Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™)
Evidence concerning the importance of glucose lowering in the prevention of cardiovascular (CV) outcomes remains controversial. Given the multi-faceted pathogenesis of atherosclerosis in diabetes, it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia a...
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| Veröffentlicht in: | Cardiovascular Diabetology 2014-06, Vol.13 (1), p.102-102 |
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| creator | Zinman, Bernard Inzucchi, Silvio E Lachin, John M Wanner, Christoph Ferrari, Roberto Fitchett, David Bluhmki, Erich Hantel, Stefan Kempthorne-Rawson, Joan Newman, Jennifer Johansen, Odd Erik Woerle, Hans-Juergen Broedl, Uli C |
| description | Evidence concerning the importance of glucose lowering in the prevention of cardiovascular (CV) outcomes remains controversial. Given the multi-faceted pathogenesis of atherosclerosis in diabetes, it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone. The SGLT-2 inhibitor empagliflozin improves glucose control, body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes. The aim of the ongoing EMPA-REG OUTCOME™ trial is to determine the long-term CV safety of empagliflozin, as well as investigating potential benefits on macro-/microvascular outcomes.
Patients who were drug-naïve (HbA1c ≥7.0% and ≤9.0%), or on background glucose-lowering therapy (HbA1c ≥7.0% and ≤10.0%), and were at high risk of CV events, were randomized (1:1:1) and treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo (double blind, double dummy) superimposed upon the standard of care. The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. CV events will be prospectively adjudicated by an independent Clinical Events Committee. The trial will continue until ≥691 confirmed primary outcome events have occurred, providing a power of 90% to yield an upper limit of the adjusted 95% CI for a hazard ratio of |
| doi_str_mv | 10.1186/1475-2840-13-102 |
| format | Article |
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Patients who were drug-naïve (HbA1c ≥7.0% and ≤9.0%), or on background glucose-lowering therapy (HbA1c ≥7.0% and ≤10.0%), and were at high risk of CV events, were randomized (1:1:1) and treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo (double blind, double dummy) superimposed upon the standard of care. The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. CV events will be prospectively adjudicated by an independent Clinical Events Committee. The trial will continue until ≥691 confirmed primary outcome events have occurred, providing a power of 90% to yield an upper limit of the adjusted 95% CI for a hazard ratio of <1.3 with a one-sided α of 0.025, assuming equal risks between placebo and empagliflozin (both doses pooled). Hierarchical testing for superiority will follow for the primary outcome and key secondary outcomes (time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina pectoris) where non-inferiority is achieved.
Between Sept 2010 and April 2013, 592 clinical sites randomized and treated 7034 patients (41% from Europe, 20% from North America, and 19% from Asia). At baseline, the mean age was 63 ± 9 years, BMI 30.6 ± 5.3 kg/m2, HbA1c 8.1 ± 0.8%, and eGFR 74 ± 21 ml/min/1.73 m2. The study is expected to report in 2015.
EMPA-REG OUTCOME™ will determine the CV safety of empagliflozin in a cohort of patients with type 2 diabetes and high CV risk, with the potential to show cardioprotection.
