PMID- 35255547
OWN - NLM
STAT- MEDLINE
DCOM- 20221208
LR  - 20221228
IS  - 2233-6087 (Electronic)
IS  - 2233-6079 (Print)
IS  - 2233-6079 (Linking)
VI  - 46
IP  - 6
DP  - 2022 Nov
TI  - A Real-World Study of Long-Term Safety and Efficacy of Lobeglitazone in Korean 
      Patients with Type 2 Diabetes Mellitus.
PG  - 855-865
LID - 10.4093/dmj.2021.0264 [doi]
AB  - 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.
FAU - Kim, Bo-Yeon
AU  - Kim BY
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of 
      Medicine, Bucheon, Korea.
FAU - Kwon, Hyuk-Sang
AU  - Kwon HS
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of 
      Korea, Seoul, Korea.
FAU - Kim, Suk Kyeong
AU  - Kim SK
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Konkuk 
      University School of Medicine, Seoul, Korea.
FAU - Noh, Jung-Hyun
AU  - Noh JH
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Inje 
      University Ilsan Paik Hospital, College of Medicine, Inje University, Goyang, 
      Korea.
FAU - Park, Cheol-Young
AU  - Park CY
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, 
      Korea.
FAU - Park, Hyeong-Kyu
AU  - Park HK
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Soonchunhyang University Seoul Hospital, Soonchunhyang University College of 
      Medicine, Seoul, Korea.
FAU - Song, Kee-Ho
AU  - Song KH
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Konkuk 
      University School of Medicine, Seoul, Korea.
FAU - Won, Jong Chul
AU  - Won JC
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Inje 
      University Sanggye Paik Hospital, College of Medicine, Inje University, Seoul, 
      Korea.
FAU - Yu, Jae Myung
AU  - Yu JM
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Hallym 
      University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, 
      Seoul, Korea.
FAU - Lee, Mi Young
AU  - Lee MY
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Wonju 
      Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, 
      Korea.
FAU - Lee, Jae Hyuk
AU  - Lee JH
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea.
FAU - Lim, Soo
AU  - Lim S
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul 
      National University Bundang Hospital, Seoul National University College of 
      Medicine, Seongnam, Korea.
FAU - Chun, Sung Wan
AU  - Chun SW
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of 
      Medicine, Cheonan, Korea.
FAU - Jeong, In-Kyung
AU  - Jeong IK
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Kyung 
      Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, 
      Seoul, Korea.
FAU - Chung, Choon Hee
AU  - Chung CH
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Wonju 
      Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, 
      Korea.
FAU - Han, Seung Jin
AU  - Han SJ
AD  - Department of Endocrinology and Metabolism, Ajou University School of Medicine, 
      Suwon, Korea.
FAU - Kim, Hee-Seok
AU  - Kim HS
AD  - Department of Drug Safety Research, Chong Kun Dang Pharmaceutical Corporation, 
      Seoul, Korea.
FAU - Min, Ju-Young
AU  - Min JY
AD  - Department of Drug Safety Research, Chong Kun Dang Pharmaceutical Corporation, 
      Seoul, Korea.
FAU - Kim, Sungrae
AU  - Kim S
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      College of Medicine, The Catholic University of Korea, Seoul, Korea.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20220308
PL  - Korea (South)
TA  - Diabetes Metab J
JT  - Diabetes & metabolism journal
JID - 101556588
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Glycated Hemoglobin)
RN  - 0 (Hypoglycemic Agents)
RN  - MY89F08K5D (lobeglitazone)
RN  - 0 (Thiazolidinediones)
SB  - IM
MH  - Humans
MH  - Cholesterol, LDL
MH  - *Diabetes Mellitus, Type 2/drug therapy/chemically induced
MH  - Glycated Hemoglobin/analysis
MH  - Hypoglycemic Agents/adverse effects
MH  - Retrospective Studies
MH  - *Thiazolidinediones/adverse effects
MH  - Republic of Korea
PMC - PMC9723193
OTO - NOTNLM
OT  - Diabetes mellitus, type 2
OT  - Lobeglitazone
OT  - Observational study
OT  - Thiazolidinediones
COIS- CONFLICTS OF INTEREST In-Kyung Jeong was editor in chief of the Diabetes & 
      Metabolism Journal from 2020 to 2021. Jung Hyun Noh was associate editor of the 
      Diabetes & Metabolism Journal from 2020 to 2021. They were not involved in the 
      review process of this article. Otherwise, there was no conflict of interest. 
      Statistical analysis was supported by Chong Kun Dang Pharmaceutical Corporation. 
      H.S.K and J.Y.M are employees of Chong Kun Dang Pharmaceutical Corporation.
EDAT- 2022/03/08 06:00
MHDA- 2022/12/06 06:00
PMCR- 2022/11/01
CRDT- 2022/03/07 20:29
PHST- 2021/09/27 00:00 [received]
PHST- 2021/12/07 00:00 [accepted]
PHST- 2022/03/08 06:00 [pubmed]
PHST- 2022/12/06 06:00 [medline]
PHST- 2022/03/07 20:29 [entrez]
PHST- 2022/11/01 00:00 [pmc-release]
AID - dmj.2021.0264 [pii]
AID - dmj-2021-0264 [pii]
AID - 10.4093/dmj.2021.0264 [doi]
PST - ppublish
SO  - Diabetes Metab J. 2022 Nov;46(6):855-865. doi: 10.4093/dmj.2021.0264. Epub 2022 
      Mar 8.