The Early Use of Insulin and Oral Anti diabetic Drugs

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1

2 The Early Use of Insulin and Oral Anti diabetic Drugs NPS Outreach Pharmacists for Remote Aboriginal Health Services Strategy A remote perspective Dr Hugh Heggie

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4 National Medicine Policy To provide timely access to medicines with accepted standards of quality, safety & efficacy. The Quality use of Medicines program includes consultation and education with the consumer as well as all other significant stakeholders. Best Practice model in Aboriginal Health in NT Challenges as Educators

5 Where are we?

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7

8

9 KISS

10 KEEP INSULIN SAFE & SIMPLE

11 MAKE INSULIN YOUR FRIEND

12 Key Messages Early and continuing lifestyle interventions

13 Key Messages Early and continuing lifestyle interventions Initiate insulin early by adding night time basal insulin to oral antidiabetic agents

14 Key Messages Early and continuing lifestyle interventions Initiate insulin early by adding night time basal insulin to oral antidiabetic agents Ensure metformin is part of ongoing therapy and use of thiazolidinediones does not delay the progression to insulin

15 Key Messages Early and continuing lifestyle interventions Initiate insulin early by adding night time basal insulin to oral antidiabetic agents Ensure metformin is part of ongoing therapy and use of thiazolidinediones does not delay the progression to insulin Review use of thiazolidinediones in heart failure and ischaemic heart disease

16 Concepts of Health

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18 Background Diabetes is a major risk factor for morbidity and mortality due to coronary heart disease, cerebrovascular disease and peripheral vascular disease. Macrovascular disease accounts for up to 75% of deaths in people with type 2 diabetes. Diabetes is also associated with a risk of microvascular complications, including retinopathy, nephropathy and neuropathy. In Australia the prevalence of diabetes has trebled over the last two decades, and the onset is occurring at an earlier age. 7.5% of adults aged 25 years and over were shown to have diabetes in the 1999 AusDiab study. Approximately one in four Australians aged over 25 years have either diabetes or pre diabetes (IGT or IFG). Importantly, only half of the people with diabetes are actually aware that they have it. The Metabolic Syndrome is a term used to describe the common condition involving various cardiovascular risk factors in conjunction with insulin resistance. Patients with the Metabolic Syndrome are at high risk of developing diabetes in the future, and are at high CVD risk. Hence recognition and early management of this syndrome may have impact on prevention of diabetes and CVD.

19 What are we talking about Diabetes is a lack of or reduced effectiveness of endogenous Insulin It is a far reaching & complex metabolic derangement, including hyperglycaemia, that leads to serious vascular complications Type 1 Type 2 Abnormalities of Glucose regulation Gestational

20 Type 1 DM There is insulin deficiency and always requires Insulin therapy. There is a genetic predisposition to Islet cell damage. May be associated with other auto immune abnormalities & positive Islet cell antibodies. Presentation is usually acute with Keto acidosis: unwell, ketones, hyperventilation, weight loss, polyuria. This may be precipitated by sepsis. Diagnosis is usually clinical with FBGL > 7

21 Type 2 DM Reduced Insulin secretion & effectiveness Typical natural history Preliminary phase (IGT): opportunity!! Symptomatic phase Complications: Vascular: 3 5 x MI, 2 x CVA Renal (raised ACR) : associated with increased macrovascular risk especially if hypertensive Eye disease: associated with elevated HbA1c

22 Abnormalities of glucose regulation IFG: FBG > 6.1 but <7 IGT: FBG > 7 OGTT 2h >7.8 but < 11.1 Opportunities for modification Gestational GDM GIGT Levels vary with gestation Repeat OGGT > 6wks post partum

23 Diagnosis and Screening Active case detection of asymptomatic individuals is paramount for detecting diabetes. This is because many patients have the disease for a number of years before it becomes clinically apparent, and importantly because many patients have signs of diabetes complications at diagnosis. High risk patients (as outlined in Table 1) should be screened for diabetes every year. Screening should be done by laboratory measurement of venous plasma glucose level (preferably fasting). If abnormal, the test should be repeated on another day to enable diagnosis, unless unequivocal hyperglycaemia with acute metabolic decompensation or obvious symptoms are present. Oral glucose tolerance tests should only be performed where fasting plasma glucose level lies in the uncertain range (i.e. between 5.5 and 6.9 mmol/l).