Clinicaltrials.gov NCT01131676.</description><identifier>ISSN: 1475-2840</identifier><identifier>EISSN: 1475-2840</identifier><identifier>DOI: 10.1186/1475-2840-13-102</identifier><identifier>PMID: 24943000</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Adult ; Aged ; Benzhydryl Compounds - therapeutic use ; Body mass index ; Cardiovascular disease ; Cardiovascular Diseases - diagnosis ; Cardiovascular Diseases - drug therapy ; Cardiovascular Diseases - epidemiology ; Colleges & universities ; Diabetes ; Diabetes Mellitus, Type 2 - diagnosis ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - epidemiology ; Double-Blind Method ; Drug dosages ; Female ; Glucosides - therapeutic use ; Glycosylated hemoglobin ; Health aspects ; Hospitals ; Humans ; Hypertension ; Hypoglycemic Agents - therapeutic use ; Kidney diseases ; Lipids ; Male ; Middle Aged ; Prospective Studies ; Research Design ; Risk factors ; Study Protocol ; Treatment Outcome ; Young Adult</subject><ispartof>Cardiovascular Diabetology, 2014-06, Vol.13 (1), p.102-102</ispartof><rights>COPYRIGHT 2014 BioMed Central Ltd.</rights><rights>2014 Zinman et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.</rights><rights>Copyright © 2014 Zinman et al.; licensee BioMed Central Ltd. 2014 Zinman et al.; licensee BioMed Central Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b617t-65b2cdfbac46933b10cb68b23145a28745f8b3c41fb1c36f0964fcd7b52ca5e23</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4072621/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4072621/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,865,886,27929,27930,53796,53798</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24943000$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zinman, Bernard</creatorcontrib><creatorcontrib>Inzucchi, Silvio E</creatorcontrib><creatorcontrib>Lachin, John M</creatorcontrib><creatorcontrib>Wanner, Christoph</creatorcontrib><creatorcontrib>Ferrari, Roberto</creatorcontrib><creatorcontrib>Fitchett, David</creatorcontrib><creatorcontrib>Bluhmki, Erich</creatorcontrib><creatorcontrib>Hantel, Stefan</creatorcontrib><creatorcontrib>Kempthorne-Rawson, Joan</creatorcontrib><creatorcontrib>Newman, Jennifer</creatorcontrib><creatorcontrib>Johansen, Odd Erik</creatorcontrib><creatorcontrib>Woerle, Hans-Juergen</creatorcontrib><creatorcontrib>Broedl, Uli C</creatorcontrib><title>Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™)</title><title>Cardiovascular Diabetology</title><addtitle>Cardiovasc Diabetol</addtitle><description>Evidence concerning the importance of glucose lowering in the prevention of cardiovascular (CV) outcomes remains controversial. Given the multi-faceted pathogenesis of atherosclerosis in diabetes, it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone. The SGLT-2 inhibitor empagliflozin improves glucose control, body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes. The aim of the ongoing EMPA-REG OUTCOME™ trial is to determine the long-term CV safety of empagliflozin, as well as investigating potential benefits on macro-/microvascular outcomes.
Patients who were drug-naïve (HbA1c ≥7.0% and ≤9.0%), or on background glucose-lowering therapy (HbA1c ≥7.0% and ≤10.0%), and were at high risk of CV events, were randomized (1:1:1) and treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo (double blind, double dummy) superimposed upon the standard of care. The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. CV events will be prospectively adjudicated by an independent Clinical Events Committee. The trial will continue until ≥691 confirmed primary outcome events have occurred, providing a power of 90% to yield an upper limit of the adjusted 95% CI for a hazard ratio of <1.3 with a one-sided α of 0.025, assuming equal risks between placebo and empagliflozin (both doses pooled). Hierarchical testing for superiority will follow for the primary outcome and key secondary outcomes (time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina pectoris) where non-inferiority is achieved.
Between Sept 2010 and April 2013, 592 clinical sites randomized and treated 7034 patients (41% from Europe, 20% from North America, and 19% from Asia). At baseline, the mean age was 63 ± 9 years, BMI 30.6 ± 5.3 kg/m2, HbA1c 8.1 ± 0.8%, and eGFR 74 ± 21 ml/min/1.73 m2. The study is expected to report in 2015.
EMPA-REG OUTCOME™ will determine the CV safety of empagliflozin in a cohort of patients with type 2 diabetes and high CV risk, with the potential to show cardioprotection.
