Alia Gilani Health Inequalities Pharmacist

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1 Alia Gilani Health Inequalities Pharmacist

2 THE SOUTH ASIAN HEALTH FOUNDATION (U.K.) (Registered Charity No )

3 1. Case Study 2. Factors influencing prescribing 3. Special Considerations 4. Prescribing Do s and Don'ts

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5 - 70-year-old woman with type 2 diabetes, obesity and - Hypertension Diabetes duration: approximately 5 years HbA1c 65 mmol/mol (8.1%) BMI 31 kg/m2 BP 128/78 mmhg No microalbuminuria; creatinine 80 μmol/l Normal liver function studies No history of retinopathy, neuropathy or CV disease Family history of CV disease with early stroke Lives alone *Case Based on NEJM 2008; 358:3

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7 Add Pioglitazone Add NPH insulin before bedtime Add exenatide BD Add a DPP4I Add an SU Add a SGLT-2 inhibitor

8 Diabetes medications: Metformin 1000 mg bd Gliclazide 80 mg bd Other medications unchanged HbA1c 53 mmol/mol (7.0%) BMI 32 kg/m2 What now?

9 Add Pioglitazone Add NPH insulin before bedtime Add exenatide BD Add a DPP4I Add an SU Add a SGLT-2 inhibitor

10 Medications unchanged: Metformin 1000 mg bd Gliclazide 80 mg bd HbA1c 65 mmol/mol (8.1%) BMI 33 kg/m2 Background retinopathy and microalbuminuria What now?

11 Add Pioglitazone Add NPH insulin before bedtime Add exenatide BD Add a DPP4I Add an SU Add a SGLT-2 inhibitor

12 The Dilemma of no right answer!

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14 A retrospective cohort study of 81,571 people in the UK from the period between Jan 2004-Dec 2006 followed up until April 2011found: 1 The mean HbA 1c at intensification with an OAD or insulin for people taking one, two, or three OADs was 8.7, 9.1, and 9.7% The probability of patients with poor glycaemic control taking one, two, or three OADs, intensifying at end of follow-up with an OAD, was % and with insulin %. 1. Khunti K, Wolden ML, Thorsted BL et al. Clinical Inertia in People With Type 2 Diabetes: A retrospective cohort study of more than 80,000 people. Diabetes Care 2013 Jul 22. (E pub ahead of print)

15 Low adherence is estimated to be up to 78% in diabetes 1 Estimated opportunity of health gains because of nonadherence per annum for diabetes in England is 100 million 2 1. Ho PM et al. Archives of Internal medicine 2006; 166(17): Trueman P et al. Evaluation of the scale, causes and costs of waste medicines. London: YHE/School of Pharmacy, 2010

16 COST BENEFIT

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18 UKPDS 1 ACCORD 2 ADVANCE 3 VADT 4 Currie et al 5 CONTROL, Cochrane and BMJ Meta-analysis 6,7,8 1. UKPDS Group. Intensive blood-glucose control with sufonylureas or insulin compared with conventional treatment and risk of complications in patient with Type 2 diabetes (UKPDS 33). Lancet 1998; 352; ACCORD Study Group. Effects of Intensive glucose lowering in Type 2 diabetes. N Engl J Med2008; 358: The ADVANCE collaborative Group. Intensive blood glucose control and vascular outcomes in patients with Type 2 diabetes. N Engl J Med 200; 358: VADT Investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med 2009; 360: Currie CJ et al. Survival as a function of HbA1c in people with Type 2 diabetes: a retrospective cohort study. Lancet 2010; 375: CONTROL writing group. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia 2009; 52: Hemmingsen B et al. Cochrane Database of Systematic Reviews Issue 6. Art No: CD DOI: / CD pub2 8. Boussageon R et al. BMJ 2011; 343: d4169

19 Randomisation Intensive vs Conventional Treatment 1997 (20 years) Trial End 10-year Post-Trial Follow Up (Non-Interventional) 2007 (30 years) Any diabetes related endpoint 12% * 25% * 16%** (NS) 9%* 24% * 15% * Microvascular disease Myocardial infarction [ *p<0.05 **p=0.052 ] Intensive vs Conventional Treatment NS = Not significant 1 Adapted from Holmann RR at al UKPDS 80 NEJM (15) Adapted from Unnikrishnan AG et al UKPDS 33.Lancet

20 A second agent to be added if HbA1c >6.5 1 Triple therapy to be considered if HbA1c >7.5% 1 Newer agents to be continued if there is at least a 0.5% reduction of HbA1c at 6 months 1 Prescribing decision should be made on and individualised basis with due consideration given to factors like age, co-morbidities, patient choice, adherence 1. MeReC Bulletin. Improving outcomes in Type 2 Diabetes. 2011;21(5): 1-9

21 Pro s Cons Older Diabetes Therapies Newer Diabetes Therapies Inexpensive Experience of use Outcome Data Weight neutral Less Hypo risk Option in those who wish to avoid injections side effect (hypo s, weight gain) Insulin dependent therapies can loose affect over time due to nature of T2DM Cost Lack of outcome data Potential ADR(?)

