In April 2015, an FDA advisory panel voted to include new safety information about potential heart failure side effects on the label of the diabetes drug Onglyza (saxaglipton). This was after the panel reviewed the results of the “SAVOR” trial, in which researchers found that patients taking Onglyza to lower blood sugar levels were 27 percent more likely to be hospitalized for heart failure.
The FDA has also required manufacturer AstraZeneca to conduct additional trials on the drug to determine its safety profile when it comes to cardiovascular disease. Cardiologist Gabriel Steg, M.D., from Paris, France, however, has questioned the usefulness of these studies, stating that he believed the money could be better used to improve the care of those with diabetes.
Doctors Question Use of Resources in Clinical Trials
Steg was commenting on the studies at the European Society of Cardiology (ESC) 2015 Congress, according to Medscape. He noted that there are more than 150,000 patients enrolled in trials meant to determine the cardiovascular risks associated with type 2 diabetes medications like Onglyza, and that he wondered if the studies were diverting money from more important tasks.
“I suggest that it is time to stop wasting resources on noninferiority trials and to work on truly improving diabetes care,” he said.
Dr. Jaakko Tuomilehto from the University of Helsinki, Finland, agreed, stating that it was a waste of resources to be conducting these trials, and that the money could be used to do other research that would improve care for those with diabetes.
Diabetes Drug Trials Help Determine Cardiovascular Risks
Still others are looking forward to the results of these studies. Diabetes patients are already at a higher risk for cardiovascular problems than the general population, and should not be subjected to medications that may increase that risk further.
The drugs being tested are newer-generation diabetes drugs like Onglyza, which are effective at lowering blood glucose levels, but do it in a way that is different from previous drugs. Onglyza, for example, stimulates the pancreas to make more insulin after a meal. Other newer drugs, like Invokana (canagliflozin), work on the kidneys to increase glucose excretion via the urine.
It’s important that doctors know whether these drugs may increase risk of heart problems, especially in patients who may already be at risk for the disease, such as those with high blood pressure or who are overweight.
Eldrin Lewis, M.D., MPH, of the cardiovascular medicine division at Brigham and Women’s Hospital in Boston, noted at the ESC meeting that heart-failure outcomes in trials like those being conducted now are important because some studies have shown an increased risk for heart failure. He added that in the outcomes of the “ELIXA” trial, which examined the diabetes drug “Lyxumia” (a drug similar to Onglyza), patients who were hospitalized for heart failure had a nine-fold higher risk of dying than those who weren’t.
“This excess mortality suggests there are important events to capture among patients with diabetes,” he noted.
This particular trial did not show any connection between the medication and the risk of hospitalization for heart failure, however.
Onglyza Now Carries Cardiovascular Warnings
Though it seems the ELIXA study confirmed the cardiovascular safety of Lyxumia, there has been no such confirmation with Onglyza. Instead, the most recent study indicates a significantly increased risk of heart failure among those taking the medication.
Onglyza now carries a warning about the potential cardiovascular risks, but it did not before this year. Patients who took it and then suffered heart failure may be able to recover damages in an Onglyza lawsuit.
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