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Management of Type 2 Diabetes in Treatment-Naive Elderly Patients

Benefits and risks of vildagliptin monotherapy

¹ Vermont College of Medicine, Burlington, Vermont
² Dallas Diabetes and Endocrine Center, Dallas, Texas
³ St. Lukes-Roosevelt Hospital, New York, New York
⁴ State University of New York Downstate Medical Center, Brooklyn, New York
⁵ Novartis Pharma AG, Basel, Switzerland
⁶ Novartis Pharmaceuticals Corporation, East Hanover, NJ

Address correspondence and reprint requests to Anja Schweizer, PhD, Novartis Pharma AG, Postfach, CH-4002 Basel, Switzerland. E-mail: anja.schweizer{at}novartis.com

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 (AM) in A1C was –1.2 ± 0.1% in older and –1.0 ± 0.0% in younger vildagliptin-treated patients (P = 0.092), and the AM 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 (AM –0.9 ± 0.3 kg, P = 0.007), whereas smaller, nonsignificant decreases occurred in younger patients (AM –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.

Abbreviations: AM, adjusted mean change • DPP-4, dipeptidyl peptidase IV • FPG, fasting plasma glucose • GFR, glomerular filtration rate • GLP-1, glucagon-like peptide-1 • OAD, oral antidiabetic drug • SAE, serious adverse event

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