Abstract 9876: Relative Efficacy of Aspirin Therapy in Relation to C-Reactive Protein Levels in Type 2 Diabetic Patients: Subgroup Analysis Derived From the JPAD Trial

Abstract

Background: The Japanese primary prevention of atherosclerosis with aspirin for diabetes (JPAD) trial was undertaken to examine the efficacy of aspirin therapy. It was a multicenter, prospective, randomized, open label, blinded end-point trial conducted from 2002 through 2008 and it had a median follow-up of 4.37 years. Low-grade chronic inflammation, as indicated by levels of the inflammatory marker C-reactive protein (CRP), prospectively defines the risk of atherosclerotic complications. Methods: CRP levels were measured in 1529 patients (772 aspirin therapy patients; and, 757 non-aspirin therapy patients) of the JPAD trial at enrollment. In this subgroup analysis of the JPAD trial, we divided the 1529 patients into either a high CRP group (CRP≥ 0.1 mg /dl) or a low CRP group (CRP< 0.1 mg/dl) according to the baseline CRP levels. We compared the incidence rates of primary cardiovascular events in aspirin users and non-aspirin users, respectively. Results: There were no significant differences in the incidence rates of acute myocardial infarction between the High CRP Group and the Low CRP Group (hazard ratio, 1.45; 95% confidence interval, 0.46-6.37; log-rank P=0.5623). The incidence rate of stroke events though was significantly higher in the High CRP Group (44 patients (pts) of 1131) than in the Low CRP Group (7 pts of 398; log-rank P=0.0361, Figure). There was no significant difference in the incidence rates of stroke events between the High CRP Group (20 pts of 562) and the Low CRP Group (5 pts of 210) in the aspirin users, but there was a significant difference between the High CRP Group (24 pts of 569) and the Low CRP Group (2 pts of 188) in the non-aspirin users (Figure). Conclusions: Our subgroup analysis of the JPAD trial demonstrates that CRP level predicts the incidence of stroke events in patients with type 2 diabetes mellitus. Aspirin therapy is significantly more effective at preventing stroke events, especially in high CRP patients with type 2 diabetes mellitus.