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Empagliflozin reduced blood pressure for patients with type 2 diabetes, hypertension

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CHICAGO — In patients with type 2 diabetes and hypertension, empagliflozin significantly reduced blood pressure in addition to improving blood glucose levels, according to research presented at the joint meeting of the International Congress of Endocrinology and the Endocrine Society.

“This anti-diabetic medication does block the reabsorption of glucose in the kidney, resulting in glucosuria and therefore control of blood sugar,” Afshin Salsali, MD, executive director of the Diabetes and Metabolism area for Boehringer Ingelheim Pharma, said during his presentation. “However, we noticed throughout the phases of treatment there’s a trend toward blood-pressure reduction.”

Salsali, along with Ilkka Tikkanen, MD, of Helsinki University Central Hospital, Finland, and colleagues, evaluated safety and efficacy of empagliflozin treatment in patients (mean age, 60.2; BMI=32.6) with no background of anti-diabetic medication; they were randomized to receive empagliflozin, 10 mg (n=276), empagliflozin, 25 mg (n=276) or placebo (n=271) once daily for 12 weeks.

Patients included in the analysis received at least one treatment dose and had baseline HbA1c and 24-hour systolic blood pressure (SBP) values taken. Changes in these two measurements from baseline served as primary endpoints; changes seen in a baseline 24-hour diastolic blood pressure (DBP) measurement was a secondary endpoint.

The mean differences observed for 10 mg and 25 mg vs. placebo at 12 weeks were, respectively:

• HbA1c: ‑0.62% (‑0.72%, ‑0.52%) and -0.65% (-0.75%, -0.55%) (both P<0.001);
• Mean 24-hour SBP: ‑3.44 mm Hg (-4.78, -2.09) and -4.16 mm Hg (-5.50, -2.83) (both P<0.001); and
• Mean 24-hour DBP: ‑1.36 mm Hg (‑2.15, -0.56) and -1.72 mm Hg (-2.51, -0.93) (both P<0.01).

Adverse events were reported by 48.9% of patients on 10 mg, 51.4% on 25 mg and 52.6% of patients on placebo. Events consistent with volume depletion were reported by a single patient on empagliflozin 10 mg and placebo.

“Empagliflozin treatment at 10 mg and 25 mg for a duration of 12 weeks was associated with a significant and clinically meaningful reduction in systolic and diastolic blood pressure in patients with type 2 diabetes and hypertension,” Salsali said.

The EMPA-REG OUTCOME trial is currently evaluating the long-term effect of these same dosages of the medication on cardiovascular disease, Salsali noted. “We expect the results of the study to be out in 2015.”— by Allegra Tiver

For More Information: Tikkanen I. Abstract LB-OR02-6. Presented at: The joint meeting of the International Congress of Endocrinology and the Endocrine Society; June 21-24, 2014; Chicago.

Disclosures: Salsali reports being an employee for Boehringer Ingelheim. Tikkanen is a consultant and speaker for Boehringer Ingelheim.