Boehringer Ingelheim and Eli Lilly reported pooled data Tuesday at the EASD meeting showing that the experimental agent empagliflozin significantly reduced systolic blood pressure in patients with type 2 diabetes compared to placebo. The SGLT2 inhibitor is currently being investigated in a late-stage clinical trial programme in adults with type 2 diabetes, with pivotal studies expected to finish later this year and potential regulatory filings planned in the US and Europe in 2013.
The analysis included two Phase IIb trials designed to assess the safety and efficacy of two doses of empagliflozin alone or as an add-on to metformin in adults with type 2 diabetes. Results of the studies, which included more than 900 patients, demonstrated that empagliflozin led to reductions in mean systolic blood pressure at 12-week of 3.8 mmHg and 4.5 mmHg for the two drug doses, versus 1.2 mmHg for placebo. The companies noted that in patients who had baseline systolic blood pressure greater than 140 mmHg, mean reductions of 17.0 mmHg and 13.4 mmHg were observed with the two doses of empagliflozin, compared with 10.4 mmHg for placebo.
Data also indicated that reductions in diastolic blood pressure were numerically greater with both empagliflozin doses compared to placebo, although Boehringer Ingelheim and Eli Lilly noted that the differences were not significant. The analysis demonstrated that reductions in both systolic and diastolic blood pressure were independent of the reductions seen in HbA1c or weight.
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