Best Evidence Analyses and Commentary

American Diabetes Association Revises Standards of Care
Lucas Reinhartz, Kimberly Crowell, Kristin Ludolph, Courtney Roberts, PharmD Candidates Ryan Wargo, PharmD, BCACP; Marcus Campbell, PharmD, BC-ADM
03/13/13

The American Diabetes Association (ADA) issues clinical practice guidelines for the “Standards of Medical Care in Diabetes” every January. Some of the major revisions to the 2013 guideline include recommendations for a less stringent systolic blood pressure goal and individualization of blood glucose self-monitoring. These revisions and other changes are reviewed:

Hypertension: The new ADA recommended blood pressure goal in diabetic patients has been revised from <130/80 mmHg to <140/80 mmHg (B).1-3 The primary data for this recommendation came from the result of the ACCORD trial, which found no statistical difference in the rate of nonfatal major cardiovascular events or all-cause death when SBP goal was increased to 140 mmHg. Only the annual rate of stroke showed statistically significant reductions with intensive treatment (SBP <120mmHg); however, serious adverse events were higher.2 In addition, a subgroup analysis of the INVEST trial found a higher rate of all-cause mortality in diabetic patients with a targeted SBP of <130 mmHg compared to <140 mmHg.3 For diabetic patients with confirmed BP ≥140/80 mmHg, the recommended treatment is to initiate pharmacological therapy followed by titration combined with lifestyle changes to achieve blood pressure goals (B).1

Dyslipidemia: Patients with type 2 diabetes often have elevated lipid levels leading to increased risk for CV complications. LDL cholesterol-targeted statin therapy remains the preferred treatment strategy for diabetic patients with dyslipidemia (A); however, recommendations regarding the use of combination therapy have changed. Combination therapy with a statin and a fibrate or niacin has been associated with an increased risk for abnormal transaminase levels, myositis, and rhabdomyolysis and has not been shown to reduce the rate of CV events compared to monotherapy.5-7 Based on clinical evidence, combination therapy has been shown not to provide additional benefit over statin therapy alone and is not generally recommended (A).1

Glucose Monitoring: The new ADA self-monitoring of blood glucose (SMBG) recommendations focus on the fact that each patient will require their own individualized frequency and timing of their tests. patients on multiple dose insulin (MDI) or insulin pump therapy should do SMBG at least prior to meals and snacks, occasionally after meals, at bedtime, prior to exercise, when they suspect low blood glucose, after treating low blood glucose until they have normal levels, and prior to critical tasks (B).1 This evidence was demonstrated in a database study finding that one additional SMBG per day decreased A1c by 0.20% (P<0.001) and a higher frequency of SMBG was related to better metabolic control and fewer acute complications.4

Hypoglycemia: The ACCORD trial found that patients with cognitive impairment at baseline were associated with a greater risk of severe hypoglycemia.8 In addition, a longitudinal cohort study of older patients with type 2 diabetes showed that patients with a history of severe hypoglycemia were associated with a higher risk of dementia.9 Therefore, it is recommended to re-evaluate treatment for patients who have experienced >1 severe hypoglycemic episodes and remain unaware about hypoglycemic care (E), to assess cognitive function regularly for patients with low or declining cognition, and suggest increased attention for hypoglycemia by clinician, patient, and caregivers (B). Also, insulin treated patients with hypoglycemia unawareness or an episode of severe hypoglycemia should be advised on how to raise their blood glucose (A).1

Prevention/Delay of Type 2 Diabetes: Pre-diabetic patients often present with other cardiovascular risk factors including obesity, hypertension and dyslipidemia. The Diabetes Prevention Program Outcomes Study found that appropriate management of these risk factors yields less cardiovascular events.10 Therefore, it is recommended to screen and treat modifiable risk factors for CVD (B).1

Retinopathy Screening and Treatment: In the RISE and RIDE trials, researchers found that anti-vascular endothelial growth factor (VEGF) therapy with ranibizumab showed improved vision and reductions in the need for laser coagulation procedures in patients with macular edema.11 On the basis of these two trials, therapy with anti-VEGF agents is now indicated for diabetic macular edema (A).1

Immunization: The Advisory Committee on Immunization Practices (ACIP) reports that acute HBV infection is about twice as high in diabetic versus non-diabetic adults age ≥23 years and that some evidence shows a higher fatality rate in diabetics with HBV.12Based on these reports, unvaccinated adults age 19-59 years are recommended to receive the hepatitis B vaccination series, and vaccination for adults age 60 years or more should be considered (C).1

 

 References

  1. American Diabetes Association. Standards of medical care in diabetes—2013. Diabetes Care 2013 January; 36:S11-S66
  2. CushmanWC, Evans GW, Byington RP, et al.; ACCORD Study Group. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010;362:1575–1585
  3. Cooper-DeHoff RM, Gong Y, Handberg EM, et al. Tight blood pressure control and cardiovascular outcomes among hypertensive patients with diabetes and coronary artery disease. JAMA 2010;304:61–68
  4. Jones PH, Davidson MH. Reporting rate of rhabdomyolysis with fenofibrate + statin versus gemfibrozil + any statin. Am J Cardiol 2005;95:120–122
  5. Boden WE, Probstfield JL, Anderson T, et al.; AIM-HIGH Investigators. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. N Engl J Med 2011;365:2255–2267
  6. The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010;362:1563-74
  7. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329:977-986
  8. Nathan DM, Cleary PA, Backlund JY, et al. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005;353:26432653
  9. DeWittDE, HirschIB.Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientific review. JAMA 2003;289:2254226
  10. Rosenstock J, Dailey G, Massi-Benedetti M, Fritsche A, Lin Z, Salzman et al. Reduced hypoglycemia risk with insulin glargine: a meta-analysis comparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care 2005;28:950955
  11. Bennett WL, Maruthur NM, SinghS, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med 2011;154:602613
  12. Centers for Disease Control and Prevention. Use of hepatitis B vaccination for adults with diabetes mellitus: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2012;60:1709–1711
  13. Ziegler R, Heidtmann B, Hilgard D, Hofer S, Rosenbauer J, Holl R; DPVWiss Initiative. Frequency of SMBG correlates with HbA1c and acute complications in children and adolescents with type 1 diabetes. Pediatr Diabetes 2011;12:11–17
  14. Punthakee Z, Miller ME, Launer LJ, Williamson JD, Lazar RM, Cukierman-Yaffee T et al. Poor Cognitive Function and Risk of Severe Hypoglycemia in Type 2 Diabetes Post hoc epidemiologic analysis of the ACCORD trial. Diabetes Care 2012 Apr; 35(4), 787-793
  15. Whitmer RA, Karter AJ, Yaffe K, Quesenberry CP, Selby JV. Hypoglycemic episodes and risk of dementia in older patients with type 2 diabetes mellitus. JAMA 2009;301:1565157
  16. Orchard TJ, Temprosa M, Barrett-Connor E, Fowler SE, Goldberg RB, Mather KJ et al. Long-term effects of the Diabetes Prevention Program interventions on cardiovascular risk factors: a report from the DPP Outcomes Study. Diabet Med. 2013 Jan;30(1):46-55
  17. Nguyen QD, Brown DM, Marcus DM, et al. RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology 2012;119:789–801

 

 

 


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