Low-dose aspirin shows neutral CV benefit, increases bleeding risk in type 2 diabetes
NEW ORLEANS — In patients with type 2 diabetes, low-dose aspirin therapy did not affect the risk for CV events, but increased risk for gastrointestinal bleeding compared with patients not assigned aspirin therapy, according to data presented at the American Heart Association Scientific Sessions.
A team of researchers in Japan analyzed data on 1,621 patients with type 2 diabetes and no pre-existing CVD who participated in the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JAPD), a randomized, open-label, standard-care controlled trial examining the benefit of low-dose aspirin. The mean age at baseline was 65 years, 55% were men and the mean duration of diabetes was 7 years). The study was initiated in 2002; 2,160 patients who retained their original allocation were included in the per-protocol analysis.
Patients were assigned to receive aspirin therapy (81 mg or 100 mg daily; n = 992) or no aspirin (n = 1,168). After the trial ended in April 2008, researchers followed patients biennially until July 2015 (mean, 10.3 years) without changing previously assigned therapies. The original JAPD trial and follow-up period constitute the JAPD2 study.
The primary endpoints were time to first occurrence of CV death, fatal or nonfatal CAD, fatal or nonfatal stroke and peripheral vascular disease.
During follow-up, 317 CV events occurred: 151 in the aspirin group and 166 in the non-aspirin group. Researchers observed no between-group differences for the primary endpoints; the HR for aspirin therapy was 1.14 (95% CI, 0.91-1.42). Results persisted after adjustment for age, sex, glycemic control, kidney function, smoking status, hypertension and dyslipidemia (HR = 1.04; 95% CI, 0.83-1.3).
Within the cohort, 25 patients in the aspirin group and 12 patients in the non-aspirin group developed GI bleeding. There were no between-group differences for hemorrhagic stroke.
“The post-trial follow-up of the JPAD trial, comprising a mean observation during and after the trial of over a decade, indicated that long-term therapy with low-dose aspirin is not associated with lower cardiovascular events in Japanese patients with type 2 diabetes in a primary prevention setting,” Yoshihiko Saito, MD, PhD, from the first department of internal medicine at Nara Medical University in Nara, Japan, and colleagues wrote in a study abstract presented here. “On the other hand, low-dose aspirin therapy was associated with a significantly increased incidence of gastrointestinal bleeding.” – by Regina Schaffer
Saito Y, et al. Presentation 318 – Ancel Keys Memorial Lecture: Lifestyle and Medical. Presented at: American Heart Association Scientific Sessions; Nov. 12-16, 2016; New Orleans.
Disclosure: Saito reports receiving research grants, honoraria or serving as an expert witness on behalf of multiple pharmaceutical companies. The Ministry of Health Labor and Welfare of Japan and the Japan Heart Foundation supported this study.