ADA/EASD Guidelines. Simon Heller. University of Sheffield

Transcription

1 ADA/EASD Guidelines Simon Heller University of Sheffield

2 Presenter Disclosure Advisy Board Member: Eli Lilly, NovoNdisk, Sanofi Aven<s, Takeda Consultant: Eli Lilly, NovoNdisk, Takeda, Boeringher Ingelheim Research Suppt: Medtronic Speaker s Bureau: Eli Lilly, NovoNdisk, Sanofi Aven<s, Takeda, Astra Zeneca, Johnson & Johnson

3 Outline Development of the joint guidelines, <melines and how they were modified Reac<on to the guidelines A summary of the EASD/ADA guidelines The gap between guidelines and supp<ng people with diabetes in achieving target glucose levels

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5 Ra3onale f 2006 algithm prac<<oners are omen lem without a clear pathway of therapy to fol. We developed the foling consensus approach to the management of hyperglycaemia in the non- pregnant adult to help guide health care providers in choosing the most appropriate interven<ons f their pa<ents with type 2 diabetes.

6 EASD/ADA Algithm 2006, choices were rela<vely simple

7 EASD/ADA Guidelines 2008 becoming me complicated

8 Response to ADA/EASD guidelines I believe that diabetes treatment is too complex to be reduced to a useful algithm. type 2 diabetes therapy con<nues to very much rely on the experience of the physician.. even less consensus outside the restricted group of specialists who fmulated this... Is it f the general prac<<oner? I am strongly ast distribu<ng a printed list of recommenda<ons and hoping f the best. Cerasi Diabetologia 2006

9 Intro to 2012 posi3on statement an update was deemed necessary because of contempary infma<on on the benefits/risks of glycaemic control, recent evidence concerning efficacy and safety of several new drug classes, the withdrawal/ restric<on of others and increasing calls f a move towards me pa<ent- centred care The implementa<on of these guidelines will require thoughxul clinicians to integrate current evidence with other constraints and impera<ves in the context of pa<ent- specific facts

10 ADA- EASD Posi3on Statement Update: Management of Hyperglycemia in T2DM, ANTIHYPERGLYCEMIC THERAPY Implementa3on Strategies - Ini3al drug therapy - Advancing to dual combina3on therapy - Advancing to triple combina3on therapy - Transi3ons to and 3tra3ons of insulin 4. OTHER CONSIDERATIONS Age Sex/racial/ethnic/gene3c differences Combidi3es (CAD, HF, CKD, Liver disease, Hypoglycemia- prone) 5. FUTURE DIRECTIONS / RESEARCH NEEDS Diabetes Care 2012;35: ; Diabetologia 2012;55: Diabetes Care 2015;38: ; Diabetologia 2015; /s

11 ADA- EASD Posi3on Statement Update: Management of Hyperglycemia in T2DM, Pa3ent- Centered Approach...providing care that is respec2ul of and responsive to individual pa6ent preferences, needs, and values - ensuring that pa6ent values guide all clinical decisions. Gauge pa3ent s preferred level of involvement. Exple, where possible, therapeu3c choices. Consider using decision aids. Shared Decision Making a collaba3ve process between pa3ent and clinician, using best available evidence and taking into account the pa3ent s preferences and values Final decisions regarding lifestyle choices ul3mately lie with the pa3ent. Diabetes Care 2012;35: ; Diabetologia 2012;55:

12 Figure'1.'Modula$on'of'the' intensiveness'of'glucose' ering'therapy'in't2dm' PATIENT / DISEASE FEATURES Risks potentially associated with and other drug adverse effects me stringent Approach to the management of hyperglycemia HbA1c' 7%(' less stringent Disease duration newly diagnosed long-standing Life expectancy long sht Usually not modifiable Imptant combidities absent few / mild severe Established vascular complications absent few / mild severe Patient attitude and expected treatment effts ly motivated, adherent, excellent self-care capacities less motivated, non-adherent, po self-care capacities Potentially modifiable Resources and suppt system Readily available limited Diabetes Care 2015;38: ; Diabetologia 2015; /s

