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KMID : 1200020220460060855
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Diabetes & Metabolism Journal
2022 Volume.46 No. 6 p.855 ~ p.865
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A Real-World Study of Long-Term Safety and Efficacy of Lobeglitazone in Korean Patients with Type 2 Diabetes Mellitus
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Kim Bo-Yeon
Kwon Hyuk-Sang
Kim Suk-Kyeong
Noh Jung-Hyun
Park Cheol-Young
Park Hyeong-Kyu
Song Kee-Ho
Won Jong-Chul
Yu Jae-Myung
Lee Mi-Young
Lee Jae-Hyuk
Lim Soo
Chun Sung-Wan
Jeong In-Kyung
Chung Choon-Hee
Han Seung-Jin
Kim Hee-Seok
Min Ju-Young
Kim Sung-Rae
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Abstract
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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.
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KEYWORD
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Diabetes mellitus, type 2, Lobeglitazone, Observational study, Thiazolidinediones
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