Safety, Efficacy of Saxagliptin Assessed in T2DM Patients with Moderate CKD

A post-hoc analysis was conducted on the effect of saxagliptin 2.5mg and 5mg vs. placebo on glycemic measures
A post-hoc analysis was conducted on the effect of saxagliptin 2.5mg and 5mg vs. placebo on glycemic measures

Both saxagliptin 2.5mg and 5mg daily improved glycemic control and were generally well tolerated in patients with type 2 diabetes and moderate chronic kidney disease, a study in Diabetes Therapy reported.

Currently, the recommended dose for saxagliptin in patients with moderate or severe renal impairment (CrCl ≤50mL/min) is 2.5mg. Researchers from AstraZeneca and MedImmune conducted a post-hoc analysis to assess the effect of saxagliptin 2.5mg and 5mg daily vs. placebo on glycemic measures in patients with type 2 diabetes and an estimated glomerular filtration rate (eGFR) of 45–60mL/min/1.73m^2. They pooled safety and efficacy data from nine 24-week, randomized, placebo-controlled clinical trials. 

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The analysis showed mean change from baseline in HbA1c was significantly greater with saxagliptin 2.5mg daily (–0.6%; P=0.036 vs.placebo) and 5mg daily (–0.9%; P<0.001 vs. placebo) compared with placebo (-0.2%). Also, there were more reductions in fasting plasma glucose and 2-hour postprandial glucose, and a significantly higher proportion of patients achieved HbA1c <7% with the 5mg dose vs. placebo (44.8% vs. 20.0%; P=0.004 vs. placebo).

Study authors found that the incidence of hypoglycemia was not significantly different across groups (16.2% saxagliptin 5mg vs. 12.2% saxagliptin 2.5mg vs. 11.3% placebo).

Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is currently approved as adjunct to diet and exercise in type 2 diabetes, as monotherapy or combination therapy. It is marketed under the brand name Onglyza.

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