AACE Pre-Diabetes Guidelines

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New AACE Guidelines for Prediabetes Management CME

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CME Author: Laurie Barclay, MD

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Release Date: July 25, 2008; Valid for credit through July 25, 2009

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Learning Objectives

Upon completion of this activity, participants will be able to:

1. Describe lifestyle recommendations for patients with prediabetes.

2. Describe pharmacotherapy that may be appropriate for some patients with

prediabetes.

Authors and Disclosures

Laurie Barclay, MD

Disclosure: Laurie Barclay, MD, has disclosed no relevant financial

relationships.

Brande

Disclosure: Brande has disclosed no relevant financial

information.

July 25, 2008 - The management of prediabetes involves intensive lifestyle

management and setting treatment goals of blood pressure and lipid level control

matching those for diabetes, according to a consensus statement released July 23

by the American Association of Clinical Endocrinologists (AACE). Subsequent

publication of the final document in Endocrine Practice is planned for later

this year.

" As individuals and as a society, we need to address those forces which are

creating the epidemic of obesity, diabetes, and prediabetes, " Yehuda Handlesman

MD, FACP, FACE, treasurer of AACE and medical director of the Metabolic

Institute of America, said in a news release. " We understand the difficulties in

implementing solutions, but as an association of endocrinologists we are

committed to supporting community and national efforts in every way we can. "

The new guidelines are the first comprehensive treatment regimen for patients

with prediabetes recommended by a consensus of experts in diabetes and metabolic

disorders. The consensus statement offers specific guidelines regarding

lifestyle modification as well as pharmaceutical intervention where appropriate.

US prevalence of prediabetes, defined by elevated fasting glucose levels or

impaired glucose tolerance, is greater than 56 million. However, an even greater

number of individuals with prediabetes have not yet been diagnosed.

Because prediabetes increases the risk for cardiovascular disease as well as for

the development of type 2 diabetes, these guidelines extend the overall effort

to recognize and treat type 2 diabetes sooner and more intensively.

Because no pharmacologic therapies are currently approved by the US Food and

Drug Administration (FDA) to prevent the development of diabetes in patients

with prediabetes, the expert panel recommends a 2-fold approach to treating

prediabetes.

The first goal is aggressive lifestyle management to prevent the progression to

type 2 diabetes, following guidelines established by the Diabetes Prevention

Program of the US government.

" Although lifestyle can clearly modify the progression of patients towards overt

diabetes, it may not be sufficient, " said Alan J. Garber, MD, PhD, FACE,

professor of medicine, Baylor College of Medicine in Houston, Texas, and

chairman of the Consensus Conference. " Medications may well be required,

particularly in high risk groups. "

The second goal is to avoid cardiovascular complications, with use of

pharmacotherapy for those patients whose prediabetes is refractory to lifestyle

modifications. In addition to medications for glycemic control, this strategy

involves use of medications for hypertension and hypercholesterolemia when

appropriate. High-risk individuals with levels of blood glucose approaching

those seen in diabetes, hypertension, or hyperlipidemia should consider closer

clinician monitoring of their risk factors.

" The data show that there is a spectrum of severity, with the most severely

affected approaching the risks of people with diagnosed type 2 diabetes, " said

Einhorn, MD, FACP, FACE, vice president of AACE and medical director of

the Scripps Whittier Institute for Diabetes in La Jolla, California. " In these

highest risk individuals, who represent a minority, pharmacologic strategies may

be appropriate if intensive lifestyle therapies fail. Regardless, all

individuals at risk for diabetes should be aware of the level of their risk

factors and be prepared to take action. "

Specific questions and pertinent comments addressed in the Consensus Statement

are as follows:

1. What is the spectrum between normal glucose tolerance, prediabetes, and

diabetes, and what criteria should be used to diagnose each of these?

Normal glucose levels are defined as a fasting blood glucose level of less than

100 mg/dL and a postchallenge level of less than 140 mg/dL. Those considered

diagnostic for diabetes are a fasting blood glucose level of 126 mg/dL or more

and a postchallenge level of 200 mg/dL or more; the spectrum in between is

poorly defined. In some individuals, these intermediate levels of glucose

(fasting glucose level of 100 - 125 mg/dL; 2-hour levels of 140 - 199 mg/dL) may

be a harbinger of overt type 2 diabetes, cardiovascular disease, and

microvascular complications.

