Optimum Care in Type 2 Diabetes: Does One Size Fit All? James LaSalle on behalf of the Global Partnership for Effective Diabetes Management This slideset was developed in 2009 with support from GlaxoSmithKline Need to individualize patient care "Good glycaemic control continues to have an essential role in type 2 diabetes management... However, having reviewed the evidence, we recognise that individualising targets and/or treatment according to patient type is paramount. For example, while early intervention is preferred wherever appropriate, certain high risk groups may not respond to overly intensive glucose-lowering regimens such as that utilised in ACCORD." Del Prato S, et al. Int J Clin Pract 2009; in press. Patient groups requiring special consideration • Newly diagnosed individuals with type 2 diabetes, but no complications – Overweight or obese adults – Lean adults • Individuals with a history of poor glycemic control – No complications – History of CVD • Individuals at risk of hypoglycemia Del Prato S, et al. Int J Clin Pract 2009; in press. Case study: Newly-diagnosed adults, no complications, overweight/obese HbA1c > 6.5% BMI > 25 kg/m2 Typically > 30 years of age Mild symptoms or asymptomatic Diagnosis before emergence of complications No associated comorbidities e.g. hypertension, dyslipidemia Del Prato S, et al. Int J Clin Pract 2009; in press. Stepwise approach: delays control and leaves patients at risk of complications Diet and exercise OAD monotherapy OAD monotherapy uptitration OAD combination OAD + basal insulin OAD + multiple daily insulin injections 10 HbA1c (%)1 9 Mean 8 7 6 OAD = oral antidiabetic Duration of diabetes 1. Adapted from Del Prato S, et al. Int J Clin Pract 2005; 59:1345–1355. 2. Stratton IM, et al. BMJ 2000; 321:405–412. Copyright 2005 Blackwell Publishing Ltd. Reproduced with permission of Blackwell Publishing Ltd. Early, intensive intervention: reach glycemic goals and reduce the risk of complications 10 Diet and exercise OAD monotherapy HbA1c (%)1 9 8 OAD combination OAD uptitration OAD + basal insulin OAD + multiple daily insulin injections Mean 7 6 OAD = oral antidiabetic Duration of diabetes 1. Adapted from Del Prato S, et al. Int J Clin Pract 2005; 59:1345–1355. 2. Stratton IM, et al. BMJ 2000; 321:405–412. Copyright 2005 Blackwell Publishing Ltd. Reproduced with permission of Blackwell Publishing Ltd. Newly diagnosed adults, no complications, overweight/obese Practical guidance: glycemic targets GOAL: Bottom of target range (HbA1c 6.5–7%), even in patients with modest hyperglycemia (HbA1c < 7.5%) HOW: Aim for HbA1c as close to normal as can safely be achieved without causing hypoglycemia or marked weight gain If HbA1c < 7.5%, consider agents not associated with hypoglycemia that address the underlying pathophysiology of diabetes Del Prato S, et al. Int J Clin Pract 2009; in press. Newly diagnosed adults, no complications, overweight/obese Practical guidance: other considerations • As for all people with type 2 diabetes, diet and exercise should be continually reinforced • Overweight and obese patients are at increased risk of CVD, pay particular attention to managing all CV risk factors Glycemic control = Lipid-lowering = Antihypertensives Del Prato S, et al. Int J Clin Pract 2009; in press. Case study: newly diagnosed adults, no complications, lean HbA1c > 6.5% BMI < 25 kg/m2 Typically > 30 years of age Mild symptoms or asymptomatic Diagnosis before emergence of complications No associated comorbidities, e.g. hypertension, dyslipidemia Del Prato S, et al. Int J Clin Pract 2009; in press. Lean patients may have a greater degree of -cell dysfunction • Most individuals with type 2 diabetes are overweight or obese but this varies across the world South-East Asia* < 40% of T2D are obese North America almost 90% of T2D are obese • In lean patients, -cell dysfunction is often more marked compared with overweight/obese individuals – Particularly in some non-western populations – LADA may also be more prevalent in lean patients Brunetti P. Int J Clin Pract 2007; 61:3–9. Newly diagnosed adults, no complications, lean Practical guidance: glycemic targets GOAL: Bottom of target range (HbA1c 6.5–7%), even in patients with modest hyperglycemia (HbA1c < 7.5%) HOW: Aim for HbA1c as close to normal as can safely be achieved without causing hypoglycemia or marked weight gain Del Prato S, et al. Int J Clin Pract 2009; in press. Newly diagnosed adults, no complications, lean Practical guidance: other considerations • Increased likelihood of β-cell dysfunction, therefore early therapy should include agents that support β-cell function • Despite lower CV risk, lean individuals should still -cell be educated about maintaining a healthy dysfunction lifestyle to prevent weight gain • Since LADA may be present, consider testing for autoantibodies, where possible Del Prato S, et al. Int J Clin Pract 2009; in press. Case study: history of inadequate glycemic control, no complications Likely to be older than newly diagnosed individuals No complications and a longer duration of diabetes with inadequate glycemic control (HbA1c > 7.5%) ≥ 1 year No associated comorbidities, e.g. hypertension, dyslipidemia Del