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Management of Type Diabetes NICE miocardial infarction

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									Managing
T2DM is easy
Background

   Replaces all existing T2 guidelines except:
       Foot care (CG10 2004)
       Pregnancy (CG63 2008)


   Quick reference guide is short and easy to
    digest
       All diabetes practitioners need to read
       Should be available in all DM clinics for reference
Caveats

    Does not consider many newer drugs
        DPP-IV
        Detemir
    Exenatide only briefly touched on
    Doesn’t include data from the latest
     type 2 studies
        UKPDS 80 and 81
        ADVANCE, ACCORD
Patient education

   Should be offered to all at diagnosis
       Ideally structured group education in accordance
        with DoH guidance
       Individual education to same standard where
        group sessions are inappropriate
   Annual reinforcement and review

   Current position locally
       BANES - DESMOND
       Wiltshire – X-PERT
       Somerset - DESMOND
Dietary advice

   General advice
       Include high fibre, low GI CHO
       Include low fat dairy and oily fish
       Control saturated fats and trans fatty acids
       Discourage ‘diabetic’ foods
   Action
       Provide individualised and ongoing advice from a
        healthcare professional with expertise and
        competencies in nutrition
       Initial target weight loss 5-10%
Assessment of glycaemic control

   General target HbA1c 6.5%, but
    individualise
   Demonstrate how any reduction
    benefits future health
 Simple clinic demonstration


Complications




                7   9   11   13   HbA1c
Assessment of glycaemic control
   Check 2-6 monthly until stable, then 6
    monthly
   Seek specialist advice if HbA1c result
    discrepant or invalid
Self monitoring

   HBGM should be available:
       To those on insulin
       To those on OHAs capable of causing
        hypos
       To assess changes in BGs resulting from
        medication change
       To monitor during intercurrent illness
       To ensure safety during activities eg
        driving
Self monitoring (2)

   Discuss purpose, interpretation and how
    to act on HBGM
   Only initiate at diagnosis as an integral
    part of self-management education
   Assess at least annually in a structured
    way
       Equipment
       Technique
       Understanding and utilisation
Blood glucose-lowering therapy

        HbA1c >= 6.5% after trial of lifestyle


                   Metformin
           (with active dose titration)
Notes on Metformin
   Step up over several weeks to avoid GI
    upset
   Try SR MFN if GI s/e
   Review dose if Cr >130 or eGFR <45
   Stop if Cr >150 or eGFR <30
   Caution where there is a risk of sudden
    deterioration in renal function
Blood glucose-lowering therapy

         HbA1c >= 6.5% after trial of lifestyle


                     Metformin
             (with active dose titration)


                                                HbA1c <6.5%
             HbA1c >= 6.5%
                                            Monitor for deterioration


        Metformin + Sulphonylurea
        (with active dose titration)
Notes on SUs
   Prescribe cheap version (avoiding
    glibenclamide)
   Educate patient about risk of hypos,
    particularly if has renal impairment
   Consider rapid-acting secretagogue for
    patients with erratic lifestyles
   Offer once-daily if concordance is a
    problem
Blood glucose-lowering therapy

              HbA1c >= 6.5% after trial of lifestyle


                            Metformin
                    (with active dose titration)


                                                       HbA1c <6.5%
                    HbA1c >= 6.5%
                                                   Monitor for deterioration


             Metformin + Sulphonylurea
             (with active dose titration)


                                      HbA1c <7.5%
    HbA1c >= 7.5%
                                  Monitor for deterioration
Blood glucose-lowering therapy (2)
                                          HbA1c >= 7.5%


                                         Add TZD or insulin
                                     (with active dose titration)


                      HbA1c >= 7.5%                             HbA1c <7.5%
                                                            Monitor for deterioration


            Insulin + Metformin + Sulphonylurea
                  (with active dose titration)


        HbA1c >= 7.5%               HbA1c <7.5%
                                Monitor for deterioration


    Intensify insulin regimen
Notes on glitazones
   Warn patient about significant oedema
   Do not initiate or continue if evidence of
    heart failure or at higher risk of fracture
   Select drug based on most up-to-date
    advice from regulatory authorities, cost
    and safety
   Consider pio with insulin if high doses
    ineffective
    Exenatide
   Consider if
       BMI >35 (adjust for ethic group)
       Patient had specific psychological, biochemical or
        physical problems arising from high body weight
       HbA1c ≥ 7.5% after MFN and SU
       Would otherwise be starting high cost Rx (TZD or
        insulin)
   Continue if
      ≥1% reduction of HbA1c at 6 months

