Diabetes Care Alphabet Strategy
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  • 1. Diabetes Care THE ALPHABET STRATEGY
  • 2.
    • It is estimated that 1.4 million people in the UK have diabetes mellitus.
      • Up to 1.25 million have type 2 diabetes
      • 0.15 million have type 1 diabetes
    • There may be as many as one million undiagnosed cases.
    • A new patient is diagnosed with type 2 diabetes every 5 minutes.
    UK prevalence of diabetes mellitus
  • 3.
    • Retinopathy
    • Most common cause of blindness in people of working age
    Nephropathy 16% of all new patients needing renal replacement therapy Erectile Dysfunction May affect up to 50% of men with long-standing diabetes Coronary and cerebrovascular Disease 2–4 fold increased risk of coronary heart disease and stroke, 75% have hypertension Foot Problems 15% of people with diabetes develop foot ulcers; 5–15% of people with diabetic foot ulcers need amputations The Audit Commission. Testing Times. A Review of Diabetes Services in England and Wales, 2000. Chronic complications of diabetes
  • 4. 50% of newly presenting patients with type 2 diabetes already have one or more complications at diagnosis . Retinopathy: 21% Hypertension: 35% Stroke or TIA: 1% Absent foot pulses: 13% Intermittent claudication: 3% Ischaemic skin changes to feet: 6% Erectile dysfunction: 20% Plasma creatinine >120  mol/l: 3% Myocardial Infarction: 1% Abnormal ECG: 18% UKPDS Group. Diabetes Research 1990;13:1–11. Complications at diagnosis in the UKPDS
  • 5. Goodkin G. Journal of Occupational Medicine 1975;17(11): 716–721. Donnelly R, et al. British Medical Journal 2000; 320: 1062–1066. Life expectancy and diabetes 40 45 50 55 60 65 70 75 80 85 15-19 20-29 30-39 40-49 50-59 60-70 Life expectancy (yrs) Diabetics Non Diabetics Age at diagnosis (yrs)
  • 6. Diabetes in the UK Indo - Asian community Asian European Men Women Age groups 20–39 40–59 60–79 20–39 40–59 60–79 30% 25% 20% 15% 10% 5% 0%
  • 7. U.K. economic costs Diabetes UK. May 2000. Year 2000 projected NHS diabetes expenditure ( 9% ) : £4,878,000,000 Equivalent to: per week £93,807,692 per day £13,401,098 per hour £ 558,379 per minute £ 9,306 per second £ 155 50% of Costs are due to premature complications
  • 8.  
  • 9. GMS Contract NICE National Service Framework Guidelines Increasing prevalence Evidence base User expectations
  • 10. Glycaemia Lipids Blood pressure Lifestyle Multi -disciplinary Patient oriented Audit Feet Eyes
  • 11. “ Excellence requires that important, simple things are done right all the time . ” National Service Framework for Coronary Heart Disease
  • 12. Patel V, Morrissey J The Alphabet Strategy British Journal of Diabetes & Vascular Disease, 2002: 2: 1: 58-59
  • 13. The Alphabet Strategy
    • A dvice
    • B lood pressure
    • C holesterol
    • D iabetes control
    • E ye examination
    • F eet examination
    • G uardian drugs
    • H eart risk score
  • 14. The Alphabet Strategy
    • A dvice Smoking , diet , exercise
    • B lood pressure < 140/80
    • C holesterol TC ≤ 5, LDL : HDL ≤ 3
    • D iabetes control HbA1c ≤ 7%
    • E ye examination Annual examination
    • F eet examination Annual examination
    • G uardian drugs Aspirin, ACEI, statins &c
    • H eart risk score UKPDS, Framingham
  • 15. A is for ...
    • ADVICE
    •  
  • 16.
    • Adherence to diet and medication
    • Smoking cessation, exercise, weight reduction
    • Ensure diabetes education and advise Diabetes UK membership
    • Stress role of the dietician, podiatrist and diabetes care nurses
    • Regular follow-up with comprehensive Annual Review is essential. 20% of patients with early severe complications will be persistent Diabetes Clinic non-attenders
    • Lifestyle targets: weight reduction > 5% if obese , fat intake < 30% of energy intake , saturated fat < 10% of energy intake , fibre > 15g per 1000 calories, exercise for four hours / week.
    Advice
  • 17.  
  • 18. Prevention of progression of IGT to diabetes Finnish Diabetes Prevention Study Intensive lifestyle intervention reduced progression to diabetes by 58%. Diabetes Prevention Program Intensive lifestyle management reduced diabetes by 58%. Standard lifestyle advice plus metformin reduced diabetes by 31% Incidence of diabetes was 11, 7.8 and 4.8 cases per 100 person years with placebo, metformin and intensive lifestyle intervention respectively.
