Comparison of the Efficacy and Tolerability Profile of Liraglutide, a Once-Daily Human GLP-1 Analog, in Patients With Type 2 Diabetes >/=65 and <65 Years of Age: A Pooled Analysis from Phase III Studies.

BACKGROUND: Managing elderly patients with type 2 diabetes poses particular challenges, so it is important to evaluate the efficacy and tolerability profile of antidiabetic therapies specifically in this patient population. OBJECTIVE: The aim of our study was to compare the efficacy and tolerability profile of liraglutide, a GLP-1 analog, in elderly (>=65 years) and younger (<65 years) patients with type 2 diabetes. METHODS: A pooled analysis of 6 randomized, placebo-controlled, multinational trials included data from 3967 patients aged18 to 80 years with type 2 diabetes and glycosylated hemoglobin (HbA(1c)) of 7% to 11%. Of these, 552 patients >=65 years received liraglutide 1.8 mg, liraglutide 1.2 mg, or placebo; 2231 patients <65 years received liraglutide 1.8 mg, liraglutide 1.2 mg, or placebo for 26 weeks. End points were: change in HbA(1c), fasting plasma glucose, body weight, and blood pressure: as marked to identify elements tracked for change from baseline; hypoglycemic episodes; and adverse events. RESULTS: Reduction in HbA(1c) from baseline was significantly greater with liraglutide 1.8 mg versus placebo (least squares mean difference: >=65 years, 0.91% [95% CI, 0.69-1.12]; <65 years, 1.17% [95% CI, 1.06-1.28]; both, P < 0.0001) and with liraglutide 1.2 mg versus placebo (>=65 years, 0.87% [95% CI, 0.64-1.11]; <65 years, 1.10% [95% CI, 0.98-1.22]; both, P < 0.0001). For fasting plasma glucose, comparable results were observed between liraglutide 1.8 mg or 1.2 mg and placebo for both age groups (P < 0.0001). No statistically significant difference in body weight change was seen with liraglutide between the age groups. The proportion of patients reporting minor hypoglycemia was low and appeared comparable between the >=65-year-old (4.3%-15.2%) and <65-year-old (8%-13.2%) groups. Likewise, adverse events appeared comparable in nature and frequency. CONCLUSION: Liraglutide provides effective glycemic control and is well tolerated in patients >=65 and <65 years of age with type 2 diabetes. These data suggest that liraglutide may be a suitable treatment option for older patients who may have additional age-related complications. [ABSTRACT FROM AUTHOR]