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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
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
Received March 8, 2023  Accepted June 28, 2023  Published online May 20, 2024  
DOI: https://doi.org/10.4093/dmj.2023.0077    [Epub ahead of print]
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AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
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.
Drug/Regimen
Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Ji Eun Jun, In-Kyung Jeong, Jae Myung Yu, Sung Rae Kim, In Kye Lee, Kyung-Ah Han, Sung Hee Choi, Soo-Kyung Kim, Hyeong Kyu Park, Ji-Oh Mok, Yong-ho Lee, Hyuk-Sang Kwon, So Hun Kim, Ho-Cheol Kang, Sang Ah Lee, Chang Beom Lee, Kyung Mook Choi, Sung-Ho Her, Won Yong Shin, Mi-Seung Shin, Hyo-Suk Ahn, Seung Ho Kang, Jin-Man Cho, Sang-Ho Jo, Tae-Joon Cha, Seok Yeon Kim, Kyung Heon Won, Dong-Bin Kim, Jae Hyuk Lee, Moon-Kyu Lee
Diabetes Metab J. 2020;44(1):78-90.   Published online June 20, 2019
DOI: https://doi.org/10.4093/dmj.2018.0265
  • 9,821 View
  • 192 Download
  • 7 Web of Science
  • 8 Crossref
AbstractAbstract PDFSupplementary MaterialPubReader   
Background

Cardiovascular risk remains increased despite optimal low density lipoprotein cholesterol (LDL-C) level induced by intensive statin therapy. Therefore, recent guidelines recommend non-high density lipoprotein cholesterol (non-HDL-C) as a secondary target for preventing cardiovascular events. The aim of this study was to assess the efficacy and tolerability of omega-3 fatty acids (OM3-FAs) in combination with atorvastatin compared to atorvastatin alone in patients with mixed dyslipidemia.

Methods

This randomized, double-blind, placebo-controlled, parallel-group, and phase III multicenter study included adults with fasting triglyceride (TG) levels ≥200 and <500 mg/dL and LDL-C levels <110 mg/dL. Eligible subjects were randomized to ATOMEGA (OM3-FAs 4,000 mg plus atorvastatin calcium 20 mg) or atorvastatin 20 mg plus placebo groups. The primary efficacy endpoints were the percent changes in TG and non-HDL-C levels from baseline at the end of treatment.

Results

After 8 weeks of treatment, the percent changes from baseline in TG (−29.8% vs. 3.6%, P<0.001) and non-HDL-C (−10.1% vs. 4.9%, P<0.001) levels were significantly greater in the ATOMEGA group (n=97) than in the atorvastatin group (n=103). Moreover, the proportion of total subjects reaching TG target of <200 mg/dL in the ATOMEGA group was significantly higher than that in the atorvastatin group (62.9% vs. 22.3%, P<0.001). The incidence of adverse events did not differ between the two groups.

Conclusion

The addition of OM3-FAs to atorvastatin improved TG and non-HDL-C levels to a significant extent compared to atorvastatin alone in subjects with residual hypertriglyceridemia.

