000128015 001__ 128015 000128015 005__ 20241125101137.0 000128015 0247_ $$2doi$$a10.1007/s10787-023-01264-3 000128015 0248_ $$2sideral$$a135174 000128015 037__ $$aART-2023-135174 000128015 041__ $$aeng 000128015 100__ $$0(orcid)0000-0001-5932-2889$$aLanas, Angel$$uUniversidad de Zaragoza 000128015 245__ $$aComparison of gastrointestinal adverse events between fast release tablets and regular acetylsalicylic acid (aspirin) galenics after short-term use: a meta-analysis of randomized clinical trials 000128015 260__ $$c2023 000128015 5060_ $$aAccess copy available to the general public$$fUnrestricted 000128015 5203_ $$aThis study aimed at determining whether there is a difference in the safety profile between fast release (FR) aspirin tablets and regular galenic formulations of aspirin. This study was based on a clinical study database pool (Bayer HealthCare) including 84 clinical studies and 16,095 human subjects. The meta-analysis included 72 studies applying a single dose of aspirin of at most 1000 mg and was, therefore, based on individual data from 9288 subjects. Of these, 6029 subjects took aspirin and 3259 subjects took placebo. Endpoints were adverse events (AEs) of any kind and, especially of gastrointestinal (GI) nature. Event incidence and odds ratios (OR) based on Mantel–Haenszel risk estimates were calcuated. Subjects on aspirin FR had a significantly decreased OR of 0.65 [0.48, 0.90] [95% confidence interval] for all AEs and of 0.39 [0.20, 0.79] for drug-related all AEs versus placebo. The risk of all GI AEs tended to be reduced for subjects on aspirin FR (0.65 [0.41; 1.03]), but not for drug-related GI AEs. Subject on aspirin mono and aspirin mono (plain only, w/o FR) showed an increased risk of drug-related all AEs compared to placebo (1.34 [1.11; 1.62] and 1.43 [1.13; 1.80]). However, subjects on aspirin FR and those on regular aspirin had almost the same risk of all determined AEs. In conclusion, aspirin FR tablets showed a comparable GI tolerability to regular galenic formulations of aspirin after short-term treatment. Major GI complication did not occur after intake of any galenic formulation of aspirin. 000128015 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000128015 590__ $$a4.6$$b2023 000128015 592__ $$a0.952$$b2023 000128015 591__ $$aTOXICOLOGY$$b17 / 106 = 0.16$$c2023$$dQ1$$eT1 000128015 593__ $$aPharmacology$$c2023$$dQ1 000128015 591__ $$aIMMUNOLOGY$$b56 / 181 = 0.309$$c2023$$dQ2$$eT1 000128015 593__ $$aPharmacology (medical)$$c2023$$dQ1 000128015 593__ $$aImmunology$$c2023$$dQ2 000128015 594__ $$a8.0$$b2023 000128015 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000128015 700__ $$aWerz, Oliver 000128015 700__ $$aMikhail, Engy 000128015 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000128015 773__ $$g31, 5 (2023), 2369-2381$$pInflammopharmacology.$$tINFLAMMOPHARMACOLOGY$$x0925-4692 000128015 8564_ $$s1148344$$uhttps://zaguan.unizar.es/record/128015/files/texto_completo.pdf$$yVersión publicada 000128015 8564_ $$s2533109$$uhttps://zaguan.unizar.es/record/128015/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000128015 909CO $$ooai:zaguan.unizar.es:128015$$particulos$$pdriver 000128015 951__ $$a2024-11-22-12:01:17 000128015 980__ $$aARTICLE