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

被引：10

作者：

Kim, Bo-Yeon ^{[1
]}

Kwon, Hyuk-Sang ^{[2
]}

Kim, Suk Kyeong ^{[3
]}

Noh, Jung-Hyun ^{[4
]}

Park, Cheol-Young ^{[5
]}

Park, Hyeong-Kyu ^{[6
]}

Song, Kee-Ho ^{[3
,7
]}

Won, Jong Chul

Yu, Jae Myung ^{[8
]}

Lee, Mi Young ^{[9
]}

Lee, Jae Hyuk ^{[10
]}

Lim, Soo ^{[11
]}

Chun, Sung Wan ^{[12
]}

Jeong, In-Kyung ^{[13
]}

Chung, Choon Hee ^{[9
]}

Han, Seung Jin ^{[14
]}

Kim, Hee-Seok ^{[15
]}

Min, Ju-Young ^{[15
]}

Kim, Sungrae ^{[16
,17
]}

机构：

[1] Soonchunhyang Univ, Bucheon Hosp, Coll Med, Div Endocrinol & Metab,Dept Internal Med, Bucheon, South Korea

[2] Catholic Univ Korea, Yeouido St Marys Hosp, Coll Med, Dept Internal Med,Div Endocrinol & Metab, Yeouido St, Seoul, South Korea

[3] Konkuk Univ, Sch Med, Dept Internal Med, Div Endocrinol & Metab, Seoul, South Korea

[4] Inje Univ, Ilsan Paik Hosp, Coll Med, Dept Internal Med,Div Endocrinol & Metab, Goyang, South Korea

[5] Sungkyunkwan Univ, Kangbuk Samsung Hosp, Sch Med, Dept Internal Med,Div Endocrinol & Metab, Seoul, South Korea

[6] Soonchunhyang Univ, Seoul Hosp, Coll Med, Div Endocrinol & Metab,Dept Internal Med, Seoul, South Korea

[7] Inje Univ, Sanggye Paik Hosp, Coll Med, Dept Internal Med,Div Endocrinol & Metab, Seoul, South Korea

[8] Hallym Univ, Kangnam Sacred Heart Hosp, Coll Med, Div Endocrinol & Metab,Dept Internal Med, Seoul, South Korea

[9] Yonsei Univ Wonju, Wonju Severance Christian Hosp, Coll Med, Div Endocrinol & Metab,Dept Internal Med, Wonju, South Korea

[10] Hanyang Univ, Myongji Hosp, Coll Med, Dept Internal Med,Div Endocrinol & Metab, Goyang, South Korea

[11] Seoul Natl Univ, Bundang Hosp, Coll Med, Div Endocrinol & Metab,Dept Internal Med, Seongnam, South Korea

[12] Soonchunhyang Univ, Cheonan Hosp, Coll Med, Div Endocrinol & Metab,Dept Internal Med, Cheonan, South Korea

[13] Kyung Hee Univ, Hosp Gangdong, Coll Med, Dept Internal Med,Div Endocrinol & Metab, Seoul, South Korea

[14] Ajou Univ, Sch Med, Dept Endocrinol & Metab, Suwon, South Korea

[15] Chong Kun Dang Pharmaceut Corp, Dept Drug Safety Res, Seoul, South Korea

[16] Catholic Univ Korea, Coll Med, Dept Internal Med, Div Endocrinol & Metab, Seoul, South Korea

[17] Catholic Univ Korea, Coll Med, Dept Internal Med, Div Endocrinol & Metab, 222 Banpo Daero, Seoul 06591, South Korea

来源：

DIABETES & METABOLISM JOURNAL | 2022年 / 46卷 / 06期

关键词：

Diabetes mellitus; type; 2; Lobeglitazone; Observational study; Thiazolidinediones; BONE-MINERAL DENSITY; GAMMA AGONIST; DOUBLE-BLIND; FLUID RETENTION; BLADDER-CANCER; HEART-FAILURE; PIOGLITAZONE; THIAZOLIDINEDIONES; RISK; TROGLITAZONE;

D O I：

10.4093/dmj.2021.0264

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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% & PLUSMN; 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.

引用

页码：855 / 865

页数：11

共 40 条

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