  • 19. B is for ...
    • BLOOD PRESSURE
    •  
  • 20. UKPDS design Adapted from UK Prospective Diabetes Study (UKPDS) Group Lancet 1998;352:837-853; Turner R et al Ann Intern Med 1996;124(1 pt 2):136-145. Aim To determine whether intensified blood glucose control , with either sulphonylurea or insulin , reduces the risk of macrovascular or microvascular complications in type 2 diabetes. To determine the effect of aggressive blood pressure control . Study Population 3867 newly diagnosed type 2 diabetic patients who were asymptomatic after 3 months of diet ; fasting glucose 6.1–15 mmol/l (110–270 mg/dl) ; treat for 10 years .
  • 21. UKPDS : diabetes related endpoints
      • Diabetes related death
      • Non fatal myocardial infarction , heart failure or angina
      • Non fatal stroke
      • Amputation
      • Renal failure
      • Retinal photocoagulation or vitreous haemorrhage
      • Cataract extraction or blind in one eye
  • 22. UKPDS : diabetes-related deaths 0% 5% 10% 15% 20% 0 3 6 9 % of patients with events Years from randomisation Tight blood pressure control (758) Less tight blood pressure control (390) Risk reduction 32% ( p=0.019 )
  • 23. UKPDS : microvascular endpoints Risk reduction 37% ( p=0.0092 ) 0% 5% 10% 15% 20% 25% 0 3 6 9 % patients with event Years from randomisation Tight Blood Pressure Control (758) Less Tight Blood Pressure Control (390)
  • 24. UKPDS blood pressure control study In 1148 type 2 diabetic patients a tight blood pressure control policy which achieved blood pressure of 144 / 82 mm Hg gave reduced risk for : Any diabetes-related endpoint 24% p=0.0046 Diabetes-related deaths 32% p=0.019 Stroke 44% p=0.013 Microvascular disease 37% p=0.0092 Heart failure 56% p=0.0043 Retinopathy progression 34% p=0.0038 Deterioration of vision 47% p=0.0036
  • 25.  
  • 26. C is for ...
    • CHOLESTEROL
    •  
  • 27. MRC/BHF Heart Protection Study : eligibility
    • Increased CHD risk due to prior disease :
    • Myocardial infarction or other CHD ;
    • Occlusive disease of non-coronary arteries ; or
    • Diabetes mellitus or treated hypertension
    • Age 40-80 years
    • Total cholesterol >3.5 mmol/l ( >135mg/dl)
    • Statin or vitamins not considered clearly indicated or contraindicated by patient’s own doctors
  • 28. SIMVASTATIN: CAUSE-SPECIFIC MORTALITY Risk ratio and 95% CI STATIN PLACEBO Cause of death (10269) (10267) STATIN better STATIN worse CHD 577 701 Other vascular 214 242 ALL VASCULAR 791 943 (7.7%) (9.2%) 17% SE 4.4 reduction (2P<0.0002) Neoplastic 352 337 Respiratory 93 111 Other medical 76 91 Non-medical 16 21 ALL NON-VASCULAR 537 560 (5.2%) (5.5%) 5% SE 5.9 reduction ALL CAUSES 1328 1503 (12.9%) (14.6%) 12% SE 3.5 reduction (2P<0.001) 0.4 0.6 0.8 1.0 1.2 1.4
  • 29. SIMVASTATIN: MAJOR VASCULAR EVENTS Risk ratio and 95% CI STATIN PLACEBO Vascular event (10269) (10267) STATIN better STATIN worse Total CHD 914 1234 Total stroke 456 613 Revascularisation 926 1185 ANY OF ABOVE 2042 2606 (19.9%) (25.4%) 24% SE 2.6 reduction (2P<0.00001) 0.4 0.6 0.8 1.0 1.2 1.4
  • 30. SIMVASTATIN: VASCULAR EVENT by PRIOR DISEASE STATIN worse Risk ratio and 95% CI STATIN PLACEBO Baseline feature (10269) (10267) STATIN better STATIN worse Previous MI 1007 1255 Other CHD (not MI) 452 597 No prior CHD CVD 182 215 PVD 332 427 Diabetes 279 369 ALL PATIENTS 2042 2606 (19.9%) (25.4%) 24% SE 2.6 reduction (2P<0.00001) 0.4 0.6 0.8 1.0 1.2 1.4
  • 31. SIMVASTATIN: VASCULAR EVENT by PRIOR LIPID LEVELS Risk ratio and 95% CI STATIN PLACEBO Baseline feature (10269) (10267) STATIN better STATIN worse LDL (mmol/l) Het  2 2 = 3.0 < 3.0 (116 mg/dl) 602 761  3.0 < 3.5 483 655  3.5 (135 mg/dl) 957 1190 Total cholesterol (mmol/l) Het  2 2 = 0.5 <5.0 (193 mg/dl) 361 476  5.0 < 6.0 746 965  6.0 (232 mg/dl) 935 1165 ALL PATIENTS 2042 2606 (19.9%) (25.4%) 24% SE 2.6 reduction (2P<0.00001) 0.4 0.6 0.8 1.0 1.2 1.4
  • 32. HPS : main conclusions
    • After allowance for non-compliance, 40mg daily simvastatin safely reduces the risk of heart attack , of stroke and of revascularisation by at least one-third .
