New drug seen helpful in elderly type 2 diabetics

By Will Boggs, MD

NEW YORK (Reuters Health) - An oral anti-diabetes drug called vildagliptin, also known by the brand name Galvus, is an effective single-drug therapy for previously untreated elderly patients with type 2 diabetes, according to a report in the journal Diabetes Care.

"Vildagliptin delivers strong efficacy and tolerability in the elderly -- the fastest growing group of type 2 diabetes patients," Novartis Pharma AG spokesperson Navjot Rai told Reuters Health. Three of the study's investigators are at Novartis.

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

Dr. Richard E. Pratley, from Vermont College of Medicine, Burlington, Vermont and colleagues assessed the efficacy and tolerability of vildagliptin in 238 treatment-naive elderly patients with type 2 diabetes.

Vildagliptin decreased hemoglobin A1c, a measure of long-term glucose control, by 1.2 percent from starting level of 8.3 percent, the investigators report, compared with a reduction of 1 percent from a starting point of 8.6 percent overall (including patients older and younger than 65 years).

Normal hemoglobin A1c levels are less than 7 percent, and in the current study nearly half the elderly patients achieved this target, the report indicates.

There was no significant effect of vildagliptin on body weight, the researchers note, and treatment produced modest improvements in the lipid profile.

Adverse events, including hypoglycemia (low blood sugar), 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.

"Clinical trials have consistently demonstrated the robust efficacy and good tolerability of vildagliptin in combination with many oral diabetes therapies," Rai said. "Vildagliptin has been studied in diverse ethnicities, various ages of patients, and disease stages."

SOURCE: Diabetes Care, December 2007.