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## Complete Summary

#### GUIDELINE TITLE

Guidelines on diabetes, pre-diabetes, and cardiovascular diseases.

#### BIBLIOGRAPHIC SOURCE(S)

Task Force on Diabetes and Cardiovascular Diseases. Ryden L, Standl E,
Bartnik M, Van den Berghe G, Betterridge J, de Boer MJ, Cosentino F,
Jonsson B, Laakso M, Malmberg K, Priori S, Ostergren J, Tuomilehto J,
Thrainsdottir I. Guidelines on diabetes, pre-diabetes, and
cardiovascular disease: full text. Sophia Antipolis, France: European
Society of Cardiology (ESC); 2007. 72 p. \[711 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [February 28, 2008, Heparin Sodium
    Injection](http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2):
    The U.S. Food and Drug Administration (FDA) informed the public that
    Baxter Healthcare Corporation has voluntarily recalled all of their
    multi-dose and single-use vials of heparin sodium for injection and
    their heparin lock flush solutions. Alternate heparin manufacturers
    are expected to be able to increase heparin production sufficiently
    to supply the U.S. market. There have been reports of serious
    adverse events including allergic or hypersensitivity-type
    reactions, with symptoms of oral swelling, nausea, vomiting,
    sweating, shortness of breath, and cases of severe hypotension.

-   [February 26, 2008, Avandia
    (rosiglitazone)](http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avandia):
    A new Medication Guide for Avandia must be provided with each
    prescription that is dispensed due to the U.S. Food and Drug
    Administration\'s (FDA\'s) determination that this medication could
    pose a serious and significant public health concern.

-   [November 14, 2007, Avandia
    (rosiglitazone)](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia2):
    New information has been added to the existing boxed warning in
    Avandia\'s prescribing information about potential increased risk
    for heart attacks.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

-   Diabetes (type 1 and type 2) and pre-diabetes

-   Cardiovascular diseases

#### GUIDELINE CATEGORY

Diagnosis\
Management\
Prevention\
Risk Assessment\
Screening\
Treatment

#### CLINICAL SPECIALTY

Cardiology\
Endocrinology\
Internal Medicine

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

To improve the management of:

-   Patients with overt diabetes

-   Patients at risk of developing diabetes, as demonstrated by impaired
    glucose tolerance

-   Cardiovascular diseases in these patient populations

#### TARGET POPULATION

-   Patients with overt diabetes

-   Patients at risk of developing diabetes, as demonstrated by impaired
    glucose tolerance

-   Patients with co-existing diabetes or pre-diabetes and
    cardiovascular diseases

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis, Screening, Risk Assessment**

1.  Definition and classification of diabetes and pre-diabetes states
    based on level of subsequent cardiovascular complications

2.  Screening for diabetes type 2 based on oral glucose tolerance test
    (OGTT) and risk scores

3.  Identification of subjects at high risk for cardiovascular disease
    or diabetes

**Treatment/Management/Prevention**

1.  Patient education to improve metabolic and blood pressure control

2.  Life style counselling and therapy

3.  Self-monitoring of glucose

4.  Statin therapy

5.  Establishment of treatment targets: blood pressure, glycaemic
    control, low-density lipoprotein (LDL)-cholesterol, high-density
    lipoprotein (HDL)-cholesterol, triglycerides, smoking, weight,
    physical activity, dietary habits

