Patients with type 2 diabetes experienced significant reductions in systolic blood pressure after treatment with empagliflozin that were independent of changes in HbA1c and weight, according to data presented at the 48th European Association for the Study of Diabetes Annual Meeting in Berlin.
Researchers conducted a pooled analysis of data from two randomized, double blind, placebo-controlled trials evaluating the safety and efficacy of empagliflozin (Boehringer Ingelheim, Eli Lilly and Company) alone (n=408) or as add-on to metformin (n=495) in adults with type 2 diabetes. Treatment duration was 12 weeks, with 152 patients assigned empagliflozin 10 mg, 152 assigned empagliflozin 25 mg and 153 assigned placebo. At baseline, mean age was 57.9 years; BMI was 30.3; and HbA1c was 7.9%, according to the study abstract. Sixty-seven percent were also on antihypertensive medication.
After 12 weeks, mean systolic BP decreased by 3.8 mm Hg in the empagliflozin 10-mg groups and by 4.5 mm Hg in the 25-mg groups vs. 1.2 mm Hg in the placebo groups. These reductions were more pronounced among patients with baseline systolic BP >140 mm Hg who were assigned empagliflozin 10 mg and 25 mg, as compared with placebo (17 mm Hg and 13.4 mm Hg vs. 10.4 mm Hg).
The researchers also noted greater reductions in diastolic BP with both empagliflozin doses vs. placebo, although these numbers did not reach statistical significance.
Results suggested no correlation between changes in BP and changes in pulse rate. Pearson correlation coefficients between weight and systolic BP changes were 0.1 and 0.4 for empagliflozin 10 mg and 25 mg, respectively, vs. 0.12 for placebo (P>.14 for each), according to the abstract. Between HbA1c and systolic BP changes, coefficients were –0.09 and –0.02 for empagliflozin 10 mg and 25 mg, respectively, vs. 0.11 for placebo. None of these correlations were statistically significant.
Empagliflozin was well-tolerated, the researchers said, and adverse event rates were similar among treatment and placebo groups (34.2% and 31.6% in empagliflozin 10-mg and 25-mg groups, and 34.6% in placebo groups). The most common events included urinary tract and genital infections.
For more information:
Hach T. #770. Presented at: the European Association for the Study of Diabetes 48th Annual Meeting; Oct. 1-5, 2012; Berlin.
Disclosure: This study was supported by Boehringer Ingelheim.