    • 5 years of statin treatment typically prevents these “major vascular events” in about :
    • 100 of every 1000 with previous MI
    • 80 &quot; &quot; other CHD
    • 70 &quot; &quot; diabetes (age 40+)
    • 70 &quot; &quot; previous stroke
    • 70 &quot; &quot; other PVD
    • … irrespective of cholesterol level, age, sex or other treatment .
  • 33. CARDS Collaborative Atorvastatin Diabetes Study Helen Colhoun, John Betteridge, Paul Durrington, Graham Hitman, Andrew Neil, Shona Livingstone, Margaret Thomason, Michael Mackness, Valentine Menys, John Fuller on behalf of the CARDS Investigators Presented at ADA 2004
  • 34. Primary prevention diabetes patients with one other risk factor (hypertension, smoker, micro-albuminuria, retinopathy) CARDS Design Placebo Atorvastatin 10mg Placebo 2838 patients
  • 35. Treatment effect on the primary endpoint 21 (1.5%) 24 (1.7%) 51 (3.6%) 83 (5.8%) Atorva* 48% (11- 69) 39 (2.8%) Stroke 31% (16- 59) 34 (2.4%) Coronary revascularisation 36% (9- 55) 77 (5.5%) Acute coronary events 37% (17- 52) p=0.001 127 (9.0%) Primary endpoint ** Hazard Ratio Risk Reduction (CI) Placebo* Event * N (% randomised) .2 .4 .6 .8 1 1.2 Favours Atorvastatin Favours Placebo ** Fatal MI, other acute CHD death , n on fatal MI , u nstable angina , CABG , f atal stroke , n on fatal stroke
  • 36. Treatment effect on the primary endpoint by lipid levels 29% (-5-52) p=0.40 43 (6.1) 60 (8.4) Trig. < 1.7 44% (18-62) 40 (5.5) 67 (9.6) Trig. ≥ 1.7 38% (9-58) 44 (6.1) 66 (9.5) LDL-C ≥ 3.06 47 (6.4) 36 (5.2) 39 (5.6) Atorva** 41% (11-61) 62 (8.4) HDL-C ≥ 1.35 35% (5-55) p=0.71 65 (9.6) HDL-C < 1.35 37% (6-58) p=0.96 61 (8.5) LDL-C < 3.06 Hazard Ratio Risk Reduction (CI) Placebo** Subgroup* * units in mmol/L ** N (% of randomised) .2 .4 .6 .8 1 1.2 Favours Atorvastatin Favours Placebo
  • 37. CHD prevention trials with statins in diabetes : CHD Endpoints: † HPS = first major vascular event; †† CARE = absolute risk of coronary events; ** CARDS: Acute Coronary Events ‡ 4S = major CHD events; ‡‡ 4S reanalysis = major coronary events. Cohorts: *HPS = risk reduction for the entire cohort (nondiabetics and patients with diabetes). Footnote: NS = results not statistically significant. 1. HPS Collaborative Group. Lancet. 2002;360:7-22. 2. Goldberg RB, Mellies MJ, Sacks FM, et al. Circulation. 1998;98:2513-2519. 3. Py ö r ä l ä K, Pedersen TR, Kjekshus J, et al. Diabetes Care. 1997;20:614-620. 4. Haffner SM, Alexander CM, Cook TJ, et al. Arch Intern Med. 1999;159:2661-2667. CARDS Study ADA 2004. GREACE Study Secondary Prevention Primary Prevention 12% NS 24%* 3051 Simvastatin HPS 1 42% 32% 483 Simvastatin 4S reanalysis 4 ‡‡ 55% 59% 32% 202 313 Simvastatin Atorvastatin 24mg 4S 3 ‡ GREACE 25% 23% 586 Pravastatin CARE 2 †† 37%** 26 -33 % 25%* 2838 2912 Atorvastatin 10mg Simvastatin 40mg CARDS HPS 1 † CHD risk red n Diabetes CHD risk red n Nondiabetics Number of patients Drug Study
  • 38. Cholesterol Treat all d iabetes patients with statins! (evidence if total cholesterol greater than 3.5 mmol/l) Alphabet t arget : t otal cholesterol <4 . 0 LDL <2 HDL ≥ 1.0: GMS t arget : t otal cholesterol <5 . 0
  • 39. D is for ...
