presented at the 73^rd Scientific Sessions June 26, 2013