Citations

Citations to this article as recorded by  
  • Current trends in solving the problem of residual cardiovascular risk
    N. Yu. Obedkova, A. A. Guslyakova, G. S. Mal, E. G. Obedkov
    Meditsinskiy sovet = Medical Council.2024; (6): 155.     CrossRef
  • Association Between Omega‐3 Fatty Acid Intake and Dyslipidemia: A Continuous Dose–Response Meta‐Analysis of Randomized Controlled Trials
    Tianjiao Wang, Xin Zhang, Na Zhou, Yuxuan Shen, Biao Li, Bingshu E. Chen, Xinzhi Li
    Journal of the American Heart Association.2023;[Epub]     CrossRef
  • Nutraceutical support in the prevention and treatment of cardiovascular diseases
    E. V. Gracheva, E. A. Starovoytova, E. S. Kulikov, N. A. Kirillova, S. V. Fedosenko, M. A. Balaganskaya, D. V. Kromka
    Rational Pharmacotherapy in Cardiology.2023; 19(3): 298.     CrossRef
  • Effect of coadministration of omega-3 fatty acids with glimepiride on glycemic control, lipid profile, irisin, and sirtuin-1 in type 2 diabetes mellitus patients: a randomized controlled trial
    Rehab H. Werida, Aalaa Ramzy, Youssri Nassief Ebrahim, Maged Wasfy Helmy
    BMC Endocrine Disorders.2023;[Epub]     CrossRef
  • The Effect of Dietary Interventions on Hypertriglyceridemia: From Public Health to Molecular Nutrition Evidence
    Karla Paulina Luna-Castillo, Xochitl Citlalli Olivares-Ochoa, Rocío Guadalupe Hernández-Ruiz, Iris Monserrat Llamas-Covarrubias, Saraí Citlalic Rodríguez-Reyes, Alejandra Betancourt-Núñez, Barbara Vizmanos, Erika Martínez-López, José Francisco Muñoz-Valle
    Nutrients.2022; 14(5): 1104.     CrossRef
  • The effect of omega-3 fatty acids and its combination with statins on lipid profile in patients with hypertriglyceridemia: A systematic review and meta-analysis of randomized controlled trials
    Yunjiao Yang, Wen Deng, Yanmei Wang, Tongyi Li, Yiding Chen, Cong Long, Qing Wen, Yue Wu, Qiu Chen
    Frontiers in Nutrition.2022;[Epub]     CrossRef
  • Comparison of the Efficacy and Safety of Atorvastatin 40 mg/ω-3 Fatty Acids 4 g Fixed-dose Combination and Atorvastatin 40 mg Monotherapy in Hypertriglyceridemic Patients who Poorly Respond to Atorvastatin 40 mg Monotherapy: An 8-week, Multicenter, Random
    Jong Shin Woo, Soon Jun Hong, Dong Hoon Cha, Kee Sik Kim, Moo Hyun Kim, Jun-Won Lee, Myung Ho Jeong, Jin-Ok Jeong, Jun-Hee Lee, Doo Soo Jeon, Eun Joo Cho, Soon Kil Kim, Jun Kwan, Chang Gyu Park, Hae Young Lee, Taek Jong Hong, Jinho Shin, Ho Joong Youn, Do
    Clinical Therapeutics.2021; 43(8): 1419.     CrossRef
  • All-Cause Mortality and Cardiovascular Death between Statins and Omega-3 Supplementation: A Meta-Analysis and Network Meta-Analysis from 55 Randomized Controlled Trials
    Jeongseon Kim, Tung Hoang, Ji-Myung Kim, So Young Bu, Jeong-Hwa Choi, Eunju Park, Seung-Min Lee, Eunmi Park, Ji Yeon Min, In Seok Lee, So Young Youn, Jee-Young Yeon
    Nutrients.2020; 12(10): 3203.     CrossRef
Others
Effect of Atorvastatin on Growth Differentiation Factor-15 in Patients with Type 2 Diabetes Mellitus and Dyslipidemia
Ji Min Kim, Min Kyung Back, Hyon-Seung Yi, Kyong Hye Joung, Hyun Jin Kim, Bon Jeong Ku
Diabetes Metab J. 2016;40(1):70-78.   Published online February 19, 2016
DOI: https://doi.org/10.4093/dmj.2016.40.1.70
  • 4,335 View
  • 33 Download
  • 5 Web of Science
  • 5 Crossref
AbstractAbstract PDFPubReader   
Background

Elevated serum levels of growth differentiation factor-15 (GDF-15) are associated with type 2 diabetes. Therefore, the effects of atorvastatin on metabolic parameters and GDF-15 levels in patients with type 2 diabetes and dyslipidemia were evaluated.

Methods

In this prospective randomized trial from February 2013 to March 2014, 50 consecutive type 2 diabetic patients with a low density lipoprotein cholesterol (LDL-C) levels ≥100 mg/dL were enrolled. The patients were divided into two groups based on the amount of atorvastatin prescribed, 10 mg/day (n=23) or 40 mg/day (n=27). The effect of atorvastatin on metabolic parameters, including lipid profiles and GDF-15 levels, at baseline and after 8 weeks of treatment were compared.

Results

The baseline metabolic parameters and GDF-15 levels were not significantly different between the two groups. After 8 weeks of treatment, the total cholesterol (TC) and LDL-C levels were significantly decreased in both groups. The mean changes in TC and LDL-C levels were more significant in the 40 mg atorvastatin group. The GDF-15 level was decreased in the 10 mg atorvastatin group, from 1,460.6±874.8 to 1,451.0±770.8 pg/mL, and was increased in the 40 mg atorvastatin group, from 1,271.6±801.0 to 1,341.4±855.2 pg/mL. However, the change in the GDF-15 level was not statistically significant in the 10 or 40 mg atorvastatin group (P=0.665 and P=0.745, respectively).

Conclusion

The GDF-15 levels were not significantly changed after an 8-week treatment with atorvastatin in type 2 diabetic patients.

