Empagliflozin for Patients with Type 2 Diabetes and Hypertension

San Diego—Patients with type 2 diabetes and hypertension who received 10 mg or 25 mg of empagliflozin once daily for 12 weeks had significant and clinically meaningful reductions in systolic and diastolic blood pressure, according to a phase 3, randomized, double-blind, parallel group, placebo-controlled trial.

Results were presented at the EASD meeting in a poster presentation. The poster was titled Empagliflozin Improves Blood Pressure in Patients with Type 2 Diabetes and Hypertension.

Empagliflozin, a potent and selective sodium glucose cotransporter 2 inhibitor, is being developed to treat type 2 diabetes. Boehringer Ingelheim, the manufacturer of empagliflozin, plans on testing the drug in more than 10 phase 3 trials enrolling more than 14,500 people, according to the company.

In this study, 823 patients with type 2 diabetes and hypertension were randomized in a 1:1:1 ratio to receive 10 mg of empagliflozin, 25 mg of empagliflozin, or placebo once daily for 12 weeks. Patients were at least 18 years of age, had a BMI ≤45 kg/m², had an HbA1c level between 7.0% and 10.0%, and were on a diet and exercise regimen. The mean age was 60.2 years, the mean body mass index (BMI) was 32.6 kg/m², the mean body weight was 95.2 kg, and the mean hemoglobin A1c (HbA1c) level was 7.90%. In addition, 39.9% of patients were females.

After 12 weeks of treatment, patients in the 10 mg empagliflozin group had a mean reduction in 24-hour systolic blood pressure of 3.4 mmHg, patients in the 25 mg empagliflozin group had a mean reduction of 4.2 mmHg, and patients in the placebo group had a mean increase of 0.5 mmHg. The differences between each of the empagliflozin groups and the placebo group were statistically significant (P<.001 in each comparison).

In addition, the mean reduction in 24-hour diastolic blood pressure was 1.4 mmHg in the 10 mg empagliflozin group and 1.7 mmHg in the 25 mg empagliflozin group, while the placebo group had a mean increase of 0.3 mmHg. The differences between each of the empagliflozin groups and the placebo group were statistically significant (P<.001 in each comparison).

Further, at week 12, 7.9% of patients in the placebo group, 17.9% of patients in the 10 mg empagliflozin group (P=.002 versus placebo), and 16.2% of patients in the 25 mg empagliflozin group (P=.009 versus placebo) had controlled blood pressure, which the authors defined as <130/80 mmHg.

Patients in the 10 mg empagliflozin group had a mean reduction in HbA1c level of 0.59%, patients in the 25 mg empagliflozin group had a mean reduction of 0.62%, and patients in the placebo group had a mean increase of 0.03%. The differences between each of the empagliflozin groups and the placebo group were statistically significant (P<.001 in each comparison). In addition, the mean reduction in body weight was 0.18 kg in the placebo group, 1.68 kg in the 10 mg empagliflozin group, and 2.16 kg in the 25 mg empagliflozin group. The differences between each of the empagliflozin groups and the placebo group were statistically significant (P<.001 in each comparison).

Adverse events were found in 52.6% of patients in the placebo group, 48.9% of patients in the 10 mg empagliflozin group, and 51.4% of patients in the 25 mg empagliflozin group. Five patients in the placebo group, 4 patients in the 10 mg empagliflozin group, and 6 patients in the 25 mg empagliflozin group had an adverse event that led to discontinuing the study.

This study was funded by Boehringer Ingelheim.