Abstract

aims: This study examined differences in patient characteristics between patients with type 2 diabetes (T2DM) treated with sitagliptin (SITA) vs other oral antihyperglycemic agents (OAHA) in real-world practice in the US. Methods: The General Electric Centricity electronic medical record database, covering 9 million US patients of all ages from 49 states, was used to select patients with T2DM, aged >=30 years, who received their first SITA, metformin, sulfonylureas, or thiazolidinediones prescriptions (Rx) as index Rx between Oct 2006 and June 2008. Included patients were new to OAHA mono, dual or triple therapy. Patient’s demographics, diagnoses, Rxs, and lab results were extracted for the 1 year period (baseline) prior to index Rx. Baseline characteristics were stratified by mono, dual, or triple therapy and were compared between regimens with and without SITA. Adjusted logistic regression analyses were used to estimate odds ratio (OR) associated with SITA use in relation to patient characteristics. results: Among 45418 patients new to OAHA monotherapy, 1091 (2.4%) received SITA. Compared to patients initiating other OAHA, patients on SITA were older (64 vs 61 years), had higher HbA1c (7.4% vs 7.1%) with fewer patients at HbA1c <7% (46% vs 58%), had higher serum creatinine (106 vs 88 mmol/L), and had higher prevalence of macro(18.1% vs 12.7%) and microvascular (15.1% vs 6.8%) conditions (all p<0.0001). Adjusted logistic regression shows that significant predictors of prescribing SITA were older age (OR 1.01, 95% CI 1.00, 1.02), higher HbA1c level (OR 1.13, 95% CI 1.08, 1.18), and presence of retinopathy (OR 2.29, 95% CI 1.38, 3.80) or renal insufficiency (OR 2.65, 95% CI 2.20, 3.19). Of 24806 patients new to dual therapy, 2261 (9.1%) were on SITA regimens. Relative to patients on other dual regimens, patients prescribed SITA dual regimens were older, had higher serum creatinine, had higher prevalence of macroand micro-vascular conditions, and greater use of lipid lowering and antihypertensive drugs (all p<0.0001). Among 10774 patients new to triple therapy, 3194 (29.6%) were on triple SITA regimens. Relative to patients on other triple regimens, patients on SITA triple regimens were older, had higher serum creatinine and greater use of antihypertensive or lipid-lowering drugs (all p<0.0001). Lipid lowering Rx was associated with higher adjusted likelihood of prescribing SITA dual and triple therapy. conclusion: This study found that patients with T2DM who were prescribed SITA were older and likely to have more preexisting diabetic complications and comorbidities compared to patients who received other common OAHA in real-world practice. This has important implications for future observational studies, in that estimated outcome measures may be biased.

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