Compliance-adjusted estimates of aspirin effects in older persons in the ASPREE randomized trial

Am J Epidemiol. 2023 Aug 8:kwad168. doi: 10.1093/aje/kwad168. Online ahead of print.ABSTRACTThe ASPirin in Reducing Events in the Elderly (ASPREE) trial recruited 19,114 participants across Australia and the United States during 2010-14. Participants were randomized to receive either 100mg aspirin daily or matching placebo, with disability-free survival as the primary outcome. During a median 4.7 years of follow-up, 37% of participants in the aspirin group permanently ceased taking their study medication and 10% commenced open label aspirin (OLA). In the placebo group, 35% and 11% ceased study medication and commenced OLA, respectively. In order to estimate compliance-adjusted effects of aspirin, we applied rank preserving structural failure time models. The results for disability-free survival and most secondary endpoints were similar in intention-to-treat and compliance-adjusted analyses. For major hemorrhage, cancer mortality, and all-cause mortality, compliance-adjusted effects of aspirin indicated greater risks than were seen in intention-to-treat analyses. These findings were robust in a range of sensitivity analyses. In accordance with the original trial analyses, compliance-adjusted results showed an absence of benefit with aspirin for primary prevention in older people along with an elevated risk of clinically significant bleeding.PMID:37552955 | DOI:10.1093/aje/kwad168

Source: Am J Epidemiol - August 8, 2023 Category: Epidemiology Authors: C L Smith J Kasza R L Woods J E Lockery B Kirpach C M Reid E Storey M R Nelson R C Shah S G Orchard M E Ernst A M Tonkin A M Murray J J McNeil R Wolfe Source Type: research