Efficacy of ertugliflozin in monotherapy or combination therapy in patients with type 2 diabetes: A pooled analysis of placebo-controlled studies
Background: This pooled analysis assessed the efficacy of ertugliflozin versus placebo as monotherapy or with other antihyperglycaemic agents across patient subgroups defined by demographic and disease characteristics. Methods: Data from three phase III randomised, placebo-controlled, double-blind s...
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| Veröffentlicht in: | Diabetes & vascular disease research 2019-09, Vol.16 (5), p.415-423 |
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| creator | Liu, Jie Tarasenko, Lisa Terra, Steven G Huyck, Susan Wu, Larry Pong, Annpey Calle, Roberto A Gallo, Silvina Darekar, Amanda Mancuso, James P |
| description | Background:
This pooled analysis assessed the efficacy of ertugliflozin versus placebo as monotherapy or with other antihyperglycaemic agents across patient subgroups defined by demographic and disease characteristics.
Methods:
Data from three phase III randomised, placebo-controlled, double-blind studies (NCT01958671, NCT02033889 and NCT02036515) with similar designs and populations were pooled (N = 1544).
Results:
At Week 26, placebo-adjusted least squares mean changes from baseline in glycated haemoglobin with ertugliflozin 5 and 15 mg were −0.8% (95% confidence interval: −0.9, −0.7) and −0.9% (–1.0, −0.8), respectively. Reductions were consistent across subgroups. Placebo-adjusted least squares mean changes in body weight were −1.8 kg (−2.2, −1.4) for both ertugliflozin doses; for systolic blood pressure, these were −3.4 mmHg (−4.8, −2.0) and −3.5 mmHg (−4.9, −2.0) for ertugliflozin 5 and 15 mg, respectively. Higher proportions of patients receiving ertugliflozin had glycated haemoglobin |
| doi_str_mv | 10.1177/1479164119842513 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_AFRWT</sourceid><recordid>TN_cdi_proquest_miscellaneous_2231976844</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_1479164119842513</sage_id><sourcerecordid>2231976844</sourcerecordid><originalsourceid>FETCH-LOGICAL-c379t-32f7097a31fdf819c8a3fc4a50860c5488e6ab6eb2891d0a6dfeee1cc5f7bccb3</originalsourceid><addsrcrecordid>eNp1kc9L5TAQx8Pi4q_1vifJ0Us107RN6k3EXQXBy-65pOnkGUmbmqTI87_wPzaP9_QgCAOZme9nvoEZQn4DOwcQ4gIq0UJTAbSyKmvgP8ghiLosZK73cp7lYqMfkKMYnxirG1HLfXLAgUngAg7J240xViu9pt5QDGlZOWucf7UTzTH6yadHDGrOeqDaj72dVLJ-oh_tTM25g1OK9MWmR5rWM9KSDlb1mDBe0is6e-9woGpSbh1t3Hw1O6Wx94X2UwrebeSYlsFi_EV-GuUinuzeY_L_z82_69vi_uHv3fXVfaG5aFPBSyNYKxQHMxgJrZaKG12pmsmG6bqSEhvVN9iXsoWBqWYwiAha10b0Wvf8mJxtfefgnxeMqRtt1OicmtAvsStLDq1oZFVllG1RHXyMAU03BzuqsO6AdZtDdF8PkUdOd-5LP-LwOfCx-QwUWyCqFXZPfgl5O_F7w3dNbpP7</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2231976844</pqid></control><display><type>article</type><title>Efficacy of ertugliflozin in monotherapy or combination therapy in patients with type 2 diabetes: A pooled analysis of placebo-controlled studies</title><source>SAGE Open Access Journals</source><creator>Liu, Jie ; Tarasenko, Lisa ; Terra, Steven G ; Huyck, Susan ; Wu, Larry ; Pong, Annpey ; Calle, Roberto A ; Gallo, Silvina ; Darekar, Amanda ; Mancuso, James P</creator><creatorcontrib>Liu, Jie ; Tarasenko, Lisa ; Terra, Steven G ; Huyck, Susan ; Wu, Larry ; Pong, Annpey ; Calle, Roberto A ; Gallo, Silvina ; Darekar, Amanda ; Mancuso, James P</creatorcontrib><description>Background:
This pooled analysis assessed the efficacy of ertugliflozin versus placebo as monotherapy or with other antihyperglycaemic agents across patient subgroups defined by demographic and disease characteristics.
