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Combination drug approved for CV prevention in patients at risk for gastric ulcers
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Aralez Pharmaceuticals announced that the FDA has approved its fixed-dose combination of enteric-coated aspirin and omeprazole, a proton pump inhibitor, for secondary prevention of CV and cerebrovascular events in patients at risk for developing gastric ulcers associated with aspirin.
Approval of the combination drug (Yosprala) was based on two randomized controlled trials of the combination drug (325 mg aspirin/40 mg omeprazole) vs. enteric-coated aspirin 325 mg alone, according to a press release issued by the company.
In those studies, the patients assigned the combination drug had a significantly lower rate of endoscopic gastric ulcers and were less likely to discontinue therapy because of upper gastrointestinal adverse events, the company stated in the release.
“Aspirin is the gold standard for the prevention of recurrent CVD, but the challenge that we face in preventive cardiology is adherence,” Lori Mosca, MD, MPH, PhD, professor of medicine emerita at Columbia University Medical Center and director of the American Heart Association Go Red for Women Strategically Focused Research Network Center at Columbia, told Cardiology Today. “The range of nonadherence is 10% to 20%, which is substantial given the public health epidemic we have for the prevalence of CVD. One of the most common problems cited for nonadherence is stomach issues. This new therapeutic option to deliver a combination in a single tablet of something to protect against recurrent events and also protect the gastric lining is potentially paradigm-changing for us, given the challenges we’ve faced with side effects in this population.”
The combination uses a proprietary system (Intelli-COAT) that sequentially delivers immediate-release omeprazole, designed to elevate the gastric pH, followed by delayed-release enteric-coated aspirin 81 mg or 325 mg, which dissolves when gastric pH is 5.5 or greater, which reduces risk for stomach ulcers, according to the release. – by Erik Swain
For more information:
Lori Mosca, MD, MPH, PhD, can be reached at Columbia University Medical Center, 51 Audubon Ave., Room 501, New York, NY 10032; email: ljm10@cumc.columbia.edu.
Disclosure: Mosca reports consulting for Amarin and Aralez.