2. What clinical risks ensue if prediabetes is not treated?

In the large DECODE Study, risks for all-cause mortality increased linearly as

the 2-hour blood glucose level increased from 95 to 200 mg/dL. In the Diabetes

Prevention Program, approximately 8% of patients with impaired glucose tolerance

had diabetic retinopathy as did nearly 13% of those whose condition progressed

to diabetes. The STOP NIDDM trial showed an increase in hypertension (> 140/90

mm Hg) in the placebo-treated patients with impaired glucose tolerance during a

3-year period, with an increase in clinical cardiovascular disease (CVD) events

by approximately 5% during 4 years. The Honolulu Heart Study showed that

postchallenge hyperglycemia was associated with an increase in sudden death

during a 23-year follow-up.

3. What goals and treatment modalities should the management of prediabetes

target?

Intensive lifestyle management is preferred because it is safe and effective in

improving glycemia and reducing cardiovascular risk factors. Treatment goals for

blood pressure and lipid control should match those for diabetes. Individuals

with prediabetes should reduce weight by 5% to 10% and maintain it long term,

using strategies such as patient self-monitoring, realistic and stepwise goal

setting, stimulus control, cognitive strategies, social support, and appropriate

reinforcement.

Regular, moderate-intensity physical activity is recommended for 30 to 60

minutes daily, at least 5 days weekly. Diet should be low in total fat,

saturated fat, and trans-fatty acids and should include adequate dietary fiber.

Lower sodium intake and avoidance of excess alcohol are recommended for blood

pressure control.

Because the FDA has not yet approved any drugs to prevent diabetes, any decision

to start pharmacotherapy for prediabetes must consider available evidence and a

risk-benefit analysis. For persons with prediabetes at particularly high risk,

pharmacologic glycemic treatment may be considered in addition to lifestyle

strategies. Metformin and acarbose are safe and have strong evidence for a

reduction in the development of diabetes from prediabetes. Thiazolidinediones

also reduce the risk for progression from prediabetes to diabetes, but there are

safety concerns including congestive heart failure or fractures.

Lipid level goals should be the same for persons with prediabetes and those with

established diabetes. Statins are recommended to achieve treatment goals of 100

mg/dL for low-density lipoprotein cholesterol levels, 130 mg/dL for

nonhigh-density lipoprotein cholesterol levels, and 90 mg/dL for apolipoprotein

B. Fibrates, bile acid sequestrants, ezetimibe, and other drugs may be useful

adjunctive therapy in some patients. Niacin may improve lipid profile but has a

potential for adverse glycemic effect.

Patients with prediabetes should have the same target blood pressure currently

recommended for persons with diabetes (systolic < 130 mm Hg and diastolic 80 mm

Hg). Angiotensin-converting enzyme inhibitors or angiotensin receptor blockers

are recommended as first-line agents and calcium channel blockers as second-line

treatment. Because of adverse effects on glycemia, thiazides and/or â-blockers

should be avoided if possible.

Aspirin is recommended for all persons with prediabetes who are not at increased

risk for gastrointestinal tract, intracranial, or other bleeding.

4. How should prediabetes and its treatment be monitored?

Patients with prediabetes should have an annual glucose tolerance test and

twice-yearly testing for microalbuminuria and fasting plasma glucose, hemoglobin

A1C, and lipid levels. Patients at highest risk (> 1 of impaired glucose

tolerance, impaired fasting glucose level, or metabolic syndrome) should be

monitored more carefully.

5. How cost effective is treating prediabetes?

The costs of preventing diabetes can be balanced against cost savings realized

from fewer patient-years of the disease, complications, and hospitalizations.

6. What additional research should be done to clarify diagnosis and management

of prediabetes?

The authors present recommendations for future research in prediabetes.

Amylin Pharmaceuticals, Inc, Daiichi Sankyo, Inc, GlaxoKline, LifeScan,

Inc, Merck & Co, Inc, Novo Nordisk Inc, and Roche Laboratories Inc supported

this consensus statement.

AACE Consensus Statement of the AACE Task Force on Pre-diabetes. Released July

23, 2008.

Learning Objectives for This Educational Activity

Upon completion of this activity, participants will be able to:

1. Describe lifestyle recommendations for patients with prediabetes.

2. Describe pharmacotherapy that may be appropriate for some patients with

prediabetes.

Clinical Context

Although the US prevalence of prediabetes, defined by elevated fasting glucose

levels or impaired glucose tolerance, exceeds 56 million, an even larger number

of individuals with prediabetes are still undiagnosed. Prediabetes increases the

risk not only for the development of type 2 diabetes but also for cardiovascular

disease. Some people with prediabetes already have microvascular changes such as

retinopathy, amputations, or renal failure.

The AACE has convened a panel expert in management of diabetes and metabolic

disorders to issue guidelines for comprehensive treatment of patients with

prediabetes. These recommendations highlight a 2-fold approach to management,

with lifestyle modifications for all patients as well as pharmaceutical

intervention for patients at particularly high risk for the development of

diabetes.

