New Diabetes Guideline Urges Tailored Therapy

Clinicians should take an individualized, patient-centric approach when treating type 2 diabetes, according to a joint statement from American and European diabetes organizations.

Both HbA1c targets and pharmacological interventions should be tailored to patients’ needs and preferences, said the position statement from the American Diabetes Association and the European Association for the Study of Diabetes, published in both Diabetes Care and Diabetologia.

“The wide range of pharmacological choices, along with conflicting data about some of those choices, and differences in how patients respond to medications, makes it difficult to prescribe a single treatment regimen based on an algorithm that is designed to work for everyone,” Vivian Fonseca, president of ADA, said in a statement.

M. Sue Kirkman, MD, senior vice president for medical affairs and community information, told MedPage Today that ADA has not had an official position statement on this topic before, and that clinicians have relied on a consensus algorithm developed by the two organizations.

Kirkman said the new position statement is very different from prior algorithms in that it is less prescriptive and doesn’t recommend specific agents to be used after metformin. The previous consensus statement - which was written in 2006 when there was less data on now widely used agents such as GLP-1 agonists and DPP-4 inhibitors - was to “choose among insulin, a sulfonylurea, or a [thiazolidinedione].”

“We don’t want to say that some classes should be used and others shouldn’t,” Kirkman said. “We recognize there are many FDA approved classes of medications that can be used.”

Instead, the new guideline discusses the risks and benefits of the various drug classes that are available, since “there’s more known about particular adverse events with certain therapies” than there was when the prior consensus document was released, Kirkman said.

The lack of comparative-effectiveness data between drug classes also contributes to the less-prescriptive nature of the new statement and enforces the need for tailored therapy, the researchers wrote.

Lifestyle intervention still remains the first step in management, but the statement also calls for patient education focusing on diet and exercise in order to achieve lifestyle changes.

Metformin remains the first-line drug, but after that there’s limited data for guidance, although double or triple combination therapy with oral or injectable agents is reasonable, the statement said.

Choosing those drugs should center around side effects and patient needs and preferences. Classes with a risk of bone fracture, such as the TZDs, could pose particular problems for postmenopausal women, for instance, while agents that promote weight loss, such as the GLP-1 agonists, may be preferable over those that induce weight gain.

Clinicians should also take into account risks of hypoglycemia with certain agents, the statement said.

The guideline authors didn’t call much attention to the risk of myocardial infarction that caused some European countries to pull rosiglitazone (Avandia) from the market and tightened restrictions on its prescription in the U.S. other than to say it is “no longer widely available” owing to those concerns.

Eventually, many patients will need insulin therapy, either alone or in combination, to maintain glucose control, the researchers wrote.

They acknowledged that glycemic targets also need to be tailored to individuals, as recent evidence “suggests that not everyone benefits from aggressive glucose management.”

A color-coded chart recommends more strict management for those who are highly motivated, have a low risk of hypoglycemia, are newly diagnosed, have a long life expectancy, are free of important comorbidities, and have no established vascular complications. For patients on the other ends of these spectra, the statement recommends less stringent management.

It also calls for comprehensive cardiovascular risk reduction to be a “major focus” of therapy.

The statement was supported by the EASD and the ADA.

The researchers reported relationships with Abbott Diabetes Care, Amylin, Bayer, Becton Dickinson, Boehringer Ingelheim, Calibra, DexCom, Eli Lilly, Halozyme, Helmsley Trust, Hygieia, Johnson & Johnson, Medtronic, NIH, Novo Nordisk, Roche, sanofi, Takeda, Merck, AstraZeneca, Biodel, Bristol-Myers Squibb, Diartis Pharmaceuticals, Hoffman-La Roche, Pfizer, TransPharma Medical, Merck Sharp & Dohme, Poxel Pharma, GlaxoSmithKline, Tolerx, Berlin-Chemie, Intarcia, Versartis, and Merck Serono.


Primary source: Diabetologia
Source reference: Inzucchi SE, et al “Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Position statement of the ADA and the EASD” Diabetalogia 2012; DOI: 10.1007/s00125-012-2534-0.

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