24 RBG normal 3 8 Consider DM if: FBG > 7 Diagnosis HbA1c > 6.5 ( if >7: increased microvascular damage) RBG > 11.1 with symptoms GTT 2h > 11.1

25 Diabetes, IGT & IFG Diagnosis Venous plasma glucose concentration (mmol/l)* Diabetes Fasting and/or 2 hour post glucose load Impaired glucose tolerance (IGT) 2 hour post glucose load 7.8 to 11.0 Impaired fasting glycaemia (IFG) Fasting 5.6 to 6.9

26 Aims of Treatment To optimise glycaemic control with control of long term hyperglycaemia without risk of hypoglycaemia To monitor weight, blood, urine, BP, fundoscopy, feet To do global assessment: renal function, BP <130, eye damage, LVH, IHD, smoking, lipids, psychological To prevent complications, especially macrovascular disease & mortality Plan for pregnancy

27 Adjust treatment to suit lifestyle

28 Risk Factors People at high risk for undiagnosed type 2 diabetes are: People with impaired glucose tolerance or impaired fasting glycaemia (see page 17) Aboriginal and Torres Strait Islanders aged 35 years, or younger if they are overweight Pacific Islanders, Chinese and people from the Indian subcontinent aged 35 years People aged 45 years (not from one of the above mentioned ethnic groups) who have one or both of the following: obesity (BMI 30 kg/m 2 ) hypertension People with clinical cardiovascular disease (myocardial infarction, angina, stroke or peripheral vascular disease) Women with polycystic ovary syndrome with obesity The following are also at high risk but further studies are needed to evaluate net clinical or economic benefit of routine screening: Women with previous gestational diabetes People aged 55 years, if no other risk factors are present People aged 45 years, with a first degree relative with type 2 diabetes Note also that certain medications can affect glucose metabolism and increase the risk of diabetes. Drug induced hyperglycaemia

29 Evidence shows that small changes towards target levels for multiple risk factors can have a large impact on diabetes outcomes, even if the various targets for type 2 diabetes are not met. Monitoring and treatment of cardiovascular risk factors is as important (if not more) than optimal glycaemic control in diabetes management. This involves assessment and treatment of hypertension, dyslipidaemia, overweight/obesity, and where appropriate cigarette smoking. Monitoring of blood glucose concentrations and glycaemic control (utilising HbA1C measurements) is paramount. The issue of post-prandial glucose concentrations is an area of continuing controversy. It has been proposed that reduction in post-prandial glucose concentration can improve diabetes outcomes and decrease progression of IGT to diabetes. However, further research is needed to determine whether use of treatment which focuses on reducing post-prandial blood glucose levels is effective in reducing the morbidity and mortality associated with diabetes and its complications. Patients with diabetes require appropriate monitoring for diabetes complications this includes regular eye and feet examinations and screening for microalbuminuria. Influenza and pneumococcal vaccinations are advised for people with diabetes.

30 Lifestyle Modification Life long lifestyle modifications are of the utmost importance for people with diabetes. This population should received ongoing education about healthy eating, exercise, strategies to achieve weight loss and smoking cessation. Such measures should be continually addressed, and the use of a multidisciplinary team approach is required to achieve best possible changes. The incidence of overweight and obesity has been escalating in Australia in recent years, and is strongly linked to the escalating prevalence of diabetes. The recommended meal plan for people with diabetes is the same healthy eating plan which is advised for all Australians. There is no clear cut formula for carbohydrate, fat or protein intake. High fibre, low energy density carbohydrates are still recommended to contribute about 50% of total energy intake. Choosing healthy carbohydrates with a low glycaemic index may assist some patients in improving glycaemic control; however, this remains an area of some controversy. Dietary fat should be less than 30% of the total energy intake, and protein intake approximately 10 20% of total energy intake. Evidence for safety and efficacy of high protein/low carbohydrate diets is lacking overall, such that these diets cannot be routinely advocated at present. All patients should be encouraged to undertake moderate intensity physical activity for at least 30 minutes on most or preferably all days of the week. Building more movement and activity into daily routines (incidental activity) rather than focusing primary on exercise as a structured activity may be of most success. For overweight patients, a weight loss of 5 10% of body weight should be the initial aim. The priority should then be weight maintenance. Lifestyle modifications, involving healthy eating, exercise, and behavioural therapy, are the first line strategy for achieving weight loss and maintenance, but pharmacotherapy may be considered for some people. Cigarette smoking in patients with diabetes increases the risk of morbidity and mortality from macrovascular and microvascular complications. Smoking status should regularly be assessed in all people with diabetes, and counselling, and pharmacotherapy if appropriate, provided to assist patients with smoking cessation.

