BCG polysaccharide and nucleic acid(Zhejiang Wansheng Pharmaceutical Co., Ltd.)

Sulfonylurea (SU) and dipeptidyl peptidase-4 (DPP-4) inhibitors are most common secondary agents that are added to metformin monotherapy. Real-world studies have become increasingly important in providing evidence of treatment effectiveness in clinical practice and real-world data could help appropriate therapeutic information. Therefore, this study aims to compare the glycemic effectiveness of SU and DPP-4 inhibitors, which are added to metformin monotherapy in real clinical practice using electronic medical record (EMR) data. EMR data of type 2 diabetes patients treated at Seoul National University Hospital from December 2002 to December 2012 were retrieved and analyzed. The patients were divided into three groups: patients who maintained metformin monotherapy (M), and patients who added SU (MS) or DPP-4 inhibitors (MD) to metformin monotherapy. The mean change in HbA1c level, the proportion of patients achieving the HbA1c target < 7.0%, proportion of patients with treatment failure, and probability of treatment failure occurrence and changes in prescription were evaluated to compare glycemic control efficacy between SU and DPP-4 inhibitors. The MS showed significantly greater reduction in the Hb1Ac level than MD. The proportion of patients achieving HbA1c < 7.0% is higher in MD, whereas the proportion of patients with treatment failure was greater in MS. The probability of the treatment failure and probability of changes in the prescription were lower in MD than MS with hazard ratio of 0.499 and 0.579, respectively. In conclusion, this real-world study suggested that DPP-4 inhibitors are expected to show more durable glycemic control efficacy than SU in long-term use.

To analyze the durability of monotherapy with different classes of oral hypoglycemic agents (OHAs) in drug naïve patients with type 2 diabetes mellitus (T2DM) in real life.

Men and women with T2DM, who were new users of OHA monotherapy and registered in the Swedish National Diabetes Register July 2005–December 2011, were available (n=17 309) and followed for up to 5.5 years. Time to monotherapy failure, defined as discontinuation of continuous use with the initial agent, switch to a new agent, or add-on treatment of a second agent, was analyzed as a measure of durability. Baseline characteristics were balanced by propensity score matching 1:5 between groups of sulfonylurea (SU) versus metformin (n=4303) and meglitinide versus metformin (n=1308). HRs with 95% CIs were calculated using Cox regression models.

SU and meglitinide, as compared with metformin, were associated with increased risk of monotherapy failure (HR 1.74; 95% CI 1.56 to 1.94 and 1.66; 1.37 to 2.00 for SU and meglitinide, respectively). When broken down by type of monotherapy failure, SU and meglitinide were associated with an increased risk of add-on treatment of a second agent (HR 3.14; 95% CI 2.66 to 3.69 and 2.52; 1.89 to 3.37 for SU and meglitinide, respectively) and of switch to a new agent (HR 2.81; 95% CI 2.01 to 3.92 and 3.78; 2.25 to 6.32 for SU and meglitinide, respectively). The risk of discontinuation did not differ significantly between the groups.

In this nationwide observational study reflecting clinical practice, SU and meglitinide showed substantially increased risk of switch to a new agent or add on of a second agent compared with metformin. These results indicate superior glycemic durability with metformin compared with SU and also meglitinide in real life.