DM Full Guideline (2010) - VA/DoD Clinical Practice Guidelines Home

Version 4.0
VA/DoD Clinical Practice Guideline
for the Management of Diabetes Mellitus
The study included 3,700 persons with type 1 and type 2 DM and with diabetic retinopathy. In this study, those
patients with type 2 DM randomized to receive a 650 mg dose of aspirin per day, had no significant improvement in
cardiovascular outcomes. In considering this result, however, the issue of generalizability arose. This group of
patients with diabetes with retinopathy may have represented a population with more severe diabetes that perhaps
puts them at higher risk of cardiovascular complications. Because of the insufficient power of this study, the lack of
demonstrated benefit of antiplatelet therapy in this group should be taken as only a tentative suggestion that such
therapy may not be useful as a routine practice among persons with type 2 DM.
Sacco et al. (2003) concluded that “low dose aspirin might be less effective in patients with DM as compared with
the general population” in primary prevention of cardiovascular events. The study was suggested as inconclusive
due to low statistical power. Ogawa et al. (2008) examined the efficacy of low dose aspirin for primary prevention
of atherosclerotic events in Japanese patients with type 2 diabetes. There was no statistical difference in
atherosclerotic events in the patients treated with low dose aspirin. However, there was a statistical difference in a
prespecified subgroup analysis of atherosclerotic events in patients over age 65.
When considering the value of antiplatelet therapy in persons with DM, the opposite question is also valid: what are
the potential dangers of such therapy for persons with DM? de Gaetano (2001) reported that aspirin users
experienced more bleeding episodes, but concluded that the safety profile was acceptable. Hansen et al. (2000)
investigated a possible contraindication to the use of aspirin in persons with DM. They conducted a small study to
determine whether the use of aspirin interfered with the classification of albumin excretion rate (AER) or monitoring
of antiproteinuric treatment in such patients. They found that “treatment with 150 mg ASA daily did not have any
impact on AER or glomerular filtration rate (GFR) in patients with type 1 diabetes with macroalbuminuria.” This
initial evidence suggests that aspirin does not jeopardize antiproteinuric treatment monitoring in persons with DM.
Ogawa et al. (2008) found no statistically significant difference in hemorrhagic stroke or gastrointestinal bleeding
between the treatment and control groups. Sacco et al. (2003) did find a statistically significant increase (1.9% in
aspirin group vs. 0.2% in control group) gastrointestinal bleeding in the treatment group.
The findings of the studies suggest that these recommendations may be applicable for patients with type 1 DM;
however, there is no evidence to support this intuitively appealing observation. Patients with type 1 DM may be
individually evaluated for aspirin therapy, with consideration of both duration of disease and the presence of other
cardiovascular risk factors.
EVIDENCE
Recommendation Sources LE QE SR
1 Aspirin therapy for patients with
type 2 DM and evidence of
large vessel disease.
Antiplatelet Trialists'
Collaboration, 1994
de Gaetano, 2001
I Good A
2 Aspirin therapy for patients with
type 2 DM age ≥ 40 with and
one or more other
cardiovascular risk factors
3 Aspirin therapy for younger
patients (age 30 to 40) with
type 2 DM or with type 1 DM
and other cardiovascular risk
factors
Antiplatelets Trialists'
Collaboration, 1994
de Gaetano, 2001
EDTRS, 1992
Ogawa et al., 2008
Sacco et al., 2003
I Fair B
Working Group Consensus III Poor I
LE-Level of Evidence; QE = Quality of Evidence; SR = Strength of Recommendation (see Appendix A)
Module D: Core Page 22