6.  Thromobolytic therapy for acute myocardial infarction

7.  Angiography

8.  Revascularization (percutaneous coronary interventions, coronary
    artery bypass surgery)

9.  Prostacyclin infusion in lieu of revascularization for limb
    ischaemia

10. Beta-blocker therapy

11. Antiplatelet therapy (aspirin, clopidogrel, low-molecular-weight
    heparin)

12. Angiotensin-converting enzyme (ACE) inhibitor or
    angiotensin-II-receptor blocker therapy

13. Glycoprotein IIb/IIIa inhibitor therapy

14. Aldosterone antagonists

15. Diuretics

16. Insulin therapy

17. Pharmacological therapy for diabetes or impaired glucose tolerance

#### MAJOR OUTCOMES CONSIDERED

-   Relative risk for and prevalence of diabetes and cardiovascular
    disease

-   Incidence of stroke

-   Morbidity and mortality

-   Cost-effectiveness of interventions

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Levels of Evidence**

**Level of Evidence A**: Data derived from multiple randomized clinical
trials or meta-analyses

**Level of Evidence B**: Data derived from a single randomized clinical
trial or large non-randomized studies

**Level of Evidence C**: Consensus of opinion of the experts and/or
small studies, retrospective studies, registries

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The European Society of Cardiology (ESC) and the European Association
for the Study of Diabetes (EASD) have decided to develop joint,
evidence-based guidelines for \"Diabetes and Cardiovascular Diseases.\"
Experts from both sides were asked to form a Task Force and to write
state-of-the-art chapters. Although individual authors have been
assigned to draft the manuscripts according to their specific area of
expertise, the guidelines were then extracted and harmonized as a true
team effort by the whole group. Hence, the names of all authors appear
only on the cover of these guidelines as members of the writing group.
Some of the members of the Task Force were helped in the literature
search and writing process by members of their respective teams and
these contributors are also named on the cover as contributors.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Classes of Recommendations**

**Class I**: Evidence and/or general agreement that a given diagnostic
procedure/treatment is beneficial, useful, and effective

**Class II**: Conflicting evidence and/or a divergence of opinion about
the usefulness/efficacy of the treatment or procedure

**Class IIa**: Weight of evidence/opinion is in favour of
usefulness/efficacy

**Class IIb**: Usefulness/efficacy is less well established by
evidence/opinion

**Class III**: Evidence or general agreement that the treatment or
procedure is not useful/effective and in some cases may be harmful

#### COST ANALYSIS

**The Cost-effectiveness of Intervention**

There have been many studies investigating the cost-effectiveness of
different treatment strategies for diabetic patients. Here the guideline
developers will focus on the prevention of macrovascular complications,
as they are the largest contributor to the costs associated with the
disease.

Lipid-lowering using statins in diabetics have been studied in several
studies. In a subgroup of the Scandinavian Simvastatin Survival Study
(4S) Trial, cost-effectiveness ratios of treating diabetic patients with
20 to 40 mg simvastatin were found to be well below the levels that are
usually considered cost-effective. Diabetic patients were also enrolled
in the Heart Protection Study (HPS), which indicated acceptable
cost-effectiveness ratios for patients with this risk level. One
important thing to consider about these studies is that they used a cost
of simvastatin prior to the expiry date of the patent. Thereafter the
price dropped substantially which would mean that statin use in
diabetics is likely to be cost-saving in secondary prevention and
associated with very low cost-effectiveness ratios in primary
prevention.

Another approach to prevention of macrovascular complication is through
blood pressure control. This has been studied as part of the United
Kingdom Prospective Diabetes Study (UKPDS), where tight blood pressure
control using beta-blockers and angiotensin-converting enzyme
(ACE)-inhibitors was investigated. A recent cost-effectiveness analysis
of this intervention indicated that this treatment strategy was
associated with a very high cost-effectiveness. In another study, a
group of researchers investigated the cost-effectiveness of doxazosin in
Italy and the United Kingdom, and also found acceptable
cost-effectiveness ratios.

It can be concluded that the costs associated with diabetes make up a
considerable share of the resources spent on healthcare throughout
Europe. As the most important cost drivers are complications caused by
the disease, proper management in the prevention of complications is
essential.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The guidelines were reviewed by independent referees appointed by the
two scientific organizations whose identity were disclosed, once all
criticisms and suggestions had been incorporated into the text to
achieve the broadest possible expertise and consensus. The referees are
also acknowledged with their names on the cover and are an important,
integral part of this scientific guideline exercise.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Definitions for the recommendation classes (I, II, IIa, IIb III) and
levels of evidence (A, B, C) are given at the end of the \"Major
Recommendations.\"

**Definition, Classification, and Screening of Diabetes and Pre-diabetic
Glucose Abnormalities**

**Definition and Classification of Diabetes**

The definition and diagnostic classification of diabetes and its
pre-states should be based on the level of the subsequent risk of
cardiovascular complications. **Class I, Level of Evidence B**.

**Screening for Undiagnosed Diabetes**

Early stages of hyperglycaemia and asymptomatic type 2 diabetes are best
diagnosed by an oral glucose tolerance test (OGTT) that gives both
fasting and two-hours post-load glucose (2-hPG) values. **Class I, Level
of Evidence B**.

**Detection for People at High Risk for Diabetes**

Primary screening for the potential type 2 diabetes can be done most
efficiently using a non-invasive risk score, subsequently combined with
a diagnostic oral glucose tolerance testing in people with high score
values. **Class I, level of Evidence A**.

