title: Low-dose aspirin therapy in patients with type 2 diabetes and reduced glomerular filtration rate: subanalysis from the JPAD trial.
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.
  
  
  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).
authors.affiliation: First Department of Internal Medicine, Nara Medical University, Kashihara, Nara, Japan. yssaito@naramed-u.ac.jp
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Saito
authors.forename: Takeshi
authors.initials: T
authors.lastname: Morimoto
authors.forename: Hisao
authors.initials: H
authors.lastname: Ogawa
authors.forename: Masafumi
authors.initials: M
authors.lastname: Nakayama
authors.forename: Shiro
authors.initials: S
authors.lastname: Uemura
authors.forename: Naofumi
authors.initials: N
authors.lastname: Doi
authors.forename: Hideaki
authors.initials: H
authors.lastname: Jinnouchi
authors.forename: Masako
authors.initials: M
authors.lastname: Waki
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Soejima
authors.forename: Seigo
authors.initials: S
authors.lastname: Sugiyama
authors.forename: Sadanori
authors.initials: S
authors.lastname: Okada
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Akai
mesh_terms: D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D050197:Atherosclerosis / Q000517:prevention & control*; D003404:Creatinine / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D003925:Diabetic Angiopathies / Q000453:epidemiology / Q000517:prevention & control*; D003928:Diabetic Nephropathies / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000453:epidemiology / Q000517:prevention & control; D058729:Peripheral Arterial Disease / Q000453:epidemiology / Q000517:prevention & control; D011446:Prospective Studies; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology / Q000517:prevention & control
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003404:Creatinine; D001241:Aspirin