13 Monotherapy Dual therapy! Healthy eating, weight control, increased physical activity & diabetes education risk neutral/ GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote moderate risk risk edema, HF, fxs risk neutral rare SGLT2 risk GU, dehydration risk GI est risk variable Triple therapy If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote SGLT-2 -i -i -i -i Combination injectable therapy! Figure'2.'An$<hyperglycemic'therapy'''''' in't2dm:'general'recommenda$ons' If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding : Basal Insulin Mealtime Insulin Diabetes Care 2015;38: ; Diabetologia 2015; /s

14 Monotherapy Dual therapy! Healthy eating, weight control, increased physical activity & diabetes education risk neutral/ GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote moderate risk risk edema, HF, fxs risk neutral rare SGLT2 risk GU, dehydration risk GI est risk variable Triple therapy If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote SGLT-2 -i -i -i -i Combination injectable therapy! Figure'2.'An$<hyperglycemic'therapy'''''' in't2dm:'general'recommenda$ons' If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding : Basal Insulin Mealtime Insulin Diabetes Care 2015;38: ; Diabetologia 2015; /s

15 Monotherapy Dual therapy! Healthy eating, weight control, increased physical activity & diabetes education risk neutral/ GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote moderate risk risk edema, HF, fxs risk neutral rare SGLT2 risk GU, dehydration risk GI est risk variable Triple therapy If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote SGLT-2 -i -i -i -i Combination injectable therapy! Figure'2.'An$<hyperglycemic'therapy'''''' in't2dm:'general'recommenda$ons' If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding : Basal Insulin Mealtime Insulin Diabetes Care 2015;38: ; Diabetologia 2015; /s

16 Monotherapy Dual therapy! Healthy eating, weight control, increased physical activity & diabetes education risk neutral/ GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote moderate risk risk edema, HF, fxs risk neutral rare SGLT2 risk GU, dehydration risk GI est risk variable Triple therapy If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote SGLT-2 -i -i -i -i Combination injectable therapy! If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding : Basal Insulin Mealtime Insulin Diabetes Care 2015;38: ; Diabetologia 2015; /s

17 Monotherapy Megmin' intolerance'' contraindica$on' HbA1c' 9%' Dual therapy! Healthy eating, weight control, increased physical activity & diabetes education risk neutral/ GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote moderate risk risk edema, HF, fxs risk neutral rare SGLT2 risk GU, dehydration risk GI est risk variable Triple therapy If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote SGLT-2 -i -i -i Uncontrolled' hyperglycemia' (catabolic'features,'' BG' 300<350'mg/dl,' HbA1c' 10<12%)' Combination injectable therapy! Basal Insulin -i If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding : Mealtime Insulin Diabetes Care 2015;38: ; Diabetologia 2015; /s

18 Monotherapy Dual therapy! Healthy eating, weight control, increased physical activity & diabetes education risk neutral/ GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote moderate risk risk edema, HF, fxs risk neutral rare SGLT2 risk GU, dehydration risk GI est risk variable Triple therapy If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote SGLT-2 -i -i -i -i Figure)2A.)An/Ehyperglycemic) Combination therapy)in)t2dm:)) injectable Avoidance*of** therapy! If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding : Basal Insulin Mealtime Insulin Diabetes Care 2015;38: ; Diabetologia 2015; /s

19 Monotherapy Dual therapy! Healthy eating, weight control, increased physical activity & diabetes education risk neutral/ GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote moderate risk risk edema, HF, fxs risk neutral rare SGLT2 risk GU, dehydration risk GI est risk variable Triple therapy If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote SGLT-2 -i -i -i -i Figure)2B.)An/Ehyperglycemic) Combination therapy)in)t2dm:)) injectable Avoidance*of*weight** therapy! If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding : Basal Insulin Mealtime Insulin Diabetes Care 2015;38: ; Diabetologia 2015; /s