**Epidemiology of Diabetes, Impaired Glucose Homeostasis (IGH), and
Cardiovascular Risk**

**Diabetes and Coronary Artery Disease (CAD)**

The relationship between hyperglycaemia and cardiovascular disease (CVD)
is to be seen as a continuum. For each 1% increase of glycated
haemoglobin (HbA~1C~), there is a defined increased risk for CVD.
**Class I, Level of Evidence A**.

The risk of CVD for people with overt diabetes is increased by two to
three times for men and three to five times for women compared to people
without diabetes. **Class I, Level A**.

**IGH and CAD**

*Cardiovascular Risk and Post-Prandial Hyperglycaemia*

Information on post-prandial (post-load) glucose provides better
information about the future risk for CVD than fasting glucose, and
elevated post-prandial glucose also predicts the cardiovascular risk in
subjects with normal fasting glucose levels. **Class I, Level of
Evidence A**.

*Glycaemic Control and Cardiovascular Risk*

Improved control of post-prandial glycaemia may lower cardiovascular
risk and mortality. **Class IIb, Level of Evidence C**.

**Gender Differences in CAD Related to Diabetes**

Glucometabolic perturbations carry a particularly high risk for
cardiovascular morbidity and mortality in women, who in this respect
need special medical attention. **Class IIa, Level of Evidence B**.

**Glucose Homeostasis and Cerebrovascular Disease**

People with diabetes and impaired glucose tolerance (IGT) have an
increased risk for stroke. **Class I, Level of Evidence A**.

In stroke patients, unrecognized hyperglycaemia is mostly high post-load
glucose seen in the OGTT, whereas the measurement of fasting glucose is
insensitive in detecting unrecognized hyperglycaemia. **Class I, Level
of Evidence B**.

**Identification of Subjects at High Risk for CVD or Diabetes**

**The Metabolic Syndrome**

The metabolic syndrome identifies people at a higher risk of CVD than
that in the general population, although it may not provide a better or
even equally good prediction of cardiovascular risk than scores based on
the major cardiovascular risk factors (age, blood pressure, smoking, and
serum cholesterol). **Class II, Level of Evidence B**.

**Risk Charts**

Several cardiovascular risk assessment tools exist and they can be
applied to both non-diabetic and diabetic subjects. **Class I, level of
Evidence A**.

An assessment of predicted type 2 diabetes risk should be part of the
routine health care using the risk assessment tools available. **Class
II, Level of Evidence A**.

Patients without known diabetes but with established CVD should be
investigated with an OGTT. **Class I, Level of Evidence B**.

**Preventing Progression to Diabetes**

People at high risk for type 2 diabetes should receive appropriate life
style counselling and if needed pharmacological therapy to reduce or
delay their risk of developing diabetes. This may also decrease their
risk of CVD. **Class I, Level of Evidence A**.

In people with IGT, the onset of diabetes can be delayed by certain
drugs (such as metformin, acarbose and rosiglitazone). **Class I, Level
of Evidence A**.

**Prevention of CVD by Physical Activity**

Diabetic patients should be advised to be physically active in order to
decrease their cardiovascular risk. **Class I, Level of Evidence A**.

**Treatment to Reduce Cardiovascular Risk**

**Life Style and Comprehensive Management**

Structured patient education improves metabolic and blood pressure
control. **Class I, Level of Evidence A**.

Non-pharmacological life style therapy improves metabolic control.
**Class I, Level of Evidence A**.

Self-monitoring improves glycaemic control. **Class I, Level of Evidence
A**.

**Glycaemic Control**

Near normoglycaemic control reduces microvascular complications. **Class
I, Level of Evidence A**.

Near normoglycaemia reduces macrovascular complications. **Class I,
Level of Evidence A**.

Intensified insulin therapy in type 1 diabetes improves morbidity and
mortality. **Class I, Level of Evidence A**.

Early, stepwise increase of therapy towards pre-defined treatment
targets improves a composite of morbidity and mortality in type 2
diabetes. **Class IIa, Level of Evidence B**.

Early initiation of insulin should be considered in patients with type 2
diabetes failing glucose target, and in patients with excessive
post-prandial glucose excursions. Meal-time short-acting insulin is
recommended. **Class IIb, Level of Evidence C**.

Metformin is recommended as first line drug in overweight type 2
diabetes. **Class IIb, Level of Evidence C**.

**Dyslipidaemia**

*Secondary Prevention*

Elevated low-density lipoprotein (LDL)- and low high-density lipoprotein
(HDL)-cholesterol are important risk factors in people with diabetes.
**Class I, Level of Evidence A**.

Statins are first-line agents for lowering LDL-cholesterol in diabetic
patients. **Class I, Level of Evidence A**.