Study Highlights

* Individuals with prediabetes have glucose levels lower than those with

diabetes but higher than normal (fasting glucose level, 100 - 125 mg/dL; 2-hour

levels, 140 - 199 mg/dL).

* Prediabetes may be associated with, or may increase the risk for,

cardiovascular disease and microvascular complications, and it may lead to the

development of overt type 2 diabetes.

* All patients with prediabetes should have intensive lifestyle management,

which is safe and effective in improving glycemia and in decreasing

cardiovascular risk.

* Treatment goals for blood pressure and lipid control should match those for

diabetes.

* Individuals with prediabetes should lose 5% to 10% of body weight and maintain

it long term.

* Regular, moderate-intensity physical activity is recommended for 30 to 60

minutes daily at least 5 days weekly.

* Diet should be low in total fat, saturated fat, and trans-fatty acids and

should include adequate dietary fiber.

* For blood pressure control, lower sodium intake and avoidance of excess

alcohol are recommended.

* No drugs are currently FDA approved for prediabetes, so decisions to start

pharmacotherapy must be based on a risk-benefit analysis.

* For persons with prediabetes at particularly high risk, pharmacologic glycemic

treatment may be considered in addition to lifestyle changes.

* Metformin and acarbose are safe and effective in helping prevent diabetes.

* Although thiazolidinediones decrease the risk for progression from prediabetes

to diabetes, safety concerns include congestive heart failure or fractures.

* Lipid level goals for persons with prediabetes should be the same as for those

with established diabetes.

* Statins are recommended if needed to achieve treatment goals for low-density

lipoprotein cholesterol levels (100 mg/dL), nonhigh-density lipoprotein

cholesterol levels (130 mg/dL), and apolipoprotein B (90 mg/dL).

* In some patients, fibrates, bile acid sequestrants, ezetimibe, and other drugs

may be useful adjunctive therapy.

* Niacin may improve lipid profile but has a potential for adverse glycemic

effect.

* Patients with prediabetes should have the same target blood pressure as do

persons with diabetes (systolic < 130 mg Hg; diastolic 80 mm Hg).

* Angiotensin-converting enzyme inhibitors or angiotensin receptor blockers are

recommended as first-line agents and calcium channel blockers as second-line

treatment of hypertension.

* Thiazides and/or â-blockers should be used with caution because of adverse

effects on glycemia.

* All persons with prediabetes who are not at increased risk for

gastrointestinal tract, intracranial, or other bleeding should take aspirin.

* Monitoring for patients with prediabetes should include an annual glucose

tolerance test and twice-yearly testing for microalbuminuria and fasting plasma

glucose, hemoglobin A1C, and lipid levels.

* Highest-risk patients should be monitored more often.

* The costs of prediabetes management may be offset by cost savings from reduced

patient-years of the disease, complications, and hospitalizations.

Pearls for Practice

* All patients with prediabetes should have intensive lifestyle management,

which is safe and effective in improving glycemia and in decreasing

cardiovascular risk. Treatment goals for blood pressure and lipid level control

should match those for diabetes. Target weight loss is 5% to 10% of body weight,

which should be maintained long term, following a diet low in total fat,

saturated fat, and trans-fatty acids and containing adequate dietary fiber.

* No drugs are currently FDA approved for prediabetes, so decisions to start

pharmacotherapy must consider specific patient risks and benefits. For persons

with prediabetes at particularly high risk, pharmacologic glycemic treatment may

be considered in addition to lifestyle changes, preferably with metformin and

acarbose.

According to the ACCE consensus statement, which of the following statements

about recommended lifestyle interventions in persons with prediabetes is

correct?

Only highest-risk patients with prediabetes should have lifestyle interventions

Treatment goals for blood pressure and lipid level control are less rigorous

than those for patients with diabetes

Individuals with prediabetes should lose 5% to 10% of body weight and maintain

it long term

Low-intensity physical activity is recommended for 15 minutes daily, 4 to 5 days

weekly

According to the ACCE consensus statement, which of the following statements

about pharmacotherapy for patients with prediabetes is not correct?

Thiazolidinediones are currently FDA approved for prediabetes

Metformin and acarbose are safe and effective in helping prevent diabetes

In some patients who are taking statins, fibrates may be useful adjunctive

therapy

Angiotensin-converting enzyme inhibitors or angiotensin receptor blockers are

recommended as first-line agents and calcium channel blockers as second-line

treatment of hypertension

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News Author

Laurie Barclay, MD

is a freelance reviewer and writer for Medscape.

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CME Author

Laurie Barclay, MD

is a freelance reviewer and writer for Medscape.

Disclosure: Laurie Barclay, MD, has disclosed no relevant financial

relationships.

Brande

is the News CME editor for Medscape Medical News.

Disclosure: Brande has disclosed no relevant financial

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