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ASCEND study results: Definitive data on the use of aspirin and omega-3 fatty acids in diabetic patients
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Three quarters of participants reported taking a statin, and over a third were previously on aspirin but had no clear clinical indication for it (and they and their GP were agreeable to stopping this in order to take part in ASCEND).
ESC Congress News 2018 - Munich, Germany
27 Aug 2018
Yesterday, the presentation of Hot Line results from the UK ASCEND (A Study of Cardiovascular Events iN Diabetes) study1 brought us closer to finding out whether aspirin or omega-3 fatty acid supplements are useful for primary prevention of cardiovascular events in individuals with diabetes and no prior history of cardiovascular disease.
Topic(s):
Diabetes and the Heart
Risk Factors and Prevention
Starting in 2005, 15,480 patients with diabetes (94% had type 2) were randomised to receive aspirin 100 mg daily or matching placebo and, separately in a factorial design, omega-3 fatty acid supplements or matching placebo. Participants were followed for a mean of 7.4 years.1
Patients had a mean age of 63.3 years, 63% were male, 83% were overweight and 62% had hypertension. Diabetes was managed with agents other than insulin in most cases (58%) and, in fewer cases, by insulin (alone or with other agents, 25%) or diet alone (16%).1
The composite primary efficacy outcome (shown in 9% of patients overall) was non-fatal myocardial infarction, non-fatal stroke or transient ischaemic attack or vascular death (excluding confirmed intracranial haemorrhage). The primary safety outcome for the aspirin comparison (experienced by 4% of patients overall) was any major bleed.1 Information was available at the end of the study for over 99% of participants.
Professor Jane Armitage (Nuffield Department of Population Health, University of Oxford, Oxford, UK), who presented results of the aspirin analyses (Abstract 2315) reports, "There was a significant 12% reduction in serious vascular events (8.5% vs 9.6%; rate ratio, 0.88; 95% confidence interval [CI], 0.79-0.97; p=0.01). In contrast, major bleeding was increased by 29% (4.1% with aspirin vs 3.2% with placebo: rate ratio, 1.29; 95% CI 1.09-1.52; p=0.003), with most of the excess being gastrointestinal (GI) bleeding and other extracranial bleeding."
"The benefits from avoiding serious vascular events with aspirin were largely counterbalanced by the excess of major bleeds it caused."
There was no significant effect of aspirin on incident cancers-GI (approximately 2% in each group) and others (11.6% with aspirin vs 11.5% with placebo)-and no suggestion that benefits were beginning to emerge with longer follow-up.
"Average adherence to omega-3 fatty acid capsules was 77%, but this did not impact the primary outcome of serious vascular events," says Professor Louise Bowman (Nuffield Department of Population Health, University of Oxford, Oxford, UK) (Abstract 2317). "During follow-up, serious vascular events occurred in 8.9% receiving omega-3 fatty acids and 9.2% receiving placebo (rate ratio, 0.97; 95% CI, 0.87-1.08; p=0.55). There was also no effect on the composite outcome of a serious vascular event or revascularisation (11.4% vs 11.5%, respectively), and no significant between-group differences in the rates of nonfatal serious adverse events."
"ASCEND provides robust data from one of the longest duration and largest studies of omega-3 fatty acid supplements, offering some certainty about their lack of any clear benefit, although they appear to be safe. This supports recent meta-analyses findings and should lead to reconsideration of guideline recommendations," she says.
"The aspirin results are also important," says Prof. Armitage, "as there has been major uncertainty about whether or not aspirin should be routinely used for primary prevention in diabetes. In the context of the well-treated ASCEND population, the overall benefit of a reduction in occlusive vascular events was lost when the increase in major bleeds was taken into account."
Bowman L, et al. Am Heart J 2018;198:135-144.
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