Comparison of the Efficacy and Tolerability Profile of Liraglutide, a Once-Daily Human GLP-1 Analog, in Patients With Type 2 Diabetes ?5 and <65 Years of Age: A Pooled Analysis from Phase III Studies

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• 作者：Bruce W.  ; Bode MD¹ ;   ; ^{bbode001@aol.com} ; Jason  ; Brett MD² ; Ali  ; Falahati PhD³ ; Richard E.  ; Pratley MD⁴
• 关键词：efficacy ; elderly ; liraglutide ; tolerability ; type 2 diabetes
• 刊名：The American Journal of Geriatric Pharmacotherapy
• 出版年：2011
• 出版时间：December 2011
• 年：2011
• 卷：9
• 期：6
• 页码：423-433
• 全文大小：1234 K

文摘

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 (?5 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 ?5 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: ?5 years, 0.91 % [95 % CI, 0.69?.12]; <65 years, 1.17 % [95 % CI, 1.06?.28]; both, P < 0.0001) and with liraglutide 1.2 mg versus placebo (?5 years, 0.87 % [95 % CI, 0.64?.11]; <65 years, 1.10 % [95 % CI, 0.98?.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 ?5-year-old (4.3 % ?5.2 % ) and <65-year-old (8 % ?3.2 % ) groups. Likewise, adverse events appeared comparable in nature and frequency.

Conclusion

Liraglutide provides effective glycemic control and is well tolerated in patients ?5 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.