Galvus Effective Monotherapy for Treatment For Type 2 Diabetics

The DPP-IV inhibitor vildagliptin (Galvus) is effective monotherapy for treatment-naive elderly patients with type 2 diabetes, according to a report in the December issue of Diabetes Care. "Vildagliptin delivers strong efficacy and tolerability in the elderly, the fastest growing group of type 2 diabetes patients," according to the  Novartis Pharma AG spokesperson Navjot Rai. Richard E. Pratley, from Vermont College of Medicine, Burlington, Vermont and colleagues assessed the efficacy and tolerability of vildagliptin monotherapy in 238 previously untreated elderly patients with type 2 diabetes.

Vildagliptin decreased hemoglobin A1c by 1.2% from a baseline of 8.3%, the authors report, compared with a reduction of 1% from a baseline of 8.6% overall (including patients above and below 65 years old). Fasting plasma glucose also decreased significantly in elderly patients after vildagliptin treatment.

Nearly half the elderly patients achieved the American Diabetes Association recommended target A1c (below 7%), the report indicates.  There was no significant effect of vildagliptin on body weight, the researchers note, and treatment produced modest improvements in the fasting lipid profile.

Adverse events, including hypoglycemia, occurred no more often among elderly patients than among younger patients, the investigators say, and there were no serious adverse events attributed to vildagliptin therapy.

Vildagliptin is approved for use in Europe but has not yet been approved by the US Food and Drug Administration. The agency issued an approvable letter for the drug in February 2007.