Both saxagliptin 2.5 mg and 5 mg 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 2.5 mg. Researchers from AstraZeneca and MedImmune conducted a post-hoc analysis to assess the effect of saxagliptin 2.5 mg and 5 mg daily vs placebo on glycemic measures in patients with type 2 diabetes and an estimated glomerular filtration rate (eGFR) of 45 to 60mL/min/1.73m2. 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 2.5 mg daily (–0.6%; P=0.036 vs.placebo) and 5 mg 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 5 mg 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 5 mg vs 12.2% saxagliptin 2.5 mg 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.
- Perl S, Cook W, Wei C, Iqbal N, and Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther 2016. doi:10.1007/s13300-016-0184..
This article originally appeared on MPR