title: Is Long-Term Low-Dose Aspirin Therapy Associated with Renal Dysfunction in Patients with Type 2 Diabetes? JPAD2 Cohort Study.
abstract: BACKGROUND
  Low-dose aspirin is widely recommended for patients at high risk for cardiovascular disease (CVD); however, it remains uncertain whether long-term treatment adversely affects renal function in patients with diabetes. We investigated whether long-term low-dose aspirin affects renal dysfunction in patients with diabetes.
  
  
  METHODS
  We conducted a randomized controlled trial (RCT), the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) trial, to evaluate low-dose aspirin as primary prevention for CVD in patients with type 2 diabetes. We followed the patients with negative urine dipstick albumin of the JPAD trial in a cohort study after the RCT period was completed. Patients were randomly allocated to receive aspirin (81 mg or 100 mg daily, aspirin group) or no aspirin (no aspirin group). After the RCT, the treating physician decided whether to administer aspirin. We evaluated the incidence of positive urine dipstick albumin and annual changes in estimated glomerular filtration rate (eGFR).
  
  
  RESULTS
  Positive urine dipstick albumin developed in 297 patients in the aspirin group (n = 1,075) and 270 patients in the no aspirin group (n = 1,098) during follow-up (median, 8.5 years). Intention-to-treat analysis showed low-dose aspirin did not increase the incidence of positive urine dipstick albumin (hazard ratio [HR], 1.17; 95% confidence interval [CI], 0.995-1.38). On-treatment analysis yielded similar results (HR, 1.08; 95% CI, 0.92-1.28). Multivariable analysis showed the incidence of positive urine dipstick albumin was higher among the elderly and those with elevated serum creatinine, high hemoglobin A1c, or high blood pressure; however, low-dose aspirin did not increase the risk of positive urine dipstick albumin. There were no significant differences in annual changes in eGFR between the groups (aspirin, -0.8 ± 2.9; no aspirin, -0.9 ± 2.5 ml/min/1.73 m(2)/year).
  
  
  CONCLUSIONS
  Long-term low-dose aspirin does not affect eGFR and positive urine dipstick albumin in patients with type 2 diabetes.
authors.affiliation: Department of Diabetology, Nara Medical University, Kashihara, Nara, Japan.|First Department of Internal Medicine, Nara Medical University, Kashihara, Nara, Japan.
authors.forename: Sadanori
authors.initials: S
authors.lastname: Okada
authors.affiliation: Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Morimoto
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan.
authors.forename: Hisao
authors.initials: H
authors.lastname: Ogawa
authors.affiliation: Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.
authors.forename: Mio
authors.initials: M
authors.lastname: Sakuma
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Soejima
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Nakayama
authors.affiliation: Diabetes Care Center, Jinnouchi Hospital, Kumamoto, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Jinnouchi
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Shizuoka City Hospital, Shizuoka, Japan.
authors.forename: Masako
authors.initials: M
authors.lastname: Waki
authors.affiliation: Department of Diabetology, Nara Medical University, Kashihara, Nara, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Akai
authors.affiliation: Department of Diabetology, Nara Medical University, Kashihara, Nara, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Ishii
authors.affiliation: First Department of Internal Medicine, Nara Medical University, Kashihara, Nara, Japan.|Department of Regulatory Medicine of Blood Pressure, Nara Medical University, Kashihara, Nara, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Saito
mesh_terms: D000368:Aged; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000503:physiopathology*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D007668:Kidney / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged
chemical_list: D001241:Aspirin