Leicester Diabetes Centre 2012

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2 Therapeutic Inertia Dr Samuel Seidu.

3 Declaration of interests Sam Seidu has acted as advisory board member and/or speaker for Novartis, Janssen, Novo Nordisk, Lilly, Boehringer Ingelheim, MSD, Amgen, Astra Zeneca, and Sanofi.

4 Session Objective Definition of therapeutic inertia Explore the variations and causes of inertia across Europe. Explore the Cardiovascular consequences of therapeutic inertia.

5 People with Type 2 diabetes do not achieve optimal glucose control mainly due to... 1 Disease progression: Progressive nature of diabetes requiring continuous therapy intensification 1 2 Clinical inertia: Failure to initiate or intensify treatment in a timely manner in people with diabetes whose health is likely to improve with this intensification 2 3 Patient adherence: Suboptimal adherence to diet and lifestyle measures 1 4 Medication short-comings: Side-effects of most antidiabetic drugs, in particular, hypoglycaemia and weight gain 1 1. Haluzik M. J Endocrinol 2014;221:E Strain WD, et al. Diabetes Ther 2014;5:

6 What is clinical inertia? Failure to advance therapy when required Insulin is often only initiated after years of poor glycaemic control Despite TTT trials demonstrating effectiveness and simplicity of adding insulin therapy to treatment regimens Multifaceted problem in clinical practice worldwide TTT, treat to target Caputo et al. IDF abstract book P-1450

7 Intensification is delayed despite suboptimal glycaemic control 1 Clinical inertia contributes to suboptimal glycaemic control 1 Patients experience long periods in poor glycaemic control 1 Mean HbA 1c at intensification with an OAD or insulin (%) 10% 9% 8% 7% 6% 5% 4% 3% 2% 1% 0% 8,7% 9,1% 9,7% One OAD Two OADs Three OADS OAD, oral antidiabetic drug. Median time from above HbA 1c cutoff to intensification with an additional OAD (years) 1. Khunti K, et al. Diabetes Care 2013;36: Taking one OAD 2,9 53 mmol/mol (7.0%) 7,2 7,2 Taking two OADs 1,9 58 mmol/mol (7.5%) 1,6 6,9 64 mmol/mol (8.0%)

8 Examples of patients with Type 2 diabetes who are early in their disease progression Case study:- Newly diagnosed patient Case study:- Patient already receiving treatment 48-year-old woman recently diagnosed At diagnosis: HbA 1c 92 mmol/mol (10.6%) BP 142/88 mmhg BMI 31 kg/m 2 egfr 68 ml/min./1.73 m 2 History of dyslipidaemia Leads a fairly sedentary lifestyle; ex-smoker 66-year-old man diagnosed 18 months ago At diagnosis: HbA 1c 66 mmol/mol (8.2%) BP 150/86 mmhg egfr 52 ml/min./1.73 m 2 BMI 30 kg/m 2 Initiated D&E intervention and metformin 850 mg BID. After 12 months on examination: HbA 1c 69 mmol/mol (8.5%) BP 155/85 mmhg egfr 46 ml/min./1.73 m 2 National data:- Percentage of patients reaching target HbA 1c ( 58 mmol/mol) 1 CCG selection Type 2 (%) England and Wales 65.8% BID, twice a day; BMI, body mass index; BP, blood pressure; egfr, estimated glomerular filtration rate 1. National Diabetes Audit 2011/2012. Report 1.

9 Factors predicting escalation of treatment Unpublished audit data; PCADS 2016

10 Need for regular HbA1c monitoring and target setting For every additional unit increase in HbA1c target, HCPs were 0.86 times less likely to escalate treatment. For every additional increase in the last HbA1c recorded, HCP were more 1.05 times more likely to escalate treatment than not.

11 Issues that underpin clinical inertia Multimorbidity Hypoglycaemia Complex regimens Data about perceived insulin outcomes Lack of patient adherence to treatment Lack of education Financial incentives

12 Comorbidities are frequent in patients with diabetes 1 Hypertension 39,5% Cardiac dysrhythmias Other forms CHD Heart failure Hypertensive heart disease Chronic kidney disease Chronic bronchitis Disorders lipid metabolism Other lung diseases Overweight/obesity Atherosclerosis Ill-defined cerebrovascular disease 22,0% 21,7% 19,8% 16,4% 13,6% 11,6% 10,2% 9,2% 7,8% 7,6% 6,9% Chronic liver disease/cirrhosis 6,3% 0% 10% 20% 30% 40% 50% The proportion of diagnosed comorbidities in hospitalised diabetic patients (%) 1. Valent F, et al. J Diabetes Investig 2013;4:

