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Topic Abstract

Diabetes mellitus (DM) and its cardiovascular and renal complications create an enormous burden on our healthcare system, and cause nearly 200,000 US deaths per year. An estimated 69% of patients with DM are prescribed oral antidiabetic drugs (OADs), which were licensed for use largely based on the evaluation of their effects on surrogate outcomes such as glucose and HbA1C. For older OADs such as metformin and sulfonylureas as well as more recently licensed thiazolidinediones and meglitinides, direct comparisons of their clinical effectiveness and safety over extended periods of use is limited. A recent AHRQ-commissioned systematic review synthesized available information on the comparative effectiveness and safety of OADs. Our study will provide answers to some of the key gaps in knowledge identified in the AHRQ-sponsored review using local and national data from the Veterans Affairs (VA) Healthcare system. We will perform a retrospective cohort study of new users of OADs and control for baseline differences in age, body weight, HbA1C, and co-morbidities. We will determine whether metformin has a more beneficial and durable effect on proximal clinical outcomes including HbA1C, weight, and lipid profiles than other OADs. We will also compare rates of OADs-associated hospitalizations for hypoglycemia, and determine whether there are important differences between specific sulfonylureas with respect to serious hypoglycemia. Finally, for initial OADs regimens, we will compare time to development or progression of distal DM-related complications including chronic kidney disease, acute myocardial infarction, stroke and death.