2008 Clinical Practice Guidelines - Canadian Diabetes Association

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2008 CLINICAL PRACTICE GUIDELINES S124 out diabetes. Generally, heart failure in people with diabetes should be treated similarly to those without diabetes, although comorbidities such as renal dysfunction may be more prevalent in people with diabetes and may influence heart failure drug doses and monitoring of therapy. Treatment choices for diabetes (i.e. dietary and/or pharmacologic therapy) each have advantages and disadvantages in heart failure patients. Metformin Metformin is an effective oral antihyperglycemic agent but, based on isolated case reports and a biochemical rationale for a risk of lactic acidosis (16-18), it is approved for use under a warning in the setting of several conditions, including heart failure.Two large meta-analyses and a smaller case series have evaluated the occurrence and outcomes of lactic acidosis with the use of metformin or other antihyperglycemic agents in over 40 000 subjects, including those with heart failure. Only subjects with a serum creatinine of up to 150 µmol/L were included in the meta-analyses, and up to 200 µmol/L in the case series. Lactic acidosis was not increased, and cardiovascular outcomes in heart failure patients taking metformin were better than in those taking other antihyperglycemic agents.The current evidence suggests that patients with heart failure fare at least as well, if not better, with metformin than with other antihyperglycemic agents if they have only mild to moderate renal dysfunction (estimated glomerular filtration rate [eGFR] >30 mL/min). As such, metformin should still be considered as first-line therapy in heart failure patients with mild to moderate renal dysfunction (16-18). Thiazolidinediones Thiazolidinediones (TZDs) are known to cause fluid retention, although this is generally mild. Recent studies suggest that this is not a direct toxic effect on the myocardium.The Prospective Pioglitazone Clinical Trial In Macrovascular Events (PROAC- TIVE) study of pioglitazone in individuals at risk of cardiac ischemic events showed that TZDs were associated with fewer cardiac ischemic events, but at the cost of an increase in heart failure hospitalizations (2% absolute excess over 2.8 years, or 5000 subjects, a significant reduction of new glucose intolerance and cardiovascular events (0.8% absolute reduction) were seen with rosiglitazone, but a small excess of new-onset heart failure was also observed (0.4% absolute excess) (20). A recently completed randomized trial comparing the efficacy of rosiglitazone, metformin or glyburide monotherapy in people with type 2 diabetes reported a greater treatment failure rate of monotherapy with glyburide or metformin compared to rosiglitazone, but an increase in reported heart failure with rosiglitazone. When only adjudicated events were considered, there was no significant difference in cardiovascular-related or heart failure-related mortality in any arm (21). Recent reports suggest that the fluid retention can be safely managed with careful observation, taking care not to increase diuretic therapy in the absence of either symptoms or signs of central volume overload rather than just peripheral edema (17,18). In an addition to product monographs in November 2007, Health Canada advised that, “Treatment with all rosiglitazone products is now contraindicated in patients with any stage of heart failure, (i.e. NYHA Class I, II, III or IV).” (22) A recent meta-analysis (23) has not confirmed any difference in the risk of congestive heart failure between rosiglitazone and pioglitazone. Glitazones may be used cautiously in patients with stable mild heart failure if close specialist monitoring is available, but should not be used in patients with unstable or severe heart failure. A detailed discussion of the rationale and evidence for the treatment approach to heart failure patients is available in the Canadian Cardiovascular Society consensus recommendations (http://www.hfcc.ca) (1,24). RECOMMENDATIONS 1. Individuals with diabetes and heart failure should receive the same heart failure therapies as those identified in the evidence-based Canadian Cardiovascular Society heart failure recommendations (http://www.hfcc.ca) [Grade D, Consensus]. 2. Unless contraindicated, metformin may be used in people with type 2 diabetes and heart failure [Grade C, Level 3 (16,17)]. Metformin should be temporarily withheld if renal function acutely worsens, and should be discontinued if renal function significantly and chronically worsens [Grade D, Consensus]. 3. Physicians should be aware that people taking TZDs are at increased risk of heart failure and may present with symptoms such as increased dyspnea and peripheral edema [Grade B, Level 2 (19,20)]. 4. In people with diabetes and heart failure and an eGFR
