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Aspirin An Update on its Use for Primary Prevention of Cardiovascular Events in People with Diabetes

Aspirin An Update on its Use for Primary Prevention of Cardiovascular Events in People with Diabetes . Joseph M. Bumgarner, MD Internal Medicine, PGY-1 ACC Noon Conference November 24, 2010. Questions to Consider.

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Aspirin An Update on its Use for Primary Prevention of Cardiovascular Events in People with Diabetes

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  1. AspirinAn Update on its Use for Primary Prevention of Cardiovascular Events in People with Diabetes Joseph M. Bumgarner, MDInternal Medicine, PGY-1 ACC Noon ConferenceNovember 24, 2010

  2. Questions to Consider • What is the evidence regarding aspirin to prevent initial CV events in people with diabetes? • How can we reconcile the results of the available primary prevention trials? • What are the risks of aspirin and are they different for people with diabetes? • What do we know about the recommended dosage range? • What are the current recommendations?

  3. History of Aspirin 3000 BC 1763 1899 1985

  4. Pharmacology of Aspirin Aspirin inhibits the production of thromboxane A2 by its effect on the enzyme cyclooxygenase (COX)

  5. Diabetes: Burden of Disease Percentage of Adults with DM in 2004 Centers for Disease Control and Prevention: National Diabetes Surveillance System. Available online at: http://www.cdc.gov/diabetes/statistics/index.htm. Retrieved 11/22/2010.

  6. Diabetes: Burden of Disease Percentage of Adults with DM in 2006 Centers for Disease Control and Prevention: National Diabetes Surveillance System. Available online at: http://www.cdc.gov/diabetes/statistics/index.htm. Retrieved 11/22/2010.

  7. Diabetes: Burden of Disease Percentage of Adults with DM in 2008 Centers for Disease Control and Prevention: National Diabetes Surveillance System. Available online at: http://www.cdc.gov/diabetes/statistics/index.htm. Retrieved 11/22/2010.

  8. Cardiovascular Disease Among Diabetics Increased Risk in DM Mechanisms of Risk in DM Increased thrombosis tendency both in coronary arteries and elsewhere Increased platelet activity Poor endothelial function when compared to controls • 2-4x increased risk of CV events • If over 65, CHD accounts for 68% of deaths while stroke accounts for 16% • High 1-year mortality rate post-MI: 44% in diabetic men, 37% in diabetic women Aspirin has been shown to be effective in reducing CV morbidity and mortality in high risk patients with a history of MI or Stroke (Secondary Prevention) The FDA has NOT approved aspirin for Primary Prevention, and its use in this setting is controversial for both patients with and without DM

  9. Recommendations for Aspirin and Primary Prevention USPSTF 2007 (recently updated in 2009) ADA/AHA 2007 Aspirin therapy (75–162 mg/day) should be recommended as a primary prevention strategy in those with diabetes at increased cardiovascular risk, including those who are >40 years of age or who have additional risk factors (family history of CVD, hypertension, smoking, dyslipidemia, or albuminuria). • Men 45 to 79 yrs when potential benefit due to a reduction in MI outweighs the potential harm due to an increase in GI bleeding. Grade: A • Women 55 to 79 yrs when potential benefit of a reduction in ischemic strokes outweighs the potential harm of an increase in GI bleeding. Grade: A

  10. The Studies IncludedN = 11,787 The British Medical Doctors (BMD) Physicians’ Health Study (PHS) Early Treatment of Diabetic Retinopathy Study (ETDRS) Thrombosis Prevention Trial (TPT) Hypertension Optimal Treatment (HOT) Primary Prevention Project (PPP) Women’s Health Study (WHS) Japanese Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) Prevention of Progression of Arterial Disease and Diabetes (POPADAD)

  11. 1. What is the evidence regarding aspirin to prevent initial CV events in people with diabetes? MCE: Major Coronary Event (CHD death + Nonfatal MI + Sudden Death)

  12. 2. How can we reconcile the results of the available primary prevention trials? A bit of background… The Antithrombotic Trialists’ Collaboration of the original 6 trials for primary prevention in the general population published in 2009 showed: • Overall, aspirin reduced the risk of vascular events by 12% (RR 0.88, 95% CI 0.82-0.94). There was some evidence of a difference in aspirin effect by sex: • 23% reduced CHD risk in men (RR 0.77, 95% CI 0.67-0.89). • 23% reduced Stroke risk in women (RR 0.77, 95% CI 0.59-0.99). And specifically in those with Diabetes: - The effect of aspirinon major vascular events was similar for patients with diabetes (RR 0.88, 95% CI 0.67 to 1.15).

