The effect of EMPAgliflozin on markers of inflammation in patients with concomitant type 2 diabetes mellitus and Coronary ARtery Disease: the EMPA-CARD randomized controlled trial
Abstract Systemic inflammation and oxidative burden in patients with type 2 diabetes mellitus (T2DM) causes deleterious cardiovascular outcomes. We sought to investigate the clinical antioxidative and anti-inflammatory effects of empagliflozin. Platelet function, oxidant and antioxidant biomarkers a...
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| Format: | Article |
| Language: | English |
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BMC
2022-11-01
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| Series: | Diabetology & Metabolic Syndrome |
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| Online Access: | https://doi.org/10.1186/s13098-022-00951-5 |
| _version_ | 1828296989313335296 |
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| author | Sepehr Gohari Tara Reshadmanesh Hadi Khodabandehloo Amir Karbalaee-Hasani Hassan Ahangar Shahram Arsang-Jang Faramarz Ismail-Beigi Mohsen Dadashi Samin Ghanbari Homa Taheri Mojtaba Fathi Muhammad Javad Muhammadi Reyhaneh Mahmoodian Atieh Asgari Mohammadreza Tayaranian Mehdi Moharrami Mahsa Mahjani Bijan Ghobadian Hossein Chiti Sheida Gohari |
| author_facet | Sepehr Gohari Tara Reshadmanesh Hadi Khodabandehloo Amir Karbalaee-Hasani Hassan Ahangar Shahram Arsang-Jang Faramarz Ismail-Beigi Mohsen Dadashi Samin Ghanbari Homa Taheri Mojtaba Fathi Muhammad Javad Muhammadi Reyhaneh Mahmoodian Atieh Asgari Mohammadreza Tayaranian Mehdi Moharrami Mahsa Mahjani Bijan Ghobadian Hossein Chiti Sheida Gohari |
| author_sort | Sepehr Gohari |
| collection | DOAJ |
| description | Abstract Systemic inflammation and oxidative burden in patients with type 2 diabetes mellitus (T2DM) causes deleterious cardiovascular outcomes. We sought to investigate the clinical antioxidative and anti-inflammatory effects of empagliflozin. Platelet function, oxidant and antioxidant biomarkers and pro-inflammatory agents at baseline and at 26 weeks were measured. A total of 95 patients (41.05% male, mean age 62.85 ± 7.91 years, mean HbA1c 7.89 ± 0.96%) with concomitant T2DM and coronary artery disease (CAD) were randomized (1:1) to receive empagliflozin (10 mg/daily) or placebo. Patients treated with empagliflozin had lower levels of interleukin 6 (IL-6) (adjusted difference (adiff): − 1.06 pg/mL, 95% CI − 1.80; − 0.32, P = 0.006), interleukin 1β (IL-1β) and high-sensitive C-reactive protein (Hs-CRP) (adiff: − 4.58 pg/mL and − 2.86 mg/L; P = 0.32 and 0.003, respectively) compared to placebo. There were elevations in super oxidase dismutase (SOD) activity, glutathione (GSHr), and total antioxidant capacity (TAC) with empagliflozin (adiff: 3.7 U/mL, 0.57 muM, and 124.08 mmol/L, 95% CI 1.36; 6.05, 0.19; 0.95, and 47.98; 200.18, P = 0.002, 0.004, and 0.002, respectively). While reactive oxygen species (ROS) improved significantly (adiff: − 342.51, 95% CI − 474.23; − 210.79, P < 0.001), the changes in catalase activity (CAT), malondialdehyde (MDA), or protein carbonyl groups (PCG) were not significant. Moreover, the P-selectin antigen expression on platelet surface was significantly reduced (adiff: − 8.81, 95% CI − 14.87; − 2.75, P = 0.005). Markers of glycemic status (fasting blood glucose, HbA1c, and HOMA-IR (homeostatic model assessment for insulin resistance) significantly improved (P < 0.001). Among patients with T2DM and CAD, 6-month treatment with empagliflozin can mitigate inflammation, platelet activity and oxidative stress and is associated with clinical cardiovascular benefits. Trial Registration Iranian Registry of Clinical Trials. www.IRCT.ir , Identifier: IRCT20190412043247N2. Registration Date: 6/13/2020. Registration timing: prospective |
