April 19, 2012 — The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have issued a joint position statement emphasizing patient-specific treatment of hyperglycemia in persons with type 2 diabetes. The new guidelinesare reported concurrently in the April 19 online edition of Diabetes Care and in Diabetologia.
"All guidelines are in a state of evolution based on new information, and the overall standard of care is updated every January," Vivian Fonseca, MD, ADA president of medicine and science, told Medscape Medical News in a telephone interview.
The last guidelines specific to management of hyperglycemia were published about 4-5 years ago, and more recent developments have been incorporated into the new guidelines."
The impetus underlying the new guidelines was the growing complexity and controversy surrounding contemporary glycemic management in persons with type 2 diabetes. Factors complicating management include the increasing number and variety of available pharmacotherapy, issues regarding potential adverse effects, and new uncertainties concerning the effects of intensive glycemic control on macrovascular complications.
Dr. Fonseca, who is also professor of medicine and endocrinology at Tulane University in New Orleans, Louisiana, explained that there has been a small change in what the optimal blood glucose goal should be. On the basis of findings from ACCORD (Action to Control Cardiovascular Risk in Diabetes study) and other studies, the ADA has set the HbA1c goal at 7% in general, but with some individualization.
"For patients with advanced cardiovascular disease, reduced life expectancy, and multiple medical problems, for example, the goal may be higher," Dr. Fonseca said. "For patients who are newly diagnosed and very motivated, the goal may be lower."
Another recent change underlying the new guidelines is the recognition that many people with diabetes will need multiple agents. For example, the dipeptidyl peptidase-4 (DPP4) inhibitors have become available since the last hyperglycemia guideline was published.
Patient-Centered Management
Rather than using clearly defined algorithms, the new guidelines are less prescriptive and more patient-centered. Recommendations are tailored to individual patient needs, preferences, and tolerances and are based on differences in age and disease course. Other factors affecting individualized treatment plans include specific symptoms, comorbid conditions, weight, race/ethnicity, sex, and lifestyle.
"We start with metformin, and if the patient is not meeting goal in 3 months, we change therapy based on patient-specific factors," said Dr. Fonseca, who was not involved in writing the new guidelines.
"There have been no good studies comparing all available treatment strategies, so we base the decision on individual factors such as willingness to self-inject, or need for weight loss. If that fails, we try another option. There is no clear-cut decision tree as there was in the previous hyperglycemia guideline, because this guideline is more patient-centric."
The position statement mandates diabetes education for all patients, to be administered to individuals or groups. The curriculum should highlight dietary intervention and the key role of increased physical activity and weight management, when appropriate, in an individual or group setting.
"The new guideline should actually be easier for physicians to implement because there is greater flexibility in management, offering a road map rather than a single path," Dr. Fonseca concluded. "The ADA guidelines in general are already fairly widely implemented, and we are seeing benefits from that. Over the past 10-15 years, HbA1c has been dropping, and over the past year, there has started to be a drop in rates of diabetes-related blindness, retinopathy, dialysis, and amputation. But there still remain a large number of patients with these outcomes, so we still have a ways to go."
Key Points
Key recommendations in the new ADA/EASD statement include the following:
- Glycemic targets and treatments to lower glucose must be individualized according to specific patient characteristics.
- The mainstay of any type 2 diabetes treatment program is still diet, exercise, and education.
- Metformin is the preferred first-line drug, in the absence of contraindications.
- Data are limited regarding use of agents other than metformin. A reasonable approach is combination therapy with 1 to 2 additional oral or injectable agents, with the goal of minimizing side effects to the extent possible.
- To maintain glycemic control, many patients will ultimately need insulin monotherapy or in combination with other medications.
- Whenever possible, the patient should participate in all treatment decisions, focusing on their preferences, needs, and values.
- A major treatment goal must be comprehensive cardiovascular risk reduction.
Others Weigh in on the New Guidelines
In an accompanying editorial, Diabetes Care editor William Cefalu, MD, notes that some experts prefer an algorithm-based management plan offering consistent treatment guidelines, whereas others favor flexible treatment options based on specific pathophysiology.
"The most attractive aspect of the new position statement is that more than any other previously reported guidelines to date, it clearly emphasizes that 'one size clearly does not fit all'," Dr. Cefalu writes.
EASD President Andrew J.M. Boulton also commended the new guidelines for their patient-specific approach.
"The new guidelines were prepared using the best available evidence," Dr. Boulton said in a news release. "Diabetes is a condition which affects people in a multitude of ways: the new guidelines take a more holistic approach, focusing on treating the patient as an individual and understanding that treatments need to be 'made to measure,' an approach that will likely improve not only patient care, but also quality of life."
The statement authors report various financial disclosures with Abbott Diabetes Care, Amylin, Bayer, Becton Dickinson, Boehringer Ingelheim, Calibra, DexCom, Eli Lilly, Halozyme, Helmsley Trust, Hygieia, Johnson & Johnson, Medtronic, National Institutes of Health, Novo Nordisk, Roche, Sanofi, Takeda, Merck, AstraZeneca, Biodel Inc; Bristol-Myers Squibb, Diartis Pharmaceuticals Inc, F. Hoffmann-La Roche, Halozyme Therapeutics, Medtronic MiniMed, Pfizer Inc, TransPharma Medical Ltd, Poxel Pharma, Astra-BMS, GlaxoSmithKline, Novartis, Servier,Tolerx, Berlin-Chemie, Diartis, Intarcia Therapeutics, sanofi-aventis Pharma, Versartis, MSD, and/or Merck Serono. Dr. Fonseca states that he has no conflicts of interest regarding the new guidelines. He has been involved in research trials funded by Novo Nordisk, sanofi-aventis, Eli Lilly, Reata, Abbott, Mesoblast, Pan-American Laboratory, and Takeda. He has been a consultant for Takeda, Novo Nordisk, sanofi-aventis, Eli Lilly, Pan-American Laboratory, Daichi-Sankyo, Xoma, Astra Zeneca, Abbott, Bristol-Myers Squibb, and GlaxoSmithKline.
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