Boehringer, Lilly (LLY) Phase IIb of SGLT-2 Shows Significant Reduction in SBP
Tweet
Share
E-mailGet Alerts LLY Hot Sheet
Join SI Premium – FREE
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) announce data from a pooled analysis of two phase IIb trials in adults with type 2 diabetes (T2D) for an investigational SGLT-2 inhibitor, empagliflozin, at the 48th European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin. The new analysis showed a reduction in systolic blood pressure with empagliflozin, which, in the study, was independent of the reductions observed in blood glucose or weight, based on a statistical measure called the Pearson correlation coefficient.
Empagliflozin is part of a class of drugs being investigated for the reduction of blood glucose levels in adults with T2D. SGLT-2 inhibitors have been shown to reduce blood glucose, measured as hemoglobin A1c (HbA1c or A1C), by acting independently of insulin action. A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months.
The pooled analysis includes data from two randomized, double-blind, placebo-controlled trials with treatment durations of 12 weeks (poster #770), 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 10 mg or 25 mg.1 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 >140 mmHg at baseline.
At week 12, reductions in mean SBP of 3.8 mmHg and 4.5 mmHg were observed with empagliflozin 10 mg and 25 mg, respectively, versus 1.2 mmHg for placebo. Mean SBP at baseline of 131.3 mmHg and 132.5 mmHg were observed with empagliflozin 10 mg and 25 mg, respectively, versus 134.3 mmHg with placebo. For both dosages, this reduction in SBP was statistically significant compared to placebo. In patients with higher SBP at baseline (>140 mmHg), mean reductions of 17.0 mmHg and 13.4 mmHg were observed with empagliflozin 10 mg and 25 mg, respectively, and 10.4 mmHg 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 2.3 mmHg and 2.7 mmHg for empagliflozin 10mg and 25mg, respectively, and 1.8 mmHg for placebo. For patients with high DBP (>85 mmHg), reductions were 8.1 mmHg and 7.6 mmHg 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 0.10 and 0.04 for empagliflozin 10 mg and 25 mg, respectively, and 0.12 for placebo. Between A1C and SBP changes, the coefficients were -0.09 and -0.02 for empagliflozin 10 mg and 25 mg, respectively, and 0.11 for placebo. None of these correlations reached statistical significance.
Empagliflozin is part of a class of drugs being investigated for the reduction of blood glucose levels in adults with T2D. SGLT-2 inhibitors have been shown to reduce blood glucose, measured as hemoglobin A1c (HbA1c or A1C), by acting independently of insulin action. A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months.
The pooled analysis includes data from two randomized, double-blind, placebo-controlled trials with treatment durations of 12 weeks (poster #770), 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 10 mg or 25 mg.1 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 >140 mmHg at baseline.
At week 12, reductions in mean SBP of 3.8 mmHg and 4.5 mmHg were observed with empagliflozin 10 mg and 25 mg, respectively, versus 1.2 mmHg for placebo. Mean SBP at baseline of 131.3 mmHg and 132.5 mmHg were observed with empagliflozin 10 mg and 25 mg, respectively, versus 134.3 mmHg with placebo. For both dosages, this reduction in SBP was statistically significant compared to placebo. In patients with higher SBP at baseline (>140 mmHg), mean reductions of 17.0 mmHg and 13.4 mmHg were observed with empagliflozin 10 mg and 25 mg, respectively, and 10.4 mmHg 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 2.3 mmHg and 2.7 mmHg for empagliflozin 10mg and 25mg, respectively, and 1.8 mmHg for placebo. For patients with high DBP (>85 mmHg), reductions were 8.1 mmHg and 7.6 mmHg 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 0.10 and 0.04 for empagliflozin 10 mg and 25 mg, respectively, and 0.12 for placebo. Between A1C and SBP changes, the coefficients were -0.09 and -0.02 for empagliflozin 10 mg and 25 mg, respectively, and 0.11 for placebo. None of these correlations reached statistical significance.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Amplitude Therapeutics signs taRNA vaccine deal with Eli Lilly
- Blue Moon Metals cleared to build at Nevada tungsten project
- Holcim to acquire Fermacell from James Hardie for EUR 840M
Create E-mail Alert Related Categories
Corporate News, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
