Hemoglobin A1c outcomes and health care resource use in type 2 diabetes mellitus patients treated with combination oral antidiabetic drugs through step therapy and loose-dose and fixed-dose combinations.

Purpose: To compare outcomes of type 2 diabetes mellitus (T2DM) patients initiating therapy with FDC vs. those with loose-dose combination (LDC) or step therapy (ST) in a managed care population.

Design: A retrospective claims database analysis.

Methodology: Treatment-naive T2DM patients who were continuously enrolled in a health plan during 2006-2009 were studied. Eligible patients were assigned to FDC, LDC, or ST cohorts. Glycated hemoglobin goal attainment (HbA1c < 7%) was assessed using the American Diabetes Association (ADA) treatment guidelines. Health care resources use and costs, including inpatient, emergency room (ER), and ambulatoryvisits, were measured during the 12 months after therapy initiation. All-cause and diabetes-related use and costs were assessed.

Principal Findings: 21,048 patients met study criteria (FDC n = 8,416, ST n = 8,407, LDC n = 4,225), and 1,926 of these patients had HbA1c results. FDC patients had lower rates of post-index all-cause inpatient stays and ER visits compared with the other cohorts. FDC patients had lower average counts of diabetes-related ambulatory visits (2.7) compared with ST (3.7; p < 0.001) and LDC (3.2; p < 0.001) and significantly lower average post-index all-cause and diabetes-related costs compared with the other cohorts, with average all-cause costs for FDC, ST, and LDC of $8,445, $10,515, and $9,688, respectively, and diabe-tes-related costs of $1,641, $2,099, and $1,900, respectively. FDC patients had higher rates of achieving HbA1c goal (61%) compared to ST (48%; p < 0.001) or LDC (52%; p = 0.015). Differences in outcomes remained following multivariate analyses.

Conclusion: Treatment with FDC was associated with lower health care resources use and costs and better likelihood of HbA1c goal attainment.