In diabetic patients with CVD, statin therapy should be initiated
regardless of baseline LDL-cholesterol with a treatment target of
[\<]{.underline}1.8 mmol/L. **Class I, Level of Evidence B**.

*Primary Prevention*

Statin therapy should be considered in adult patients with type 2
diabetes, without CVD, if total cholesterol \>3.5 mmol/L (\>135 mg/dL),
with treatment aiming for an LDL-cholesterol reduction of 30 to 40%.
**Class IIb, Level of Evidence B**.

Given the high lifetime risk of CVD, it is suggested that all type 1
patients over the age of 40 years should be considered for statin
therapy. In patients 18 to 39 years (either type 1 or type 2), statin
therapy should be considered when other risk factors are present, e.g.,
nephropathy, poor glycaemic control, retinopathy, hypertension,
hypercholesterolaemia, features of the metabolic syndrome, or family
history of premature vascular disease.  **Class IIb, Level of Evidence
C**.

*Guidelines for HDL Cholesterol and Triglycerides*

In diabetic patients with hypertriglyceridaemia \>2 mmol/L (177 mg/dL)
remaining after having reached the LDL-cholesterol target, it is
recommended that statin therapy should be increased to reduce non-HDL
cholesterol with a goal of therapy 0.8 mmol/L (31 mg/dL) higher than
that identified for LDL. In patients on maximum dose, or maximum
tolerated dose of statin, where LDL-C or non-HDL-C is not to goal, the
addition of ezetimibe, a specific inhibitor of cholesterol absorption,
should provide effective further cholesterol reduction. In some cases
combination therapy with nicotinic acid or fibrates may be considered. 
**Class IIb, level of Evidence B**.

**Blood Pressure**

In patients with diabetes and hypertension, the recommended target for
blood pressure control is \<130/80 mm Hg. **Class I, Level of Evidence
B**.

The cardiovascular risk in patients with diabetes and hypertension is
substantially enhanced. The risk can be effectively reduced by blood
pressure-lowering treatment. **Class I, Level of Evidence A**.

The diabetic patient usually requires a combination of several
anti-hypertensive drugs for satisfactory blood pressure control. **Class
I, Level of Evidence A**.

The diabetic patient should be prescribed a renin-angiotensin system
(RAS) inhibitor as part of the blood pressure-lowering treatment.
**Class I, Level of Evidence A**.

Screening for microalbuminuria and adequate blood pressure-lowering
therapy including the use of angiotensin-converting enzyme
(ACE)-inhibitors and angiotensin receptor-II-blockers, improves micro-
and macrovascular morbidity in type 1 and type 2 diabetes. **Class I,
Level of Evidence A**.

**Management of CVD**

**Treatment Principles**

*Risk Stratification*

Early risk stratification should be part of the evaluation of the
diabetic patient after acute coronary syndromes (ACS). **Class IIa,
Level of Evidence C**.

*Treatment Targets*

Treatment targets, as listed in the table below, should be outlined and
applied in each diabetic patient following an ACS. **Class IIa, Level of
Evidence C**.

