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Background Gastrointestinal (GI) toxicity from aspirin is high at the time of initiation of therapy. Objective The current analysis aimed to determine rates of endoscopically detected gastroduodenal erosions and ulcers after 7 days of either immediate release aspirin (IR-ASA) or a novel, pharmaceutical lipid-aspirin complex (PL-ASA) liquid formulation that has an antiplatelet effect similar to IR-ASA. Methods Two randomized, single blind, multicenter active control studies comparing upper GI damage after 7 days of 325 mg PL-ASA or IR-ASA in healthy volunteers not taking a gastroprotectant and who had a negative baseline endoscopy were pooled at the patient level. The primary outcome was the composite of &amp;gt;5 erosions and/or ≥1 ulcer (≥3 mm deep) assessed by a treatment-blinded reviewer at repeat endoscopy on day 7. Results Out of 451 randomized subjects (mean age 57 years, 47% males), 441 completed the 7-day endoscopy and represent the full analysis set. PL-ASA significantly reduced the primary outcome by 34% compared with IR-ASA (25.7% vs. 39%, p=0.0032) (figure). Notably, for ulcers there was a 61% reduction with PL-ASA (6.0% vs. 14.8%, p=0.0018) (Figure 1). The mean number of gastric erosions per patient was also reduced with PL-ASA (2.8±7.3 vs. 4.2±7.5, p&amp;lt;0.0001), while erosions in the duodenum were not different (1.4±7.1 vs. 0.9±2.3, p=0.45). Conclusion The novel PL-ASA liquid capsules reduced rates of GI injury compared with IR-ASA tablets. The combination of reliable platelet inhibition with less GI injury makes PL-ASA an attractive new aspirin therapy option. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): PLx Pharma

european heart journal

Reduced gastric injury with a novel, liquid lipid-aspirin formulation: results from a pooled, patient level analysis of two randomized endoscopy studies In healthy volunteers