Methods:
Data from three phase III randomised, placebo-controlled, double-blind studies (NCT01958671, NCT02033889 and NCT02036515) with similar designs and populations were pooled (N = 1544).
Results:
At Week 26, placebo-adjusted least squares mean changes from baseline in glycated haemoglobin with ertugliflozin 5 and 15 mg were −0.8% (95% confidence interval: −0.9, −0.7) and −0.9% (–1.0, −0.8), respectively. Reductions were consistent across subgroups. Placebo-adjusted least squares mean changes in body weight were −1.8 kg (−2.2, −1.4) for both ertugliflozin doses; for systolic blood pressure, these were −3.4 mmHg (−4.8, −2.0) and −3.5 mmHg (−4.9, −2.0) for ertugliflozin 5 and 15 mg, respectively. Higher proportions of patients receiving ertugliflozin had glycated haemoglobin <7.0%, weight loss ⩾5% and systolic blood pressure <130 mmHg versus placebo. Ertugliflozin and placebo safety profiles were similar, including incidences of hypoglycaemia, urinary tract infection and hypovolaemia. Genital mycotic infection and adverse events related to osmotic diuresis were more common with ertugliflozin.
Conclusion:
Ertugliflozin demonstrated efficacy as monotherapy or with other antihyperglycaemic agents in patients with different demographic and disease characteristics and was generally well tolerated.</description><identifier>ISSN: 1479-1641</identifier><identifier>EISSN: 1752-8984</identifier><identifier>DOI: 10.1177/1479164119842513</identifier><identifier>PMID: 31081371</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Aged ; Biomarkers - blood ; Blood Glucose - drug effects ; Blood Glucose - metabolism ; Blood Pressure - drug effects ; Bridged Bicyclo Compounds, Heterocyclic - adverse effects ; Bridged Bicyclo Compounds, Heterocyclic - therapeutic use ; Clinical Trials, Phase III as Topic ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - diagnosis ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - physiopathology ; Drug Therapy, Combination ; Female ; Glycated Hemoglobin A - metabolism ; Humans ; Male ; Middle Aged ; Randomized Controlled Trials as Topic ; Sodium-Glucose Transporter 2 Inhibitors - adverse effects ; Sodium-Glucose Transporter 2 Inhibitors - therapeutic use ; Treatment Outcome</subject><ispartof>Diabetes & vascular disease research, 2019-09, Vol.16 (5), p.415-423</ispartof><rights>The Author(s) 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c379t-32f7097a31fdf819c8a3fc4a50860c5488e6ab6eb2891d0a6dfeee1cc5f7bccb3</citedby><cites>FETCH-LOGICAL-c379t-32f7097a31fdf819c8a3fc4a50860c5488e6ab6eb2891d0a6dfeee1cc5f7bccb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/1479164119842513$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/1479164119842513$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,776,780,21945,27830,27901,27902,44921,45309</link.rule.ids><linktorsrc>$$Uhttps://journals.sagepub.com/doi/full/10.1177/1479164119842513?utm_source=summon&utm_medium=discovery-provider$$EView_record_in_SAGE_Publications$$FView_record_in_$$GSAGE_Publications</linktorsrc><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31081371$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Liu, Jie</creatorcontrib><creatorcontrib>Tarasenko, Lisa</creatorcontrib><creatorcontrib>Terra, Steven G</creatorcontrib><creatorcontrib>Huyck, Susan</creatorcontrib><creatorcontrib>Wu, Larry</creatorcontrib><creatorcontrib>Pong, Annpey</creatorcontrib><creatorcontrib>Calle, Roberto A</creatorcontrib><creatorcontrib>Gallo, Silvina</creatorcontrib><creatorcontrib>Darekar, Amanda</creatorcontrib><creatorcontrib>Mancuso, James P</creatorcontrib><title>Efficacy of ertugliflozin in monotherapy or combination therapy in patients with type 2 diabetes: A pooled analysis of placebo-controlled studies</title><title>Diabetes & vascular disease research</title><addtitle>Diab Vasc Dis Res</addtitle><description>Background:
This pooled analysis assessed the efficacy of ertugliflozin versus placebo as monotherapy or with other antihyperglycaemic agents across patient subgroups defined by demographic and disease characteristics.