Clinicaltrials.gov NCT01131676.</description><subject>Adult</subject><subject>Aged</subject><subject>Benzhydryl Compounds - therapeutic use</subject><subject>Body mass index</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular Diseases - diagnosis</subject><subject>Cardiovascular Diseases - drug therapy</subject><subject>Cardiovascular Diseases - epidemiology</subject><subject>Colleges & universities</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - diagnosis</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - epidemiology</subject><subject>Double-Blind Method</subject><subject>Drug dosages</subject><subject>Female</subject><subject>Glucosides - therapeutic use</subject><subject>Glycosylated hemoglobin</subject><subject>Health aspects</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Kidney diseases</subject><subject>Lipids</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Research Design</subject><subject>Risk factors</subject><subject>Study Protocol</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1475-2840</issn><issn>1475-2840</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNp1ks9rFDEUxwdRbK3ePUnAS4Wdml-TmbkUlmWtQkultOfwkkm2KZnJmswU7Nn_wbt_mn-JWbcurSg5JOR93ycv7_uK4jXBR4Q04j3hdVXShuOSsJJg-qTY3109fXDeK16kdIMxqRtBnhd7lLecYYz3i-8XMLowgDcz1JnkVsMMwdAhBcl4NxikryGCHk10aXQ6oWARoJgloXd3ppuhtQdtVCh1GMYYvDcd0hA7F24h6clDRGEadegNGqMDvwGYfg0r76wPd25Ah8uzz_PyYnmCzq8uF-dny5_ffrx7WTyz4JN5db8fFFcflpeLj-Xp-cmnxfy0VILUYykqRXVnFWguWsYUwVqJRlFGeAW0qXllG8U0J1YRzYTFreBWd7WqqIbKUHZQHG-560n1ptMmfwK8XEfXQ_wqAzj5ODK4a7kKt5LjmgpKMmCxBSgX_gN4HMmtkBtj5MYYSZjMvmXK4X0ZMXyZTBpl75I23sNgwpQkqThhoq0py9K3f0lvwhSzg79VuGlrTDfAo61qla2VbrAhP67z6kzvslXGunw_r1grGsr5Bou3CTqGlKKxuy-QXGUetn8V_eZh73YJf6aL_QIgQNIR</recordid><startdate>20140619</startdate><enddate>20140619</enddate><creator>Zinman, Bernard</creator><creator>Inzucchi, Silvio E</creator><creator>Lachin, John M</creator><creator>Wanner, Christoph</creator><creator>Ferrari, Roberto</creator><creator>Fitchett, David</creator><creator>Bluhmki, Erich</creator><creator>Hantel, Stefan</creator><creator>Kempthorne-Rawson, Joan</creator><creator>Newman, Jennifer</creator><creator>Johansen, Odd Erik</creator><creator>Woerle, Hans-Juergen</creator><creator>Broedl, Uli C</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IAO</scope><scope>3V.</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20140619</creationdate><title>Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™)</title><author>Zinman, Bernard ; Inzucchi, Silvio E ; Lachin, John M ; Wanner, Christoph ; Ferrari, Roberto ; Fitchett, David ; Bluhmki, Erich ; Hantel, Stefan ; Kempthorne-Rawson, Joan ; Newman, Jennifer ; Johansen, Odd Erik ; Woerle, Hans-Juergen ; Broedl, Uli C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b617t-65b2cdfbac46933b10cb68b23145a28745f8b3c41fb1c36f0964fcd7b52ca5e23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Benzhydryl Compounds - therapeutic use</topic><topic>Body mass index</topic><topic>Cardiovascular disease</topic><topic>Cardiovascular Diseases - diagnosis</topic><topic>Cardiovascular Diseases - drug therapy</topic><topic>Cardiovascular Diseases - epidemiology</topic><topic>Colleges & universities</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 2 - diagnosis</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - epidemiology</topic><topic>Double-Blind Method</topic><topic>Drug dosages</topic><topic>Female</topic><topic>Glucosides - therapeutic use</topic><topic>Glycosylated hemoglobin</topic><topic>Health aspects</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Kidney diseases</topic><topic>Lipids</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Research Design</topic><topic>Risk factors</topic><topic>Study Protocol</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zinman, Bernard</creatorcontrib><creatorcontrib>Inzucchi, Silvio E</creatorcontrib><creatorcontrib>Lachin, John M</creatorcontrib><creatorcontrib>Wanner, Christoph</creatorcontrib><creatorcontrib>Ferrari, Roberto</creatorcontrib><creatorcontrib>Fitchett, David</creatorcontrib><creatorcontrib>Bluhmki, Erich</creatorcontrib><creatorcontrib>Hantel, Stefan</creatorcontrib><creatorcontrib>Kempthorne-Rawson, Joan</creatorcontrib><creatorcontrib>Newman, Jennifer</creatorcontrib><creatorcontrib>Johansen, Odd Erik</creatorcontrib><creatorcontrib>Woerle, Hans-Juergen</creatorcontrib><creatorcontrib>Broedl, Uli C</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</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><jtitle>Cardiovascular Diabetology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zinman, Bernard</au><au>Inzucchi, Silvio E</au><au>Lachin, John M</au><au>Wanner, Christoph</au><au>Ferrari, Roberto</au><au>Fitchett, David</au><au>Bluhmki, Erich</au><au>Hantel, Stefan</au><au>Kempthorne-Rawson, Joan</au><au>Newman, Jennifer</au><au>Johansen, Odd Erik</au><au>Woerle, Hans-Juergen</au><au>Broedl, Uli C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™)</atitle><jtitle>Cardiovascular Diabetology</jtitle><addtitle>Cardiovasc Diabetol</addtitle><date>2014-06-19</date><risdate>2014</risdate><volume>13</volume><issue>1</issue><spage>102</spage><epage>102</epage><pages>102-102</pages><issn>1475-2840</issn><eissn>1475-2840</eissn><abstract>Evidence concerning the importance of glucose lowering in the prevention of cardiovascular (CV) outcomes remains controversial. Given the multi-faceted pathogenesis of atherosclerosis in diabetes, it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone. The SGLT-2 inhibitor empagliflozin improves glucose control, body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes. The aim of the ongoing EMPA-REG OUTCOME™ trial is to determine the long-term CV safety of empagliflozin, as well as investigating potential benefits on macro-/microvascular outcomes.