Citations

Citations to this article as recorded by  
  • The relationship of Growth differentiation factor-15 with renal damage and dyslipidemia in non-albuminuric and albuminuric Type-2 Diabetes Mellitus
    Hasan Esat Yücel, Bilal İlanbey
    Medical Science and Discovery.2022; 9(6): 334.     CrossRef
  • Comparative effectiveness of statins on non-high density lipoprotein cholesterol in people with diabetes and at risk of cardiovascular disease: systematic review and network meta-analysis
    Alexander Hodkinson, Dialechti Tsimpida, Evangelos Kontopantelis, Martin K Rutter, Mamas A Mamas, Maria Panagioti
    BMJ.2022; : e067731.     CrossRef
  • The Cytokine Growth Differentiation Factor-15 and Skeletal Muscle Health: Portrait of an Emerging Widely Applicable Disease Biomarker
    Boel De Paepe
    International Journal of Molecular Sciences.2022; 23(21): 13180.     CrossRef
  • Biomarkers of subclinical atherosclerosis in patients with psoriasis
    Hannah Kaiser, Xing Wang, Amanda Kvist-Hansen, Martin Krakauer, Peter Michael Gørtz, Benjamin D. McCauley, Lone Skov, Christine Becker, Peter Riis Hansen
    Scientific Reports.2021;[Epub]     CrossRef
  • Growth differentiation factor-15 regulates oxLDL-induced lipid homeostasis and autophagy in human macrophages
    Kathrin Ackermann, Gabriel A. Bonaterra, Ralf Kinscherf, Anja Schwarz
    Atherosclerosis.2019; 281: 128.     CrossRef
A Retrospective Study on the Efficacy of a Ten-Milligram Dosage of Atorvastatin for Treatment of Hypercholesterolemia in Type 2 Diabetes Mellitus Patients
Dong Kyun Kim, Sa Rah Lee, Min Sik Kim, Suk Hyang Bae, Jin Yeon Hwang, Jung-Min Kim, Sung Hwan Suh, Hye-Jeong Lee, Mi Kyoung Park, Duk Kyu Kim
Korean Diabetes J. 2010;34(6):359-367.   Published online December 31, 2010
DOI: https://doi.org/10.4093/kdj.2010.34.6.359
  • 5,178 View
  • 25 Download
  • 3 Crossref
AbstractAbstract PDFPubReader   
Background

There have been few clinical studies on 10 mg atorvastatin as a starting dosage for treatment of hypercholesterolemia in type 2 diabetes mellitus (T2DM) patients. This retrospective study aims to evaluate the efficacy of 10 mg dosage of atorvastatin in clinical setting.

Methods

One hundred five enrolled patients with high levels of low density lipoprotein cholesterol (LDL-C, > 100 mg/dL) took 10 mg atorvastatin. After 6 months, they were divided into 'Responder group' (LDL-C < 100 mg/dL) and 'Non-responder group' (LDL-C ≥ 100 mg/dL), and the response rate was calculated. Thereafter, we subdivided the 'Responder group' into Maintenance (10 mg), Reduced dosage (5 mg), and Discontinuance group (0 mg). The 'Non-Responder group' was subdivided into Maintenance (10 mg) and Double dosage group (20 mg). After consecutive 6 months, the response rates of each 10 mg Maintenance groups were compared to those of the other groups, respectively.

Results

Following the first 6 months, the response rate of 10 mg fixed dosage was 74.3%. In the 'Responder group', response rates of 10 mg, 5 mg and Discontinuance groups following 6 months were 52.6%, 53.1%, and 12.5%, respectively. In the 'Non-responder group', response rates of 10 mg and 20 mg groups were 28.6% and 50.0%. Baseline LDL-C levels and body mass index (BMI) of 'Responder group' were significantly lower than those of 'Non-responder group' (P = 0.004, respectively).

Conclusion

Hypercholesterolemia treatment with 10 mg, fixed dosage of atorvastatin was effective in three quarters of the subjects during the first 6-month treatment; however, a significant number of patients with high LDL-C levels and/or BMI require higher starting and maintenance dosage.