    • DIABETES CONTROL 
  • 40.
      • Does intensive glucose control reduce the risk of diabetes complications ?
    UKPDS glucose control study
  • 41. UKPDS : diabetes related endpoints
      • Diabetes related death
      • Non fatal myocardial infarction , heart failure or
      • angina
      • Non fatal stroke
      • Amputation
      • Renal failure
      • Retinal photocoagulation or vitreous haemorrhage
      • Cataract extraction or blind in one eye
  • 42. UKPDS : any diabetes related endpoint 0% 20% 40% 60% 0 3 6 9 12 15 % of patients with an event Years from randomisation Intensive (2729) Conventional (1138) Risk reduction 12%
  • 43. HbA 1c % 7.0% versus 7.9% -35% -30% -25% -20% -15% -10% -5% 0% any diabetes endpoints MI micro vasculars Retinal laser cataract Micro albuminuria 12% 16% 25% 29% 24% 33% P=0.029 P=0.052 P=0.0099 P=0.0031 P=0.046 P<0.001
  • 44. UKPDS : glycaemic control
  • 45. E is for ...
    • EYE SCREENING
  • 46.  
  • 47. Diabetic retinopathy
    • Diabetic retinopathy is the commonest cause of blindness under the age of 65 in the Western World.
    • 21% of Type 2 diabetics have retinopathy at diagnosis.
    • 1500 new cases of blindness could be prevented by screening in UK yearly.
    • 20 years after diagnosis 95% with Type 1 diabetes have retinopathy ...
    • ... as do 60% of patients with Type 2 diabetes.
  • 48. Eye screening
    • The Diabetes National Service Framework guarantees :
    • Screening of 80% of people with diabetes by 2006
    • Rising to 100% by the end of 2007
    • By digital retinal photography
    • Based on a diabetes register
  • 49. F is for ...
    • FOOT SCREENING
  • 50.  
  • 51. Foot screening
    • Annual review essential - by GP, Practice Nurse , Diabetes Nurse or , ideally , podiatrist .
    • Examination should include: inspection , foot pulses , capillary refill , 10g monofilament testing, vibration sense .
    • If evidence of neuropathy or ischaemia refer to podiatrist since risk of ulceration is high . If ulceration present refer urgently to foot at risk clinic .
  • 52. G is for ...
    • GUARDIAN DRUGS
  • 53. Guardian drugs
    • Aspirin 75mg od:
    • Diabetes UK advocates considering aspirin prophylaxis against cardiovascular events in all diabetic patients ( >30yrs ) with any of the following:
    • Myocardial infarction, angina, hypertension (>140/80 or on treatment), AF, diabetic retinopathy, peripheral vascular disease and microalbuminuria.
    • Also if : Indo-Asian, obese (BMI > 25), dyslipidaemia, CHD risk > 15%, FH of CHD, smokers.
    • Grossly under-implemented : 23% in UK, 20% in USA . ( But 83% at George Eliot ! )
  • 54.
    • ACE-inhibitors have a special role in preventing diabetes complications (HOPE and Micro-HOPE) :
    • There is now a cardiovascular disease prevention licence for ramipril 10 mg daily in normo-tensive diabetic patients > 55 years with these risk factors :
    • Controlled hypertension
    • Cholesterol > 5.2 mmol/l or HDL < 0.9 mmol/l
    • Currently smoking
    • Micro-albuminuria.
