Aspirin ineffective for primary prevention of cardiovascular events in low-risk diabetes patients
medwireNews: Long-term treatment with low-dose aspirin does not reduce the risk for cardiovascular events in Japanese patients with type 2 diabetes without pre-existing atherosclerotic disease, suggest 10-year results of the JPAD trial.
“Based on the absence of cardiovascular efficacy coupled with significantly increased gastrointestinal bleeding risk, low-dose aspirin is not recommended for Japanese patients with type 2 diabetes in the absence of prevalent atherosclerotic cardiovascular disease,” say study authors Yoshihiko Saito (Nara Medical University, Kashihara, Japan) and colleagues.
As presented at the American Heart Association Scientific Sessions 2016 meeting (New Orleans, Louisiana, USA) and reported in Circulation, the team found that cardiovascular events occurred in 15.2% of 992 participants receiving aspirin over a median follow-up of 10.3 years, compared with 14.2% of 1168 not receiving aspirin (hazard ratio=1.14).
Aspirin treatment significantly increased the rate of gastrointestinal bleeding, which occurred in 2% of patients receiving aspirin versus 0.9% of those in the control group. However, the overall incidence of hemorrhagic events was similar between the two groups, with corresponding rates of 6% and 5%, and aspirin did not increase the risk for hemorrhagic stroke.
For the trial, which was open-label, participants with type 2 diabetes and no pre-existing cardiovascular diseases were randomly assigned to receive daily low-dose aspirin (either 81 mg uncoated or 100 mg enteric-coated) or no treatment.
After trial completion in 2008, patients who had not met the primary endpoint in JPAD participated in JPAD-2. The patients were given low-dose aspirin therapy (either 81 mg or 100 mg/day) at the discretion of each physician and followed up every 2 years until 2015 in the JPAD-2 study.
“Long term follow-up results were consistent with the [JPAD] randomized trial findings,” write the authors, noting that aspirin did not significantly reduce the risk for cardiovascular events at 4.4 years of follow-up.
Based on the results of primary prevention trials in the general population, the authors explain that earlier in 2016, the US Preventive Services Task Force “recommended low-dose aspirin therapy for primary prevention of cardiovascular events in adults aged 50 to 59 years who have a 10% or greater 10-year cardiovascular disease risk, and are not at increased risk for bleeding.”
But they add: “In patients with diabetes, however, the JPAD2 study could not demonstrate aspirin’s benefit for primary prevention.”
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