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Two recent studies raise doubts about whether the side effects of Onglyza and Januvia actually increase the risk of heart failure, amid continuing concerns about the popular diabetes drugs within the regulatory and medical community.
The new research comes only a few months after the FDA issued warning about potential risk of heart failure with Onglyza and questions have also been raised about whether a similar risk is associated with use of Januvia, which is part of the same class of medications, known as dipepitdyl peptidase-4 (DPP-4) inhibitors.
In a study published last month in the medical journal JAMA Cardiology, as well as a study published earlier this week in the Annals of Internal Medicine, researchers failed to find any association between use of the diabetes drugs and a heart failure risk.
The study published in the Annals of Internal Medicine was funded by the FDA, looking at data from 18 health insurance and health systems. It involved 78,553 Onglyza users and nearly 300,000 Januvia users from 2006 to 2013. The other study was an analysis of a clinical trial known as the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), which involved data on 14,671 patients, about half of whom were given Januvia and half of whom were given a placebo.
Neither showed a statistically significant increase in hospitalization from heart failure or heart failure mortality. However, the studies contradict findings from previous research.
Onglyza and Januvia Heart Concerns
Januvia (sitagliptin) is one of Merck & Co’s best-selling drugs and top drugs currently on the market in the United States. It brought the in sales of $1.9 billion during 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, as well as other health concerns.
Onglyza (saxagliptin) 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, for treatment of type 2 diabetes and generated more than $700 million in sales in 2012.
Most of the concerns over the heart failure risk in recent years has focused on Onglyza, which led the FDA to require new warnings earlier last month and a growing number of individuals nationwide are now pursuing an Onglyza lawsuit against AstraZeneca, alleging that consumers and the medical community were not provided adequate warnings about the potential heart risks.
Concerns about the link between Onglyza and heart failure emerged following the publication of a study, known as “SAVOR”, by the New England Journal of Medicine in 2013.
In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential Onglyza heart risks, after a review of data from clinical trials suggested 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.
On April 5, the FDA issued a drug safety communication following the results of a review started in 2014. The FDA announced that new heart failure warnings will required for the diabetes drugs Onglyza, Kombiglyze XR, Nesina, Kazano, and Oseni, which are part of a class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors. The warning did not impact Januvia.