Empagliflozin does not change cardiac index nor systemic vascular resistance but rapidly improves left ventricular filling pressure in patients with type 2 diabetes: a randomized controlled study
BackgroundIn the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial) treatment with the sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin significantly reduced heart failure hospitalization (HHF) in patients with type 2 diabetes mellitus (T2D) and established cardi...
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| creator | Rau, Matthias Thiele, Kirsten Hartmann, Niels-Ulrik Korbinian Schuh, Alexander Altiok, Ertunc Moellmann, Julia Keszei, Andras P. Boehm, Michael Marx, Nikolaus Lehrke, Michael |
| description | BackgroundIn the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial) treatment with the sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin significantly reduced heart failure hospitalization (HHF) in patients with type 2 diabetes mellitus (T2D) and established cardiovascular disease. The early separation of the HHF event curves within the first 3 months of the trial suggest that immediate hemodynamic effects may play a role. However, hitherto no data exist on early effects of SGLT2 inhibitors on hemodynamic parameters and cardiac function. Thus, this study examined early and delayed effects of empagliflozin treatment on hemodynamic parameters including systemic vascular resistance index, cardiac index, and stroke volume index, as well as echocardiographic measures of cardiac function.MethodsIn this placebo-controlled, randomized, double blind, exploratory study patients with T2D were randomized to empagliflozin 10 mg or placebo for a period of 3 months. Hemodynamic and echocardiographic parameters were assessed after 1 day, 3 days and 3 months of treatment.ResultsBaseline characteristics were not different in the empagliflozin (n=22) and placebo (n=20) group. Empagliflozin led to a significant increase in urinary glucose excretion (baseline: 7.322.7 g/24 h; day 1: 48.434.7 g/24 h; p |
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The early separation of the HHF event curves within the first 3 months of the trial suggest that immediate hemodynamic effects may play a role. However, hitherto no data exist on early effects of SGLT2 inhibitors on hemodynamic parameters and cardiac function. Thus, this study examined early and delayed effects of empagliflozin treatment on hemodynamic parameters including systemic vascular resistance index, cardiac index, and stroke volume index, as well as echocardiographic measures of cardiac function.MethodsIn this placebo-controlled, randomized, double blind, exploratory study patients with T2D were randomized to empagliflozin 10 mg or placebo for a period of 3 months. Hemodynamic and echocardiographic parameters were assessed after 1 day, 3 days and 3 months of treatment.ResultsBaseline characteristics were not different in the empagliflozin (n=22) and placebo (n=20) group. Empagliflozin led to a significant increase in urinary glucose excretion (baseline: 7.322.7 g/24 h; day 1: 48.434.7 g/24 h; p<0.001) as well as urinary volume (1740<plus/minus>601 mL/24 h to 2112 +/- 837 mL/24 h; p=0.011) already after one day compared to placebo. Treatment with empagliflozin had no effect on the primary endpoint of systemic vascular resistance index, nor on cardiac index, stroke volume index or pulse rate at any time point. In addition, echocardiography showed no difference in left ventricular systolic function as assessed by left ventricular ejections fraction and strain analysis. However, empagliflozin significantly improved left ventricular filling pressure as assessed by a reduction of early mitral inflow velocity relative to early diastolic left ventricular relaxation (E/e') which became significant at day 1 of treatment (baseline: 9.2 +/- 2.6; day 1: 8.5 +/- 2.2; p=0.005) and