Sitagliptin tolerated as well as other antidiabetic agents

The DPP-IV inhibitor, sitagliptin, was well tolerated among patients with type 2 diabetes, according to results of a pooled analysis recently published online.

Researchers from Merck Research Laboratories pooled 12 double-blind, phase-2b and phase-3 studies that included patients treated with the 100 mg per day dose of sitagliptin (Januvia, Merck) for at least 18 weeks and up to two years in duration. The studies included 6,139 patients who received either sitagliptin (n=3,415) or placebo, pioglitazone, metformin, sulfonylurea, sulfonylurea and metformin, or metformin and rosiglitazone (n=2,724).

Patients in both groups experienced similar incidence rates of overall adverse events, serious adverse events and discontinuations due to adverse events. The rate of serious adverse events was about 7% in each group.

The incidence rate for hypoglycemia was higher in the group that did not receive sitagliptin, with a rate of 10.9% compared with 3.4% in the sitagliptin group. Hypoglycemia was the only specific adverse event with a between-group difference greater than 1%, according to the researchers.

Drug-related adverse events and discontinuations due to drug-related adverse events were also higher in the group not receiving sitagliptin (17.7% vs. 12.9%), which the researchers attributed to the increased incidence rate of hypoglycemia.

They found no differences between the groups for cardiac-related and ischemia-related adverse events or laboratory adverse events. – by Tina DiMarcantonio

BMC Endocr Disord. 2008;doi:10.1186/1472-6823-8-14.

This study, reported by Merck researchers, is a nice analysis of a total of over 6,000 patients, some of whom have been on sitagliptin up to two years and they did a very thorough comparison of any adverse effects with those exposed to sitagliptin vs. those not exposed. There was no increase in adverse effects from use of sitagliptin. In fact, the one adverse effect, hypoglycemia, seemed to be of increased prevalence in the group that was not exposed to sitagliptin, according to the researchers, on the basis of people who were on sulfonylureas getting hypoglycemia. I don’t think there is much controversy about the article. I think they’ve done a pretty thorough job in looking at adverse effects and at least thus far it looks like sitagliptin is a very safe drug. Obviously more long-term data to follow.

– Philip Levy, MD

Endocrine Today Editorial Board member