31 Reasons for starting sooner 1 In the UKPDS 34 study, intensive treatment of overweight diabetic patients with metformin reduced the risk of any diabetes related endpoint, compared with conventional treatment, including a number of individual macrovascular end points. In UKPDS 33 intensive blood glucose control with insulin or sulfonylureas reduced the risk of microvascular complications, but did not significantly reduce the risk of macrovascular complications, diabetes related deaths or all cause mortality compared to conventional therapy. Outcome data for thiazolidinediones is discussed in the updated section on these medicines. Multiple agents are often needed to achieve optimal glycaemic control.

32 Reasons for starting sooner 2 By reducing HbA1c by 1% there is: 21% reduction in macrovascular diabetic deaths (requires control of hypertension, lipids) Heart attacks Strokes 43% reduction in amputation 37% reduction in microvascular damage Kidney disease Eye damage

33 Antihyperglycaemics in the management of type 2 diabetes Key Messages Ensure metformin is part of ongoing therapy and use of thiazolidinediones does not delay the progression to insulin

34 Practical Points Metformin is usually the initial drug of choice in people with type 2 diabetes, particularly in those who are overweight. Combination therapy and/or treatment of insulin will be necessary to achieve optimal glycaemic control eventually in most patients with type 2 diabetes. Choice of agents to use should take into consideration: patient s weight, availability and cost (and PBS restrictions), outcome evidence, patient comorbidites, adverse effects and drug interaction potential of the agent, compliance factors, blood glucose picture and patient s lipid profile.

35 Combination therapy Short term hyperglycaemia can result in vascular changes. In addition, diagnosis of type 2 diabetes is often delayed by several years, and many patients have signs of diabetic complications at diagnosis. Hence, delaying the use of combination products where monotherapy is not achieving ideal glycaemic control, and delaying the introduction of insulin where oral treatment is failing to maintain glycaemic control, is not acceptable. Glucovance (metformin plus glibenclamide) is the only combination oral antihyperglycaemic product currently available in Australia. The usefulness of this product is limited due to the fixed doses in the preparation. The usual cautions with glibenclamide apply. Outcomes studies assessing optimal agents to use in combination regimens are lacking. Common and acceptable oral drug combinations include metformin plus a sulfonylurea, metformin plus a thiazolidinedione, or a sulfonylurea plus a thiazolidinedione. Where two oral drug combinations fail, current evidence is lacking with regard whether use of triple oral therapy or insulin alone or in combination with oral agents is the most ideal approach. Until such data is available, this decision should be individualized. If triple oral therapy is decided on, a trial for 2 to 3 months should be sufficient to assess whether it is likely to be effective or not. Introduction of insulin therapy, where it is necessary, should not be delayed for more than a few months. When the decision to introduce insulin in made, continuation of oral therapy (particularly with insulin sensitizers) is generally associated with less weight gain and improved glycaemic control than when using insulin as monotherapy.

36 Management Approach Patient motivation, engagement & education are central Use principles of adult learning to promote autonomy & independence: explicit learning objectives, group learning Educate & negotiate on all aspects: diet, Rx Multidisciplinary team approach to fully engage, develop self help strategies Regular follow up & monitoring DO NOT TREAT IN ISOLATION: GLOBAL

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38 Management of Diabetes Type 1 DM Insulin: basal (Intermediate nocte) +/ bolus (short ac) or split mixed(short plus intermediate bd: mane ac & 6pm ac) Diet: low fat/sugar, high fibre/complex CHO Exercise: regular/moderate (watch intense/long) Monitoring

39 Management of Diabetes Type 2 DM If markedly symptomatic: may require oral antidiabetic medication In acute illness or pregnancy: may require insulin Otherwise: DIET EXERCISE OTHER FACTORS MEDICATIONS

40 Exercise!

41 Secondary Hyperglycaemic Factors Illnesses UTI Dental infection Hyperthyroidism Occult malignancy Medications Oral contraceptive Corticosteroids Thiazides Beta blockers Antipsychotic agents Phenytoin Glucosamine

42 Make Insulin Your Friend Make Insulin Your Friend

43 Anti diabetic Drugs Sensitisers Biguanides: Metformin Helps to reduce weight Safe but watch if tissue hypoxia, elev. Cr, GA Thiazolidinediones (Glitazones): also reduce insulin resistance but side effects Rosiglitazone: fluid retention, HA, dyspepsia Secretogogues Sulphonylureas: Gliclazide (medium), Nateglimide (short). Watch hypoglycaemia.