Citations

Citations to this article as recorded by  
  • Preparation and Release Behavior of Atorvastatin Calcuim - Encapsulated Polyoxalate Microspheres
    Cheon Jung Lee, Su Young Kim, Hyun Gu Lee, Jaewon Yang, Jin Young Park, Se Rom Cha, Dong-Kwon Lim, Dongwon Lee, Gilson Khang
    Polymer Korea.2014; 38(5): 656.     CrossRef
  • A Retrospective Study on the Efficacy of a Ten-Milligram Dosage of Atorvastatin for Treatment of Hypercholesterolemia in Type 2 Diabetes Mellitus Patients (Korean Diabetes J 2010;34:359-67)
    Eun-Jung Rhee
    Diabetes & Metabolism Journal.2011; 35(1): 86.     CrossRef
  • Response: A Retrospective Study on the Efficacy of a Ten-Milligram Dosage of Atorvastatin for Treatment of Hypercholesterolemia in Type 2 Diabetes Mellitus Patients (Korean Diabetes J 2010;34:359-67)
    Dong Kyun Kim, Sa Rah Lee, Min Sik Kim, Suk Hyang Bae, Jin Yeon Hwang, Jung-Min Kim, Sung Hwan Suh, Hye-Jeong Lee, Mi Kyoung Park, Duk Kyu Kim
    Diabetes & Metabolism Journal.2011; 35(1): 88.     CrossRef
Efficacy Evaluation of Atorvastatin in Korean Hyperlipidemic Patients with Type 2 Diabetes Mellitus.
Dong Seop Choi, Duk Kyu Kim, Doo Man Kim, Seong Yeon Kim, Moon Suk Nam, Yong Soo Park, Ho Sang Shon, Chul Woo Ahn, Kwan Woo Lee, Ki Up Lee, Moon Kyu Lee, Choon Hee Chung, Bong Yeon Cha
Korean Diabetes J. 2006;30(4):292-302.   Published online July 1, 2006
DOI: https://doi.org/10.4093/jkda.2006.30.4.292
  • 2,167 View
  • 20 Download
  • 3 Crossref
AbstractAbstract PDF
BACKGROUND
NCEP ATP III Guideline recommends aggressive treatments of diabetic dyslipidemia, recognizing diabetes mellitus as CHD risk equivalents. This study was conducted to evaluate the effectiveness and safety of atorvastatin in hyperlipidemic patients with Type 2 diabetes mellitus through post-marketing drug use investigation of atorvastatin. METHODS: An open, multi-center, non-comparison, titrated dosage study was conducted in hyperlipidemic patients, who were treated with atorvastatin at first visiting hospitals from Mar. 2004 to Sep. 2004. 96 endocrinologists participated from 66 centers in this study. Total 2,182 hyperlipidemic patients were enrolled and 1,514 patients among them were accompanied by diabetes mellitus. Efficacy was evaluated at later than 4-week treatment by % change of total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol from baseline. Percent of patients reaching LDL-cholesterol level less than 100 mg/dL was also analyzed. The adverse events incidence and abnormalities of clinical laboratory values were evaluated for safety monitoring. RESULTS: Total cholesterol, triglycerides, and LDL-cholesterol level were reduced by 26.6%, 12.0%, and 34.8%, respectively, in diabetic hyperlipidemic patients after atorvastatin treatment. The patients with LDL-cholesterol level of less than 100 mg/dL were increased from 2.8% to 52.6%. Atorvastatin was considered to be safe because adverse drug reactions were reported in 32 patients (1.5%) of total 2,182 patients. CONCLUSION: Atorvastatin was effective and safe in hyperlipidemic patients with type 2 diabetes mellitus.

Citations

Citations to this article as recorded by  
  • Response: A Retrospective Study on the Efficacy of a Ten-Milligram Dosage of Atorvastatin for Treatment of Hypercholesterolemia in Type 2 Diabetes Mellitus Patients (Korean Diabetes J 2010;34:359-67)
    Dong Kyun Kim, Sa Rah Lee, Min Sik Kim, Suk Hyang Bae, Jin Yeon Hwang, Jung-Min Kim, Sung Hwan Suh, Hye-Jeong Lee, Mi Kyoung Park, Duk Kyu Kim
    Diabetes & Metabolism Journal.2011; 35(1): 88.     CrossRef
  • A Retrospective Study on the Efficacy of a Ten-Milligram Dosage of Atorvastatin for Treatment of Hypercholesterolemia in Type 2 Diabetes Mellitus Patients
    Dong Kyun Kim, Sa Rah Lee, Min Sik Kim, Suk Hyang Bae, Jin Yeon Hwang, Jung-Min Kim, Sung Hwan Suh, Hye-Jeong Lee, Mi Kyoung Park, Duk Kyu Kim
    Korean Diabetes Journal.2010; 34(6): 359.     CrossRef
  • The Association of Plasma HDL-Cholesterol Level with Cardiovascular Disease Related Factors in Korean Type 2 Diabetic Patients
    Hye Sook Hong, Jong Suk Park, Han Kyoung Ryu, Wha Young Kim
    Korean Diabetes Journal.2008; 32(3): 215.     CrossRef

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