Onglyza Study Finds No Cardiovascular Benefits

Defective drug lawyers at Pintas & Mullins Law Firm highlight a recent study examining AstraZeneca and Bristol-Myers Squibb’s cardiovascular drug Onglyza (the generic is saxagliptin), which found no cardiovascular benefits in patients when compared to a placebo.

The trial, titled “SAVOR-TIMI-53 Cardiovascular Outcomes Trial of Onglyza,” included 16,500 patients with type 2 diabetes and cardiovascular disease (or multiple risk factors) from 25 countries. Researchers gave half the participants a placebo and the other half Onglyza. Fortunately, the patients administered the drug did not experience any serious or fatal side effects from the drug; they did not, however, experience any benefits in cardiovascular health either.

Researchers noted that Onglyza failed to show superiority to the placebo in reducing the possibility of cardiovascular death, heart attack, and stroke. Onglyza is a DPP-4 inhibitor, and is intended as an add-on treatment to changes in diet and exercise to control and improve blood sugar levels in patients with type 2 diabetes. People with this type of diabetes are at very high risk of heart attack and other adverse cardiovascular events, which is why they are often prescribed drugs to help lessen that risk.

Timothy Anderson, an analyst for Sanford Bernstein, wrote that Onglyza will now join the extensive list of other oral pharmaceuticals that have failed to actually lessen the risk of or prevent cardiovascular events. The “top-line” results from the study were released to the public in a BusinessWire press release, as the full results are scheduled to be presented at the European Society of Cardiology’s annual meeting in early September. Anderson notes that the top-line results did not include information about the drugs’ effect on the pancreas. Indeed, Onglyza has not ever been tested in patients with a history of pancreatitis.

There has been recent controversy – and an FDA investigation – into the effects of DPP-4 inhibitors on the pancreas, including concerns of pancreatic cancer. Because diabetes is so abundant (it has increased more than 700 percent over the past 50 years), this issue is of grave concern to both the public and health care officials alike.

As a result of the diabetic epidemic, there an array of diabetes drugs currently on American markets, many of which have been found to do more harm than good. For example, GlaxoSmithKline’s popular drug Avandia was recently subject to an FDA advisory committee meeting to reconsider its safety. In 2010 the FDA sharply curtailed the drugs’ use after reports of its negative cardiac and pancreatic side effects. Avandia turned out to be causing heart attacks in diabetic patients, a demographic already predisposed to cardiac events. Consequently, it was heavily restricted in the U.S. and pulled completely from European markets.

On the other side of the fence, Onglyza is now proven to not cause any cardiovascular benefits whatsoever. Although Avandia caused an estimated 83,000 heart attacks between 1999 and 2007, Onglyza failed to prevent countless others from occurring. There have, conversely, been post-market reports of acute pancreatitis and serious hypersensitivity reactions in patients taking Onglyza.

The most common adverse reactions associated with this drug include upper respiratory tract infections, headaches, and urinary tract infections. As many as 80% of type 2 diabetes patients will experience and possibly die from a cardiovascular event in their lifetime. Due to the aging population and the prevalence of obesity in the United States, the rate of type 2 diabetes is expected to reach more than 550 million Americans by 2030.

Defective drug lawyers at Pintas & Mullins Law Firm urge Americans with type 2 diabetes to stay up-to-date on these types of studies, reports and FDA alerts. If you or a loved one was seriously injured from effects of a defective drug, you may be entitled to significant compensation for any medical bills, lost wages, or pain and suffering, through a lawsuit against the manufacturer.


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