Methods:
Data from three phase III randomised, placebo-controlled, double-blind studies (NCT01958671, NCT02033889 and NCT02036515) with similar designs and populations were pooled (N = 1544).
Results:
At Week 26, placebo-adjusted least squares mean changes from baseline in glycated haemoglobin with ertugliflozin 5 and 15 mg were −0.8% (95% confidence interval: −0.9, −0.7) and −0.9% (–1.0, −0.8), respectively. Reductions were consistent across subgroups. Placebo-adjusted least squares mean changes in body weight were −1.8 kg (−2.2, −1.4) for both ertugliflozin doses; for systolic blood pressure, these were −3.4 mmHg (−4.8, −2.0) and −3.5 mmHg (−4.9, −2.0) for ertugliflozin 5 and 15 mg, respectively. Higher proportions of patients receiving ertugliflozin had glycated haemoglobin <7.0%, weight loss ⩾5% and systolic blood pressure <130 mmHg versus placebo. Ertugliflozin and placebo safety profiles were similar, including incidences of hypoglycaemia, urinary tract infection and hypovolaemia. Genital mycotic infection and adverse events related to osmotic diuresis were more common with ertugliflozin.
Conclusion:
Ertugliflozin demonstrated efficacy as monotherapy or with other antihyperglycaemic agents in patients with different demographic and disease characteristics and was generally well tolerated.</description><subject>Aged</subject><subject>Biomarkers - blood</subject><subject>Blood Glucose - drug effects</subject><subject>Blood Glucose - metabolism</subject><subject>Blood Pressure - drug effects</subject><subject>Bridged Bicyclo Compounds, Heterocyclic - adverse effects</subject><subject>Bridged Bicyclo Compounds, Heterocyclic - therapeutic use</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Diabetes Mellitus, Type 2 - blood</subject><subject>Diabetes Mellitus, Type 2 - diagnosis</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - physiopathology</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Sodium-Glucose Transporter 2 Inhibitors - adverse effects</subject><subject>Sodium-Glucose Transporter 2 Inhibitors - therapeutic use</subject><subject>Treatment Outcome</subject><issn>1479-1641</issn><issn>1752-8984</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc9L5TAQx8Pi4q_1vifJ0Us107RN6k3EXQXBy-65pOnkGUmbmqTI87_wPzaP9_QgCAOZme9nvoEZQn4DOwcQ4gIq0UJTAbSyKmvgP8ghiLosZK73cp7lYqMfkKMYnxirG1HLfXLAgUngAg7J240xViu9pt5QDGlZOWucf7UTzTH6yadHDGrOeqDaj72dVLJ-oh_tTM25g1OK9MWmR5rWM9KSDlb1mDBe0is6e-9woGpSbh1t3Hw1O6Wx94X2UwrebeSYlsFi_EV-GuUinuzeY_L_z82_69vi_uHv3fXVfaG5aFPBSyNYKxQHMxgJrZaKG12pmsmG6bqSEhvVN9iXsoWBqWYwiAha10b0Wvf8mJxtfefgnxeMqRtt1OicmtAvsStLDq1oZFVllG1RHXyMAU03BzuqsO6AdZtDdF8PkUdOd-5LP-LwOfCx-QwUWyCqFXZPfgl5O_F7w3dNbpP7</recordid><startdate>201909</startdate><enddate>201909</enddate><creator>Liu, Jie</creator><creator>Tarasenko, Lisa</creator><creator>Terra, Steven G</creator><creator>Huyck, Susan</creator><creator>Wu, Larry</creator><creator>Pong, Annpey</creator><creator>Calle, Roberto A</creator><creator>Gallo, Silvina</creator><creator>Darekar, Amanda</creator><creator>Mancuso, James P</creator><general>SAGE Publications</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>7X8</scope></search><sort><creationdate>201909</creationdate><title>Efficacy of ertugliflozin in monotherapy or combination therapy in patients with type 2 diabetes: A pooled analysis of placebo-controlled studies</title><author>Liu, Jie ; Tarasenko, Lisa ; Terra, Steven G ; Huyck, Susan ; Wu, Larry ; Pong, Annpey ; Calle, Roberto A ; Gallo, Silvina ; Darekar, Amanda ; Mancuso, James P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c379t-32f7097a31fdf819c8a3fc4a50860c5488e6ab6eb2891d0a6dfeee1cc5f7bccb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Aged</topic><topic>Biomarkers - blood</topic><topic>Blood Glucose - drug effects</topic><topic>Blood Glucose - metabolism</topic><topic>Blood Pressure - drug effects</topic><topic>Bridged Bicyclo Compounds, Heterocyclic - adverse effects</topic><topic>Bridged Bicyclo Compounds, Heterocyclic - therapeutic