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					Type 2 Diabetes: Notes for key slides 2 — Management of CV risk
factors

Slide 1
A major concern in type 2 diabetes is the increased risk of cardiovascular disease (CV)
disease,1 and this should be addressed by considering interventions for which there is
evidence of a reduction in CV events. The evidence suggests that controlling blood
glucose alone or in preference to other strategies will not achieve anything like the
reduction in risk that can be achieved by controlling other modifiable risk factors such as
blood pressure (BP).2,3,4 In this set of key slides we are going to look at what the
guidelines state, and some of the evidence, about the management of CV risk factors,
such as hypertension, lipids, and antiplatelet treatment in people with type 2 diabetes.


For further information and detail please view Part 3 of the eLearning in less than 60 mins
workshop.


Slide 2
The next two slides summarise the NICE guidance on BP control in type 2 diabetes. 1 The
target BP to aim for in people with type 2 diabetes is less than 130/80mmHg if they have
end-organ damage or less than 140/80mmHg if they don’t have such damage. 1 However,
both these targets can be challenging to meet, and agreeing individualised targets is
important, as there is pragmatic advice and some evidence that any reduction in BP
towards these levels is likely to be beneficial.5,6


The next slide details antihypertensive drug choice, but it is important to note that if people
are already on antihypertensives at the time of diagnosis, changes should only be made to
their medication if there is poor BP control or if current medications are not appropriate
because of metabolic problems or microvascular complications.1 An example of this might
be if they have kidney damage and should, therefore, be on an ACE inhibitor.1



Slide 3
If BP is confirmed to be consistently above target (following NICE’s advice around blood
pressure measurements), then lifestyle advice should be offered in the first instance and
continued even if drug treatment is needed.1 This includes advice on diet, exercise,

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stopping smoking and reducing alcohol, caffeine and salt intake. If drug treatment is
needed, the first-line antihypertensive agent for most people with type 2 diabetes is a
once-daily, generic ACE inhibitor, with some exceptions, as detailed here and on the next
slide.1


If individually agreed BP targets are not met, it is recommended that treatment is stepped
up to dual therapy with an ACE inhibitor and either a thiazide diuretic or a calcium-channel
blocker (CCB), then triple therapy with all three of these.1 Most people with type 2 diabetes
will need more than one antihypertensive to reduce their BP sufficiently, and a generic
ACE inhibitor plus bendroflumethiazide 2.5mg once-daily seems a reasonable choice for
many.


BP should be monitored every 1–2 months until at or below target.1 Lifestyle measures
should be continued at all stages.1 People are not always aware about just how much
difference they can make to their BP — and therefore their CV risk — by making some
lifestyle changes. For example, the average reduction in diastolic and systolic BP
produced by dietary changes is 5 or 6mmHg, and 40% of people will have a reduction of
10mmHg or more.5 That might well reduce the number of medicines someone has to take,
and might even mean they don’t need medicines at all.


Slide 4
As we’ve already seen in the algorithm on the previous slide, NICE recommend a generic
ACE inhibitor as the first-line antihypertensive agent in people with diabetes. NICE
selected ACE inhibitors as the first-line antihypertensive in people with diabetes as there is
some evidence that they have greater renal benefits than other classes of
antihypertensives in people with type 2 diabetes. However, there is no evidence that ACE
inhibitors have any CV benefits over other classes of drugs.1


Exceptions to the choice of ACE inhibitors as first-line BP-lowering treatment are:
     people of African-Caribbean descent who should receive an ACE inhibitor plus either a
      diuretic or a generic CCB
     women who could become pregnant, who NICE recommend should receive a CCB first
      line


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For people who are truly intolerant of ACE inhibitors due to cough, an angiotensin-2
receptor antagonist (A2RA) is an alternative.1


Slide 5
One point we want to emphasise is that thiazide diuretics are an appropriate
antihypertensive agent for people with diabetes. In the ALLHAT study, which, in the
opinion of the NPC, is still the single most important drug trial in hypertension to date, the
thiazide diuretic, chlortalidone, was unsurpassed in lowering BP and reducing CV
outcomes.7


This study recruited more than 42,000 people with hypertension and at least one other risk
factor for heart disease. More than one-third of people had type 2 diabetes, making this
one of the largest studies in this group of patients. In subgroups of patients with either
impaired fasting glucose, or true diabetes at baseline, again, diuretic therapy was
unsurpassed in preventing the combined primary outcome of fatal coronary heart disease
or non-fatal MI.7


Significantly more cases of diabetes were seen in the chlortalidone group than in the ACE
inhibitor or CCB group. However, the absolute difference between groups was small. 7


We also have further reassurance from long-term follow up of the SHEP study, in which
people with isolated systolic hypertension were treated with chlortalidone, plus a beta
blocker or reserpine if necessary, or placebo.


More people in the treatment group developed diabetes as defined by raised glucose
levels but, importantly, this did not lead to any worse outcomes than in people who did not
develop diabetes.8


Slide 6
Most people with type 2 diabetes should be offered a statin as they will fulfil the criteria
outlined on this slide. For example, they will either be 40 years of age or older and have a
normal to high CV risk for someone with type 2 diabetes; 40 years of age or older and
have a low CV risk for someone with type 2 diabetes, but a CV risk greater than 20% when
assessed using the UKPDS risk engine; or less than 40 years of age with a poor CV risk
profile.1
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Generic simvastatin, up to 40mg daily, is the first-choice statin. Once a statin has been
prescribed for a patient with type 2 diabetes, NICE recommend assessing lipid profiles
after 1–3 months, then annually thereafter.1


Slide 7
In the type 2 diabetes guideline, NICE recommend that simvastatin is increased from
40mg daily to 80mg daily unless total cholesterol is below 4mmol/L or low-density
lipoprotein (LDL) cholesterol is below 2mmol/L.1 It’s really important to note that these
figures are a threshold which should prompt consideration of increasing the dose, not
targets to reach.