remained apparent throughout the study. This was primarily attributable to reduced early mitral inflow velocity E (baseline: 0.8 +/- 0.2 m/s; day 1: 0.73 +/- 0.2 m/sec; p=0.003).Conclusions Empagliflozin treatment of patients with T2D has no significant effect on hemodynamic parameters after 1 or 3 days, nor after 3 months, but leads to rapid and sustained significant improvement of diastolic function. Trial registration EudraCT Number: 2016-000172-19; date of registration: 2017-02-20 (clinicaltrialregister.eu)</description><identifier>ISSN: 1475-2840</identifier><identifier>EISSN: 1475-2840</identifier><identifier>DOI: 10.1186/s12933-020-01175-5</identifier><identifier>PMID: 33413355</identifier><language>eng</language><publisher>LONDON: Springer Nature</publisher><subject>Analysis ; Blood pressure ; Cardiac & Cardiovascular Systems ; Cardiovascular diseases ; Cardiovascular System & Cardiology ; Care and treatment ; Clinical trials ; Congestive heart failure ; Dextrose ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Diabetes therapy ; Diastolic function ; Echocardiography ; Endocrinology & Metabolism ; Glucose ; Heart ; Heart failure ; Heart rate ; Hemodynamic parameters ; Hypertension ; Life Sciences & Biomedicine ; Medical research ; Medicine, Experimental ; Na+/glucose cotransporter ; Original Investigation ; Placebos ; Science & Technology ; SGLT2 inhibitors ; Standard deviation ; Type 2 diabetes ; Urine ; Variables ; Velocity ; Ventricle</subject><ispartof>Cardiovascular Diabetology, 2021-01, Vol.20 (1), p.6-6, Article 6</ispartof><rights>COPYRIGHT 2021 BioMed Central Ltd.</rights><rights>2021. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>47</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000608278200001</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c563t-cec50bf7ef4e8854196746545c3a3771a5d6714a321037574853628266fd97333</citedby><cites>FETCH-LOGICAL-c563t-cec50bf7ef4e8854196746545c3a3771a5d6714a321037574853628266fd97333</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7791833/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7791833/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,865,886,2103,2115,27929,27930,39263,53796,53798</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33413355$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rau, Matthias</creatorcontrib><creatorcontrib>Thiele, Kirsten</creatorcontrib><creatorcontrib>Hartmann, Niels-Ulrik Korbinian</creatorcontrib><creatorcontrib>Schuh, Alexander</creatorcontrib><creatorcontrib>Altiok, Ertunc</creatorcontrib><creatorcontrib>Moellmann, Julia</creatorcontrib><creatorcontrib>Keszei, Andras P.</creatorcontrib><creatorcontrib>Boehm, Michael</creatorcontrib><creatorcontrib>Marx, Nikolaus</creatorcontrib><creatorcontrib>Lehrke, Michael</creatorcontrib><title>Empagliflozin does not change cardiac index nor systemic vascular resistance but rapidly improves left ventricular filling pressure in patients with type 2 diabetes: a randomized controlled study</title><title>Cardiovascular Diabetology</title><addtitle>CARDIOVASC DIABETOL</addtitle><addtitle>Cardiovasc Diabetol</addtitle><description>BackgroundIn the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial) treatment with the sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin significantly reduced heart failure hospitalization (HHF) in patients with type 2 diabetes mellitus (T2D) and established cardiovascular disease. The early separation of the HHF event curves within the first 3 months of the trial suggest that immediate hemodynamic effects may play a role. However, hitherto no data exist on early effects of SGLT2 inhibitors on hemodynamic parameters and cardiac function. Thus, this study examined early and delayed effects of empagliflozin treatment on hemodynamic parameters including systemic vascular resistance index, cardiac index, and stroke volume index, as