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New research suggests that side effects of Onglyza and Nesina may not actually be harmful to the heart, as once suspected, but also suggest that the diabetes drugs do not appear to be helpful in preventing heart problems.
Two new studies were published this week in the New England Journal of Medicine, looking at the heart risks and benefits of Onglyza and Nesina. Both drugs belong to a class of diabetes drugs known as DPP-4 inhibitors, which the research suggests may neither improve nor worsen the risk of fatal or non-fatal cardiac events.
The drugs are also part of a broader class of diabetes treatments known as incretin mimetics, which also include Byetta and Januvia. Because incretin mimetics have been linked to concerns about pancreatic cancer and pancreatitis, researchers also examined that, but found no increased risk. However, the Onglyza study did show a slight increase in the risk of hospitalization from heart failure.
The Nesina study looked at 5,380 patients and the Onglyza study looked at data from 16,492 patients.
The Onglyza study found no increase or decrease in the rate of ischemic events, but did find an increased rate of heart failure hospitalization. Pancreatitis rates were the same for patients given Onglyza as for those not given the drug. The results were similar with Nesina, except no increased heart failure hospitalization rate was detected.
Researchers concluded that while DPP-4 inhibitors may not increase heart risks in most cases, doctors might want to avoid them for patients with heart failure problems.
DPP-4 drugs lower blood sugar levels and are generally well tolerated by patients. The leading DPP-4 inhibitor is Januvia, a blockbuster drug by Merck. Onglyza, by AstraZeneca, generated $709 million in sales last year.
The studies were performed by researchers at Harvard and were also presented at the annual meeting of the European Society of Cardiology in Amsterdam.
In March 2013, the FDA and European drug regulators launched investigations into the potential risk of pancreatic cancer from incretin mimetics after results of a small, independent study found evidence of precancerous cells in the pancreas of users of the drugs.
Late last month, the federal regulators released statements indicating that their review of all available data has found no evidence of a connection between pancreatic cancer and use of Januvia or other incretin mimetics.
Amid the concerns, a number of Byetta lawsuits and Januvia lawsuits have been filed by former users of those incretin mimetics, alleging that side effects of the diabetes treatments caused them to develop pancreatic cancer.