Earlier treatment urged for type 2 diabetes; new guidelines focus on lowering glucose

Lifestyle changes and metformin use are recommended as first-line therapies for patients with this disease.

By Susan J. Landers — Posted Sept. 4, 2006

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Inspiring a sea change in the way physicians approach type 2 diabetes is the intent of a new consensus document by the American Diabetes Assn. and its European counterpart. Specifically, this user-friendly algorithm was developed to motivate primary care doctors to treat high blood glucose levels aggressively.

Its message is clear: No longer should A1c levels of 7% or higher be tolerated. Treatment should begin immediately, and there should be an on-going and persistent focus on lowering that number.

The directive, which was published in the August Diabetes Care, also focuses on this treatment style as a way to free physicians from what many people see as the clinical inertia that is blocking appropriate care for patients with diabetes.

There is no doubt that type 2 diabetes constitutes a huge health concern. The Centers for Disease Control and Prevention estimates that more than 20 million people age 20 and older in the United States already have the disease. Growing levels of obesity promise that more will soon follow.

Many studies have found that the risk it poses to nearly all parts of the body is lowered when blood glucose levels are brought as close to the nondiabetic range as possible. But findings also show that it's sometimes two or three years before this control is reached, said John Buse, MD, PhD, director of the University of North Carolina's Diabetes Care Center in Chapel Hill. He was one of several authors of the algorithm.

"Some data suggest that even people with A1c's over 8% have a delay of more than a year in intensifying therapy or adding another therapy," Dr. Buse said.

To overcome this time lag, the algorithm recommends advising patients to make necessary lifestyle changes and prescribing the oral drug metformin right away, even at the initial visit, if blood sugar levels aren't normal, he added.

Metformin, a generic drug that's been available for about 30 years, was thought to be a good choice by the panel of physicians and other scientists who developed the guidance -- "a logical first step in managing diabetes," Dr. Buse said.

As a next step, if blood sugar levels are still not in good control, the panel urges trying one of several other oral agents, such as a sulfonylurea or a thiazolidinedione, or adding insulin. Although patients and physicians still may balk at the use of insulin, fearing it as an end-of-the-line treatment, its use has gained greater acceptance in recent years, he said.

The document notes that A1c levels of 7% or higher are a "call to action to initiate or change therapy." In this regard, the ADA runs counter to the position of the American Assn. of Clinical Endocrinologists, which endorses lowering A1c levels to 6.5% or less.

"We think the scientific evidence suggests that 6.5%is a better target than 7%," said Richard Hellman, MD, AACE president-elect.

Dr. Hellman also questioned the absence of post-meal glucose evaluations from the algorithm. Research indicates that post-meal blood glucose is very important, he said. "Most of the information [in the algorithm] looks at what is going on before meals. ... I think that's a mistake."

In addition, he faulted what he saw as the paper's downplaying the need for patient self-monitoring when oral hypoglycemic medication regimens are used. "From a safety standpoint, the more feedback patients have about their blood glucose levels, the more opportunities are provided to patients to protect themselves."

While generally supportive of the vigorous advocacy for reducing blood glucose levels and establishing a treatment time line, Dr. Hellman said he would prefer a more comprehensive approach. "If it helps many doctors get a start, that's a positive. But if it's too simplified in some areas, that's a negative. It should be correct."

A place to start

Others, though, called the guidance an important first step. "One of the biggest problems in primary care has been clinical inertia," said Robert Cuddihy, MD, medical director of the International Diabetes Center in Minneapolis. "The easier we can make [diabetes treatment], the better."

"The one good aspect of this consensus statement is that it focuses the primary care physician on the basics," agreed Richard E. Pratley, MD, professor of medicine and director of the University of Vermont's Diabetes and Metabolism Translational Medicine Unit in Burlington.

And it's not just primary care physicians who are failing to get patients to goal quickly, Dr. Pratley said. "I think everybody needs to take that message away." He noted that most primary care physicians probably already use metformin and a sulfonylurea or metformin and a thiazolidinedione. "So I'm not sure it advances their thinking that much."

The document also focuses attention on evidence-based treatments and prevents care from being driven by the latest offerings from pharmaceutical companies, he added.

But all agree the treatment of diabetes is poised to change soon as other drugs come on the market. One -- inhaled insulin -- already has been approved, and a new class of medications is proceeding through the pipeline.

The next step in improving patient care could include such things as point-of-care lab testing, Dr. Cuddihy said. Then physicians would have patients' A1c measures when they are seen, rather than a week later.

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Therapy strategy

The following recommendations are intended for primary care physicians who are initiating or adjusting therapy for patients with type 2 diabetes:

Step 1 Urge lifestyle changes -- weight loss and increased physical activity -- and prescribe metformin.

If A1c levels remain at 7% or higher, go to:

Step 2 Prescribe additional therapies such as insulin, a sulfonylurea, a thiazolidinedione or any of a number of other medications. Insulin is recommended rather than adding a third oral drug.

Source: "Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy," by the American Diabetes Assn. and the European Assn. for the Study of Diabetes

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Children at risk

As if there isn't enough evidence of the harm diabetes can cause to adult hearts, a new study finds that one in five young people with the disease already has developed two or more additional risk factors for premature heart disease.

Researchers for the SEARCH for Diabetes in Youth Study found that the rate was especially high, 92%, among those with type 2 diabetes. Fourteen percent of those with type 1 had two or more risk factors, which included being overweight or obese and having high blood pressure or high triglycerides.

As is the case with adults, cardiovascular risk factors were higher among minority groups than among non-Hispanic whites. For example, rates were 68% among American Indians and 37% for Asian-Pacific Islanders. They were also higher for girls.

The overall prevalence of having two or more risk factors was 21% among the 1,083 girls and 1,013 boys studied. Study subjects were all younger than 20. For children ages 3 to 9 the rate was 7%; for young people 10 to 19 it was 25%.

"It used to be that when you saw someone younger than 13, they had type 1 diabetes," said Robert Cuddihy, MD, medical director of the International Diabetes Center in Minneapolis. "But of the last five kids I've seen, four were type 2."

There is a link between type 2 and metabolic syndrome, he said. With metabolic syndrome comes abdominal obesity, hypertension and hyperlipidemia -- all of which are associated with cardiac disease.

This threat to young people poses another challenge to the health care system, he noted. "We're dealing with aging baby boomers and now we have an increasing population of youth who are sedentary, obese, have diabetes and are going to need care, too."

Starting early is key to helping these children avoid heart disease. The cardiovascular risks are likely there before they get diabetes, Dr. Cuddihy said. "Instead of mom saying, 'Eat your spinach and go play ball with your friends,' they are eating at McDonald's and playing video games."

The study appeared in the August Diabetes Care.

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External links

"Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy," Diabetes Care, August (link)

American Assn. of Clinical Endocrinologists guidelines for treating diabetes (link)

National Diabetes Quality Improvement Alliance (link)

AMA diabetes-related policy (link)

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