Lobeglitazone, a Novel Thiazolidinedione, Improves Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes: Its Efficacy and Predictive Factors Related to Responsiveness

Lee, Yong-ho; Kim, Jae Hyeon; Kim, So Ra; Jin, Heung Yong; Rhee, Eun-Jung; Cho, Young Min; Lee, Byung-Wan

The present study has some limitations that should be addressed in future studies. Lobeglitazone is a novel TZD; thus, its long-term safety in treating patients with NAFLD has not been established. Moreover, findings from the current study should be taken with some caution in that our clinical trials included a relatively small number of participants, without having any quality control for CAP measurements conducted by the five centers. Additionally, we did not perform liver biopsy, which is the gold standard method, to evaluate the status of NAFLD because it is a highly invasive and costly procedure. Furthermore, our study does not clearly show how lobeglitazone works on NAFLD. Finally, we performed a single-arm trial without a placebo or an active arm. However, even with these limitations, the current study has several strengths: First, we conducted a study with the novel drug lobeglitazone to assess its additional benefits on NAFLD in T2D patients. Second, to the best of our knowledge, this is the first trial to demonstrate that CAP can be used as a simple, non-invasive tool to quantify and monitor changes in liver fat content during intervention. Finally, we identified several parameters that may be used to predict NAFLD-patient response to lobeglitazone treatment.