well as echocardiographic measures of cardiac function.MethodsIn this placebo-controlled, randomized, double blind, exploratory study patients with T2D were randomized to empagliflozin 10 mg or placebo for a period of 3 months. Hemodynamic and echocardiographic parameters were assessed after 1 day, 3 days and 3 months of treatment.ResultsBaseline characteristics were not different in the empagliflozin (n=22) and placebo (n=20) group. Empagliflozin led to a significant increase in urinary glucose excretion (baseline: 7.322.7 g/24 h; day 1: 48.434.7 g/24 h; p<0.001) as well as urinary volume (1740<plus/minus>601 mL/24 h to 2112 +/- 837 mL/24 h; p=0.011) already after one day compared to placebo. Treatment with empagliflozin had no effect on the primary endpoint of systemic vascular resistance index, nor on cardiac index, stroke volume index or pulse rate at any time point. In addition, echocardiography showed no difference in left ventricular systolic function as assessed by left ventricular ejections fraction and strain analysis. However, empagliflozin significantly improved left ventricular filling pressure as assessed by a reduction of early mitral inflow velocity relative to early diastolic left ventricular relaxation (E/e') which became significant at day 1 of treatment (baseline: 9.2 +/- 2.6; day 1: 8.5 +/- 2.2; p=0.005) and remained apparent throughout the study. This was primarily attributable to reduced early mitral inflow velocity E (baseline: 0.8 +/- 0.2 m/s; day 1: 0.73 +/- 0.2 m/sec; p=0.003).Conclusions Empagliflozin treatment of patients with T2D has no significant effect on hemodynamic parameters after 1 or 3 days, nor after 3 months, but leads to rapid and sustained significant improvement of diastolic function. Trial registration EudraCT Number: 2016-000172-19; date of registration: 2017-02-20 (clinicaltrialregister.eu)</description><subject>Analysis</subject><subject>Blood pressure</subject><subject>Cardiac & Cardiovascular Systems</subject><subject>Cardiovascular diseases</subject><subject>Cardiovascular System & Cardiology</subject><subject>Care and treatment</subject><subject>Clinical trials</subject><subject>Congestive heart failure</subject><subject>Dextrose</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes therapy</subject><subject>Diastolic function</subject><subject>Echocardiography</subject><subject>Endocrinology & Metabolism</subject><subject>Glucose</subject><subject>Heart</subject><subject>Heart failure</subject><subject>Heart rate</subject><subject>Hemodynamic parameters</subject><subject>Hypertension</subject><subject>Life Sciences & Biomedicine</subject><subject>Medical research</subject><subject>Medicine, Experimental</subject><subject>Na+/glucose cotransporter</subject><subject>Original Investigation</subject><subject>Placebos</subject><subject>Science & Technology</subject><subject>SGLT2 inhibitors</subject><subject>Standard deviation</subject><subject>Type 2 diabetes</subject><subject>Urine</subject><subject>Variables</subject><subject>Velocity</subject><subject>Ventricle</subject><issn>1475-2840</issn><issn>1475-2840</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>HGBXW</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>DOA</sourceid><recordid>eNqNks1u1DAUhSMEoqXwAiyQJTZIaIp_4p-wQKpGBSpVYgNry3Fupq4SO9jOlOnr8WJ4JqVqWaEscmWf813b91TVa4JPCVHiQyK0YWyFKV5hQiRf8SfVMalLQVWNnz6oj6oXKV1jTKQS5Hl1xFhNGOP8uPp9Pk5mM7h-CLfOoy5AQj5kZK-M3wCyJnbOWOR8B7_KRkRplzKMzqKtSXYeTEQRkkvZeAuonTOKZnLdsENunGLYFtwAfUZb8Dm6xdC7YXB-g6biTHOEQkeTya5IErpx-Qrl3QSIotK6hQzpIzIF67swulvokA2FFYahlCnP3e5l9aw3Q4JXd_-T6sfn8-_rr6vLb18u1meXK8sFyysLluO2l9DXoBSvSSNkLXjNLTNMSmJ4JySpDaMEM8llrTgTVFEh-q6RjLGT6mLhdsFc6ym60cSdDsbpw0KIG21idnYAXfqYvmXQlp51GVJDpTCk4w0o0QK0hfVpYU1zO0Jn989jhkfQxzveXelN2GopG6IOh3l3B4jh5wwp69ElC8NgPIQ5aVpLwQUVpCnSt_9Ir8McfXmqvUpJKhQlRXW6qDamXMD5PpS-tnzdftzBQxkb6DPBMW9E3ahioIvBxpBShP7-9ATrfUD1ElBdAqoPAdW8mN48vPe95W8ii0AtghtoQ59sSYWFexnGWGBFpaKlwmTtcslN8Osw-1ys7__fyv4AF9IGhA</recordid><startdate>20210107</startdate><enddate>20210107</enddate><creator>Rau, 