Efficacy and Safety of Metformin and Atorvastatin Combination Therapy vs. Monotherapy with Either Drug in Type 2 Diabetes Mellitus and Dyslipidemia Patients (ATOMIC): Double-Blinded Randomized Controlled Trial

被引：0

作者：

Lee, Jie-Eun ^{[1
]}

Yu, Seung Hee ^{[2
]}

Kim, Sung Rae ^{[3
]}

Ahn, Kyu Jeung ^{[4
]}

Song, Kee-Ho ^{[5
]}

Lee, In-Kyu ^{[6
]}

Shon, Ho-Sang ^{[7
]}

Kim, In Joo ^{[8
]}

Lim, Soo ^{[9
]}

Kim, Doo-Man ^{[10
]}

Chung, Choon Hee ^{[11
]}

Lee, Won-Young ^{[12
]}

Lee, Soon Hee ^{[13
]}

Kim, Dong Joon ^{[14
]}

Cho, Sung-Rae ^{[15
]}

Jung, Chang Hee ^{[16
]}

Jeon, Hyun Jeong ^{[17
]}

Lee, Seung-Hwan ^{[18
]}

Park, Keun-Young ^{[19
]}

Rhee, Sang Youl ^{[20
]}

Kim, Sin Gon ^{[21
]}

Park, Seok O. ^{[22
]}

Kim, Dae Jung ^{[23
]}

Kim, Byung Joon ^{[24
]}

Lee, Sang Ah ^{[25
]}

Kim, Yong-Hyun ^{[26
]}

Kim, Kyung-Soo ^{[27
]}

Seo, Ji A. ^{[28
]}

Nam-Goong, Il Seong ^{[29
]}

Lee, Chang Won ^{[30
]}

Kim, Duk Kyu ^{[31
]}

Kim, Sang Wook ^{[32
]}

Cho, Chung Gu ^{[33
]}

Kim, Jung Han ^{[34
]}

Kim, Yeo-Joo ^{[35
]}

Yoo, Jae-Myung ^{[36
]}

Min, Kyung Wan ^{[37
]}

Lee, Moon-Kyu ^{[1
]}

机构：

[1] Eulji Univ, Uijeongbu Eulji Med Ctr, Dept Internal Med, Div Endocrinol & Metab,Sch Med, 712 Dongil Ro, Uijongbu 11759, South Korea

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

[3] Catholic Univ Korea, Bucheon St Marys Hosp, Coll Med, Div Endocrinol & Metab,Dept Internal Med, Bucheon, South Korea

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

[5] Konkuk Univ, Med Ctr, Dept Internal Med, Div Endocrinol & Metab, Seoul, South Korea

[6] Kyungpook Natl Univ, Kyungpook Natl Univ Hosp, Sch Med, Div Endocrinol & Metab,Dept Internal Med, Daegu, South Korea

[7] Daegu Catholic Univ, Dept Internal Med, Div Endocrinol & Metab, Med Ctr, Daegu, South Korea

[8] Pusan Natl Univ Hosp, Dept Internal Med, Div Endocrinol & Metab, Busan, South Korea

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

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

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

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

[13] Inje Univ, Dept Internal Med, Div Endocrinol & Metab, Busan Paik Hosp, Busan, South Korea

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

[15] Changwon Fatima Hosp, Dept Internal Med, Div Endocrinol & Metab, Chang Won, South Korea

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

[17] Chungbuk Natl Univ, Chungbuk Natl Univ Hosp, Coll Med, Div Endocrinol & Metab,Dept Internal Med, Cheongju, South Korea

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

[19] Konyang Univ Hosp, Dept Internal Med, Div Endocrinol & Metab, Daejeon, South Korea

[20] Kyung Hee Univ, Kyung Hee Univ Hosp, Coll Med, Dept Endocrinol & Metab, Seoul, South Korea

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

[22] Gwangmyeong Sungae Hosp, Dept Internal Med, Div Endocrinol & Metab, Gwangmyeong, South Korea

[23] Ajou Univ, Ajou Univ Hosp, Dept Internal Med, Div Endocrinol & Metab,Sch Med, Suwon, South Korea

