Phase 2b Trial Update of Empagliflozin for Reduction of Blood Pressure in Type 2 Diabetes

Boehringer Ingelheim and Lilly announced data from a pooled analysis of two Phase 2b trials of empagliflozin, showing a reduction in systolic blood pressure independent of changes in blood glucose and weight in adults with type 2 diabetes (T2D).

The pooled analysis included data from two randomized, double-blind, placebo-controlled trials with treatment durations of 12 weeks, assessing the safety and efficacy of empagliflozin alone (n=408) or as add-on to metformin (n=495) in adult patients with T2D. Patients were treated with either empagliflozin 10mg or 25mg. At Week 12, the investigators assessed changes in both systolic and diastolic blood pressure, as well as calculated the Pearson correlation coefficients to measure whether changes in A1C or weight were related to changes in systolic blood pressure (SBP). Researchers also analyzed a subgroup of patients with an SBP >140mmHg at baseline.

At Week 12, reductions in mean SBP of 3.8mmHg and 4.5mmHg were observed with empagliflozin 10mg and 25mg, respectively, vs. 1.2mmHg for placebo. Mean SBP at baseline of 131.3mmHg and 132.5mmHg were observed with empagliflozin 10mg and 25mg, respectively, vs. 134.3mmHg with placebo. For both dosages, this reduction in SBP was statistically significant compared to placebo. In patients with higher SBP at baseline (>140mmHg), mean reductions of 17mmHg and 13.4mmHg were observed with empagliflozin 10mg and 25mg, respectively, and 10.4mmHg with placebo.

Reductions in diastolic blood pressure (DBP) were numerically greater with both empagliflozin doses compared to placebo, but the differences did not reach statistical significance. For the entire cohort, the reductions in DBP were 2.3mmHg and 2.7mmHg for empagliflozin 10mg and 25mg, respectively, and 1.8mmHg for placebo. For patients with high DBP (>85mmHg), reductions were 8.1mmHg and 7.6mmHg for empagliflozin 10mg and 25mg, respectively, and 6.1 mmHg for placebo.

Overall, changes in systolic and diastolic blood pressure did not correlate with changes in pulse rate or A1C. The Pearson correlation coefficients between weight and SBP changes were 0.1 and 0.04 for empagliflozin 10mg and 25mg, respectively, and 0.12 for placebo. Between A1C and SBP changes, the coefficients were -0.09 and -0.02 for empagliflozin 10mg and 25mg, respectively, and 0.11 for placebo. None of these correlations reached statistical significance.

Empagliflozin is an investigational SGLT-2 inhibitor which has been shown to reduce hemoglobin A1c by acting independently of insulin action.

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