  13. Meta-Analysis of Trials Examining the Effects of Aspirin on Risk of Cardiovascular Disease Events in Patients With Diabetes A: Effect of Aspirin on Coronary Heart Disease Events in Patients with Diabetes 9% decreased risk of CHD events, not statistically sig. (RR 0.91, 95% CI 0.79-1.05) B: Effect of Aspirin on Risk of Stroke in Patients with Diabetes 15% decreased risk of stroke, not stat. sig. (RR 0.85, 95% CI 0.66-1.11)

  14. 3. What are the risks of aspirin and are they different for people with diabetes? Major Complications of Aspirin: • Intracranial Bleeding (hemorrhagic stroke) • Extracranial Bleeding (gi bleeding)

  15. Risk of Aspirin Risk of Hemorrhagic Stroke on low dose Aspirin: • 1 in 10,000/year Risk of GI Bleeding on low dose Aspirin: • 3 in 10,000/year in middle aged adults based on data from ATT • 1 to 10 per 1000/year among free-living older adults based on a recent large cohort study. • Patients with diabetes taking Aspirin experienced a 55% increased risk in compared with those without diabetes in the ATT trial. (RR 1.55, 95% CI 1.13-2.14) • PPIs can decrease the risk of recurrent Aspirin related GI Bleeding, but it is unclear if routine use alongside Aspirin is cost-effective

  16. 4. What do we know about the recommended dosage range? • Optimal Dose is not clearly established. • Doses used in Primary Prevention Trials range between 50mg to 650mg daily. • Evidence suggests the risk reductions achieved with 75mg to 162mg daily of Aspirin are as large as those obtained at higher doses of 500mg to 1500mg daily. • Platelets in patients with diabetes have altered function, but it is unclear how this impacts a required dose for cardioprotection. • “Therefore, while aspirin resistance appears higher in diabetic patients … these observations alone are insufficient to empirically recommend higher doses of aspirin be used in the diabetic patient at this time.”

  17. Current Recommendations • Low-dose aspirin usefor preventionis reasonable for adults with diabetes who are at increased CVDrisk (10 year riskof CVD >10%) and who are not atincreased risk forbleeding . IncreasedCVD risk patients include men>50 years and women >60 years who have one ormore of the following: Smoking, HTN, HLD, FHxof premature CVD,or albuminuria. (ACCF/AHA Class IIa, Levelof Evidence: B)(ADA Level of Evidence: C) • Aspirinshould not be recommended for CVD preventionin adults withDM at low CVD risk (men < 50 yearsand women <60 years with no major additional CVD risk factors;10-yearCVD risk under 5%) . (ACCF/AHA ClassIII, Level ofEvidence: C) (ADA Level of Evidence: C) • Low-dose aspirin use for preventionmight be consideredfor those with diabetes at intermediateCVD risk (younger patientswith one or more risk factors, orolder patients with no riskfactors, or patients with 10-yearCVD risk of 5% to 10%) untilfurther research is available.(ACCF/AHA Class IIb, Level ofEvidence: C) (ADA Level of Evidence:E)

  18. References Antithrombotic Trialists' (ATT) CollaborationBaigent C, Blackwell L, et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials Lancet 2009;373:1849-1860. Buse JB, Ginsberg HN, Bakris GL, et al. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association Diabetes Care 2007;30:162-172. Centers for Disease Control and Prevention: National Diabetes Surveillance System. Available online at: http://www.cdc.gov/diabetes/statistics/index.htm. Retrieved 11/22/2010. García S, Rodríguez LA. Cardioprotective aspirin users and their excess risk of upper gastrointestinal complications BMC Med 2006;4:22. Pignone M, Alberts MJ, ColwellJA, Cushman M, Inzucchi SE, Mukherjee D, Rosenson RS, WilliamsCD, Wilson PW, and Kirkman MS. Aspirin for primary preventionof cardiovascular events in people with diabetes: a positionstatement of the American Diabetes Association, a ScientificStatement of the American Heart Association, and an Expert ConsensusDocument of the American College of Cardiology Foundation. JAm Coll Cardiol 2010;55:2878–86. US Preventive Services Task Force Aspirin for the prevention of cardiovascular disease: U.S.. Preventive Services Task Force recommendation statement. Ann Intern Med 2009;150:396-404.

  19. Happy Thanksgiving! Any Questions?

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