+----------------------------------+-----------------------------------+
| **Table. Recommended Treatment   |                                   |
| Targets for Patients with        |                                   |
| Diabetes and CAD (adapted after  |                                   |
| the European Guidelines for      |                                   |
| Cardiovascular Disease           |                                   |
| Prevention)**                    |                                   |
+==================================+===================================+
| Blood pressure                   | \<130/80\                         |
| (systolic/diastolic; mm Hg)      | \                                 |
|                                  | \<125/75                          |
| In case of renal impairment,     |                                   |
| proteinuria \> 1g/24h            |                                   |
+----------------------------------+-----------------------------------+
| Glycaemic control                |                                   |
+----------------------------------+-----------------------------------+
| HbA~1C~ (%)^a^                   | ≤6.5                              |
+----------------------------------+-----------------------------------+
| Glucose expressed as venous      |                                   |
| plasma mmol/L (mg/dL)            |                                   |
+----------------------------------+-----------------------------------+
| Fasting                          | \<6.0 (108)                       |
+----------------------------------+-----------------------------------+
| Post-prandial (peak)             | \<7.5 (135) diabetes type 2\      |
|                                  | 7.5-9.0 (135-160) diabetes type 1 |
+----------------------------------+-----------------------------------+
| Lipid profile expressed in       |                                   |
| mmol/L (mg/dL)                   |                                   |
+----------------------------------+-----------------------------------+
| Total cholesterol                | \<4.5 (175)                       |
+----------------------------------+-----------------------------------+
| LDL-cholesterol                  | [\<]{.underline}1.8 (70)          |
+----------------------------------+-----------------------------------+
| HDL-cholesterol                  |                                   |
+----------------------------------+-----------------------------------+
|   Men                            | \>1.0 (40)                        |
+----------------------------------+-----------------------------------+
|   Women                          | \>1.2 (\>46)                      |
+----------------------------------+-----------------------------------+
| Triglycerides^b^                 | \<1.7 (\<150)                     |
+----------------------------------+-----------------------------------+
| TC/HDL^b^                        | \<3                               |
+----------------------------------+-----------------------------------+
| Smoking cessation                | Obligatory                        |
+----------------------------------+-----------------------------------+
| Regular physical activity        | \>30-45                           |
| (min/day)                        |                                   |
+----------------------------------+-----------------------------------+
| Weight control                   |                                   |
+----------------------------------+-----------------------------------+
| Body mass index (BMI) (kg/m^2^)  | \<25                              |
+----------------------------------+-----------------------------------+
| In case of overweight weight     | 10                                |
| reduction (%)                    |                                   |
+----------------------------------+-----------------------------------+
| Waist (optimum; ethnic specific; |                                   |
| cm)                              |                                   |
+----------------------------------+-----------------------------------+
| Men                              | \<94                              |
+----------------------------------+-----------------------------------+
| Women                            | \<80                              |
+----------------------------------+-----------------------------------+
| Dietary habits                   |                                   |
+----------------------------------+-----------------------------------+
| Salt intake (g/day)              | \<6                               |
+----------------------------------+-----------------------------------+
| Fat intake (% of dietary energy) |                                   |
+----------------------------------+-----------------------------------+
|   Saturated                      | \<10                              |
+----------------------------------+-----------------------------------+
|   Trans fat                      | \<2                               |
+----------------------------------+-----------------------------------+
|   Polyunsaturated n-6            | 4-8                               |
+----------------------------------+-----------------------------------+
|   Polyunsaturated n-3            | 2 g/day of linolenic acid and 200 |
|                                  | mg/day of very long chain fatty   |
|                                  | acids                             |
+----------------------------------+-----------------------------------+
| ^a^ Diabetes Control and         |                                   |
| Complication Trial-standardized, |                                   |
| for recalculation formula for    |                                   |
| some national standards in       |                                   |
| Europe.\                         |                                   |
| ^b^ Not recommended for guiding  |                                   |
| treatment, but recommended for   |                                   |
| metabolic/risk assessment        |                                   |
+----------------------------------+-----------------------------------+

**Specific Treatment**

*Thrombolysis*

Patients with acute myocardial infarction (AMI) and diabetes should be
considered for thrombolytic therapy on the same grounds as their
non-diabetic counterparts. **Class IIa, Level of Evidence A**.

*Early Revascularization*

Whenever possible, patients with diabetes and ACS should be offered
early angiography and mechanical revascularization. **Class IIa, Level
of Evidence B**.

**Anti-ischaemic Medication**

Beta-blockers reduce morbidity and mortality in patients with diabetes
and ACS. **Class IIa, Level of Evidence B**.

Aspirin should be given for the same indications and in similar dosages
to diabetic and non-diabetic patients. **Class II, Level of Evidence
B**.

Adenosine diphosphate (ADP) receptor-dependent platelet activation
(clopidogrel) should be considered in diabetic patients with ACS in
addition to aspirin. **Class IIa, Level of Evidence C**.

**ACE-Inhibitors**

The addition of an ACE-inhibitor to other effective therapies reduces
the risk for cardiovascular events in patients with diabetes and
established cardiovascular disease. **Class I, Level of Evidence A**.

**Metabolic Support and Control**

Diabetic patients with AMI benefit from tight glucometabolic control.
This may be accomplished by different treatment strategies. **Class IIa,
Level of Evidence B**.

**Revascularization (Intervention by Surgery or Percutaneous Coronary
Intervention \[PCI\] Angioplasty)**

Treatment decisions regarding revascularization in patients with
diabetes should favour coronary artery bypass graft (CABG) surgery over
percutaneous intervention. **Class IIa, Level of Evidence A**.

Whenever possible, patients with diabetes undergoing coronary bypass
surgery should be offered at least one and often multiple arterial
grafts.  **Class I, Level of Evidence C**.

*Adjunctive Therapy*

Glycoprotein IIb/IIIa inhibitors are indicated in elective PCI in
patients with diabetes. **Class I, Level of Evidence B**.