The NPC have asked NICE for clarification about this recommendation, and they have
confirmed that increasing the dose should be considered only in patients whose total
cholesterol is greater than 4mmol/L and also whose LDL cholesterol remains greater than
2mmol/L; if either figure is below that level, then increasing the dose is not
recommended.9


For people with existing or newly diagnosed CV disease or an increased albumin excretion
rate, NICE recommend considering more intensive therapy with a more effective statin or
ezetimibe to achieve the lipid levels of 4 or 2mmol/L.1


Again, these figures should be viewed as a threshold to prompt consideration of increasing
the dose, not targets to reach, and increasing the dose should be considered only in
patients whose total cholesterol is greater than 4mmol/L and also whose LDL cholesterol
is greater than 2mmol/L. Again, if either figure is below that level, then increasing the dose
is not recommended.9


Both of these recommendations were based on health economic analyses, which
suggested titration to simvastatin 80mg was cost-effective in those whose lipid levels were
not controlled to 4 or 2mmol/L. Two-step titration (first to simvastatin 80mg and then if
indicated to atorvastatin 80mg) was cost-effective in those with existing CV disease and
whose total cholesterol exceeded 4mmol/L or LDL cholesterol exceeded 2mmol/L.1
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Slide 8
With regard to fibrates NICE recommend these drugs (with fenofibrate first-line) if
triglyceride levels remain above 4.5mmol/L despite attention to other causes. A fibrate can
also be considered in addition to statin therapy if triglyceride levels remain between 2.4
and 4.5mmol/L despite statin therapy.1 However, the evidence-base is not as robust for
fibrates and there are safety issues………………….

Slide 9
In November 2007, the MHRA issued this advice to healthcare professionals: fibrates are
first-line therapy only in patients with isolated severe hypertriglyceridaemia. Combination
use of a statin and fibrates needs to be done carefully, and in particular gemfibrozil should
not be used with statins.10

Overall, statins remain the lipid-lowering agent of choice in patients with type 2 diabetes.
For some people with very high triglyceride levels and a very unusual lipid profile, which
statins are not very good at normalising, a fibrate or possibly even a fibrate plus a statin
might be a better option.However, such people have not been well represented in clinical
trials so there is little good evidence on which to guide treatment and, bearing in mind the
MHRA warnings about combination use, expert advice from a lipidologist or diabetologist
is essential here.


Slide 10
This slide summarises the NICE guidance on antithrombotic therapy in people with type 2
diabetes. It recommends low-dose aspirin for all people over 50 years of age with type 2
diabetes if their BP is controlled, and for people under 50 years of age if they have
significant other risk factors for CV disease.1


Recommendations from NICE were based mainly on data from subgroup analyses and
extrapolation from secondary prevention studies. At the time the NICE guideline was
published, there was little direct evidence of the use of low-dose aspirin in people with type
2 diabetes who did not already have CV disease. This has changed with the publication of
the POPADAD trial, a randomised controlled trial (RCT) of low-dose aspirin in people with
type 1 or type 2 diabetes without symptomatic CV disease, but with a risk factor for this.
The new evidence from the POPADAD trial (see NPCi blog 226) suggesting low-dose
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aspirin is ineffective in people with type 2 diabetes who don’t have existing CV disease,
questions its use for primary prevention in this population.11


Slide 11

To summarise recommendations to reduce the risk of CV disease in people with
type 2 diabetes.


It is important to control BP in people with type 2 diabetes.1 Immaculate technique should
be used to diagnose hypertension and monitor BP.5 Reducing BP is more important than
worrying too much about drug choice, but ACE inhibitors are first choice for most people
with type 2 diabetes, with thiazides a good addition for most.1


We have to weigh up the acceptability to the patient of increasing drug treatment with a
possibility of extra side effects and more tablets to take and balance that against any
possible further benefits from further BP lowering.


Statins are appropriate for most people with type 2 diabetes, and simvastatin 40 mg daily
is the first-choice agent for most people.1


People with existing CV disease should be offered low-dose aspirin.1 The use of low-dose
aspirin for primary prevention in people with type 2 diabetes should be assessed on an
individual patient basis, once BP is controlled.




References
1. NICE Full Clinical Guideline 66; Type 2 diabetes: the management of type 2 diabetes.
      May 2008.
2. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with
      sulphonylureas or insulin compared with conventional treatment and risk of
      complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837–853.




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3. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose
      control with metformin on complications in overweight patients with type 2 diabetes
      (UKPDS 34). Lancet 1998;352:854–865
4. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of
      macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ
      1998;317:703–713.
5. NICE Full Hypertension Guideline 34. June 2006.
6. Hansson L, et al. Effects of intensive blood-pressure lowering and low-dose aspirin in
      patients with hypertension: principal results of the Hypertension Optimal Treatment
      (HOT) randomised trial. Lancet 1998;351:1755–1762.
7. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group.
      Major outcomes in high-risk hypertensive patients randomized to angiotensin-
      converting enzyme inhibitor or calcium channel blocker vs. diuretic. JAMA
      2002;288:2981–2997.
8. MeReC Extra No. 27 Development of diabetes with thiazides: what are the
      consequences? March 2007.
9. MeReC Bulletin (19)3. Lipid-modifying treatment. December 2008.
10. MHRA Drug Safety Update (1) 4. November 2007.
11. NPCi Blog 226. Aspirin ineffective for primary prevention in patients with diabetes.




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