Safety of Januvia in Oldest Patients With Diabetes Confirmed in Study

The new study in Diabetes Care comes more than a year after the initial results of the TECOS trial were presented at the American Diabetes Association Scientific Sessions.

An evaluation of results from the oldest patients in a large cardiovascular (CV) outcomes trial of Januvia (sitagliptin) has confirmed that this group can safely take the drug to treat type 2 diabetes (T2D), even if the patients have a significant CV risk.

Results published in Diabetes Care examined the group of patients age 75 and older taking part in TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin). These new results focused on the 14% of the study participants (14,351 individuals), who were in the oldest age group. Those with T2D had glycated hemoglobin of at least 6.5% and not higher than 8.0%.

“Among older patients with well-controlled type 2 diabetes and cardiovascular disease, sitagliptin had neutral effects on cardiovascular risk and raised no significant safety concerns,” the authors wrote.

Overall safety results for Januvia were announced in June 2015 during the American Diabetes Association Scientific Sessions and showed no CV risk among a diverse group of patients taking the drug. A secondary analysis found that the drug did not increase the risk for heart failure among the T2D group.

The average age of this older cohort was 78.3 years; men made up 68% of the group and the average duration of T2D was 12 years. After an average of 2.9 years of follow-up, this group had higher events rates than younger participants: 6.46 events compared with 3.67 events per 100 person-years, for a hazard ratio (HR) of 1.72 (95% CI, 1.52-1.94). The older group also had a higher death rate (HR 2.52, 95% CI 2.20-2.89), higher rates of severe hypoglycemia (HR 1.53, 95% CI 1.15-2.03), and more fractures (HR 1.84, 95% CI 1.44-2.35).

However, Januvia did not significantly affect the primary composite outcome among the older patients (HR 1.10, 95% 0.89-1.36), and there was no significant difference in death rates (HR 1.05, 95% CI 0.83-1.32). There was also no significant differences in hospitalization for heart failure, (HR 0.99, 95% CI 0.65-1.49) or severe hypoglycemia (HR 1.03, 95% CI 0.62-171.)

Januvia, the first of the FDA approved dipeptidyl peptidase 4 (DPP-4) inhibitors, has been a sales leader for Merck, although it has been under some pressure from a new class of drugs, the sodium-glucose co-transporter-2 (SGTL2) inhibitors. The DPP-4 class worked by raising incretin levels to limit glucagon release, which promotes insulin secretion and lowers blood glucose levels.

Reference

Bethel MA, Engel SS, Green JB, et al. Assessing the safety of sitagliptin in older participants in the Trial Evaluating Cardiovascular Outcomes With Sitagliptin (TECOS) [published online January 5, 2017}. Diabetes Care. 2017; doi: https://doi.org/10.2337/dc16-1135.