Prato S, et al. Int J Clin Pract 2009; in press. Level of care in patients with type 2 diabetes and sustained hyperglycemia Proportion of patients receiving appropriate care 1.0 0.9 After 2 years, 0.8 11% of patients had still not received appropriate care* 0.7 0.6 After 12 months, 25% of patients had not 0.5 received appropriate care* 0.4 0.3 After 6 months, 0.2 41% of patients had not received appropriate care* 0.1 0 0 10 20 30 40 50 60 Months of sustained hyperglycemia *Appropriate care defined as medication intensification or HbA1c test result ≤ 7%. Lafata JE, et al. Diabetes Care 2009; 32:1447–1452. Copyright 2009 American Diabetes Association. Reprinted with permission from The American Diabetes Association. History of inadequate glycemic control, no complications Practical guidance: glycemic targets GOAL: Target near-normal HbA1c HOW: Aim for a more gradual reduction in HbA1c versus newly diagnosed individuals Reassess potential reasons for inadequate glycemic control, e.g. • overly conservative management, e.g. delay in introducing combination therapy • inadequate adherence to antidiabetic regimens • inappropriate choice of agents (e.g. agents that do not address the underlying pathophysiology) Del Prato S, et al. Int J Clin Pract 2009; in press. Challenges in increasing adherence 62% took tablets correctly in relation to food 20% regularly forgot to take Patient adherence to therapy their tablets 5% omitted tablets if their blood glucose was too high 2% omitted tablets if their blood glucose was too low Browne DL, et al. Diabet Med 2000; 17:528–531. Challenges in improving patient understanding 35% recalled receiving advice about their medication 15% knew the mechanism of Patient knowledge of oral antidiabetic agents action of their therapy 10% taking sulfonylureas knew that they could cause hypoglycemia 20% taking metformin knew it could cause gastrointestinal side effects Browne DL, et al. Diabet Med 2000; 17:528–531. History of inadequate glycemic control, no complications Practical guidance: other considerations • Implement structured educational programs to motivate individuals with type 2 diabetes to assume a more active role in managing their condition “I don’t need to take my tablets – I don’t feel ill” “Complications only occur in patients who take insulin” Del Prato S, et al. Int J Clin Pract 2009; in press. Case study: history of inadequate glycemic control and cardiovascular disease Known history of CVD Likely to have large pill burden and restrictions on choice of therapy due to comorbidities Del Prato S, et al. Int J Clin Pract 2009; in press. History of inadequate glycemic control and cardiovascular disease Practical guidance: glycemic targets GOAL: Guidance as for patients with a history of inadequate glycemic control but no complications, i.e. target near-normal HbA1c HOW: Take particular care to avoid hypoglycemia Adopt less stringent glycemic targets and aim for a more gradual reduction in HbA1c Del Prato S, et al. Int J Clin Pract 2009; in press. History of inadequate glycemic control and cardiovascular disease Practical guidance: other considerations • CV risk management should be intensified in these individuals • Be vigilant for contraindications and other limitations concerning choice of agents and possible drug interactions Del Prato S, et al. Int J Clin Pract 2009; in press. Case study: individuals at risk of hypoglycemia Previous symptoms of hypoglycemia Particularly wide daily glucose fluctuations Individuals such as the elderly who often have impaired creatinine clearance, and irregular lifestyles/eating patterns increasing susceptibility to hypoglycemia – Especially when taking hypoglycemic agents such as insulin and sulfonylureas Del Prato S, et al. Int J Clin Pract 2009; in press. Increased risk of hypoglycemia with intensive glycemic control: ACCORD Hypoglycemia (%) 20 * 15 10 16.2% * Intensive 10.5% Standard 5 5.1% 3.5% 0 Requiring medical assistance Requiring any assistance *P < 0.001 Gerstein HC, et al. N Engl J Med 2008; 358:2545–2559. Individuals at risk of hypoglycemia Practical guidance: glycemic targets WHAT: Targets should be individualized according to the risk of hypoglycemia, e.g. • history of severe or frequent hypoglycemia • kidney function • age of patient • previous CV events Del Prato S, et al. Int J Clin Pract 2009; in press. Individuals at risk of hypoglycemia Practical guidance: other considerations • Educate patients on being alert to possible hypoglycemia, to increase awareness and responsiveness to symptoms of hypoglycemia • Counseling particularly vulnerable patients such as the elderly on increased risk of hypoglycemia with irregular lifestyles/eating patterns and encourage compliance to prescribed regimens • Emphasize the importance of regular self-monitoring of glucose where appropriate Del Prato S, et al. Int J Clin Pract 2009; in press. Summary: one size does not fit all • Good glycemic control, including early intervention, remains the cornerstone of diabetes care • However, strategies to achieve glycemic targets should always ensure patient safety • Treatment should be individualized to the patient Del Prato S, et al. Int J Clin Pract 2009; in press.