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The findings of a new study raise questions about the potential link between Nesina and heart problems, which is a side effect that has been linked to similar medications like Onglyza in other studies.
Takeda Pharmaceuticals, Nesina’s manufacturer, issued a press release on June 11, announcing the results of an analysis of the EXAMINE clinical trial. The findings were presented at the American Diabetes Association’s scientific sessions and were published in the medical journal Diabetes Care.
Nesina (alogliptin) was approved in 2013 for treatment of diabetes. In April, the FDA issued a drug safety communication, announcing that new heart failure warnings will be required for the diabetes drugs Nesina and other drugs that are part of a class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors, which also includes Onglyza, Kombiglyze XR, Kazanao and Oseni.
The warning came following a Nesina and Onglyza heart failure risk safety review launched by the agency in February. However, while the FDA found enough evidence to require label warnings about the potential Nesina heart risks, researchers in this latest study found that the risk of death due to heart problems was similar between patients given Nesina and those given a placebo.
Researchers looked at data on 5,380 patients with type 2 diabetes who were given either Nesina or a placebo within 15 to 90 days of an acute coronary syndrome (ACS). They looked at mortality rates, as well as rates of nonfatal cardiovascular events, such as heart attack, stroke, or hospitalized heart failure.
According to the findings, patients taking Nesina faced about a 4.1% chance of heart problem-related death, while those taking a placebo faced a 4.9% risk.
The findings come amid other recent studies that have questioned the FDA’s concerns over Onglyza and Nesina heart risks. Two other studies in recent weeks indicated researchers were unable to find statistical evidence of heart problems with either Onglyza or Januvia, another DPP-4 inhibitor and popular diabetes drug that was not mentioned in the FDA warning in April.
In April 2015, an FDA advisory committee found enough evidence to call for Nesina and Onglyza heart failure warnings. The committee also made its decision based off the EXAMINE clinical trial results.
“Heart disease, or CV disease, is the leading cause of death in patients with Type 2 diabetes, and is responsible for between 50 and 80 percent of deaths in people with diabetes, so it’s critical we have a clear understanding of the impact these medications have on patients with Type 2 diabetes who are at a high risk for CV diseases such as those involved in EXAMINE,” said Dr. William B. White, a professor at the Calhoun Cardiology Center at the University of Connecticut School of Medicine, and one of the EXAMINE researchers, in the press release. “The post-hoc analysis indicates that mortality, including CV mortality, was not higher with alogliptin versus placebo when studied for 18 months. These data provide additional important information for the healthcare professional in evaluating treatments for people living with Type 2 diabetes.”