Adverse reactions occurring in ≥2% of YOSPRALA-treated patients and more common than in the control arm: gastritis (18% vs 16%), nausea (3% vs 2%), diarrhea (3% vs 2%), gastric polyps (2% vs 1%), noncardiac chest pain (2% vs 1%)¹  AE, adverse event, EC, enteric-coated.

*Study design: Efficacy of the omeprazole component in Yosprala was evaluated in 2 randomized, multicenter, double-blind, 6-month, Phase 3 trials in patients who had a cerebrovascular or CV diagnosis and were taking 325 mg of aspirin for ≥3 months, expected to continue treatment for ≥6 months, and at risk for aspirin-associated gastric ulcers based on being ≥55 years-of-age or 18 to 54 years old with a documented history of gastric or duodenal ulcer within the 5 years before study enrollment. Patients received Yosprala 325-mg delayed-release aspirin/40-mg immediate-release omeprazole or 325-mg of enteric-coated aspirin. Gastric and duodenal ulcer formation was assessed by gastroduodenal endoscopy at screening and after 1, 3, and 6 months of treatment.^1,3-5