Management of Type 2 Diabetes in Treatment-Naïve Elderly Patients: Benefits and Risks of Vildagliptin Monotherapy

  1. Richard E. Pratley, MD1,
  2. Julio Rosenstock, MD2,
  3. F. Xavier Pi-Sunyer, MD3,
  4. Mary Anne Banerji, MD4,
  5. Anja Schweizer, PhD (anja.schweizer{at}novartis.com)5,
  6. Andre Couturier, MSc6 and
  7. Sylvie Dejager, MD, PhD6
  1. 1University of Vermont College of Medicine, Burlington, VT
  2. 2Dallas Diabetes and Endocrine Center, Dallas, TX
  3. 3St. Lukes-Roosevelt Hospital, New York, NY
  4. 4SUNY Downstate Medical Center, Brooklyn, NY
  5. 5Novartis Pharma AG, Basel, Switzerland
  6. 6Novartis Pharmaceuticals Corporation, E. Hanover, NJ

    Abstract

    Objective: Evaluate the efficacy and safety of vildagliptin in elderly patients with type 2 diabetes.

    Research Design and Methods: Efficacy data from 5 double-blind, randomized, placebo- or active-controlled trials of ≥24 week duration were pooled. Effects of 24-week vildagliptin monotherapy (100 mg daily) were compared in younger (<65 years, n=1231) and older (≥65 years, n=238) patients. Safety data from 8 controlled clinical trials of ≥12-week duration were pooled; AE profiles in younger (n=1890) and older (n=374) patients were compared.

    Results: Mean baseline A1C and FPG were significantly lower in older (8.3±0.1% and 9.6±0.1 mmol/L, respectively; 70 years) than in younger (8.6±0.0% and 10.4±0.1 mmol/L; 50 years) 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 FPG was significantly larger in older (-1.5±0.2 mmol/L) than in younger patients (-1.1±0.1, P=0.035) patients. Body weight was significantly lower at baseline in older (83.4±1.0 kg) than in younger patients (92.0±0.6 kg) patients. Weight decreased significantly in the older subgroup (AMΔ= -0.9±0.3 kg, P=0.007), whereas smaller, non-significant decreases occurred in younger patients (AMΔ= -0.2±0.1 kg). AE rates were slightly higher in older than in younger subgroups, but lower among older, vildagliptin-treated subjects (63.6%) than in the pooled active comparator group (68.1%). Vildagliptin treatment did not increase AEs among older patients with mild renal impairment (62.0%). Hypoglycemia was rare (0.8%) in the elderly and no severe events occurred.

    Conclusions: Vildagliptin monotherapy was effective and well tolerated in treatment-naïve elderly patients.

    Footnotes

      • Received June 21, 2007.
      • Accepted September 12, 2007.
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