13 Comorbidity of top 10 common conditions. Guthrie B et al. BMJ 2012;345:e6341

14 Challenges associated with achieving optimal glycaemic goals 9,0 8,5 6,0 5,5 Type 1 diabetes Type 2 diabetes + insulin Mean HbA 1c (%) 8,0 7,5 7,0 Mean Tchol (mmol/l) 5,0 4,5 4,0 6, Year 3, Year In patients with type 1 diabetes or type 2 diabetes on insulin, there was a 0.1% relative improvement in HbA 1c vs. improvements in total cholesterol of 15% and 29%, respectively between 2001 and 2007 Currie et al. Diabetic Medicine 2010; 27:

15 QOF 2014/2015 CCG Name Number of Practices Diabetes Register DM 008 % of patients Achieving 64mmol/mol (8%) DM 009 % of patients acheiving 75mmol/mol 9% dm008 number of patients>64 mmol/mol 8% dm009 number of patinets > 75mmol/m ol (9%) NHS EREWASH CCG 12 5, NHS HARDWICK CCG 16 6, NHS MANSFIELD AND ASHFIELD CCG 28 10, NHS NEWARK & SHERWOOD CCG 14 7, NHS NORTH DERBYSHIRE CCG 36 16, NHS NOTTINGHAM CITY CCG 59 15, NHS NOTTINGHAM NORTH AND EAST CCG 21 7, NHS NOTTINGHAM WEST CCG 12 4, NHS RUSHCLIFFE CCG 12 5, NHS SOUTHERN DERBYSHIRE CCG 56 29, NHS LINCOLNSHIRE EAST CCG 30 17, NHS EAST LEICESTERSHIRE AND RUTLAN 33 16, NHS LEICESTER CITY CCG 62 26, NHS LINCOLNSHIRE WEST CCG 33 11, NHS SOUTH WEST LINCOLNSHIRE CCG 19 7, NHS WEST LEICESTERSHIRE CCG 50 20, NHS SOUTH LINCOLNSHIRE CCG 15 9,

16 Despite advances in treatment, a significant proportion of patients with Type 2 diabetes still fail to reach target HbA 1c levels GUIDANCE Study 7,597 T2DM patients Gap exists between checking HbA 1c and achieving target HbA 1c <7% Percent T2DM, type 2 diabetes mellitus. Stone MA et al. Diabetes Care April 23. HbAHbA1c checked checked Met Met HbAHbA1c 1c target target

17 Consequences of delayed intervention Patients with HbA1c 7% not receiving IT within 1 year Patients with HbA1c < 7% who received IT before 1 year of diagnosis At 5.3 years, significantly increased risk of: MI 67% (HR CI 1.39, 2.01) Stroke 51% (HR CI 1.25, 1.83) HF 64% (HR CI 1.40, 1.91) Composite CVE 62% (HR CI 1.46, 1.80) HbA1c, % Hyperglycaemic legacy Months Drive risk for complications CVE, cardiovascular endpoint; HF, heart failure; IT, treatment intensification; MI, myocardial infarction Paul S, et al. Cardiovasc Diabetol. 2015;14:100.

18 Physician barriers Physicians may be reluctant to initiate insulin due to: 1-3 beliefs about patient risk excess weight gain risks in patients with comorbidities hypoglycaemia impaired quality of life resource issues beliefs about patient competence 1. Peyrot et al. Diabetes Care 2005;28:2673 9; 2. Elgrably et al. Diabet Med 1991;8:773 7; 3. Wallace & Matthews. QJM 2000;93:369 74

19 Primary care: reasons for clinical inertia Common HCP barriers lack of time, including time to attend continuing professional development (CPD) events restrictions for prescribing newer drugs too many guidelines lack of awareness of clinical inertia perceptions about responsibility time constraints are a major issue both in terms of continuing medical education (CME), including having less time during consultations Patients barriers lack of understanding of the seriousness of their disease reluctance to start insulin early HCP, healthcare professional. Zafar A, et al. Diabetic Med. 2015;32:

20 Management of T2D Becomes More Complex Over Time At diagnosis Treatment review Older patients Disease progression Complications arise1-3 Complications such as CVD or renal impairment may become more frequent More individualised approach to treatment required QoL becomes one of the most important considerations4 1,2. Adapted from National Institute for Health and Clinical Excellence. Clinical Guideline 87. Type 2 diabetes newer agents (a partial update of CG66): quick reference guide. NICE clinical guideline 66: Type 2 Diabetes Management. Available at: (accessed November 2012). 3. Go AS, et al. N Engl J Med. 2004;351: ; 4. Morley JE. Diabet Med. 1998;15 (Suppl. 4): S41 6. Clear guidance1 Diet and exercise plan Metformin given Avoid diabetes complications

21 Thank you

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