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A randomized trial of low-dose aspirin in the prevention of clinical type 2 diabetes in women.

Pradhan AD, Cook NR, Manson JE, Ridker PM, Buring JE - Diabetes Care (2008)

Bottom Line: Subclinical inflammation is linked with the development of type 2 diabetes, and epidemiologic data suggest that this association may be stronger in women.Analyses accounting for treatment duration and adherence similarly found no beneficial effects.These data suggest that long-term low-dose aspirin does not prevent the development of clinical type 2 diabetes in initially healthy women.

View Article: PubMed Central - PubMed

Affiliation: Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. apradhan@partners.org.

ABSTRACT

Objective: Subclinical inflammation is linked with the development of type 2 diabetes, and epidemiologic data suggest that this association may be stronger in women. Although small clinical studies have shown a prominent hypoglycemic effect of short-term high-dose aspirin, no randomized trials have directly evaluated the efficacy of aspirin in diabetes prevention at doses acceptable for use in routine clinical practice. We evaluated whether chronic low-dose aspirin prevents the development of clinical diabetes among initially healthy American women.

Research design and methods: Subjects were enrolled in the Women's Health Study, a 10-year randomized double-blind, placebo-controlled trial of aspirin and vitamin E for primary prevention of cardiovascular disease and cancer. Between 1992 and 1995, 38,716 women aged > or =45 years and free of clinical diabetes were randomly assigned to either low-dose aspirin or placebo (median follow-up 10.2 years). Documented clinical type 2 diabetes was prospectively evaluated throughout the trial.

Results: Among women randomly assigned to receive aspirin (n = 19,326) or placebo (n = 19,390), there was no statistically significant difference in the incidence of type 2 diabetes. There were 849 cases of diabetes in the aspirin group and 847 in the placebo group (rate ratio 1.01 [95% CI 0.91-1.11]). Stratification by diabetes risk factors including age, BMI, family history of diabetes, physical activity, A1C, and high-sensitivity C-reactive protein did not support a modulating effect of these variables. Analyses accounting for treatment duration and adherence similarly found no beneficial effects.

Conclusions: These data suggest that long-term low-dose aspirin does not prevent the development of clinical type 2 diabetes in initially healthy women.

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Cumulative incidence of type 2 diabetes in the aspirin and placebo groups.
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f1: Cumulative incidence of type 2 diabetes in the aspirin and placebo groups.

Mentions: The cumulative incidence curves according to treatment assignment were similar throughout follow-up (Fig. 1) (log-rank P = 0.92). A test of the proportionality hazards assumption showed no deviation from proportionality (P = 0.27). In separate analyses that considered newly diagnosed diabetes in the first 5 years of follow-up versus thereafter, aspirin therapy was associated with an RR of 0.99 (95% CI 0.86–1.15) during the first 5 years and 1.01 (0.90–1.15) after 5 years. We found no difference when patients with potentially undiagnosed diabetes documented during the first 2 or 5 years of follow-up were excluded. In these analyses the RRs were 0.99 (0.89–1.09) and 1.01 (0.90–1.15), respectively.


A randomized trial of low-dose aspirin in the prevention of clinical type 2 diabetes in women.

Pradhan AD, Cook NR, Manson JE, Ridker PM, Buring JE - Diabetes Care (2008)

Cumulative incidence of type 2 diabetes in the aspirin and placebo groups.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2606820&req=5

f1: Cumulative incidence of type 2 diabetes in the aspirin and placebo groups.
Mentions: The cumulative incidence curves according to treatment assignment were similar throughout follow-up (Fig. 1) (log-rank P = 0.92). A test of the proportionality hazards assumption showed no deviation from proportionality (P = 0.27). In separate analyses that considered newly diagnosed diabetes in the first 5 years of follow-up versus thereafter, aspirin therapy was associated with an RR of 0.99 (95% CI 0.86–1.15) during the first 5 years and 1.01 (0.90–1.15) after 5 years. We found no difference when patients with potentially undiagnosed diabetes documented during the first 2 or 5 years of follow-up were excluded. In these analyses the RRs were 0.99 (0.89–1.09) and 1.01 (0.90–1.15), respectively.

Bottom Line: Subclinical inflammation is linked with the development of type 2 diabetes, and epidemiologic data suggest that this association may be stronger in women.Analyses accounting for treatment duration and adherence similarly found no beneficial effects.These data suggest that long-term low-dose aspirin does not prevent the development of clinical type 2 diabetes in initially healthy women.

View Article: PubMed Central - PubMed

Affiliation: Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. apradhan@partners.org.

ABSTRACT

Objective: Subclinical inflammation is linked with the development of type 2 diabetes, and epidemiologic data suggest that this association may be stronger in women. Although small clinical studies have shown a prominent hypoglycemic effect of short-term high-dose aspirin, no randomized trials have directly evaluated the efficacy of aspirin in diabetes prevention at doses acceptable for use in routine clinical practice. We evaluated whether chronic low-dose aspirin prevents the development of clinical diabetes among initially healthy American women.

Research design and methods: Subjects were enrolled in the Women's Health Study, a 10-year randomized double-blind, placebo-controlled trial of aspirin and vitamin E for primary prevention of cardiovascular disease and cancer. Between 1992 and 1995, 38,716 women aged > or =45 years and free of clinical diabetes were randomly assigned to either low-dose aspirin or placebo (median follow-up 10.2 years). Documented clinical type 2 diabetes was prospectively evaluated throughout the trial.

Results: Among women randomly assigned to receive aspirin (n = 19,326) or placebo (n = 19,390), there was no statistically significant difference in the incidence of type 2 diabetes. There were 849 cases of diabetes in the aspirin group and 847 in the placebo group (rate ratio 1.01 [95% CI 0.91-1.11]). Stratification by diabetes risk factors including age, BMI, family history of diabetes, physical activity, A1C, and high-sensitivity C-reactive protein did not support a modulating effect of these variables. Analyses accounting for treatment duration and adherence similarly found no beneficial effects.

Conclusions: These data suggest that long-term low-dose aspirin does not prevent the development of clinical type 2 diabetes in initially healthy women.

Show MeSH
Related in: MedlinePlus