Safety and Effectiveness of Bexagliflozin in Patients With Type 2 Diabetes Mellitus and Stage 3a/3b CKD

Publication date: Available online 14 May 2019Source: American Journal of Kidney DiseasesAuthor(s): Andrew S. Allegretti, Wenbin Zhang, Wenjiong Zhou, Tara K. Thurber, Scott P. Rigby, Cynthia Bowman-Stroud, Carlos Trescoli, Pierre Serusclat, Mason W. Freeman, Yuan-Di C. HalvorsenRationale &ObjectiveHyperglycemia exacerbates the progression of chronic kidney disease (CKD), but most glucose-lowering therapies do not address morbidities associated with CKD. Sodium/glucose cotransporter 2 (SGLT2) inhibitors offer potential benefits to patients with diabetes and CKD, but their effectiveness may be diminished with decreased kidney function. We aimed to evaluate the safety and effectiveness of bexagliflozin, a novel SGLT2 inhibitor, in patients with type 2 diabetes and CKD.Study DesignPhase 3, double-blind, placebo-controlled, multicenter, multinational, randomized trial.Setting &Participants54 sites across 4 countries. Patients with CKD stage 3a or 3b, type 2 diabetes mellitus, and hemoglobin A1c level of 7.0% to 10.5% and estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m2 who were taking oral hypoglycemic agents for 8 weeks.InterventionsBexagliflozin, 20 mg, daily versus placebo for 24 weeks.OutcomesPrimary outcome was change in percent hemoglobin A1c from baseline to week 24. Secondary end points included changes in body weight, systolic blood pressure, albuminuria, and hemoglobin A1c level stratified by CKD stage.Results312 pa...
Source: American Journal of Kidney Diseases - Category: Urology & Nephrology Source Type: research

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In conclusion, the present study identified canagliflozin as a potent inhibitor of human EC proliferation. The anti-proliferative action of canagliflozin is observed in ECs isolated from both the venous and arterial circulation, and is partly due to the blockade of cyclin A expression. In addition, this study found that canagliflozin inhibits tube formation in cultured ECs and mouse aortic rings. Notably, these actions are specific for canagliflozin and not seen with other SGLT2 inhibitors. The ability of canagliflozin to exert these pleiotropic effects on EC function may contribute to both the adverse and salutary actions...
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Canagliflozin protects Heart and Kidneys – CREDENCE Trial Canagliflozin is sodium–glucose cotransporter 2 (SGLT2) inhibitor used in the treatment of type 2 diabetes mellitus. CREDENCE Trial [1] has shown that Canagliflozin provides both cardiovascular and renal protection in patients with type 2 diabetes mellitus. CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial was a double blind randomized trial comparing Canagliflozin 100 mg daily with placebo in type 2 diabetes with albuminuria and chronic kidney disease. They were also treated with renin–ang...
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