Management of Type 2 Diabetes in Treatment-Naive Elderly Patients

Abstract

OBJECTIVE—The purpose of this study was to evaluate the efficacy and safety of vildagliptin in elderly patients with type 2 diabetes. RESEARCH DESIGN AND METHODS—Efficacy data from five double-blind, randomized, placebo- or active-controlled trials of ≥24 weeks’ duration were pooled. Effects of 24-week vildagliptin monotherapy (100 mg daily) were compared in younger (<65 years, n = 1,231) and older (≥65 years, n = 238) patients. Safety data from eight controlled clinical trials of ≥12-weeks’ duration were pooled; adverse event profiles in younger (n = 1,890) and older (n = 374) patients were compared. RESULTS—Mean baseline A1C and fasting plasma glucose (FPG) were significantly lower in older (70 years: 8.3 ± 0.1% and 9.6 ± 0.1 mmol/l, respectively) than in younger (50 years: 8.7 ± 0.0% and 10.5 ± 0.1 mmol/l, respectively) patients. Despite this, the adjusted mean change from baseline (AMΔ) in A1C was −1.2 ± 0.1% in older and −1.0 ± 0.0% in younger vildagliptin-treated patients (P = 0.092), and the AMΔ in FPG was significantly larger in older (−1.5 ± 0.2 mmol/l) than in younger (−1.1 ± 0.1 mmol/l, P = 0.035) patients. Body weight was significantly lower at baseline in older (83.4 ± 1.0 kg) than in younger (92.0 ± 0.6 kg) patients. Weight decreased significantly in the older subgroup (AMΔ −0.9 ± 0.3 kg, P = 0.007), whereas smaller, nonsignificant decreases occurred in younger patients (AMΔ −0.2 ± 0.1 kg). Adverse event rates were slightly higher in older than in younger subgroups but were lower among older, vildagliptin-treated subjects (63.6%) than in the pooled active comparator group (68.1%). Vildagliptin treatment did not increase adverse events among older patients with mild renal impairment (62.0%). Hypoglycemia was rare (0.8%) in the elderly patients, and no severe events occurred. CONCLUSIONS—Vildagliptin monotherapy was effective and well tolerated in treatment-naive elderly patients.