A Real-World Study of Long-Term Safety and Efficacy of Lobeglitazone in Korean Patients with Type 2 Diabetes Mellitus
- Author:
Bo-Yeon KIM
1
;
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
Author Information
- Publication Type:Original Article
- From:Diabetes & Metabolism Journal 2022;46(6):855-865
- CountryRepublic of Korea
- Language:English
-
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.
