In a nutshell
This study investigated the safety of Januvia (sitagliptin) in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). They determined that sitagliptin was safe in these patients.
Some background
CKD is a major complication of T2D. It can lower the quality of life and increase the mortality risk. CKD can also influence the effect of many anti-diabetes medications.
Incretins are hormones that are made in the intestines in response to a meal. They encourage the body to make insulin (horomone needed to break down glucose taken in from food), and prevent the release of glucagon (a hormone that raises blood glucose). Sitagliptin is a dipeptidyl peptidase-4 (DPP4) inhibitor. DPP4 inhibitors prevent the breakdown of incretins, thus increasing insulin production.
DPP4 inhibitors have been found to improve glucose control in patients with kidney disease. However, longer-term data about the safety of DPP4 inhibitors in people with kidney disease is limited.
Methods & findings
14,528 adults with T2D participated in this study. 23% of these participants (3324 patients) had CKD. All participants were randomly given either sitagliptin or a placebo (drug with no active effect) in addition to their regular medications. The participants did not know which drug they were receiving.
Serious adverse events (such as tumors or injuries) occurred in 14.3% of participants with CKD, and 12.2% of those without CKD. Kidney failure occurred in 3.4% of those with CKD and 0.9% of those without. Severe hypoglycemia (dangerously low blood glucose) occurred at almost twice the rate in those with CKD (3.3%) than without CKD (1.7%).
When only patients with CKD were examined, no major differences in serious adverse events were found in those who received sitagliptin and those who received placebo. Diabetes-related complications (such as kidney failure and infections) occurred at a similar rate in both groups.
The bottom line
The study concluded that sitagliptin did not increase side effects compared to placebo in patients with T2D and CKD.
The fine print
All participants in this study had cardiovascular disease and were 50 years old, or older, and the majority (73.2%) were male. Thus, the results may not apply equally to all people with T2D and CKD. Furthermore, not all participants were taking the same medications in addition to either sitagliptin or placebo. This may have affected the results.
This study was funded by the manufacturers of sitagliptin.
What’s next?
Discuss the safety of sitagliptin and other DPP4 inhibitors with your physician.
Published By :
Diabetes, Obesity and Metabolism
Date :
Apr 21, 2017
