A new position statement on managing hyperglycemia in type 2 diabetes from the American Diabetes Association and the European Association for the Study of Diabetes looks beyond glycemic control and emphasizes a patient-centered approach to care.
The updated recommendations are less prescriptive than their previous guidelines and not as algorithmic.
"This follows from the general lack of comparative-effectiveness research in this area," explained Dr. Silvio E. Inzucchi, cochair of the statement’s writing group, and his coauthors. "Our intent is therefore to encourage an appreciation of the variable and progressive nature of type 2 diabetes, the specific role of each drug, the patient and disease factors that drive clinical decision-making, and the constraints imposed by age and comorbidity."
The ADA and EASD last published a joint consensus algorithm on type 2 diabetes hyperglycemia management in 2009 (Diabetologia 2009;52:17-30).
But an update was necessary, given new information on the benefits and risks of glycemic control, the emergence of safety and efficacy data on new drug classes, restrictions on and withdrawals of existing drugs, and calls for more patient-centered care, said Dr. Inzucchi, professor of medicine and director of the Yale Diabetes Center, New Haven.
The document addresses glycemic control, but it also emphasizes the importance of managing other cardiovascular risk factors in type 2 diabetes, such as blood pressure and lipid therapy, antiplatelet treatment, and smoking cession management (Diabetes Care 2012 April 19 [doi:10.2337/dc12-0413]).
Patient participation plays a greater role in the updated recommendations. "The implementation of these guidelines will require thoughtful clinicians to integrate current evidence with other constraints and imperatives in the context of patient-specific factors," the authors said.
Patient-centered care "is respectful of and responsive to individual patient preferences, needs, and values and [ensures] that patient values guide all clinical decisions," they noted. It’s an approach that is particularly appropriate in type 2 diabetes, the authors added, because "ultimately, it is patients who make the final decisions regarding their lifestyle choices and, to some degree, the pharmaceutical interventions they use."
The guidelines recommend that providers should gauge a patient’s preferred level of involvement when making treatment decisions. "There is good evidence supporting the effectiveness of this approach," the authors noted. "Importantly, engaging patients in health care decisions may enhance adherence to therapy."
Among the statement’s other recommendations:
• Glycemic control: The glycemic control target of a hemoglobin A1c less than 7% is unchanged from previous statements. However, more or less stringent targets may be warranted based on individual patient considerations, including patient attitude and expected treatment efforts, risks potentially associated with hypoglycemia, other adverse events, disease duration, life expectancy, important comorbidities, established vascular complications, resources, and available support systems.
• Lifestyle interventions: Lifestyle interventions aimed at increasing activity levels and optimizing food intake are "the foundation of any type 2 diabetes treatment program," the authors noted, and standardized general diabetes education – individual or group – is advised for all patients.
• Medication options: As with previous guidelines, metformin is deemed the optimal first-line drug unless there are contraindications. However, "after metformin, there are limited data to guide us," the group noted, adding that combination therapy with an additional 1-2 oral or injectable agents is "reasonable," with the aim of minimizing side effects as much as possible. Ultimately, many patients will require insulin therapy alone or in combination with other agents to maintain glucose control.
The document outlines considerations for the use of metformin in combination with agents from each of the major diabetes drug classes (sulfonylurea, thiazolidinedione, DPP-4 inhibitor, GLP-1 receptor antagonist, and insulin), as well as progression to the use of insulin alone and the various insulin-based regimens.
• Patient considerations: The statement also addresses patient considerations, including age, weight, sex/racial/ethnic/genetic differences, comorbidities, and hypoglycemia, about which there is now greater concern in patients with type 2 diabetes than in the past, due to recent trials suggesting that it may pose more danger than previously believed.
The statement concludes with a call for more high-quality comparative-effectiveness research on antihyperglycemic agents, with a sharper focus on quality of life issues and avoiding complications, as well as glycemic control. Also needed are clinical data on pharmacogenomics to determine how phenotype and patient/disease-specific characteristics should drive drug choices.
"Head-to-head comparisons of all combinations and permutations would be impossibly large," the authors admitted, so "informed judgment and the expertise of experienced clinicians will therefore always be necessary."
Dr. Inzucchi is an adviser or consultant to Boehringer Ingelheim, Merck, and Takeda. Yale University received research funding or supplies from Eli Lilly and Takeda. Dr. Inzucchi has participated in medical educational projects for which Yale University received unrestricted funding from Amylin, Boehringer Ingelheim, Eli Lilly, Merck, Novo Nordisk, and Takeda. All but one writing group member listed similar disclosures.