When PCI with stent implantation is performed in patients with diabetes,
drug-eluting stents (DES) should be used. **Class IIa, Level of Evidence
B**.

*Revascularization and Reperfusion in MI*

Mechanical reperfusion by means of primary PCI is the revascularization
mode of choice in diabetic patients with AMI.  **Class I, Level of
Evidence A**.

**Heart Failure and Diabetes**

**Treatment**

ACE-inhibitors are recommended as first-line therapy in diabetic
patients with reduced left ventricular (LV) dysfunction with or without
symptoms of heart failure. **Class I, Level of Evidence C**.

Angiotensin-II-receptor blockers have similar effects in heart failure
as ACE-inhibitors and can be used as an alternative or even as added
treatment to ACE-inhibitors. **Class I, Level of Evidence C**.

Beta-blockers in the form of metoprolol, bisoprolol, and carvedilol are
recommended as first-line therapy in diabetic patients with heart
failure. **Class I, Level of Evidence C**.

Diuretics, in particular loop diuretics, are important for symptomatic
treatment of patients with fluid overload due to heart failure. **Class
IIa, Level of Evidence C**.

Aldosterone antagonists may be added to ACE-inhibitors, beta-blockers,
and diuretics in diabetic patients with severe heart failure. **Class
IIb, Level of Evidence C**.

**Arrhythmias: Atrial Fibrillation (AF) and Sudden Death**

**Diabetes, AF, and Risk of Stroke**

Aspirin and anticoagulant use as recommended for patients with AF should
be rigorously applied in diabetic patients with AF to prevent stroke.
**Class I, Level of Evidence C**.

Chronic oral anticoagulant therapy in a dose adjusted to achieve a
target international normalized ration (INR) of 2 to 3 should be
considered in diabetic patients with AF and one other moderate risk
factor for thromboembolism, unless contraindicated. **Class IIa, Level
of Evidence C**.

**Sudden Cardiac Death**

Control of glycaemia even in the pre-diabetic stage is important to
prevent the development of the alterations that pre-dispose to sudden
cardiac death. **Class I, Level of Evidence C**.

Microvascular disease and nephropathy are indicators of increased risk
of sudden cardiac death in diabetic patients. **Class IIa, Level of
Evidence B**.

**Peripheral and Cerebrovascular Disease**

**Peripheral Vascular Disease**

All patients with type 2 diabetes and CVD are recommended treatment with
low-dose aspirin. **Class IIa, Level of Evidence B**.

In diabetic patients with peripheral vascular disease, treatment with
clopidogrel or low molecular weight heparin may be considered in certain
cases. **Class IIb, Level of Evidence B**.

Patients with critical limb ischaemia should if possible, undergo
revascularization procedures. **Class I, Level of Evidence B**.

An alternative treatment for patients with critical limb ischaemia not
suited for revascularization is prostacyclin infusion. **Class IIa,
Level of Evidence A**.

**Stroke**

*Prevention of Stroke*

Normalization of blood pressure is recommended in all patients with
diabetes for the prevention of stroke. **Class I, Level of Evidence A**.

For stroke prevention, blood pressure lowering is more important than
the choice of drug. Inhibition of the renin-angiotensin-aldosterone
system may have additional benefits beyond blood pressure lowering *per
se*. **Class IIa, Level of Evidence B**.

Inhibition of the renin-angiotensin-aldosterone system may be considered
also in diabetic patients with normal blood pressure levels. **Class
IIa, Level of Evidence B**.

Patients with stroke should be treated with statins according to the
same principles as non-diabetic subjects with stroke. **Class I, Level
of Evidence B**.

Antiplatelet therapy with aspirin is recommended for primary and
secondary prevention at stroke. **Class I, Level of Evidence B**.

*Treatment of Acute Stroke*

Patients with acute stroke and diabetes should be treated according to
the same principles as stroke patients without diabetes. **Class IIa,
Level of Evidence C**.

Optimization of metabolic conditions including glycaemic control should
be considered as in any other acute disease condition. **Class IIa,
Level of Evidence C**.

**Intensive Care**

Strict blood glucose control with intensive insulin therapy improves
mortality and morbidity of adult cardiac surgery patients. **Class I,
Level of Evidence B**.

Strict blood glucose control with intensive insulin therapy improves
mortality and morbidity of adult critically ill patients. **Class I,
Level of Evidence A**.

**Health Economics and Diabetes**

Lipid-lowering treatment provides a cost-effective way of preventing
complications. **Class I, Level of Evidence A**.