20 Monotherapy Dual therapy! Healthy eating, weight control, increased physical activity & diabetes education risk neutral/ GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote moderate risk risk edema, HF, fxs risk neutral rare SGLT2 risk GU, dehydration risk GI est risk variable Triple therapy If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote SGLT-2 -i -i -i -i Figure)2C.)An/Ehyperglycemic) Combination therapy)in)t2dm:)) injectable Minimiza6on*of*costs* therapy! If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding : Basal Insulin Mealtime Insulin Diabetes Care 2015;38: ; Diabetologia 2015; /s

21 Posi3on Statement vs Algithms, is this a compe33on? The 2012 posi<on statement is considerably improved compared with the 2009 statement and brings the posi<on of the ADA/EASD much closer to the AACE/ ACE algithm but does not include several imptant considera<ons and the specific prii<sa<on of alterna<ve modali<es of therapy provided by the AACE/ACE algithm. Prac<<oners would benefit from cri<cal review of both documents side by side Robard & Jellinger Diabetologia 2012

22 Response from EASD/ADA member I will take on the difficult task of comparing the AACE algithms with the posi<on statement of the ADA/ EASD a posi<on statement is not meant to be an algithm a guideline inherent in providing pa<ent- focused care, algithms are impossible. Clinicians need to determine the pa<ent's needs and preferences and then treat them appropriately Our prac<ce se`ngs are different. I want everybody to get, no maber what guideline you fol, your pa<ent's A1c down to the est level that is safe and well tolerated" Anne Peters 2013

23 The wldwide challenge of glycaemic control: mean HbA 1C in Type 2 Diabetes Canada % 11 Latin America 7.6% 1 USA 7.2% 7 Germany % 8 Greece % 3,8 Italy 8.4% 11 Spain 9.2% 8 Poland 9.0% 11 Sweden 8.7% 3 Ptugal 9.7% 3 Turkey 10.6% 3 Romania 9.9% 3 UK % 2 China 9.5% 11 India % 9,11 Japan % 11 Kea % 4 Russia 9.6% Lopez Stewart G, et al. Rev Panam Salud Publica. 2007;22:12-20; 2. Kostev K, Rathmann W. Prim Care Diabetes. 2013;7: ; 3. Oguz A, et al. Curr Med Res Opin. 2013;29: ; 4. Ko SH, et al. Diabet Med. 2007;24:55-62; 5. Arai K, et al. Endocr J. 2008;55: (type 1 and type 2 diabetes); 6. Harris AK, et al. Diabetes. 2005;54: ; 7. Hoerger TJ, et al. Diabetes Care. 2007;30: (type 1 and type 2 diabetes); 8. Liebl A, et al. Diabetes Ther. 2012;3:9; 9. Shah S, et al. Adv Ther. 2009;26: ; 10. Blak BT, et al. Diabet Med. 2012;29:e ; 11. Valensi P, et al. Int J Clin Pract. 2008;62:

24 SOLVE TM - earlier insulin initiation is needed Baseline HbA 1c at time of insulin initiation Patients (%) The average HbA 1c was 8.9% Pri to insulin ini<a<on, pa<ents had received OAD therapy f 8.7 ± 6.7 years. Pa<ents remain poly controlled on OAD treatment f prolonged periods of <me Khunti et al. Diabetes Obes Metab 2012;14(7):654 61

25 How to improve the achievement of HbA 1c targets? Adherence to medications Developing quality measures Effective use of infmation system Education (CME) Adherence to guidelines Personal feedback and suppt of primary care teams Motivating and suppting patients on self-management Zafar et al. Primary Care Diabetes 2010;4:203 7

26 Reflec3ons on the ADA/EASD guidelines People with type 2 diabetes are managed in most parts of the wld by primary care teams Most primary care teams are not knowledgable/ experienced in managing type 2 diabetes Few teams read ADA/EASD guidance Wriben guidance is useful but insufficient in supp<ng people with diabetes in reaching glucose targets

27 Conclusions The ADA/EASD posi<on statement(s): provide a comprehensive updated pa<ent centred summary of treatment in type 2 diabetes Do a po job of improving their main objec<ve (ering HbA1c), at least in Europe Current management delivered by primary care physicians is not resul<ng in HbA1c levels among their pa<ents, sufficient to prevent microvascular disease Me effec<ve approaches are required