Aralez Pharmaceuticals announced new data for YOSPRALA, a recently FDA-approved prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), demonstrated significantly lower rates of gastric and duodenal ulcers compared to aspirin alone among patients with a history of myocardial infarction at risk for secondary cardiovascular events and gastrointestinal problems related to aspirin therapy at the annual American Heart Association Scientific Sessions.
The study, titled “Efficacy and Safety of PA32540 (Enteric-Coated Aspirin 325 mg and Immediate-Release Omeprazole 40 mg) in Patients With a History of Myocardial Infarction: Analyses From Two Phase 3 Clinical Trials,” found that YOSPRALA 325 mg / 40 mg was associated with significantly lower rates of gastric ulceration compared to 325 mg of enteric-coated aspirin (2.3percent vs 7.5percent; p=0.020) in these patients. Treatment with YOSPRALA was also associated with lower rates of duodenal ulcers (2.3percent vs 9.5percent; p=0.002) compared to enteric-coated aspirin in this population. Safety results in this population were comparable with the entire study population.
“Treatment guidelines continue to support daily aspirin therapy as a critically important agent in the prevention of secondary cardiovascular events, but gastrointestinal symptoms prompt many patients to discontinue their treatment, which may leave them open to significant risk,” said Paul A. Gurbel, MD, Director of Cardiovascular Research and Director of Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Falls Church, VA. “Results of this analysis demonstrate that patients at risk for aspirin-associated gastric ulcerations with a history of myocardial infarction may derive a tolerability benefit from this fixed-dose, coordinated delivery formulation of aspirin and prescription-strength omeprazole, which may allow patients to be more compliant with potentially life saving aspirin therapy.”
YOSPRALA received U.S. Food and Drug Administration (FDA) approval on September 14, 2016 for the treatment of patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.
Study Methodology
This post-hoc analysis examined a subset of 411 patients from two similarly-designed double-blind Phase 3 clinical studies who were taking aspirin for prevention of a second heart attack. The goal was to determine if YOSPRALA reduces the risk of gastrointestinal (GI) side effects that may cause patients to curtail or discontinue their daily aspirin therapy. The primary efficacy endpoint was the cumulative proportion of patients who developed endoscopically determined gastric ulceration throughout six months of treatment.
In the study overall, participants were adults with established cardiovascular disease who had been taking 325 mg of aspirin daily for at least three months for the secondary prevention of cardiovascular events and were expected to continue daily aspirin therapy for at least six months. All patients were at risk for aspirin-associated gastric ulceration, defined as either being at least 55 years of age or 18 to 54 years old with a documented history of gastric or duodenal ulcer within five years before study enrollment. Endoscopy was performed at baseline, and after one, three and six months of treatment.
“The evidence for daily aspirin therapy in secondary prevention is well supported in the literature, as is the risk patients may face if they discontinue aspirin treatment,” said James Tursi, MD, Chief Medical Officer, Aralez Pharmaceuticals. “Literature supports an approximate three-fold increase in the risk of having, or dying from, a major adverse cardiac event if at-risk patients stop taking their aspirin1. By reducing the risk of developing gastric ulcers, YOSPRALA may help patients stay on aspirin therapy so they receive the cardio-protective benefits they need.”
Aspirin: A “Gold Standard” for Secondary Prevention
Up to an estimated 26.2 million adults in the U.S. are at risk for secondary CV events. The occurrence of secondary CV events among people with heart disease continues to be a significant problem in the U.S. Patients who have experienced a heart attack have an elevated CV risk within the first six years2 of that first event, equating to an estimated 200,000 Americans a year who go on to have a second heart attack.3
Recent guidelines from the American College of Cardiology and American Heart Association affirm the importance of daily aspirin therapy. Daily aspirin therapy, however, may cause gastrointestinal symptoms and damage, such as gastroesophageal reflux disease, gastric ulcers and even gastrointestinal bleeding, through both direct and indirect mechanisms. Unfortunately, these events can happen regardless of dose or ASA formulation, such as enteric-coating or buffering.
Filed Under: Drug Discovery
