Management of Type 2 Diabetes in Treatment-Naive 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 Ann Banerji, MD4,
  5. Anja Schweizer, PHD5,
  6. Andre Couturier, MSC6 and
  7. Sylvie Dejager, MD, PHD6
  1. 1Vermont College of Medicine, Burlington, Vermont
  2. 2Dallas Diabetes and Endocrine Center, Dallas, Texas
  3. 3St. Lukes-Roosevelt Hospital, New York, New York
  4. 4State University of New York Downstate Medical Center, Brooklyn, New York
  5. 5Novartis Pharma AG, Basel, Switzerland
  6. 6Novartis Pharmaceuticals Corporation, East Hanover, NJ
  1. Address correspondence and reprint requests to Anja Schweizer, PhD, Novartis Pharma AG, Postfach, CH-4002 Basel, Switzerland. E-mail: anja.schweizer{at}novartis.com

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.

Footnotes

  • Published ahead of print at http://care.diabetesjournals.org on 18 September 2007. DOI: 10.2337/dc07-1188. Clinical trial reg. nos. NCT00099905, NCT00099866, NCT00099918, NCT00101673, NCT00101803, and NCT00120536, clinicaltrials.gov.

    R.E.P. has received research grants and consulting fees from Novartis. J.R. has received research grants and consulting fees from Novartis. F.X.P.-S. has received research grants and consulting fees from Novartis. M.A.B. has received grant support and honoraria from Novartis.

    Additional information for this article can be found in an online appendix at http://dx.doi.org/10.2337/dc07-1188.

    A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

    The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.

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

  1. Diabetes Care vol. 30 no. 12 3017-3022
  1. Online-Only Appendix
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