Patients who were drug-naïve (HbA1c ≥7.0% and ≤9.0%), or on background glucose-lowering therapy (HbA1c ≥7.0% and ≤10.0%), and were at high risk of CV events, were randomized (1:1:1) and treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo (double blind, double dummy) superimposed upon the standard of care. The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. CV events will be prospectively adjudicated by an independent Clinical Events Committee. The trial will continue until ≥691 confirmed primary outcome events have occurred, providing a power of 90% to yield an upper limit of the adjusted 95% CI for a hazard ratio of <1.3 with a one-sided α of 0.025, assuming equal risks between placebo and empagliflozin (both doses pooled). Hierarchical testing for superiority will follow for the primary outcome and key secondary outcomes (time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina pectoris) where non-inferiority is achieved.
Between Sept 2010 and April 2013, 592 clinical sites randomized and treated 7034 patients (41% from Europe, 20% from North America, and 19% from Asia). At baseline, the mean age was 63 ± 9 years, BMI 30.6 ± 5.3 kg/m2, HbA1c 8.1 ± 0.8%, and eGFR 74 ± 21 ml/min/1.73 m2. The study is expected to report in 2015.
EMPA-REG OUTCOME™ will determine the CV safety of empagliflozin in a cohort of patients with type 2 diabetes and high CV risk, with the potential to show cardioprotection.
Clinicaltrials.gov NCT01131676.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>24943000</pmid><doi>10.1186/1475-2840-13-102</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Benzhydryl Compounds - therapeutic use Body mass index Cardiovascular disease Cardiovascular Diseases - diagnosis Cardiovascular Diseases - drug therapy Cardiovascular Diseases - epidemiology Colleges & universities Diabetes Diabetes Mellitus, Type 2 - diagnosis Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - epidemiology Double-Blind Method Drug dosages Female Glucosides - therapeutic use Glycosylated hemoglobin Health aspects Hospitals Humans Hypertension Hypoglycemic Agents - therapeutic use Kidney diseases Lipids Male Middle Aged Prospective Studies Research Design Risk factors Study Protocol Treatment Outcome Young Adult |
| title | Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™) |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-12T18%3A44%3A24IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Rationale,%20design,%20and%20baseline%20characteristics%20of%20a%20randomized,%20placebo-controlled%20cardiovascular%20outcome%20trial%20of%20empagliflozin%20(EMPA-REG%20OUTCOME%E2%84%A2)&rft.jtitle=Cardiovascular%20Diabetology&rft.au=Zinman,%20Bernard&rft.date=2014-06-19&rft.volume=13&rft.issue=1&rft.spage=102&rft.epage=102&rft.pages=102-102&rft.issn=1475-2840&rft.eissn=1475-2840&rft_id=info:doi/10.1186/1475-2840-13-102&rft_dat=%3Cgale_pubme%3EA539682443%3C/gale_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1540897022&rft_id=info:pmid/24943000&rft_galeid=A539682443&rfr_iscdi=true |