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SAN DIEGO – Bexagliflozin was effective and well-tolerated in lowering hemoglobin A1 C in patients with diabetes and stage 3a / 3b CKD, according to ASN Kidney Week.
"We run into this problem as chronic kidney disease advances. We have fewer and fewer oral agents to use, despite the fact that diabetes is obviously a leading cause of chronic kidney disease, " Andrew S. Allegretti, MD, of Mbadachusetts General Hospital, said at a press briefing, here. "Bexagliflozin is an SGLT-2 inhibitor in clinical development, and it has shown excellent results in reducing hemoglobin A1c, serum glucose and in some of the data presented here a few years ago, improving cardiovascular and renal events. The downside right now is not ok SGLT in stage 3b CKD with eGFR below 45. "
In phase 3, double-blind, placebo-controlled, multicenter, multinational, randomized trial, Allegretti and colleagues badessed 312 patients with diabetes and stage 3a / 3b CKD. The researchers randomized participants to treatment with either placebo or for 24 weeks. The study's primary endpoint was placebo-adjusted change in hemoglobin A1c. The following have been designated as secondary endpoints: changes in body weight, BP systolic, albuminuria, fasting plasma glucose and hemoglobin A1c stratified by CKD 3a / 3b status.
The results of this study are based on 24 weeks. They found lower hemoglobin A1c by 0.37% compared to placebo. CKD stage 3a showed reductions in hemoglobin A1c of 0.31%, and those with CKD stage 3b showed reductions in hemoglobin A1c of 0.43%.
Bexagliflozin yielded reductions in body weight, systolic BP, fasting plasma glucose and albuminuria geometric mean ratio. The groups had similar rates of adverse events.
According to Allegretti, the study was well-tolerated in patients with diabetes and stage 3a / 3b CKD, with similar adverse events.
"Additional advantages were reduced in body weight, systolic BP, fasting plasma glucose and albuminuria," Allegretti said. "The caveat was a short study, but we showed the data over 24 weeks." – by Jennifer Byrne
Reference:
Allegretti AS, et al. Paper FR-OR144. Presented at: ASN Kidney Week; Oct. 23-28, 2018. San Diego.
Disclosure: Allegretti reports the study was funded by Theracos LLC.
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