- Drug/Regimen
- 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
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Jie-Eun Lee, Seung Hee Yu, Sung Rae Kim, Kyu Jeung Ahn, Kee-Ho Song, In-Kyu Lee, Ho-Sang Shon, In Joo Kim, Soo Lim, Doo-Man Kim, Choon Hee Chung, Won-Young Lee, Soon Hee Lee, Dong Joon Kim, Sung-Rae Cho, Chang Hee Jung, Hyun Jeong Jeon, Seung-Hwan Lee, Keun-Young Park, Sang Youl Rhee, Sin Gon Kim, Seok O Park, Dae Jung Kim, Byung Joon Kim, Sang Ah Lee, Yong-Hyun Kim, Kyung-Soo Kim, Ji A Seo, Il Seong Nam-Goong, Chang Won Lee, Duk Kyu Kim, Sang Wook Kim, Chung Gu Cho, Jung Han Kim, Yeo-Joo Kim, Jae-Myung Yoo, Kyung Wan Min, Moon-Kyu Lee
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Diabetes Metab J. 2024;48(4):730-739. Published online May 20, 2024
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DOI: https://doi.org/10.4093/dmj.2023.0077
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- 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.
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Citations
Citations to this article as recorded by  - Real-world safety evaluation of atorvastatin: insights from the US FDA adverse event reporting system (FAERS)
Hongbing Wan, Xiuxiu Xu, Dasong Yi, Kexin Shuai
Expert Opinion on Drug Safety.2025; 24(3): 305. CrossRef - Exploration of metformin-based drug combination for mitigating diabetes-associated atherosclerotic diseases
Biao Qu, Zheng Li, Wei Hu
World Journal of Diabetes.2025;[Epub] CrossRef
- Pathophysiology
- Immune-Checkpoint Inhibitors-Induced Type 1 Diabetes Mellitus: From Its Molecular Mechanisms to Clinical Practice
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Yun Kyung Cho, Chang Hee Jung
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Diabetes Metab J. 2023;47(6):757-766. Published online July 24, 2023
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DOI: https://doi.org/10.4093/dmj.2023.0072
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6,749
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Abstract
PDFPubReader ePub
- With the increasing use of immune-checkpoint inhibitors (ICIs), such as anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and anti-programmed cell death-1 (PD-1), for the treatment of malignancies, cases of ICI-induced type 1 diabetes mellitus (ICI-T1DM) have been reported globally. This review focuses on the features and pathogenesis of this disease. T1DM is an immune-related adverse event that occurs following the administration of anti-PD-1 or anti-programmed death ligand-1 (PDL1) alone or in combination with anti-CTLA-4. More than half of the reported cases presented as abrupt-onset diabetic ketoacidosis. The primary mechanism of ICI-T1DM is T-cell stimulation, which results from the loss of interaction between PD-1 and PD-L1 in pancreatic islet. The similarities and differences between ICI-T1DM and classical T1DM may provide insights into this disease entity. ICI-T1DM is a rare but often life-threatening medical emergency that healthcare professionals and patients need to be aware of. Early detection of and screening for this disease is imperative. At present, the only known treatment for ICI-T1DM is insulin injection. Further research into the mechanisms and risk factors associated with ICI-T1DM development may contribute to a better understanding of this disease entity and the identification of possible preventive strategies.
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Citations
Citations to this article as recorded by - Diabetic ketoacidosis and hyperglycaemic hyperosmolar syndrome in patients with cancer: A multicentre study
Rabia K. Shahid, Qasem Haider, Sunil Yadav, Duc Le, Shahid Ahmed
Clinical Medicine.2025; 25(1): 100262. CrossRef - Immune checkpoint inhibitor‐related type 1 diabetes incidence, risk, and survival association
Fumika Kamitani, Yuichi Nishioka, Miyuki Koizumi, Hiroki Nakajima, Yukako Kurematsu, Sadanori Okada, Shinichiro Kubo, Tomoya Myojin, Tatsuya Noda, Tomoaki Imamura, Yutaka Takahashi
Journal of Diabetes Investigation.2025; 16(2): 334. CrossRef - Management of Immunotherapy-Induced Type 1 Diabetes
Veronica Brady
Critical Care Nursing Clinics of North America.2025; 37(1): 93. CrossRef - Type I Diabetes—A Rare Adverse Event Described in Patients Receiving Immunotherapy Versus a Side Effect from SARS-CoV-2 Infection
Raluca-Ileana Pătru, Miruna Ghigeanu, Maria-Alexandra Barbu, Andreea Iuliana Ionescu, Antone-Iordache Ionuț-Lucian
Reports.2025; 8(1): 31. CrossRef - Research Advances of Immune Checkpoint Inhibitors Related Endocrine Adverse Events
晶晶 王
Advances in Clinical Medicine.2024; 14(02): 2706. CrossRef - Immune checkpoint inhibitor‑associated diabetes mellitus in patients with HCC: Report of three cases and literature review
Gaocheng Wang, Jingjing Wang, Shuilin Dong, Zhanguo Zhang, Wanguang Zhang, Jianping Zhao
Experimental and Therapeutic Medicine.2024;[Epub] CrossRef - Type 1 diabetes: immune pathology and novel therapeutic approaches
Eleanor M. Ling, Joana R. N. Lemos, Khemraj Hirani, Matthias von Herrath
Diabetology International.2024; 15(4): 761. CrossRef - Pathophysiology, diagnosis, and management of immune checkpoint inhibitor-induced diabetes mellitus
Eleni-Rafaela Kani, Eleftheria Karaviti, Dimitra Karaviti, Eleni Gerontiti, Ioanna A. Paschou, Katerina Saltiki, Katerina Stefanaki, Theodora Psaltopoulou, Stavroula A. Paschou
Endocrine.2024; 87(3): 875. CrossRef - Use pembrolizumab may cause acute and severe adverse reactions: a case report and review
Linna Ouyang, Huixing Liu, Zhixiang Tang, Rui Wu, Yujie Zhong, Haibin Chen
International Journal of Surgery Oncology.2024; 9(3): 40. CrossRef - Pembrolizumab-Induced Insulin-Dependent Diabetes Mellitus in a Patient With Triple-Negative Breast Cancer: A Rare Immune-Related Adverse Event
Mirac Burak Tak, Zaid Munir, Ahmet Aydin
Cureus.2024;[Epub] CrossRef - Diabetes and the associated complications: The role of antioxidants in diabetes therapy and care
Lowell Dilworth, Dewayne Stennett, Aldeam Facey, Felix Omoruyi, Shada Mohansingh, Felix O. Omoruyi
Biomedicine & Pharmacotherapy.2024; 181: 117641. CrossRef - Fulminant type 1 diabetes mellitus: a neglected but high-risk adverse event associated with immune checkpoint inhibitors
Kelin Meng, Shengling Fu, Yaochen Huang, Wei Chen, Wenbin Zou
Expert Opinion on Drug Safety.2024; : 1. CrossRef - Fulminant Type 1 Diabetes Mellitus Leading to Diabetic Ketoacidosis and Mesenteric Ischemia With Necrosis Following Pembrolizumab Administration: A Case Report
Mayu Ueki, Takeshi Fukuda, Kenta Oue, Takuma Wada, Toshiyuki Sumi
Cureus.2024;[Epub] CrossRef
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