Tight control of hypertension is cost-effective. **Class I, Level of
Evidence A**.

**Definitions**:

**Classes of Recommendations**

**Class I**: Evidence and/or general agreement that a given diagnostic
procedure/treatment is beneficial, useful, and effective

**Class II**: Conflicting evidence and/or a divergence of opinion about
the usefulness/efficacy of the treatment or procedure

**Class IIa**: Weight of evidence/opinion is in favour of
usefulness/efficacy

**Class IIb**: Usefulness/efficacy is less well established by
evidence/opinion

**Class III**: Evidence or general agreement that the treatment or
procedure is not useful/effective and in some cases may be harmful

**Levels of Evidence**

**Level of Evidence A**: Data derived from multiple randomized clinical
trials or meta-analyses

**Level of Evidence B**: Data derived from a single randomized clinical
trial or large non-randomized studies

**Level of Evidence C**: Consensus of opinion of the experts and/or
small studies, retrospective studies, registries

#### CLINICAL ALGORITHM(S)

An investigational algorithm for patients with coronary artery disease
and diabetes mellitus is provided in the original guideline document.

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each
recommendation (see \"Major Recommendations\" section).

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Improvement in the quality of management of patients who have both
cardiovascular and metabolic disease in common

#### POTENTIAL HARMS

-   Hypoglycaemia and other compound-specific effects of pharmacological
    therapy for diabetes (see Table 12 in the original guideline
    document).

-   Complications of revascularization surgery

-   Compound-specific effects of pharmacological therapy for
    cardiovascular disease and prevention

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Thiazolidinediones are considered contraindicated in heart failure
patients in New York Heart Association Class III-IV because of a risk
for fluid retention and thereby worsening heart failure.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

The European Society of Cardiology (ESC) Guidelines represent the views
of the ESC and were arrived at after careful consideration of the
available evidence at the time they were written. Health professionals
are encouraged to take them fully into account when exercising their
clinical judgment. The guidelines do not, however, override the
individual responsibility of health professionals to make appropriate
decisions in the circumstances of the individual patients, in
consultation with that patient, and where appropriate and necessary the
patient\'s guardian or carer. It is also the health professional\'s
responsibility to verify the rules and regulations applicable to drugs
and devices at the time of prescription.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Chart Documentation/Checklists/Forms\
Clinical Algorithm\
Personal Digital Assistant (PDA) Downloads\
Pocket Guide/Reference Cards\
Quick Reference Guides/Physician Guides

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness\
Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Task Force on Diabetes and Cardiovascular Diseases. Ryden L, Standl E,
Bartnik M, Van den Berghe G, Betterridge J, de Boer MJ, Cosentino F,
Jonsson B, Laakso M, Malmberg K, Priori S, Ostergren J, Tuomilehto J,
Thrainsdottir I. Guidelines on diabetes, pre-diabetes, and
cardiovascular disease: full text. Sophia Antipolis, France: European
Society of Cardiology (ESC); 2007. 72 p. \[711 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2007 Jan

#### GUIDELINE DEVELOPER(S)

European Society of Cardiology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

European Society of Cardiology

#### GUIDELINE COMMITTEE

Task Force on Diabetes and Cardiovascular Diseases

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Task Force Members*: Lars Rydén (Co-Chairperson) (Sweden); Eberhard
Standl (Co-Chairperson) (Germany); Malgorzata Bartnik (Poland); Greet
Van den Berghe (Belgium); John Betterridge (UK); Menko-Jan de Boer (The
Netherlands); Francesco Consentino (Italy); Bengt Jönsson (Sweden);
Markku Laakso (Finland); Klas Malmberg (Sweden); Silvia Priori (Italy);
Jan Östergren (Sweden); Jaakko Tuomilehto (Finland); Inga Thrainsdottir
(Iceland)

*European Society of Cardiology (ESC) Committee for Practice Guidelines
(CPG)*: Silvia Priori (Chairperson) (Italy); Jean-Jacques Blanc
(France); Andrzej Budaj (Poland); John Camm (UK); Veronica Dean
(France); Jaap Deckers (The Netherlands); Kenneth Dickstein (Norway);
John Lekakis (Greece); Keith McGregor (France); Marco Metra (Italy);
João Morais (Portugal); Ady Osterspey (Germany); Juan Tamargo (Spain);
José Luis Zamorano (Spain)

