CHICAGO – Twenty-four weeks of treatment with empagliflozin in patients with type 2 diabetes achieved clinically meaningful improvements in cardiovascular risk factors as well as in glycemic control, according to pooled data from four pivotal phase III clinical trials.
Empagliflozin is a sodium glucose cotransporter 2 (SGLT2) inhibitor. This is a novel emerging class of oral diabetic medications that work by boosting urinary glucose excretion. Canagliflozin (Invokana), the first-in-class SGLT2 inhibitor, received Food and Drug Administration 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 noted at the annual scientific sessions of the American Diabetes Association.
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Dr. Thomas Hach
Empagliflozin resulted in significant, clinically meaningful improvements in blood pressure, body weight, uric acid, HDL cholesterol, hemoglobin A1c, and fasting plasma glucose, along with a modest, albeit unwelcome, 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 of Boehringer Ingelheim Pharma in Ingelheim, Germany.
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.
*Correction, 7/10/2013: An earlier version of the graphic accompanying this story incorrectly reported the change in uric acid.