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