Diabetes Metab J.  2022 Nov;46(6):855-865. 10.4093/dmj.2021.0264.

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

• Kim BY
• Kwon HS
• Kim SK
• Noh JH
• Park CY
• Park HK
• Song KH
• Won JC
• Yu JM
• Lee MY
• Lee JH
• Lim S
• Chun SW
• Jeong IK
• Chung CH
• Han SJ
• Kim HS
• Min JY
• Kim S

• KMID: 2536144
• DOI: http://doi.org/10.4093/dmj.2021.0264

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.

Keyword

Diabetes mellitus; type 2; Lobeglitazone; Observational study; Thiazolidinediones

Figure

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  Fig. 1 Changes in glycosylated hemoglobin (HbA1c, %) level during 42 months in the add-on and drug-naïve groups are shown. Values are presented as HbA1c mean (number of patients).

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  Fig. 2 Comparative analysis of varying glycosylated hemoglobin (HbA1c, %) levels during 42 months in different groups (efficacy set total vs. antidiabetic drug maintenance vs. antidiabetic drug change). Values are presented as HbA1c mean (number of patients).

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