| first_indexed | 2024-04-13T12:19:10Z |
| format | Article |
| id | doaj.art-42647a0c8a95477299835ce4e60fe0df |
| institution | Directory Open Access Journal |
| issn | 1758-5996 |
| language | English |
| last_indexed | 2024-04-13T12:19:10Z |
| publishDate | 2022-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Diabetology & Metabolic Syndrome |
| spelling | doaj.art-42647a0c8a95477299835ce4e60fe0df2022-12-22T02:47:15ZengBMCDiabetology & Metabolic Syndrome1758-59962022-11-0114111310.1186/s13098-022-00951-5The effect of EMPAgliflozin on markers of inflammation in patients with concomitant type 2 diabetes mellitus and Coronary ARtery Disease: the EMPA-CARD randomized controlled trialSepehr Gohari0Tara Reshadmanesh1Hadi Khodabandehloo2Amir Karbalaee-Hasani3Hassan Ahangar4Shahram Arsang-Jang5Faramarz Ismail-Beigi6Mohsen Dadashi7Samin Ghanbari8Homa Taheri9Mojtaba Fathi10Muhammad Javad Muhammadi11Reyhaneh Mahmoodian12Atieh Asgari13Mohammadreza Tayaranian14Mehdi Moharrami15Mahsa Mahjani16Bijan Ghobadian17Hossein Chiti18Sheida Gohari19Student Research Center, School of Medicine, Zanjan University of Medical SciencesStudent Research Center, School of Medicine, Zanjan University of Medical SciencesDepartment of Clinical Biochemistry, School of Medicine, Zanjan University of Medical SciencesDepartment of Clinical Biochemistry, School of Medicine, Zanjan University of Medical SciencesDepartment of Cardiology, School of Medicine, Mousavi Hospital, Zanjan University of Medical SciencesDepartment of Biostatistics, School of Medicine, Zanjan University of Medical SciencesDepartment of Medicine, Case Western Reserve University, University Hospitals Cleveland Medical CenterDepartment of Cardiology, School of Medicine, Mousavi Hospital, Zanjan University of Medical SciencesDepartment of Cardiology, School of Medicine, Mousavi Hospital, Zanjan University of Medical SciencesDepartment of Cardiology, School of Medicine, Mousavi Hospital, Zanjan University of Medical SciencesDepartment of Clinical Biochemistry, School of Medicine, Zanjan University of Medical SciencesStudent Research Center, School of Medicine, Zanjan University of Medical SciencesEndocrinology and Metabolism Center, Department of Internal Medicine, Imam Ali Hospital, Alborz University of Medical SciencesDepartment of Cardiology, School of Medicine, Mousavi Hospital, Zanjan University of Medical SciencesStudent Research Center, School of Medicine, Zanjan University of Medical SciencesStudent Research Center, School of Medicine, Zanjan University of Medical SciencesDepartment of Family Medicine, Alborz University of Medical ScienceEndocrinology and Metabolism Research Centre, School of Medicine, Vali-e-Asr Hospital, Zanjan University of Medical SciencesEndocrinology and Metabolism Research Centre, School of Medicine, Vali-e-Asr Hospital, Zanjan University of Medical SciencesDepartment of Systems Science and Industrial Engineering, State University of New York at BinghamtonAbstract Systemic inflammation and oxidative burden in patients with type 2 diabetes mellitus (T2DM) causes deleterious cardiovascular outcomes. We sought to investigate the clinical antioxidative and anti-inflammatory effects of empagliflozin. Platelet function, oxidant and antioxidant biomarkers and pro-inflammatory agents at baseline and at 26 weeks were measured. A total of 95 patients (41.05% male, mean age 62.85 ± 7.91 years, mean HbA1c 7.89 ± 0.96%) with concomitant T2DM and coronary artery disease (CAD) were randomized (1:1) to receive empagliflozin (10 mg/daily) or placebo. Patients treated with empagliflozin had lower levels