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24 Higher HbA1c targets recommended by ADA/American Geriatrics Society 1 Targets for HbA1c in elderly individuals defined as those >65 years old: <7.5% Healthy individuals with few chronic conditions and intact cognitive function <8.0% Complex/Intermediate: Multiple co-existing chronic conditions, mild to moderate cognitive impairment <8.5% Very complex/poor health. Mod-severe cognitive impairment 1. Kirkman SM, Briscoe VJ, Clark N et al. Diabetes in Older Adults: A consensus report. Journal of the American Geriatric Society 2012; 60(12):

25 Range of weight change (kg) Range of weight change (in kg) in response to diabetes medications Sulphonylureas Meglitinides 1 Insulin 1 Thiazolidinediones 1 Metformin DPP-4 inhibitor 2 5 GLP-1 receptor agonist 6 Weight change (Kg): (linagliptin vs glimepiride) 2, -0.6 (sitagliptin vs glipizide) 3, -1.5 (sitagliptin vs glipizide) 3, -0.3 (vildagliptin vs rosiglitazone) 4, -0.2 (vildagliptin vs glimepiride), +0.1 (vildagliptin vs gliclazide) 4, -1.1 (saxagliptin vs glipizide) 5, -1.0 to -2.8 (liraglutide in combination with metformin, metformin + glimepiride and metformin + rosiglitazone) 6 Reproduced from 1. Mitri J, Hamdy O. Expert Opin Drug Saf 2009; 8:573 8; 2. Boehringer Ingelheim and Eli Lilly and Company Limited. Trajenta (linagliptin) Summary of Product Characteristics. Aug 2011 (accessed September 2012); 3. MSD Januvia (sitagliptin) Summary of Product Characteristics Mar 2012 (accessed September 2012); 4. Novartis Galvus (vildagliptin) Summary of Product Characteristics Jul 2012 (accessed September 2012); 5. AstraZeneca Onglyza (saxagliptin) Summary of Product Characteristics. Jan 2012 (accessed September 2012); 6. Novo Nordisk Limited. Victoza (liraglutide) Summary of Product Characteristics. July 2012 (accessed September 2012). OB-3

26 Metformin* SU Acarbose Meglitinides Pioglitazone DPP-4 inhibitors Mild renal impairment Gliclazide Glimepiride Nateglinide Linagliptin Saxagliptin* Glipizide Tolbutamide Repaglinide Sitagliptin* Vildagliptin Moderate renal impairment Gliclazide Glimepiride Nateglinide Linagliptin Saxagliptin* Glipizide Tolbutamide Repaglinide Sitagliptin* Vildagliptin Severe renal impairment Gliclazide Nateglinide Linagliptin Glimepiride Repaglinide Saxagliptin* Glipizide Sitagliptin* Tolbutamide Vildagliptin End stage renal disease Gliclazide, glimepiride, glipizide, tolbutamide Nateglinide Repaglinide Linagliptin Saxagliptin * Sitagliptin* Vildagliptin Contraindicated/not recommended Dose adjustment/caution required No dose adjustment required a As described in the British National Formulary. No SmPC available for glimbenclamide. *Periodic monitoring of renal function required. SmPCS for Glucophage (metformin); Diamicron (gliclazide); Amaryl (glimepiride); Minodiab (glipizide); Tolbutamide; Glucobay (acarbose); Starlix (nateglinide); Prandin (repaglinide); Actos (pioglitazone); Trajenta (linagliptin); Onglyza (saxagliptin); Januvia (sitagliptin); Galvus (vildagliptin) all available at: (last accessed January 2013). RD-10

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28 Trial data shows median response of individuals and does not provide data as to specific patient type and response

29 Biological Vs Chronological Age ADA Recommendations Individualisation Avoid Clinical Inertia Consider targeting cardiovascular risk factors(bp, Smoking, Lipids) Check license of use of dual and triple therapy Caution in renal impairment check drug license Check contra-indications

30 NNT for 5 years to prevent CV disease 1 Cholesterol (-1mmol/l) Blood Pressure (-10/5 mmhg) HbA1c (-0.9%) CV disease Yudkin J, Richter B, Gale EA. Intensified glucose lowering in type 2 diabetes: time for a reappraisal. Diabetologia 2010; 53:

31 Promote concordance not compliance Check Adherence* before considering titrating or adding new drug therapy Not following up/monitoring new treatment therapy *It is estimated that non-adherence is responsible for an 80% increased risk of death in diabetics (Elliot R. Non adherence to medicines not solved but solvable, J Health Serv Res Policy 2009; 14: 58-61)

32 Patient centred care should be the cornerstone of treatment for each patient. And can be defined as: Providing care that is respectful of and responsive to individual patient preferences, needs, values and ensuring that patient values guide all clinical decisions 1 1. Committee on Quality healthcare: Institute of Medicine. Crossing the Quality Chasm: A new Health System for the 21 st Century. Washington DC. The National Academies Press, 2001

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