[24] Gachon Univ, Gil Med Ctr, Dept Internal Med, Div Cardiol,Coll Med, Incheon, South Korea

[25] Jeju Natl Univ, Dept Internal Med, Div Endocrinol & Metab, Sch Med, Jeju, South Korea

[26] Bundang Jesaeng Hosp, Dept Internal Med, Div Endocrinol & Metab, Seongnam, South Korea

[27] CHA Univ, CHA Bundang Med Ctr, Dept Internal Med, Div Endocrinol & Metab,Sch Med, Seongnam, South Korea

[28] Korea Univ, Coll Med, Dept Internal Med, Div Endocrinol & Metab,Ansan Hosp, Ansan, South Korea

[29] Univ Ulsan, Ulsan Univ Hosp, Dept Internal Med, Div Endocrinol & Metab,Coll Med, Ulsan, South Korea

[30] Busan St Marys Hosp, Dept Internal Med, Div Endocrinol & Metab, Busan, South Korea

[31] Dong A Univ, Dong A Univ Hosp, Dept Internal Med, Div Endocrinol & Metab,Coll Med, Busan, South Korea

[32] Kangwon Natl Univ, Kangwon Natl Univ Hosp, Dept Internal Med, Div Endocrinol & Metab,Sch Med, Chunchon, South Korea

[33] Wonkwang Univ, Wonkwang Univ Hosp, Dept Internal Med, Div Endocrinol & Metab,Sch Med, Iksan, South Korea

[34] Sungae Hosp, Dept Internal Med, Div Endocrinol & Metab, Seoul, South Korea

[35] Soonchunhyang Univ, Coll Med, Dept Internal Med, Div Cardiol,Cheonan Hosp, Cheonan, South Korea

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

[37] Eulji Univ, Nowon Eulji Med Ctr, Dept Internal Med, Div Endocrinol & Metab,Sch Med, Seoul, South Korea

来源：

DIABETES & METABOLISM JOURNAL | 2024年 / 48卷 / 04期

关键词：

Atorvastatin; Diabetes mellitus; Dyslipidemias; Metformin; GLUCOSE-METABOLISM; LDL CHOLESTEROL; ASSOCIATION; PROFILES; STATINS;

D O I：

暂无

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: It is well known that a large number of patients with diabetes also have dyslipidemia, which significantly increases the risk of cardiovascular disease (CVD). This study aimed to evaluate the efficacy and safety of combination drugs consisting of metformin and atorvastatin, widely used as therapeutic agents for diabetes and dyslipidemia. Methods: This randomized, double-blind, placebo-controlled, parallel-group and phase III multicenter study included adults with glycosylated hemoglobin (HbA1c) levels >7.0% and < 10.0%, low-density lipoprotein cholesterol (LDL-C) > 100 and < 250 mg/dL. One hundred eighty-five eligible subjects were randomized to the combination group (metformin+atorvastatin), metformin group (metformin+atorvastatin placebo), and atorvastatin group (atorvastatin+metformin placebo). The primary efficacy endpoints were the percent changes in HbA1c and LDL-C levels from baseline at the end of the treatment. Results: After 16 weeks of treatment compared to baseline, HbA1c showed a significant difference of 0.94% compared to the atorvastatin group in the combination group (0.35% vs. -0.58%, respectively; P< 0.0001), whereas the proportion of patients with increased HbA1c was also 62% and 15%, respectively, showing a significant difference (P< 0.001). The combination group also showed a significant decrease in LDL-C levels compared to the metformin group (-55.20% vs. -7.69%, P<0.001) without previously unknown adverse drug events. Conclusion: The addition of atorvastatin to metformin improved HbA1c and LDL-C levels to a significant extent compared to metformin or atorvastatin alone in diabetes and dyslipidemia patients. This study also suggested metformin's preventive effect on the glucose-elevating potential of atorvastatin in patients with type 2 diabetes mellitus and dyslipidemia, insufficiently controlled with exercise and diet. Metformin and atorvastatin combination might be an effective treatment in reducing the CVD risk in patients with both diabetes and dyslipidemia because of its lowering effect on LDL-C and glucose.

引用

页码：730 / 739

页数：14

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