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Kirsten ; Hartmann, Niels-Ulrik Korbinian ; Schuh, Alexander ; Altiok, Ertunc ; Moellmann, Julia ; Keszei, Andras P. ; Boehm, Michael ; Marx, Nikolaus ; Lehrke, Michael</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c563t-cec50bf7ef4e8854196746545c3a3771a5d6714a321037574853628266fd97333</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Analysis</topic><topic>Blood pressure</topic><topic>Cardiac & Cardiovascular Systems</topic><topic>Cardiovascular diseases</topic><topic>Cardiovascular System & Cardiology</topic><topic>Care and treatment</topic><topic>Clinical trials</topic><topic>Congestive heart failure</topic><topic>Dextrose</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes therapy</topic><topic>Diastolic function</topic><topic>Echocardiography</topic><topic>Endocrinology & Metabolism</topic><topic>Glucose</topic><topic>Heart</topic><topic>Heart failure</topic><topic>Heart rate</topic><topic>Hemodynamic parameters</topic><topic>Hypertension</topic><topic>Life Sciences & Biomedicine</topic><topic>Medical research</topic><topic>Medicine, Experimental</topic><topic>Na+/glucose cotransporter</topic><topic>Original Investigation</topic><topic>Placebos</topic><topic>Science & Technology</topic><topic>SGLT2 inhibitors</topic><topic>Standard deviation</topic><topic>Type 2 diabetes</topic><topic>Urine</topic><topic>Variables</topic><topic>Velocity</topic><topic>Ventricle</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rau, Matthias</creatorcontrib><creatorcontrib>Thiele, Kirsten</creatorcontrib><creatorcontrib>Hartmann, Niels-Ulrik Korbinian</creatorcontrib><creatorcontrib>Schuh, Alexander</creatorcontrib><creatorcontrib>Altiok, Ertunc</creatorcontrib><creatorcontrib>Moellmann, Julia</creatorcontrib><creatorcontrib>Keszei, Andras P.</creatorcontrib><creatorcontrib>Boehm, Michael</creatorcontrib><creatorcontrib>Marx, Nikolaus</creatorcontrib><creatorcontrib>Lehrke, Michael</creatorcontrib><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Web of Science - Science Citation Index Expanded - 2021</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale Academic OneFile</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Cardiovascular Diabetology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rau, Matthias</au><au>Thiele, Kirsten</au><au>Hartmann, Niels-Ulrik Korbinian</au><au>Schuh, Alexander</au><au>Altiok, Ertunc</au><au>Moellmann, Julia</au><au>Keszei, Andras P.</au><au>Boehm, Michael</au><au>Marx, Nikolaus</au><au>Lehrke, Michael</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Empagliflozin does not change cardiac index nor systemic vascular resistance but rapidly improves left ventricular filling pressure in patients with type 2 diabetes: a randomized controlled study</atitle><jtitle>Cardiovascular Diabetology</jtitle><stitle>CARDIOVASC DIABETOL</stitle><addtitle>Cardiovasc Diabetol</addtitle><date>2021-01-07</date><risdate>2021</risdate><volume>20</volume><issue>1</issue><spage>6</spage><epage>6</epage><pages>6-6</pages><artnum>6</artnum><issn>1475-2840</issn><eissn>1475-2840</eissn><abstract>BackgroundIn the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial) treatment with the sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin significantly reduced heart failure hospitalization (HHF) in patients with type 2 diabetes mellitus (T2D) and established cardiovascular disease. The early separation of the HHF event curves within the first 3 months of the trial suggest that immediate hemodynamic effects may play a role. However, hitherto no data exist on early effects of SGLT2 inhibitors on hemodynamic parameters and cardiac function. Thus, this study examined early and delayed effects of empagliflozin