A Real-World Study of Long-Term Safety and Efficacy of Lobeglitazone in Korean Patients with Type 2 Diabetes Mellitus

Bo Yeon Kim, Hyuk Sang Kwon, Suk Kyeong Kim, Jung Hyun Noh, Cheol Young Park, Hyeong Kyu Park, Kee Ho Song, Jong Chul Won, Jae Myung Yu, Mi Young Lee, Jae Hyuk Lee, Soo Lim, Sung Wan Chun, In Kyung Jeong, Choon Hee Chung, Seung Jin Han, Hee Seok Kim, Ju Young Min, Sungrae Kim

Research output: Contribution to journalArticlepeer-review

5 Citations (Scopus)


Background: Thiazolidinediones (TZDs) have been associated with various safety concerns including weight gain, bladder cancer, and congestive heart failure (CHF). This study evaluated the efficacy and safety of lobeglitazone, a novel TZD in patients with type 2 diabetes mellitus (T2DM) in real practice. Methods: In this non-interventional, multi-center, retrospective, and observational study conducted at 15 tertiary or secondary referral hospitals in Korea, a total of 2,228 patients with T2DM who received lobeglitazone 0.5 mg for more than 1 year were enrolled. Results: Overall adverse events (AEs) occurred in 381 patients (17.10%) including edema in 1.97% (n=44). Cerebrovascular and cardiovascular diseases were identified in 0.81% (n=18) and 0.81% (n=18), respectively. One case of CHF was reported as an AE. Edema occurred in 1.97% (n=44) of patients. Hypoglycemia occurred in 2.47% (n=55) of patients. Fracture occurred in 1.17% (n=26) of all patients. Lobeglitazone significantly decreased HbA1c level, resulting in a mean treatment difference of –1.05%± 1.35% (P<0.001), and decreased total cholesterol, triglyceride, and low-density lipoprotein cholesterol. However, it increased high-density lipoprotein cholesterol, regardless of statin administration. The patients who received lobeglitazone 0.5 mg showed an apparent reduction in glycosylated hemoglobin (HbA1c) from baseline during the first 6 months of treatment. The HbA1c levels remained stable between months 6 and 42. Conclusion: Lobeglitazone has long-term safety profile, good glycemic-lowering effect and long-term durability of glycemic control in real-world clinical settings.

Original languageEnglish
Pages (from-to)855-865
Number of pages11
JournalDiabetes and Metabolism Journal
Issue number6
Publication statusPublished - 2022 Nov

Bibliographical note

Funding Information:
This work was funded by Chong Kun Dang Pharmaceutical Corporation and partly supported by the Soonchunhyang University Research Fund.

Publisher Copyright:
Copyright © 2022 Korean Diabetes Association.

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism


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