Efficacy and safety of saxagliptin in older patients with type 2 diabetes mellitus

To assess the safety and efficacy of saxagliptin (5 mg once-daily) in older patients (epsilon a parts per thousand yen65 years of age) with inadequately controlled type 2 diabetes. In this retrospective subgroup analysis, data from five randomized, double-blind, placebo-controlled, multicenter, 24-week, phase 3 trials were included. The primary studies evaluated saxagliptin 5 mg once-daily (monotherapy or add-on) in patients aged 18--77 years with HbA(1c) epsilon a parts per thousand yen7.0%% (four studies) or epsilon a parts per thousand yen7.5%% (add-on to glyburide study) versus placebo. The primary efficacy endpoint of each study included in this pooled analysis was HbA(1c) change from baseline to week 24. In the five-study pooled population, 279 (16.6%%) patients were at least 65 years old; 142 received saxagliptin 5 mg once-daily and 137 received placebo. Treatment groups were well-balanced for baseline characteristics within each study. In older patients, the HbA(1c) adjusted mean change from a baseline of 8.1%% was --0.73 +/-+/- 0.16%% (mean +/-+/- SEM) with saxagliptin compared with --0.17 +/-+/- 0.14%% for placebo from a baseline of 8.0%%. Adverse event rates were similar with saxagliptin 5 mg once-daily compared with placebo in older patients. The pooled subgroup analysis of saxagliptin 5 mg once-daily monotherapy and add-on therapy trials demonstrated clinically relevant and significant efficacy for reducing HbA(1c) in older (epsilon a parts per thousand yen65 years) patients. Saxagliptin was well-tolerated in older patients with a low incidence of hypoglycemia and no weight gain.