New recommendations include: specific instructions for lifestyle intervention, and that pharmacotherapy be started at an A1c of six percent. It is estimated that there will be 418 million people worldwide with prediabetes by 2025.
Clinical recommendations for the treatment of prediabetes were issued at the American Association of Clinical Endocrinologists 18th Annual Meeting and Clinical Congress in Houston.
The consensus statement — Diagnosis and Management of Prediabetes in the Continuum of Hyperglycemia: When do the Risks of Diabetes Begin? — includes specific recommendations for lifestyle and pharmaceutical intervention where appropriate. The statement is the result of a prediabetes consensus conference held last July in Washington, D.C. There, 23 international experts in diabetes and metabolic disorders reviewed scientific data on prediabetes.
Task force member, Yehuda Handelsman, MD, stated that, “The issuing of the consensus statement today reflects our important focus on the need to manage the patient with prediabetes.”
Prediabetes is defined as impaired fasting glucose (100 mg/dL to 125 mg/dL), impaired glucose tolerance (140 mg/dL to 199mg/dL) or both. It is estimated that 314 million people worldwide have prediabetes, and that number is projected to be 418 million in 2025.
Handelsman, treasurer of AACE and medical director of the Metabolic Institute of America stated that, lately, “the numbers have become much more apparent, with sixteen percent of adolescents having diabetes and that is a huge number.”
Intensive lifestyle intervention remains the cornerstone of prevention. The task force recommended several lifestyle modifications, including:
- Weight reduction of 5% to 10%, with long-term maintenance at this level.
- At least 30 to 60 minutes of moderate to intense physical activity at least five days per week.
- A diet that includes calorie restriction, increased fiber intake and possible limitations in carbohydrate intake. Dietary recommendations specifically for blood pressure include lower sodium intake and avoidance of excess alcohol.
The task force also suggested a more aggressive approach to treating high-risk individuals with medications such as metformin, acarbose, glucagon-like peptide 1 agonists and thiazolidinediones.
Alan J. Garber, MD, said that, “There is no FDA-approved pharmacotherapy for the treatment of prediabetes, but data support the notion that agents that focus on benefitting insulin resistance can prevent diabetes.”
“It is clear that pharmacologic prevention of Type 2 diabetes is possible,” added Garber, professor of medicine at Baylor College of Medicine in Houston and chairman of the consensus conference.
Daniel Einhorn, MD, vice president of AACE and medical director of the Scripps Whittier Institute for Diabetes in La Jolla, Ca., said in a press release, “These medications illustrate a specific ‘plan of attack’ for treating prediabetes. But it’s important that caution is exercised.”
In addition, Einhorn suggested that HbA1c levels be considered as a diagnostic tool.
“An HbA1c of 6% to 6.5% indicates treatment for prediabetes with certain caveats,” he said.
This consensus statement is the first comprehensive treatment regimen for patients with prediabetes.
Jeffrey I. Mechanick, MD, stated that, “Prevention is the thrust of what the AACE meeting is about … a heightened awareness that the time to intervene is not when the disease is in front of you and the patient is in the hospital but rather to truly understand the biology of the disease and identify strategic temporal points in time to intervene and have an effect that can benefit the population at large. There is a paradigm shift at AACE — instead of focusing just on treatment and creative, innovative ways to treat — more to prevention … by addressing it earlier, not just with diet or healthy eating and physical activity but being creative by using a cocktail or different therapeutic agents that have different actions.”
Presented at the AACE Meeting, May 2009
DID YOU KNOW: FDA Considers Cheerios A Drug – A Prescription for Cheerios?
Pharma is all upset about the FDA’s recent warning letter to General Mills regarding Cheerios, the breakfast food. The FDA says the labeling on the Cheerios box makes unauthorized health claims, namely "you can Lower Your Cholesterol 4% in 6 weeks."
The FDA said that to make such a claim, General Mills must submit a New Drug Application (NDA) with clinical trial evidence to support that claim. In other words, the FDA considers Cheerios to be a drug when it makes such claims. "The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease," said the FDA letter. "Therefore, under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application."