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SAN DIEGO – Bexagliflozin has been shown to be effective and well tolerated to reduce hemoglobin A levels.1 C in diabetic patients and patients with chronic renal failure at stage 3a / 3b, according to the results of the study presented at ASN Kidney Week.
"We are facing this problem as chronic kidney disease progresses. We have fewer and fewer oral agents to use, despite the fact that diabetes is clearly a leading cause of chronic renal failure, Andrew S. Allegretti, MD, from the Massachusetts General Hospital, said at a press briefing here. "Bexagliflozin is a clinically-developed SGLT-2 inhibitor and has shown excellent results in terms of hemoglobin A1c reduction, blood glucose, and some of the data presented here a few years ago, improving cardiovascular events." and renal. The disadvantage is that there is no SGLT approved in phase 3b CKD with a GFR less than 45. "
In Phase 3, a multi-center, multicenter, randomized, double-blind, placebo-controlled trial, Allegretti and colleagues evaluated 312 patients in 54 sites with type 2 diabetes and chronic renal failure at stage 3a. / 3b. The researchers randomized participants to treatment with bexagliflozin or placebo for 24 weeks. The primary endpoint of the study was the change in placebo-adjusted hemoglobin A1c. The following parameters were identified as secondary endpoints: changes in body weight, systolic blood pressure, albuminuria, fasting glucose, and hemoglobin A1c stratified by CKD status 3a / 3b.
The researchers analyzed the efficacy data using a repeated measures methodology with an intention-to-treat population to show the effects of treatment at 24 weeks. They found that bexagliflozin decreased hemoglobin A1c by 0.37% compared with placebo. Patients with stage 3a CKD experienced a reduction in hemoglobin A1c of 0.31%, and those with stage 3b CKD showed a reduction in hemoglobin A1c of 0.43%.
Bexagliflozin resulted in a reduction in body weight, systolic blood pressure, fasting blood glucose, and the geometric mean albuminuria ratio. Groups had similar rates of adverse events.
According to Allegretti, the study showed that bexagliflozin was effective and well tolerated in diabetic patients and with chronic renal failure at stage 3a / 3b, with similar rates of adverse events.
"Additional benefits were reduced body weight, systolic blood pressure, fasting glucose and albuminuria," said Allegretti. "The warning was that it was a short study, not specifically designed to analyze the long-term results for the kidneys and the cardiovascular system, but we showed the data on a period of 24 weeks. " – by Jennifer Byrne
Reference:
Allegretti AS, et al. FR-OR144 paper. Presented at: ASN Kidney Week; October 23-28, 2018. San Diego.
Disclosure: Allegretti reports that the study was funded by Theracos LLC.
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