NEW YORK (Reuters Health) - In patients with type 2 diabetes and hypertension, empagliflozin prompts significant reductions in BP and HbA1C, according to Finnish and German researchers.
The drug was recently approved in the U.S. and Europe. It acts by selectively inhibiting sodium glucose cotransporter 2 (SGLT2), and the researchers say this leads to increased urinary glucose excretion and improvements in hyperglycemia independently of beta-cell function and insulin resistance.
In the current study, published online September 30th in Diabetes Care, Dr. Ilkka Tikkanen of Helsinki University Central Hospital and colleagues compared 10 mg or 25 mg empagliflozin once daily to placebo in 825 patients with type 2 diabetes and hypertension.
The mean seated systolic BP was 130-159 mm Hg; mean diastolic BP was 80-99 mmHg. Ambulatory blood pressure monitoring was employed during the 12-week study.
At week 12, the adjusted difference versus placebo in change from baseline in mean 24-hour SBP was -3.44 mmHg with 10 mg empagliflozin and -4.16 mmHg with 25 mg empagliflozin.
The corresponding differences in mean 24-hour DBP were -1.36 mmHg and -1.72 mmHg. All of these differences were highly significant.
For HbA1c, the adjusted mean difference versus placebo in change from baseline was -0.62% with 10 mg and -0.65% with 25 mg empagliflozin. In addition, at the end of the study, reductions in body weight were significantly greater with empagliflozin compared to placebo.
Although one death was considered drug related, the rate of serious adverse events was higher in the placebo group.
The researchers say postmarketing studies are continuing in patients at high cardiovascular risk but that both doses of the drug as tested "led to clinically meaningful improvements in SBP and DBP in patients with type 2 diabetes and hypertension, in addition to significant reductions in HbA1c and body weight."
This study was funded by Boehringer Ingelheim and Eli Lilly, which together market empagliflozin as Jardiance. Several of the authors have or have had financial relationships with the two companies.
Dr. Tikkanen did not respond to requests for comments.
SOURCE: https://bit.ly/1w3Xxot
Diabetes Care 2014.
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