Abstract 16722: 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
Introduction: Aspirin (ASA) is a cornerstone therapy for the secondary prevention of cardiovascular (CV) events. PA32540 is a novel fixed-dose, coordinated-delivery tablet containing enteric-coated (EC)-ASA 325 mg and immediate-release omeprazole 40 mg. PA3250 is designed to reduce the risk of adverse GI side effects and, in turn, improve adherence to ASA.
Methods: Among patients from an ITT population (n=1049) of 2 identically designed, randomized, double-blind phase III trials of PA32540 vs EC-ASA 325 mg, we identified and analyzed a cohort with a history of myocardial infarction (MI) for overall adverse events and GI complication assessed by endoscopy. Patients required treatment with ASA for secondary prevention of CV or cerebrovascular events, and were either ≥55 years old or 18-54 with a history of uncomplicated gastric or duodenal ulcer within the past 5 years. .
Results: Overall, 413/1049 patients had a history of MI (n=214 PA32540, n=199 EC-ASA), and 411 were included in the safety evaluation (n=2 received no study drug). Among these patients, 36 had serious treatment-emergent adverse events (TEAEs; n=19/213 [8.9%] PA32540, n=17/198 [8.6%] EC-ASA; p = NS). Cardiac TEAEs were reported in 12/213 patients (5.6%) in the PA32540 group and 9/198 patients (4.5%) in the EC-ASA group (p=NS). Adjudicated major adverse CV events were reported in 3/213 patients (1.4%) in the PA32540 group and 1/198 patients (0.5%) in the EC-ASA group (p=NS). Treatment with PA32540 was associated with lower rates of endoscopically determined gastric ulceration (5/214 [2.3%] vs 15/199 [7.5%] p=0.020) and gastroduodenal ulceration (5/214 [2.3%] vs 19/199 [9.5%]; p=0.002) vs EC-ASA. Overall, 16 patients (7.5%) in the PA32540 group and 19 patients (9.5%) in the EC-ASA group discontinued therapy due to AEs (p=NS).
Conclusions: Patients treated with PA32540 and EC-ASA for secondary cardioprotection after MI had a similar occurrence of cardiac TEAEs. However, therapy with PA32540 was associated with a more favorable safety and tolerability profile and significantly lower rates of gastric and gastroduodenal ulceration than EC-ASA. These results support PA32540 as a therapeutic option for secondary prevention of CV events in patients at risk for ASA-associated gastric ulceration.
Author Disclosures: P. Gurbel: Research Grant; Modest; Coramed, Duke Clinical Research Institute, Haemonetics, Harvard Clinical Research Institute, MedImmune, Merck, NIH, New Haven Pharmaceuticals, Sinnowa. Honoraria; Modest; AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi Sankyo/Lilly, Haemonetics, Janssen, Merck, New Haven Pharmaceuticals. Ownership Interest; Modest; Merck. Other; Modest; Patent for platelet function testing. C. Barish: Speakers Bureau; Modest; AbbVie, AMAG, American Regent, Glaxo, Janssen Biotech, Salix, Santarus. Consultant/Advisory Board; Modest; AMAG, Luitpold. J.G. Fort: Employment; Significant; Aralez. M. Koren: Research Grant; Modest; Aralez (to institution). M. McKenzie: None. J.P. Tursi: Employment; Significant; Aralez.
- © 2016 by American Heart Association, Inc.