MedWire News: Vildagliptin treatment results in comparable decreases in glycated hemoglobin (HbA1c) levels to pioglitazone treatment at 1 year in patients with Type 2 diabetes not achieving glycemic control with metformin, according to a report in the journal Diabetes Obesity and Metabolism.
The study was a continuation of a previously published 24-week, double-blind, randomized study, which compared vildagliptin (50 mg twice daily) and pioglitazone (30 mg daily) in patients receiving a stable dose of metformin (at least 1500 mg) with HbA1c levels of 7.5–11.0%.
At 24 weeks, noninferiority of vildagliptin to pioglitazone in terms of glucose lowering was demonstrated. To assess long-term safety profiles of the two agents and glucose control measures the study was continued for a further 28 weeks, with patients and investigators remaining blinded to treatment.
“Vildagliptin results in numerically comparable decreases in HbA1c levels to pioglitazone over 1 year,” report Matthew Goodman (Clinical Development Novartis Pharmaceutical Corporation, East Hanover, NJ, USA) and colleagues.
The authors observed that HbA1c levels increased between weeks 32 and 40 in the vildagliptin group, but were then maintained to week 52.
“Vildagliptin and pioglitazone were well tolerated as add-on therapy to metformin over 1 year with adverse events occurring with similar frequencies in both treatment arms,” write the authors.
One mild hypoglycemic event occurred in each group. Vildagliptin was associated with a higher incidence of gastrointestinal adverse events than pioglitazone (20.0 vs 14.6%). Peripheral edema occurred in similar proportions of vildagliptin- and pioglitazone-treated patients, in 10.8% and 11.1%, respectively.
Increase in body weight is a known side effect of thiazolidinedione treatment and was significant in the pioglitazone group, with patients gaining 2.6 kg on average. In contrast, patients in the vildagliptin group had a nonsignificant 0.2-kg increase in their weight by 1 year.
Vildagliptin provided additional HbA1c lowering to that achieved with metformin alone and comparable to that achieved with pioglitazone, with only pioglitazone causing weight gain, leading the authors to conclude: “Vildagliptin represents a useful addition to pharmacotherapy in the management of Type 2 diabetes.”
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