    Guardian drugs
  • 55. HOPE: Heart Outcomes Prevention Evaluation Study: Micro-HOPE sub study Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus Lancet 2000; 355: 253 - 59
  • 56. HOPE : MI rate - ramipril vs placebo in diabetics 0.00 0.02 0.04 0.06 0.08 0.10 0.12 0.14 0.16 0 500 1000 1500 2000 Days of Follow-up Kaplan-Meier Rates ramipril Placebo RRR = 22% (6 - 36) p= 0.01
  • 57. HOPE : stroke rate - ramipril vs placebo in diabetics 0.00 0.02 0.04 0.06 0.08 0 500 1000 1500 2000 Days of Follow-up Kaplan-Meier Rates ramipril Placebo RRR = 33% (10 - 50) p=0.0074
  • 58. HOPE : CV death - ramipril vs placebo in diabetics 0.00 0.02 0.04 0.06 0.08 0.10 0.12 0 500 1000 1500 2000 Days of Follow-up Kaplan-Meier Rates ramipril Placebo RRR = 37% (21 - 51) p=0.0001
  • 59. HOPE : main conclusions
    • In people with diabetes at risk for cardiovascular disease, addition of ramipril to other effective therapies significantly reduces:
    • CV death, strokes and myocardial infarction Total mortality Revascularisation Diabetic nephropathy
    • The benefit is independent of the effect on BP ( 2.47/1 )
    • The incidence of cough was 7%
  • 60. LIFE : losartan intervention for endpoint reduction in hypertension study Lancet 2002 ; 359 : 995 - 1003
  • 61. LIFE : total mortality – diabetes subgroup Study Month 0 6 12 18 24 30 36 42 48 54 60 66 Proportion of patients, % 24 20 16 12 8 4 0 RRR = 39%; p=0·002 Losartan Atenolol
  • 62. LIFE : new onset diabetes by treatment group Study Month 0 6 12 18 24 30 36 42 48 54 60 66 0 2 4 6 8 10 Proportion of patients, % Atenolol Losartan
  • 63.
    • Compared with atenolol-based, losartan-based antihypertensive therapy was associated with:
      • less cardiovascular morbidity and mortality (13%)
      • less stroke (25%)
      • less new diabetes (25%)
      • better tolerability with significantly fewer discontinuations for adverse events
    • … for similar blood pressure reduction .
    LIFE : main conclusions
  • 64. H is for ...
    • HEART DISEASE RISK
  • 65.  
  • 66.  
  • 67. POEM 400 : heart disease risk score UKPDS: T0 vs. Tfu p=NS Tadj vs. Tfu p<0.001 n=315
  • 68. Pulling it all together : the Steno 2 Study Multifactorial intervention in high-risk individuals with type 2 diabetes Gaede P et al (2003) N Eng J Med 348:5 p383
  • 69.  
  • 70. Steno-2 : objective To compare the effect of a targeted , intensified, multifactorial intervention with that of conventional treatment on modifiable risk factors for cardiovascular disease in patients with type 2 diabetes and microalbuminuria.
  • 71. Steno-2 : study population
    • 160 patients with T2D and microalbuminuria
    • 80 allocated to conventional treatment
    • 80 allocated to intensive treatment
    • Mean age 55.1 years
    • Mean follow-up 7.8 years
  • 72. Steno-2 vs Alphabet Strategy : targets Annually Annually F eet UKPDS risk Events H eart disease Most All ACEI / AIIA Most All G uardians : aspirin Annually Annually E yes 7.0 6.5 D iabetes Control : HbA1c% 5.0 4.5 C holesterol 140 / 80 130 / 80 (140 / 85) B lood Pressure Standard Standard A dvice Alphabet Strategy Steno-2 intensive cohort
  • 73. Steno-2 intensive cohort : results 28 AIIA use 79 ACEI use 85 Statin use 87 Aspirin use 15 HbA1c% =< 6.5 72 Total cholesterol =< 4.5 70 Diastolic BP =< 80 54 Systolic BP =< 130 % Target
  • 74. Steno-2 : CVD event reduction 33 events in 19 patients 85 events in 35 patients 6 12 Revascularisation for PVD 7 14 Amputations 3 20 Stroke : non-fatal 0 5 PCI 5 10 CABG 5 17 MI : non-fatal 7 7 Cardiovascular Death Intensive Conventional Event
  • 75. Steno-2 : CVD event reduction Conventional intensive 0 2 4 6 8 10 12 14 16 18 20 Cardiovascular Death CABG Surgery Strokes: non- fatal PVD Surgery MI: non-fatal Percutaneous Coronary Rx Amputations Number of Events 7 7 17 5 10 5 5 0 20 3 14 7 12 6
  • 76. Steno-2 : conclusion “ A target driven, long-term, intensified intervention aimed at multiple risk factors in patients with type 2 diabetes and microalbuminuria reduces the risk of cardiovascular and microvascular events by about 50%.”
  • 77. The Alphabet Strategy
    • Health care professional talk
    • Patient / carer talk
    • “ Diabetes Care 4 U” posters
    • “ Diabetes and your medication” booklet
    • Patient held record
    • Audit tools
    • Clinic letter template
    • Antenatal clinic template
    • Young persons clinic template
    • ABC guidelines
    • Website: abcdiabetescare.org.uk
  • 78.  
  • 79.  
  • 80.
    • Thank you for listening !