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The findings of a new study suggest that certain popular diabetes drugs, including Onglyza and Januvia, could lead to dangerously low blood glucose levels when combined with Micronase, DiaBeta and similar sulphonylureas used to treat diabetes.
In a study published this month by the medical journal TheBMJ, French researchers found that combining drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors and sulphonylureas can result in a condition known as hypoglycemia, which involves dangerously low blood sugar levels that may cause confusion, loss of consciousness, seizures or even death.
Researchers looked at 10 studies of placebo controlled randomized trials involving a total of 6,546 participants with type 2 diabetes. 4,020 were given DPP-4 inhibitors like Onglyza, and a sulphonylurea, while 2,526 were given a placebo along with sulphonylureas.
According to the findings, combining the two drugs increased the risk of low blood glucose by 52% overall.
“Addition of DPP-4 inhibitors to sulphonylurea to treat people with type 2 diabetes is associated with a 50% increased risk of (hypoglycemia) and to one excess case of (hypoglycemia) for every 17 patients in the first six months of treatment,” the researchers concluded. “this highlights the need to respect recommendations for a decrease in sulphonylureas dose when initiating Dpp-4 inhibitors and to assess the effectiveness of this risk minimisation strategy.”
The study comes amid increasing concern over the side effects of Onglyza and Januvia, which have been linked to concerns about an increased risk of heart problems, pancreatitis, pancreatic cancer and other complications.
Januvia (sitagliptin) is one of Merck & Co’s best-selling drugs, and one of the top drugs currently on the market in the United States. It generated $1.9 billion in sales in just the first half of 2015. Janumet is another version of the medication, which combines Januvia and Metformin, generating an additional $1 billion for the company.
In recent years, the drug maker has faced a number of Januvia lawsuits alleging that inadequate warnings were provided about the risk of users developing pancreatic cancer.
Onglyza (saxagliptin) is another popular member of the same class of diabetes drugs, which was developed jointly by AstraZeneca and Bristol-Myers Squibb, but is now owned wholly by AstraZeneca. It was approved by the FDA in July 2009, and generated more than $700 million in sales in 2012.
A number of studies have suggested a link between Onglyza and heart failure.
Amid the concerns, the FDA announced last month that new Onglyza heart failure warnings would be added to the drug. After a review of available data, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential Onglyza heart risks in April 2015, after determining that users may face a higher than expected risk of hospitalization for heart failure and all-cause mortality. The review looked at two large clinical trials involving patients with heart disease. In both trials, patients given drugs containing saxagliptin or alogliptin were at a higher risk of being hospitalized for heart failure than those given a placebo.
A number of Onglyza lawsuits are now being pursued in courts nationwide on behalf of individuals who suffered heart failure after using the diabetes drug.