44 Other Agents Acarbose: decrease breakdown of starch to sugar Anti hypertensives: ACEi, A2A, BetaB, Thiazide Lipid lowering: Statin, Fibrate Aspirin

45 Insulins 100 u/ml 1. Ultrafast (analogue rapid acting): immediate ac or pc [Clear] Humalog, Novorapid, Apidra 2. Soluble (short acting): min ac [Clear] Humulin S, Actrapid 3. Intermediate (Isophane): od or bd [Cloudy] Humulin J (NPH), Insulatard 4. Long acting (Lente): Ultratard 5. Long acting analogue: daily am/pm unrelated to food [Clear] Lantis (glargine), Levimir 6. Pre mixed eg U fast+soluble: od or bd min ac Humulin M3, Mixtard 30, Novomix 30

46 Suit lifestyle! Regimes T1 DM: begin total daily dose= 1u for 1u of BMI T2 DM: continue Metformin +/ others begin with 10u nocte usually Regular lifestyle: BD Premix Flexible lifestyle: AC U Fast or Sol with nocte Interm. or Long analogue Swap from oral: Daily (usually nocte) Interm. or Long analogue

47 First fix the fasting, Sweet Poetry! Then tackle tea, Find the hidden hypers, And check the A1c!

48 Consider Insulin in T2 DM If maximum oral Rx, suboptimal control, HbA1c [Av BG(mmol)=2A1c(%) 6] 1.Is A1c on target 2.Consider Lifestyle, Rx changes or Med. Condition Eat less, walk more, Adherence 3.Which basal insulin & injection device 4.Adjustment of basal dose +/or time 5.Consider stopping oral Rx, possibly add bolus 6.Consider problems

49 Long or Intermediate? Pros for Long: consistent profile, often once daily, less hypoglycaemia, no mixing or resuspension Cons for Long: slower onset, confusion with clear bolus, unable to mix with bolus, stings Intermediate: Isophane Long analogue: glargine

50 KISS: Keep Insulin Safe & Simple Starting Insulin is not hard, not risky & does work! Reasons for starting sooner Resistance: Psychological in patient & MO, lack of capacity, remoteness Approach: get pre prandial am BG controlled then the evening, then midday. Check A1c, look for hidden hypers during day/night

51 Basal Insulin Titration: festina lente Start 10u, adjust twice weekly to reach target <6 Usually hi FBG (liver production) If pm RBG hi consider 2 nd dose Mean FBG over Insulin increase Preceding 2 days >

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54 Addition of Bolus to Basal Insulin If Pre prandial is ok but A1c & post prandial hi consider Rapid (Very Quick) or Short (Quick). Pros for analogue: inject when eat, less hypoglycaemia, better post prandial RBG Cons for analogue: need to eat promptly, possible insulin run out, adequate CHO next meal Dose: initially 1/3 of corresponding basal & increase by 10 20%

55 Thiazolidinediones Avoid in patients with moderate severe heart failure & exercise caution in those with mild CHF Avoid rosiglitazone in patients with ischaemic heart disease: increased risk of MI Be cautious if giving insulin to a patient on pioglitazone because of oedema & rapid weight gain

56 troubleshooting Weight gain Improved glycaemic control Prandial boluses (independent of glycaemia) Oral anti D Rx (S U, glitazones) Use of premixed Overuse of insulin Monitors Injection technique

57 Troubleshooting cont d Sick days Variable activity 3 classic patterns of AM hypog 1.Insulin run out 2. the bounce 3.Poor control

58 Individualise: we are all different!

59 Case Study 1 Sue is a 55 year old T2 diabetic on insulin for the last 8 months when she was slightly overweight at 64kg. She has put on weight ++ She is now 74kg with BMI 27.5, ht 156 & her BP is elevated despite a higher dose of ACEi as well as her TG increased from 1.5 to 3.2mmol/L

60 Case Study 2 You reintroduce metformin & switch Sue from bd premix to nocte basal insulin & refer her to the dietician She returns after 10weeks happy that she initially lost 2kg in the first 6 weeks but none since.

61 Case Study 3 She has done as you suggested and is now up to walking 4000 steps perday but she is frustrated stating her BG goes UP with exercise (6.2 before, 8.3 after!)

62 Key Messages Early and continuing lifestyle interventions

63 Key Messages Early and continuing lifestyle interventions Initiate insulin early by adding night time basal insulin to oral antidiabetic agents

64 Key Messages Early and continuing lifestyle interventions Initiate insulin early by adding night time basal insulin to oral antidiabetic agents Ensure metformin is part of ongoing therapy and use of thiazolidinediones does not delay the progression to insulin

65 Key Messages Early and continuing lifestyle interventions Initiate insulin early by adding night time basal insulin to oral antidiabetic agents Ensure metformin is part of ongoing therapy and use of thiazolidinediones does not delay the progression to insulin Review use of thiazolidinediones in heart failure and ischaemic heart disease

66 Enjoy Mindil!

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