OTHER RELEVANT GUIDELINES Physical Activity and Diabetes, p. S37 Nutrition Therapy, p. S40 Pharmacologic Management of Type 2 Diabetes, p. S53 Screening for the Presence of Coronary Artery Disease, p. S99 Vascular Protection in People With Diabetes, p. S102 Management of Acute Coronary Syndromes, p. S119 REFERENCES 1. Arnold JM, Liu P, Demers C, et al; Canadian Cardiovascular Society. Canadian Cardiovascular Society consensus recommendations on heart failure 2006: diagnosis and management. Can J Cardiol. 2006;22:23-45. 2. Maisel AS, Krishnaswamy P, Nowak RM, et al. Rapid measurement of B-type natriuretic in the emergency diagnosis of heart failure; Breathing Not Properly Multinational Study Investigators. N Engl J Med. 2002;347:161-167. 3. Bell DS. Heart failure: the frequent, forgotten, and often fatal complication of diabetes. Diabetes Care. 2003;26:2433-2441. 4. Kannel WB, Hjortland M, Castelli WP. Role of diabetes in congestive heart failure: the Framingham Study. Am J Cardiol. 1974;34:29-34. 5. He J, Ogden LG, Bazzano LA, et al. Risk factors for congestive heart failure in US men and women: NHANES I epidemiologic follow-up study. Arch Intern Med. 2001;161:996-1002. 6. Johansson S, Wallander MA, Ruigomez A, et al. Incidence of newly diagnosed heart failure in UK general practice. Eur J Heart Fail. 2001;3:225-231. 7. Nichols GA, Gullion CM, Koro CE, et al. The incidence of congestive heart failure in type 2 diabetes: an update. Diabetes Care. 2004;27:1879-1884. 8. Vaur L, Gueret P, Lievre M, et al; DIABHYCAR Study Group (type 2 DIABetes, HYpertension, CArdiovascular events and Ramipril study). Development of congestive heart failure in type 2 diabetic patients with microalbuminuria or proteinuria: observations from the DIABHYCAR (type 2 DIABetes, HYpertension, CArdiovascular events and Ramipril) study. Diabetes Care. 2003;26:855-860. 9. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405-412. 10. Iribarren C, Karter AJ, Go AS, et al. Glycemic control and heart failure among adult patients with diabetes. Circulation. 2001;103:2668-2673. 11. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998; 352:837-853. 12. Gerstein HC, Mann JF,Yi Q, et al; HOPE Study Investigators. Albuminuria and risk of cardiovascular events, death, and heart failure in diabetic and nondiabetic individuals. JAMA. 2001;286:421-426. 13. Arnold JM,Yusuf S,Young J, et al; HOPE Investigators. Prevention of Heart Failure in Patients in the Heart Outcomes Prevention Evaluation (HOPE) Study. Circulation. 2003;107:1284-1290. 14. Fox KM; EUropean trial on Reduction Of cardiac events with Perindopril in stable coronary Artery disease (EUROPA) Investigators. Efficacy of perindopril in reduction of cardiovascular patients with stable coronary artery disease: a randomized, double-blind, placebo-controlled, multicentre trial (the EUROPA study). Lancet. 2003;362:782-788. 15. Braunwald E, Domanski MJ, Fowler SE, et al; PEACE Trial Investigators. Angiotensin-converting-enzyme inhibition in stable coronary artery disease. N Engl J Med.2004;351:2058-2068. 16. Eurich DT, Majumdar SR, McAlister FA, et al. Improved clinical outcomes associated with metformin in patients with diabetes and heart failure. Diabetes Care. 2005;28:2345-2351. 17. Masoudi FA, Inzucchi SE,Wang Y, et al.Thiazolidinediones, metformin, and outcomes in older patients with diabetes and heart failure: an observational study. Circulation. 2005;111:583-590. 18. Masoudi FA,Wang Y, Inzucchi SE, et al. Metformin and thiazolidinedione use in Medicare patients with heart failure. JAMA. 2003;290:81-85. 19. Dormandy JA, Charbonnel B, Eckland DJ, et al; PROACTIVE Investigators. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005;366:1279-1289. 20. DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet. 2006;368:1096-1105. 21. Kahn SE, Haffner SM, Heise MA, et al; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006;355:2427-2443. 22. GlaxoSmithKline. Health Canada Endorsed Important Safety Information on Avandia ® ,Avandamet ® and Avandaryl ® . Cardiac Safety of Avandia ® (rosiglitazone maleate).November 6,2007.Available at: avandia_hpc-cps_5-eng.pdf. Accessed September 1, 2008. 23. Lago RM, Singh PP, Nesto RW. Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomized clinical trials. Lancet. 2007;370:1129-1136. 24. Arnold JM, Howlett JG, Dorian P, et al. Canadian Cardiovascular Society Consensus Conference recommendations on heart failure update 2007: prevention, management during intercurrent illness or acute decompensation, and use of biomarkers. Can J Cardiol. 2007;23:21-45. 25. Bell DS, Lukas MA, Holdbrook FK, et al.The effect of carvedilol on mortality risk in heart failure patients with diabetes: results of a meta-analysis. Curr Med Res Opin. 2006;22:287-296. 26. Haas SJ,Vos T, Gilbert RE, et al.Are beta-blockers as efficacious in patients with diabetes mellitus as in patients without diabetes mellitus who have chronic heart failure? A meta-analysis of large-scale clinical trials. Am Heart J. 2003;146:848-853. S125 COMPLICATIONS AND COMORBIDITIES
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2008 Clinical Practice Guidelines - Canadian Diabetes Association

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