Treatment Intensification May Improve Glycemic Control Without Adverse Effects in Type 2 Diabetes
By Laurie Barclay, MD
Medscape Medical News
June 22, 2009 — Antihyperglycemic treatment intensification improves glycemic control with no worsening of mental or physical health status in patients with type 2 diabetes, according to the results of a study reported in the June issue of Diabetes Care.
"Ideally, diabetes treatment regimens should be individually designed to prevent complications and comorbidities while respecting patient preferences and optimizing quality of life," write Laura N. McEwen, PhD, from the University of Michigan in Ann Arbor, and colleagues. "The current analyses were designed to assess the impact of changes in antihyperglycemic therapies on health outcomes in managed care patients with type 2 diabetes. Specifically, we assessed the predictors of intensification of antihyperglycemic therapy, its impact on [hemoglobin] A1C, body weight, symptoms of anxiety/depression, and health status, and patient characteristics associated with improvement in A1C."
Translating Research into Action for Diabetes (TRIAD) is a study of approximately 180,000 adults with diabetes. In this analysis, the investigators examined TRIAD survey, medical record, and health plan administrative data for patients treated with diet and exercise or oral antihyperglycemic medications at baseline, who had A1C levels of more than 7.2%, and who remained with the same treatment or intensified treatment for 18 months. Intensification of therapy was defined as starting or increasing the number of classes of oral antihyperglycemic medications or starting insulin.
Of 1093 patients, 520 intensified treatment during the study. In this group, mean age was 58 ± 12?years, diabetes duration was 11 ± 9 years, and baseline A1C level was 9.1% ± 1.5%. Factors predicting treatment intensification were younger age and higher A1C level.
Treatment intensification vs no intensification was associated with a 0.49% decrease in A1C level (P < .0001), a 3-pound increase in weight (P = .003), and no change in anxiety or depression (P = .5) or in health status (P = .2). In patients who intensified treatment, predictors of improvement in A1C level were higher baseline A1C level, older age, black race/ethnicity, lower income, and more clinician visits.
"Treatment intensification improved glycemic control with no worsening of anxiety/depression or health status, especially in elderly, lower-income, and minority patients with type 2 diabetes," the study authors write. "Interventions are needed to overcome clinical inertia when patients might benefit from treatment intensification and improved glycemic control."
Limitations of this study include reliance on pharmacy claims and utilization data for determination of antihyperglycemic treatment, definition of therapy intensification based on adding classes of medications and not on increasing the dose, and failure to assess medication adherence. In addition, the time of starting new therapies could not be synchronized, and all of the patients were enrolled in managed care health plans, limiting generalizability of the findings.
"More research is needed to define and compare the glucose-lowering and side effect profiles of individual therapeutic medications, and careful consideration is needed regarding the risks of intensification in elderly patients," the study authors conclude.
The Centers for Disease Control and Prevention (Division of Diabetes Translation) and the National Institute of Diabetes and Digestive and Kidney Diseases supported this study. sanofi-aventis supported these analyses through a Research Services Contract to the University of Michigan and provided research grant support to 4 of the study authors.
Diabetes Care. 2009;32:971-976.