of interleukin 6 (IL-6) (adjusted difference (adiff): − 1.06 pg/mL, 95% CI − 1.80; − 0.32, P = 0.006), interleukin 1β (IL-1β) and high-sensitive C-reactive protein (Hs-CRP) (adiff: − 4.58 pg/mL and − 2.86 mg/L; P = 0.32 and 0.003, respectively) compared to placebo. There were elevations in super oxidase dismutase (SOD) activity, glutathione (GSHr), and total antioxidant capacity (TAC) with empagliflozin (adiff: 3.7 U/mL, 0.57 muM, and 124.08 mmol/L, 95% CI 1.36; 6.05, 0.19; 0.95, and 47.98; 200.18, P = 0.002, 0.004, and 0.002, respectively). While reactive oxygen species (ROS) improved significantly (adiff: − 342.51, 95% CI − 474.23; − 210.79, P < 0.001), the changes in catalase activity (CAT), malondialdehyde (MDA), or protein carbonyl groups (PCG) were not significant. Moreover, the P-selectin antigen expression on platelet surface was significantly reduced (adiff: − 8.81, 95% CI − 14.87; − 2.75, P = 0.005). Markers of glycemic status (fasting blood glucose, HbA1c, and HOMA-IR (homeostatic model assessment for insulin resistance) significantly improved (P < 0.001). Among patients with T2DM and CAD, 6-month treatment with empagliflozin can mitigate inflammation, platelet activity and oxidative stress and is associated with clinical cardiovascular benefits. Trial Registration Iranian Registry of Clinical Trials. www.IRCT.ir , Identifier: IRCT20190412043247N2. Registration Date: 6/13/2020. Registration timing: prospectivehttps://doi.org/10.1186/s13098-022-00951-5SGLT2 inhibitorEmpagliflozinRandomized controlled trialCoronary artery diseaseInflammationType 2 diabetes mellitus |
| spellingShingle | Sepehr Gohari Tara Reshadmanesh Hadi Khodabandehloo Amir Karbalaee-Hasani Hassan Ahangar Shahram Arsang-Jang Faramarz Ismail-Beigi Mohsen Dadashi Samin Ghanbari Homa Taheri Mojtaba Fathi Muhammad Javad Muhammadi Reyhaneh Mahmoodian Atieh Asgari Mohammadreza Tayaranian Mehdi Moharrami Mahsa Mahjani Bijan Ghobadian Hossein Chiti Sheida Gohari The effect of EMPAgliflozin on markers of inflammation in patients with concomitant type 2 diabetes mellitus and Coronary ARtery Disease: the EMPA-CARD randomized controlled trial Diabetology & Metabolic Syndrome SGLT2 inhibitor Empagliflozin Randomized controlled trial Coronary artery disease Inflammation Type 2 diabetes mellitus |
| title | The effect of EMPAgliflozin on markers of inflammation in patients with concomitant type 2 diabetes mellitus and Coronary ARtery Disease: the EMPA-CARD randomized controlled trial |
| title_full | The effect of EMPAgliflozin on markers of inflammation in patients with concomitant type 2 diabetes mellitus and Coronary ARtery Disease: the EMPA-CARD randomized controlled trial |
| title_fullStr | The effect of EMPAgliflozin on markers of inflammation in patients with concomitant type 2 diabetes mellitus and Coronary ARtery Disease: the EMPA-CARD randomized controlled trial |
| title_full_unstemmed | The effect of EMPAgliflozin on markers of inflammation in patients with concomitant type 2 diabetes mellitus and Coronary ARtery Disease: the EMPA-CARD randomized controlled trial |
| title_short | The effect of EMPAgliflozin on markers of inflammation in patients with concomitant type 2 diabetes mellitus and Coronary ARtery Disease: the EMPA-CARD randomized controlled trial |
| title_sort | effect of empagliflozin on markers of inflammation in patients with concomitant type 2 diabetes mellitus and coronary artery disease the empa card randomized controlled trial |
| topic | SGLT2 inhibitor Empagliflozin Randomized controlled trial Coronary artery disease Inflammation Type 2 diabetes mellitus |
| url | https://doi.org/10.1186/s13098-022-00951-5 |
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