      ≥ 5% reduction weight at 1 year
    Insulin

   Initiate with a structured program employing
    active dose titration
       Structured education
       Continuing telephone support
       Frequent self-monitoring
       Dose titration to target
       Dietary understanding
       Management of hypoglycaemia
       Management of acute changes in glucose control
       Support from appropriately trained HCP
    Insulin (2)

   Preferably begin with NPH insulin (OD or BD)
   Consider glargine if
       Patient requires assistance to administer insulin
       Recurrent hypos
       BD basal insulin plus OHAs would otherwise be needed
   Consider BD pre-mixed human insulin if HbA1c >9%
   Consider BD pre-mixed analogues when
       Injection immediately pre meal is preferred
       Hypos are a problem
       Marked postprandial glucose excursions
UKPDS – post trial monitoring
Background
   20 year study (1977 – 1997)
       Main results published 1998
       Revolutionised our Rx of T2D
   10 post trial surveillance just published
    at EASD
       UKPDS 80 & 81 (NEJM 2008 359)
UKPDS - Glucose Interventional Trial
    Dietary                 Randomisation                Trial end
    Run-in                    1977-1991                    1997

       744                           2,729
    Diet failure                   Intensive              Intensive
  FPG >15 mmol/l            with sulfonylurea/insulin

                                                                       P


       5,102                1,138 (411 overweight)
 Newly-diagnosed     4209      Conventional             Conventional
  type 2 diabetes                   with diet


                                                                       P

       149                   342 (all overweight)
 Diet satisfactory               Intensive                Intensive
  FPG <6 mmol/l                 with metformin

Mean age 54 years
  (IQR 48–60)
Change in HbA1c over time
                      cross-sectional, median values
            9

                    Conventional
            8
HbA1c (%)




                                         Intensive
            7


                                      6.2% upper limit of normal range
            6
            0
                0     3          6        9        12                15
                          Years from randomisation
Myocardial Infarction and Microvascular
                Disease
                        80


                        60                                  Microvascular
   1000 patient-years

                                                            disease
     Incidence per




                        40                                  Myocardial
                                                            infarction

                        20


                        0
                             0 5 6 7 8 9 10 11
                               Updated mean HbA1c (%)
                              UKPDS 35. BMJ 2000; 321: 405-12
     Microvascular Endpoints (cumulative)
                                           renal failure or death, vitreous haemorrhage or photocoagulation
                                                                                   346 of 3867 patients (9%)

                                         30%
                                                   Conventional
           % of patients with an event

                                                   Intensive
                                                   p=0.0099
                                         20%



                                         10%


                                                                       Risk reduction 25%
                                         0%                           (95% CI: 7% to 40%)
                                               0       3       6      9      12              15
                                                       Years from randomisation
UKPDS Group. Lancet. 1998;352:837-853
Myocardial Infarction (cumulative)
                                         fatal or non fatal myocardial infarction, sudden death
                                                                   573 of 3867 patients (15%)
                              30%
                                        Conventional
% of patients with an event


                                        Intensive
                                        p=0.052
                              20%



                              10%


                                                           Risk reduction 16%
                              0%                          (95% CI: 0% to 29%)
                                    0        3       6      9      12           15
                                             Years from randomisation
UKPDS
   10 year post trial surveillance just
    published at EASD
       UKPDS 80 & 81 (NEJM 2008 359)
   Post-Trial Monitoring: Patients
       1997                     2002                       2007
# in survivor cohort                               # with final year data
       2,118           Clinic      Questionnaire          1,010
Sulfonylurea/Insulin                               Sulfonylurea/Insulin


                                                                            P


      880              Clinic      Questionnaire          379
   Conventional                                        Conventional



                                                                            P

       279             Clinic      Questionnaire           136
     Metformin                                           Metformin

     Mean age                                 Mortality 44% (1,852)
    62±8 years                                Lost-to-follow-up 3.5% (146)
Post-Trial Changes in HbA1c

        UKPDS results   Mean (95%CI)
        presented
Microvascular Disease Hazard Ratio
       (photocoagulation, vitreous haemorrhage, renal failure)

 Intensive (SU/Ins) vs. Conventional glucose control




                                                                 HR (95%CI)
Myocardial Infarction Hazard Ratio
      (fatal or non-fatal myocardial infarction or sudden death)

Intensive (SU/Ins) vs. Conventional glucose control




                                                                   HR (95%CI)
Legacy Effect of Earlier Glucose Control
         After median 8.5 years post-trial follow-up

Aggregate Endpoint                                   1997    2007
Any diabetes related endpoint              RRR:      12%      9%
                                             P:      0.029   0.040
Microvascular disease                      RRR:  25%         24%
                                             P: 0.0099       0.001
Myocardial infarction                      RRR:      16%     15%
                                             P:      0.052   0.014
All-cause mortality                        RRR:       6%     13%
                                             P:       0.44   0.007
               RRR = Relative Risk Reduction, P = Log Rank
    Conclusions of glucose intervention trial

• Despite an early loss of glycaemic differences, a
  continued reduction in microvascular risk and
  emergent risk reductions for myocardial infarction and
  death from any cause were observed during 10 years
  of post-trial follow-up

• A continued benefit after metformin therapy was
  evident among overweight patients.

