000048351 001__ 48351 000048351 005__ 20200221144307.0 000048351 0247_ $$2doi$$a10.1111/1755-5922.12172 000048351 0248_ $$2sideral$$a94034 000048351 037__ $$aART-2016-94034 000048351 041__ $$aeng 000048351 100__ $$aGoldstein, J.L. 000048351 245__ $$aLong-Term Safety of a Coordinated Delivery Tablet of Enteric-Coated Aspirin 325 mg and Immediate-Release Omeprazole 40 mg for Secondary Cardiovascular Disease Prevention in Patients at GI Risk 000048351 260__ $$c2016 000048351 5060_ $$aAccess copy available to the general public$$fUnrestricted 000048351 5203_ $$aIntroduction: In two, 6-month, randomized, double-blind Phase 3 trials, PA32540 (enteric-coated aspirin 325 mg and immediate-release omeprazole 40 mg) compared to aspirin alone was associated with fewer endoscopic gastric and duodenal ulcers in patients requiring aspirin therapy for secondary cardiovascular disease (CVD) prevention who were at risk for upper gastrointestinal (UGI) events. Aims: In this 12-month, open-label, multicenter Phase 3 study, we evaluated the long-term cardiovascular and gastrointestinal safety of PA32540 in subjects who were taking aspirin 325 mg daily for =3 months for secondary CVD prevention and were at risk for aspirin-associated UGI events. Enrolled subjects received PA32540 once daily for up to 12 months and were assessed at baseline, month 1, month 6, and month 12. Results: The overall safety population consisted of 379 subjects, and 290 subjects (76%) were on PA32540 for =348 days (12-month completers). Adverse events (AEs) caused study withdrawal in 13.5% of subjects, most commonly gastroesophageal reflux disease (1.1%). Treatment-emergent AEs occurred in 76% of the safety population (11% treatment-related) and 73% of 12-month completers (8% treatment-related). The most common treatment-related AE was dyspepsia (2%). One subject had a gastric ulcer observed on for-cause endoscopy. There were five cases of adjudicated nonfatal myocardial infarction, one nonfatal stroke, and one cardiovascular death, but none considered treatment-related. Conclusions: Long-term treatment with PA32540 once daily for up to 12 months in subjects at risk for aspirin-associated UGI events is not associated with any new or unexpected safety events. 000048351 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/ 000048351 590__ $$a2.478$$b2016 000048351 591__ $$aPHARMACOLOGY & PHARMACY$$b125 / 256 = 0.488$$c2016$$dQ2$$eT2 000048351 591__ $$aCARDIAC & CARDIOVASCULAR SYSTEMS$$b61 / 126 = 0.484$$c2016$$dQ2$$eT2 000048351 592__ $$a1.095$$b2016 000048351 593__ $$aCardiology and Cardiovascular Medicine$$c2016$$dQ1 000048351 593__ $$aPharmacology (medical)$$c2016$$dQ1 000048351 593__ $$aPharmacology$$c2016$$dQ1 000048351 593__ $$aMedicine (miscellaneous)$$c2016$$dQ1 000048351 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000048351 700__ $$aWhellan, D.J. 000048351 700__ $$aScheiman, J.M. 000048351 700__ $$aCryer, B.L. 000048351 700__ $$aEisen, G.M. 000048351 700__ $$0(orcid)0000-0001-5932-2889$$aLanas, A.$$uUniversidad de Zaragoza 000048351 700__ $$aFort, J.G. 000048351 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000048351 773__ $$g34, 2 (2016), 59-66$$pCardiovascular Therapeutics$$tCardiovascular Therapeutics$$x1755-5914 000048351 8564_ $$s107369$$uhttps://zaguan.unizar.es/record/48351/files/texto_completo.pdf$$yVersión publicada 000048351 8564_ $$s91023$$uhttps://zaguan.unizar.es/record/48351/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000048351 909CO $$ooai:zaguan.unizar.es:48351$$particulos$$pdriver 000048351 951__ $$a2020-02-21-13:35:31 000048351 980__ $$aARTICLE