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Randomized Controlled Trial
. 2011 Feb;34(2):280-5.
doi: 10.2337/dc10-1615.

Low-dose aspirin therapy in patients with type 2 diabetes and reduced glomerular filtration rate: subanalysis from the JPAD trial

Collaborators, Affiliations
Randomized Controlled Trial

Low-dose aspirin therapy in patients with type 2 diabetes and reduced glomerular filtration rate: subanalysis from the JPAD trial

Yoshihiko Saito et al. Diabetes Care. 2011 Feb.

Abstract

Objective: Type 2 diabetes accompanied by renal damage is a strong risk factor for atherosclerotic events. The purpose of this study was to investigate the efficacy of low-dose aspirin therapy on primary prevention of atherosclerotic events in patients with type 2 diabetes and coexisting renal dysfunction.

Research design and methods: The Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) trial was a prospective, randomized, open-label trial conducted throughout Japan that enrolled 2,539 type 2 diabetic patients without a history of atherosclerotic diseases. Patients were assigned to the aspirin group (81 mg/day or 100 mg/day) or the nonaspirin group and followed for a median of 4.37 years. The primary end points were atherosclerotic events of fatal and nonfatal ischemic heart disease, stroke, and peripheral arterial disease.

Results: The analysis included 2,523 patients who had serum creatinine measured. In 1,373 patients with baseline estimated glomerular filtration rate (eGFR) 60-89 mL/min/1.73 m(2), the incidence of primary end points was significantly lower in the aspirin group than in the nonaspirin group (aspirin, 30/661; nonaspirin, 55/712; hazard ratio 0.57 [95% CI 0.36-0.88]; P = 0.011). Low-dose aspirin therapy did not reduce primary end points in patients with eGFR ≥ 90 mL/min/1.73 m(2) (aspirin, 9/248; nonaspirin, 11/270; 0.94 [0.38-2.3]) or those with eGFR <60 mL/min/1.73 m(2) (aspirin, 29/342; nonaspirin, 19/290; 1.3 [0.76-2.4]). The Cox proportional hazard model demonstrated a significant interaction between mild renal dysfunction (eGFR 60-89 mL/min/1.73 m(2)) and aspirin (P = 0.02).

Conclusions: These results suggest a differential effect of low-dose aspirin therapy in diabetic patients with eGFR 60-89 mL/min/1.73 m(2).

Trial registration: ClinicalTrials.gov NCT00110448.

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Figures

Figure 1
Figure 1
Percentage of primary end points by category of patients with eGFR of at least 90 mL/min/1.73 m2 (A), 60–89 mL/min/1.73 m2 (B), or <60 mL/min/1.73 m2 (C).
Figure 2
Figure 2
Subgroup analysis of incidence of primary end points.

References

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