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Empagliflozin Shows Potential as Oral Treatment for Type 2 Diabetes

Novel SGLT-2 inhibitor reduced blood pressure independent of changes in blood glucose and weight (Oct. 2)

On October 2, Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., announced data from a pooled analysis of two phase IIb trials of empagliflozin, an investigational sodium glucose cotransporter 2 (SGLT-2) inhibitor, in adults with type 2 diabetes. The trial data were presented at the 48th European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin, Germany.

The new analysis showed a reduction in systolic blood pressure (SBP) with empagliflozin that was independent of reductions observed in blood glucose or weight.

Empagliflozin belongs to a new class of drugs — SGLT-2 inhibitors — that is being investigated for the reduction of blood glucose levels in adults with type 2 diabetes. These drugs have been shown to reduce blood glucose, measured as hemoglobin A1c (HbA1c), by acting independently of insulin action. HbA1C is measured in people with diabetes to provide an index of blood glucose control for the previous 2 or 3 months.

Most classes of currently available oral treatments for type 2 diabetes depend on the actions of insulin to lower elevated blood glucose levels. In contrast, the emerging SGLT-2 inhibitor class removes glucose through the urine by blocking glucose reabsorption in the kidney.

The pooled analysis included data from two randomized, double-blind, placebo-controlled trials that assessed the safety and efficacy of treatment with empagliflozin alone (n = 408) or as add-on to metformin (n = 495) in adult patients with type 2 diabetes. The patients were treated with empagliflozin 10 mg or 25 mg. At week 12, the investigators assessed changes in both SBP and diastolic blood pressure (DBP), and measured whether changes in HbA1C or weight were related to changes in SBP. The researchers also analyzed a subgroup of patients with SBP greater than 140 mm Hg at baseline.

At week 12, reductions in mean SBP of 3.8 mm Hg and 4.5 mm Hg were observed with empagliflozin 10 mg and 25 mg, respectively, versus a mean reduction of 1.2 mm Hg with placebo. Mean SBPs at baseline of 131.3 mm Hg and 132.5 mm Hg were observed with empagliflozin 10 mg and 25 mg, respectively, versus 134.3 mm Hg with placebo. For both dosages, this reduction in SBP was statistically significant compared with placebo. In patients with higher SBPs at baseline (greater than 140 mm Hg), mean reductions of 17.0 mm Hg and 13.4 mm Hg were observed with empagliflozin 10 mg and 25 mg, respectively, compared with a mean reduction of 10.4 mm Hg with placebo.

Reductions in DBP were numerically greater with both empagliflozin doses compared with placebo, but these differences did not reach statistical significance. For the entire cohort, the reductions in DBP were 2.3 mm Hg and 2.7 mm Hg with empagliflozin 10 mg and 25 mg, respectively, versus 1.8 mm Hg with placebo. For patients with high DBP (greater than 85 mm Hg), the reductions were 8.1 mm Hg and 7.6 mm Hg with empagliflozin 10 mg and 25 mg, respectively, versus 6.1 mm Hg with placebo.

For more information, visit the Boehringer-Ingelheim Web site.

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