A Real-World Study of Long-Term Safety and Efficacy of Lobeglitazone in Korean Patients with Type 2 Diabetes Mellitus
- 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.
- All Author(s)
- B. Y. Kim
; H. S. Kwon
; S. K. Kim
; J. H. Noh
; C. Y. Park
; H. K. Park
; K. H. Song
; J. C. Won
; J. M. Yu
; M. Y. Lee
; J. H. Lee
; S. Lim
; S. W. Chun
; I. K. Jeong
; C. H. Chung
; S. J. Han
; H. S. Kim
; J. Y. Min
; S. Kim
- Issued Date
- 2022
- Type
- Article
- Keyword
- Diabetes mellitus; type 2; Lobeglitazone; Observational study; Thiazolidinediones
- Publisher
- 대한당뇨병학회
- ISSN
- 2233-6079
- Citation Title
- Diabetes & Metabolism Journal
- Citation Volume
- 46
- Citation Number
- 6
- Citation Start Page
- 855
- Citation End Page
- 865
- Language(ISO)
- eng
- DOI
- 10.4093/dmj.2021.0264
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/1885
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