A comparison study of the risk of cardiovascular events and cancers in the ASCEND study cohort and real-world population

ASCEND is the largest study of the effect of aspirin and fish oil supplementation on the risk of heart attacks, stroke and cancers in people with diabetes mellitus. The study results were published in the New England Journal of Medicine in October 2018.The study demonstrated that taking aspirin reduces the risk of serious cardiovascular events in people with diabetes, but increases the risk of bleeding. During the study follow-up period, participants developed fewer heart attacks and strokes, than expected based on reports from previous randomized trials. This observation might indicate that the epidemiology of diabetes mellitus is changing, and that people with diabetes are now at lower risk of serious vascular conditions than before, and rather than vascular disease being the main cause of death, cancer is also an important cause of death.

However, there are alternative explanations for lower rates of events observed in the clinical trial, including selection of healthier individuals by the inclusion and exclusion criteria for the trial, better compliance with evidence-based therapies within trials and inappropriate reference populations used to estimate event rates.

We will use the real-world data available from primary care practices across England to calculate rates of heart attacks, stroke, cancers, and major bleedings, in people with diabetes comparable to the ASCEND population, and compare them with rates reported in the clinical trial.

With funding from the Oxford BHF CRE we will be able to access the required primary care data.  

The study findings will be published in peer-reviewed journals, and used to inform the interpretation of the ASCEND results, as well as inform the design of future randomized trials.