treatment on hemodynamic parameters including systemic vascular resistance index, cardiac index, and stroke volume index, as well as echocardiographic measures of cardiac function.MethodsIn this placebo-controlled, randomized, double blind, exploratory study patients with T2D were randomized to empagliflozin 10 mg or placebo for a period of 3 months. Hemodynamic and echocardiographic parameters were assessed after 1 day, 3 days and 3 months of treatment.ResultsBaseline characteristics were not different in the empagliflozin (n=22) and placebo (n=20) group. Empagliflozin led to a significant increase in urinary glucose excretion (baseline: 7.322.7 g/24 h; day 1: 48.434.7 g/24 h; p<0.001) as well as urinary volume (1740<plus/minus>601 mL/24 h to 2112 +/- 837 mL/24 h; p=0.011) already after one day compared to placebo. Treatment with empagliflozin had no effect on the primary endpoint of systemic vascular resistance index, nor on cardiac index, stroke volume index or pulse rate at any time point. In addition, echocardiography showed no difference in left ventricular systolic function as assessed by left ventricular ejections fraction and strain analysis. However, empagliflozin significantly improved left ventricular filling pressure as assessed by a reduction of early mitral inflow velocity relative to early diastolic left ventricular relaxation (E/e') which became significant at day 1 of treatment (baseline: 9.2 +/- 2.6; day 1: 8.5 +/- 2.2; p=0.005) and remained apparent throughout the study. This was primarily attributable to reduced early mitral inflow velocity E (baseline: 0.8 +/- 0.2 m/s; day 1: 0.73 +/- 0.2 m/sec; p=0.003).Conclusions Empagliflozin treatment of patients with T2D has no significant effect on hemodynamic parameters after 1 or 3 days, nor after 3 months, but leads to rapid and sustained significant improvement of diastolic function. Trial registration EudraCT Number: 2016-000172-19; date of registration: 2017-02-20 (clinicaltrialregister.eu)</abstract><cop>LONDON</cop><pub>Springer Nature</pub><pmid>33413355</pmid><doi>10.1186/s12933-020-01175-5</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Analysis Blood pressure Cardiac & Cardiovascular Systems Cardiovascular diseases Cardiovascular System & Cardiology Care and treatment Clinical trials Congestive heart failure Dextrose Diabetes Diabetes mellitus (non-insulin dependent) Diabetes therapy Diastolic function Echocardiography Endocrinology & Metabolism Glucose Heart Heart failure Heart rate Hemodynamic parameters Hypertension Life Sciences & Biomedicine Medical research Medicine, Experimental Na+/glucose cotransporter Original Investigation Placebos Science & Technology SGLT2 inhibitors Standard deviation Type 2 diabetes Urine Variables Velocity Ventricle |
| title | Empagliflozin does not change cardiac index nor systemic vascular resistance but rapidly improves left ventricular filling pressure in patients with type 2 diabetes: a randomized controlled study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-12T05%3A11%3A48IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_webof&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Empagliflozin%20does%20not%20change%20cardiac%20index%20nor%20systemic%20vascular%20resistance%20but%20rapidly%20improves%20left%20ventricular%20filling%20pressure%20in%20patients%20with%20type%202%20diabetes:%20a%20randomized%20controlled%20study&rft.jtitle=Cardiovascular%20Diabetology&rft.au=Rau,%20Matthias&rft.date=2021-01-07&rft.volume=20&rft.issue=1&rft.spage=6&rft.epage=6&rft.pages=6-6&rft.artnum=6&rft.issn=1475-2840&rft.eissn=1475-2840&rft_id=info:doi/10.1186/s12933-020-01175-5&rft_dat=%3Cgale_webof%3EA650596498%3C/gale_webof%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2478726821&rft_id=info:pmid/33413355&rft_galeid=A650596498&rft_doaj_id=oai_doaj_org_article_0bfafb3ebec549339276a1d59e86beeb&rfr_iscdi=true |