• ‘Metabolic memory’
NICE 2008
     Blood pressure
   Targets
       <130/80 if kidney, eye or cerebrovascular damage
       Otherwise <140/80
   If BP above target repeat within
       1 month if >150/90
       2 months otherwise
   Once treated, monitor
       1-2 monthly until consistently below target
       Then 4-6 monthly
BP treatment
              Lifestyle advice

               ACE inhibitor

            Add CCB or diuretic

               Add other drug

    Add alpha blocker, beta blocker or K-
              sparing diuretic
UKPDS
Blood Pressure Interventional Trial
    5,102            Randomisation           Trial end
 UKPDS patients
                       1987-1991               1997


                           759
                       Tight control         Tight control
                     ACEI or ß-blocker

      1,148
BP ≥160/90 mm Hg                                                P
 or ≥150/80 on Rx

   Mean age                  390
   56±8 years         Less-tight control   Less-tight control
                    No ACEI or ß-blocker
Myocardial Infarction and Microvascular
 




   50           Disease
     per 1000 person years

                             40
      Adjusted incidence




                                     Myocardial infarction              

                             30                                
                                                         
                                                   
                             20             


                             10
                                     Microvascular endpoints
                             0
                               0 110 120 130 140 150 160 170
                              Updated mean systolic blood pressure (mm Hg)
                                          UKPDS 35. BMJ 2000; 321: 405-12
          Microvascular endpoints
                        25%
                                  Less Tight Blood Pressure Control (390)

                                  Tight Blood Pressure Control (758)
% patients with event
                        20%


                        15%



                        10%


                        5%
                                                                  risk reduction
                        0%                                        37% p=0.0092
                              0              3                6             9
                                      Years from randomisation
                            Myocardial Infarction
                           25%       Less Tight Blood Pressure Control (390)
                                     Tight Blood Pressure Control (758)
% of patients with event
                           20%


                           15%



                           10%



                           5%
                                                                    risk reduction
                           0%
                                                                    21% p=0.13
                                 0              3                 6            9
                                              Years from randomisation
       Post-Trial Monitoring: Patients

       1997                     2002                           2007
# in survivor cohort                                   # with final year data
        592            Clinic      Questionnaire                250
    Tight control                                           Tight control


                                                                                P


        292            Clinic      Questionnaire                 126
 Less-tight control                                       Less-tight control


    Mean age                                       Mortality 51% (584)
    63±8 years                                     Lost-to-follow-up 2.0% (23)
Post-Trials Changes in Blood Pressure
          UKPDS
            results
         presented         Mean (95%CI)
Microvascular Disease Hazard Ratio
     (photocoagulation, vitreous haemorrhage, renal failure)

               Less-tight vs. Tight blood pressure control




                                                               HR (95%CI)
Myocardial Infarction Hazard Ratios
    (fatal or non-fatal myocardial infarction or sudden death)

                Less-tight vs. Tight blood pressure control
  Conclusions of BP intervention trial
• The benefits of previously improved blood-pressure
  control were not sustained when between-group
  differences in blood pressure were lost

• Early improvement in blood-pressure control in
  patients with both type 2 diabetes and hypertension
  was associated with a reduced risk of complications,
  but it appears that good blood pressure control must
  be continued if the benefits are to be maintained
NICE 2008
    Nephropathy
   Annual monitoring
       ACR on early morning urine
       Serum creatinine and eGFR
   Abnormal ACR (exclude UTI and proteinuria)
       Repeat test twice within 3-4 months
       Microalbuminuria confirmed if >1 test abnormal
   Action
       ACE inhibitor to maximum tolerated dose
       Maintain BP <130/80
When is it not nephropathy?

   No significant or progressive
    retinopathy
   BP particularly high or resistant to Rx
   Heavy proteinuria (ACR>100) when
    previously normal
   Significant haematuria
   GFR rapidly worsened
   Patient systemically unwell
Retinopathy

   Important to screen at diagnosis
   Discuss reasons for attending to formal
    screening programme
   Retinal screening programme compliant
    with guidance
Neuropathy
NICE 2008 - Conclusions
   Useful document, but incomplete wrt
    hypoglycaemic therapies
   Please ensure all patients referred for
    education
   Important emphasis on early control
   BP target controversial
   Nothing radical wrt complications

								
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