- Kenny Lin, MD, MPH
A Letter to the Editor in AFP's March 15th issue pointed out that a simplified management algorithm in a previous article on noninsulin therapies for type 2 diabetes could have been misinterpreted to suggest the non-recommended combination of a dipeptidyl-peptidase-4 (DPP-4) inhibitor and a glucagon-like-peptide-1 (GLP-1) receptor agonist. According to the American Diabetes Association's 2016 Standards of Medical Care in Diabetes, however, there is little comparative data to guide second-line drug choice after metformin. Few other medications have been shown to lower mortality in patients with type 2 diabetes, and even then only in specific populations, as Dr. Middleton discussed in a recent AFP Community Blog post.
The National Institutes of Health is currently recruiting patients for a multicenter randomized trial, the Glycemia Reduction Approaches to Diabetes: A Comparative Effectiveness (GRADE) study, that will compare the benefits and harms of four medications commonly combined with metformin: 1) glimepride (a sulfonylurea); 2) sitagliptin (a DPP-4 inhibitor); 3) liraglutide (a GLP-1 receptor agonist); and 4) glargine insulin. Since the GRADE study was planned, the sodium glucose cotransporter 2 (SGLT-2) inhibitor class has come on the market, and a randomized trial found that empagliflozin reduces cardiovascular and all-cause mortality in patients with established cardiovascular disease and type 2 diabetes. This surprising result led some experts to suggest that SGLT-2 inhibitors be added to the GRADE trial or incorporated into some other comparative research study.
This kind of pragmatic diabetes research would seem to be a perfect fit for the Patient-Centered Outcomes Research Institute (PCORI). Created by the Affordable Care Act, PCORI's mission is to "improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions" by funding comparative clinical effectiveness research and research methods. However, PCORI received criticism recently after an independent analysis of its first 6 funding cycles by the American Academy of Family Physicians' Robert Graham Center concluded that "less than one-third of PCORI studies involve or are relevant to primary care."
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