Clinical experience with vildagliptin in the management of type 2 diabetes in a patient population >/=75 years: a pooled analysis from a database of clinical trials.

摘要

AIM: To report the experience with vildagliptin in a patient population with type 2 diabetes mellitus (T2DM) >/=75 years. METHODS: Efficacy data from seven monotherapy and three add-on therapy to metformin studies, respectively, of >/=24 weeks duration were pooled; effects of 24 weeks of treatment with vildagliptin (50 mg bid) in patients >/=75 years were assessed in these two pooled datasets. Safety data were pooled from 38 studies of >/=12 to >/=104 weeks duration; adverse events (AEs) profiles of vildagliptin (50 mg bid) were evaluated relative to a pool of comparators; 301 patients >/=75 years were analysed. Data in patients <75 years are provided as a reference. RESULTS: Mean age of the elderly population was 77 years. Changes in haemoglobin A1c (HbA1c) with vildagliptin in the patient group >/=75 years were -0.9% from a baseline of 8.3% in monotherapy (p < 0.0001) and -1.1% from a baseline of 8.5% in add-on therapy to metformin (p = 0.0004), and these reductions were similar to those seen in the younger patients. The corresponding weight changes in the elderly patients were -0.9 kg (p = 0.0277) and -0.2 kg [not significant (NS)], respectively, and no confirmed hypoglycaemic events, including no severe events, were reported. AEs, drug-related AEs, serious adverse events (SAEs) and deaths were reported with a lower frequency in older patients receiving vildagliptin than comparators [133.9 vs. 200.6, 14.5 vs. 21.8, 8.8 vs. 16.5 and 0.0 vs. 1.7 events per 100 subject year exposure (SYE), respectively], and the incidence of discontinuations due to AEs was similar in the two groups (7.2 vs. 7.5 events per 100 SYE, respectively). The safety profile of vildagliptin was overall similar in younger and older patients. CONCLUSIONS: Vildagliptin was effective and well-tolerated in type 2 diabetic patients >/=75 years (mean age 77 years).