Overall, patients exposed to Januvia were not more likely to die or be hospitalized compared to diabetic patients who did not take Januvia. However, they were 84% more likely to be hospitalized with heart failure (12.5% vs. 9%).
Conclusions were based on data from 7,620 patients with type-2 diabetes and incident heart failure, including 887 patients who used Januvia.
Researchers found the increased risk of heart failure hospitalization associated with Januvia persisted even after adjusting for potential confounders. They cautioned that the increased risk, if present at all, appears to be small. But they warned:
“With these considerations in mind, the present findings are important and do add to a small but growing body of evidence that suggests DPP-4 inhibitors as a class of drugs, and possibly diabetes drugs in general, may increase the risk of heart failure.”
The findings also add to a growing body of evidence linking other diabetes medications with heart failure — for example, thiazolidinedione medications and other dipeptidyl peptidase (DPP-4) inhibitors.
In February, the U.S. Food and Drug Administration (FDA) launched an investigation into a study linking Onglyza (saxagliptin) to a 27% increased risk of heart failure hospitalization. Onglyza and Januvia are both DPP-4 inhibitors. Drugs in this class have only been on the market since 2006 and the long-term safety data is lacking.
The American Diabetes Association recommends caution when prescribing diabetes medications to patients with heart failure. However, it is unclear whether the link between diabetes and heart failure is caused by medications like Januvia. It is also possible that people with diabetes are simply more likely to experience heart failure because of other health problems, such as high blood pressure, kidney problems, and heart disease.
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