title: Differential effect of low-dose aspirin for primary prevention of atherosclerotic events in diabetes management: a subanalysis of the JPAD trial.
abstract: OBJECTIVE
  Recent reports showed that low-dose aspirin was ineffective in the primary prevention of cardiovascular events in diabetic patients overall. We hypothesized that low-dose aspirin would be beneficial in patients receiving insulin therapy, as a high-risk group.
  
  
  METHODS
  This study is a subanalysis of the Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) trial-a randomized, controlled, open-label trial. We randomly assigned 2,539 patients with type 2 diabetes and no previous cardiovascular disease to the low-dose aspirin group (81 or 100 mg daily) or to the no-aspirin group. The median follow-up period was 4.4 years. We investigated the effect of low-dose aspirin on preventing atherosclerotic events in groups receiving different diabetes management.
  
  
  RESULTS
  At baseline, 326 patients were treated with insulin, 1,750 with oral hypoglycemic agents (OHAs), and 463 with diet alone. The insulin group had the longest history of diabetes, the worst glycemic control, and the highest prevalence of diabetic microangiopathies. The diet-alone group had the opposite characteristics. The incidence of atherosclerotic events was 26.6, 14.6, and 10.4 cases per 1,000 person-years in the insulin, OHA, and diet-alone groups, respectively. In the insulin and OHA groups, low-dose aspirin did not affect atherosclerotic events (insulin: hazard ratio [HR] 1.19 [95% CI 0.60-2.40]; OHA: HR 0.84 [0.57-1.24]). In the diet-alone group, low-dose aspirin significantly reduced atherosclerotic events, despite the lowest event rates (HR 0.21 [0.05-0.64]).
  
  
  CONCLUSIONS
  Low-dose aspirin reduced atherosclerotic events predominantly in the diet-alone group and not in the insulin or OHA groups.
authors.affiliation: First Department of Internal Medicine, Nara Medical University, Shijo-cho, Kashihara, Nara, Japan.
authors.forename: Sadanori
authors.initials: S
authors.lastname: Okada
authors.forename: Takeshi
authors.initials: T
authors.lastname: Morimoto
authors.forename: Hisao
authors.initials: H
authors.lastname: Ogawa
authors.forename: Masao
authors.initials: M
authors.lastname: Kanauchi
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: Mio
authors.initials: M
authors.lastname: Sakuma
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Saito
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000008:administration & dosage*; D050197:Atherosclerosis / Q000188:drug therapy / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000178:diet therapy / Q000188:drug therapy*; D003925:Diabetic Angiopathies / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000627:therapeutic use*; D008875:Middle Aged
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin; D001241:Aspirin