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- Title
A Real-World Study of Long-Term Safety and Efficacy of Lobeglitazone in Korean Patients with Type 2 Diabetes Mellitus.
- Authors
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
- Abstract
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.
- Subjects
SOUTH Korea; TYPE 2 diabetes; KOREANS; HDL cholesterol; LDL cholesterol; GLYCOSYLATED hemoglobin
- Publication
Diabetes & Metabolism Journal, 2022, Vol 46, Issue 6, p855
- ISSN
2233-6079
- Publication type
Article
- DOI
10.4093/dmj.2021.0264