*Document Reviewers*: Jaap Deckers, (CPG Review Coordinator)  (The
Netherlands); Michael Bertrand (France); Bernard Charbonnel (France);
Erland Erdmann (Germany); Ele Ferrannini (Italy); Allan Flyvbjerg
(Denmark); Helmut Gohlke (Germany); Jose Ramon Gonzalez Juanatey
(Spain); Ian Graham (Ireland); Pedro Filipe Monterio (Portugal); Klaus
Pargofer (Germany); Kalevi Pyörälä (Finland); Itamar Raz (Israel);
Guntram Schernthaner (Austria); Massimo Volpe (Italy); David Wood (UK)

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

In compliance with European Board for Accreditation in
Cardiology/European Accreditation Council for Continuing Medical
Education (EBAC/EAC CME) guidelines, all authors participating in this
programme have disclosed potential conflicts of interest that might
cause a bias in the article. The Organizing Committee is responsible for
ensuring that all potential conflicts of interest relevant to the
programme are declared to the participants prior to the CME activities.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[European Society of Cardiology (ESC) Web
site](http://www.escardio.org/guidelines-surveys/esc-guidelines/Pages/diabetes.aspx).

Print copies: Available from Oxford University Press, Great Clarendon
Street, Oxford, OX2 6DP, UK, Tel: +44 (0) 1865 353263, Fax: +44 (0) 1865
353774, Web site: <http://www.eurheartj.oxfordjournals.org/>.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Guidelines on diabetes, pre-diabetes, and cardiovascular diseases:
    executive summary. The Task Force on Diabetes and Cardiovascular
    Diseases of the European Society of Cardiology and the European
    Association for the Study of Diabetes. Eur Heart J 2007;28:88-136.
    Electronic copies: Available in Portable Document Format (PDF) from
    the [European Society of Cardiology (ESC) Web
    site](http://www.escardio.org/guidelines-surveys/esc-guidelines/GuidelinesDocuments/guidelines-diabetes-ES.pdf).

-   Diabetes, pre-diabetes, and cardiovascular diseases. Pocket
    guideline. Electronic copies: Available from the [European Society
    of Cardiology (ESC) Web
    site](http://www.escardio.org/guidelines-surveys/esc-guidelines/GuidelinesDocuments/DIABET-pocket.aspx).
    Also available for PDA download from the [ESC Web
    site](http://pocketgram.net/escardio/).

-   Recommendations for guidelines production. A document for Task Force
    Members responsible for the production and updating of ESC
    guidelines. 2006 Jun 28. 21 p. Available from the [ESC Web
    site](http://www.escardio.org/guidelines-surveys/esc-guidelines/about/Pages/rules-writing.aspx).

Print copies: Available from Oxford University Press, Great Clarendon
Street, Oxford, OX2 6DP, UK, Tel: +44 (0) 1865 353263, Fax: +44 (0) 1865
353774, Web site: <http://www.eurheartj.oxfordjournals.org/>.

Additionally, a sample type 2 diabetes risk assessment form can be found
in the [original guideline
document](http://www.escardio.org/guidelines-surveys/esc-guidelines/Pages/diabetes.aspx).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This summary was completed by ECRI Institute on June 18, 2007. This
summary was updated by ECRI Institute on November 28, 2007 following the
U.S. Food and Drug Administration advisory on the Avandia (rosiglitazone
maleate) Tablets. This summary was updated by ECRI Institute on March
10, 2008 following the U.S. Food and Drug Administration advisory on
Avandia (rosiglitazone maleate). This summary was updated by ECRI
Institute on March 14, 2008 following the updated FDA advisory on
heparin sodium injection.

#### COPYRIGHT STATEMENT

This summary is based on the original guideline, which is subject to the
guideline developer\'s restrictions.

The content of the European Society of Cardiology (ESC) Guidelines and
their derivative products has been made available for personal and
educational use only. No commercial use is authorized. No part of the
ESC Guidelines and their derivative products may be translated or
reproduced in any form without written permission from the ESC.

The ESC Guidelines or their derivative products can be: viewed, printed
or downloaded for individual use, linked to from external websites or
online media. In order to benefit from updates and additional sources of
information, the ESC recommends linking to the relevant ESC Guidelines
pages, instead of linking directly to documents themselves.

The ESC does not allow for the insertion of its Guidelines and
derivative products (full or partial) in external websites, pages,
portals or servers, unless specific exceptional permission has been
granted for such.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
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All guidelines summarized by NGC and hosted on our site are produced
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Guidelines represented on the NGC Web site are submitted by guideline
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<http://www.guideline.gov/about/inclusion.aspx> .

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Date Modified: 11/3/2008