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research-article2014

AOPXXX10.1177/1060028014561083Annals of PharmacotherapyMiyares and Davis

Letter to the Editor

Evaluation of Aspirin Use for Primary Prevention in Diabetic Patients

It is with much interest that we read the research report by Fosmire Rundgren et al1 evaluating whether patients with diabetes indicated for aspirin therapy were in fact taking it. Although the authors reference the Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) and Prevention of Progression of Arterial Disease and Diabetes (POPADAD) trials, neither trial demonstrated that low-dose aspirin therapy reduced the risk of the primary composite end points, including coronary heart disease and stroke.2,3 Whereas the lack of benefit with aspirin was reiterated in several small-scale meta-analyses, the larger-scale Antithrombotic Trialist’s (ATT) Collaboration4 evaluated 6 primary prevention trials, demonstrating a small but significant absolute risk reduction in serious vascular events (0.51% aspirin vs 0.57% control per year, P = 0.0001). Because not all patients with diabetes have the same cardiovascular disease (CVD) risk, recommendations for aspirin use are dependent on an accurate evaluation of CVD risk factors. Furthermore, the relatively high number needed to treat associated with aspirin therapy requires practitioners to evaluate risks versus benefits. Currently, there are 2 ongoing trials that will provide further guidance regarding the role of low-dose aspirin for primary prevention in patients with diabetes. Until then, it remains unclear whether aspirin for prevention of CVD events in adults with diabetes is warranted. Indeed, the authors are to be commended for their efforts in surveying patients receiving care in the community to determine indication for aspirin therapy. However, we feel that these efforts should be targeted at identifying risk factors for consideration of more established therapies. Cholesterol management with statin therapy, blood pressure control, and smoking cessation have all been proven to reduce CVD risk in patients with diabetes. Whether patients have sufficient CVD risk to warrant aspirin depends on whether these techniques have been fully incorporated. Considering the potential adverse effects associated with aspirin, if these treatments are implemented first, then fewer patients with diabetes will remain at sufficient risk to benefit from aspirin therapy. Whereas no patients in the study by Fosmire Rundgren et al1 were found to have a history of gastrointestinal bleed or hemorrhagic stroke, the major adverse events associated

Annals of Pharmacotherapy 2015, Vol. 49(1) 150­–151 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1060028014561083 aop.sagepub.com

with aspirin involve both gastrointestinal and intracranial bleeds. Recently, the Food and Drug Administration issued a warning that the bleeding potential with aspirin may outweigh the benefits when used for primary prevention. Comparatively, the risk for major adverse events (rhabdomyolysis and hemorrhagic stroke) with statins is estimated to be a 100-fold more in patient-years compared with aspirin. Additionally, the benefit of statin therapy is approximately 22% for every 39 mg/dL reduction in low-density lipoprotein cholesterol, compared with a 15% relative reduction with aspirin.5 We are pleased with the research report that Fosmire Rundgren et al1 have provided and await large-scale trials to better define the role of aspirin for primary prevention in patients with diabetes. In the meantime, we advocate for the use of more-established treatment options such as statin therapy. Marta A. Miyares, PharmD Clinical Hospital Pharmacist, Internal Medicine, Director Post Graduate Year One (PGY1) Residency Program, Pharmacy Department, Jackson Memorial Hospital, Miami, FL, USA [email protected] Kyle A. Davis, PharmD Clinical Hospital Pharmacist, Internal Medicine, Pharmacy Department, Jackson Memorial Hospital, Miami, FL, USA References 1.   Fosmire Rundgren EW, Anderson SL, Marrs JC. Evaluation of aspirin use in patients with diabetes receiving care in community health [published online October 6, 2014]. Ann Pharmacother. doi:10.1177/1060028014554444. 2.   Ogawa H, Nakayama M, Morimoto T, et al; Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial Investigators. Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial. JAMA. 2008;300:2134-2141. 3. Belch J, MacCuish A, Campbell I, et al; Prevention of Progression of Arterial Disease and Diabetes Study Group; Diabetes Registry Group; Royal College of Physicians Edinburgh. The Prevention of Progression of Arterial Disease and Diabetes (POPADAD) trial: factorial randomised placebo controlled trial of aspirin and antioxidants in patients with

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Miyares and Davis diabetes and asymptomatic peripheral arterial disease. BMJ. 2008;337:a1840. 4. Antithrombotic Trialists’ (ATT) Collaboration; Baigent C, Blackwell L, Collins R, et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative metaanalysis of individual participant data from randomised trials. Lancet. 2009;373:1849-1860.

5.  Stone NJ, Robinson JG, Lichtenstein AH, et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25, suppl 2):S1-S45.

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Evaluation of aspirin use for primary prevention in diabetic patients.

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