use</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - diagnosis</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - physiopathology</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Sodium-Glucose Transporter 2 Inhibitors - adverse effects</topic><topic>Sodium-Glucose Transporter 2 Inhibitors - therapeutic use</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Liu, Jie</creatorcontrib><creatorcontrib>Tarasenko, Lisa</creatorcontrib><creatorcontrib>Terra, Steven G</creatorcontrib><creatorcontrib>Huyck, Susan</creatorcontrib><creatorcontrib>Wu, Larry</creatorcontrib><creatorcontrib>Pong, Annpey</creatorcontrib><creatorcontrib>Calle, Roberto A</creatorcontrib><creatorcontrib>Gallo, Silvina</creatorcontrib><creatorcontrib>Darekar, Amanda</creatorcontrib><creatorcontrib>Mancuso, James P</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes & vascular disease research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Liu, Jie</au><au>Tarasenko, Lisa</au><au>Terra, Steven G</au><au>Huyck, Susan</au><au>Wu, Larry</au><au>Pong, Annpey</au><au>Calle, Roberto A</au><au>Gallo, Silvina</au><au>Darekar, Amanda</au><au>Mancuso, James P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of ertugliflozin in monotherapy or combination therapy in patients with type 2 diabetes: A pooled analysis of placebo-controlled studies</atitle><jtitle>Diabetes & vascular disease research</jtitle><addtitle>Diab Vasc Dis Res</addtitle><date>2019-09</date><risdate>2019</risdate><volume>16</volume><issue>5</issue><spage>415</spage><epage>423</epage><pages>415-423</pages><issn>1479-1641</issn><eissn>1752-8984</eissn><abstract>Background:
This pooled analysis assessed the efficacy of ertugliflozin versus placebo as monotherapy or with other antihyperglycaemic agents across patient subgroups defined by demographic and disease characteristics.
Methods:
Data from three phase III randomised, placebo-controlled, double-blind studies (NCT01958671, NCT02033889 and NCT02036515) with similar designs and populations were pooled (N = 1544).
Results:
At Week 26, placebo-adjusted least squares mean changes from baseline in glycated haemoglobin with ertugliflozin 5 and 15 mg were −0.8% (95% confidence interval: −0.9, −0.7) and −0.9% (–1.0, −0.8), respectively. Reductions were consistent across subgroups. Placebo-adjusted least squares mean changes in body weight were −1.8 kg (−2.2, −1.4) for both ertugliflozin doses; for systolic blood pressure, these were −3.4 mmHg (−4.8, −2.0) and −3.5 mmHg (−4.9, −2.0) for ertugliflozin 5 and 15 mg, respectively. Higher proportions of patients receiving ertugliflozin had glycated haemoglobin <7.0%, weight loss ⩾5% and systolic blood pressure <130 mmHg versus placebo. Ertugliflozin and placebo safety profiles were similar, including incidences of hypoglycaemia, urinary tract infection and hypovolaemia. Genital mycotic infection and adverse events related to osmotic diuresis were more common with ertugliflozin.
Conclusion:
Ertugliflozin demonstrated efficacy as monotherapy or with other antihyperglycaemic agents in patients with different demographic and disease characteristics and was generally well tolerated.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>31081371</pmid><doi>10.1177/1479164119842513</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Diabetes & vascular disease research, 2019-09, Vol.16 (5), p.415-423 |
| issn | 1479-1641 1752-8984 |
| language | eng |
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| source | SAGE Open Access Journals |
| subjects | Aged Biomarkers - blood Blood Glucose - drug effects Blood Glucose - metabolism Blood Pressure - drug effects Bridged Bicyclo Compounds, Heterocyclic - adverse effects Bridged Bicyclo Compounds, Heterocyclic - therapeutic use Clinical Trials, Phase III as Topic Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - diagnosis Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - physiopathology Drug Therapy, Combination Female Glycated Hemoglobin A - metabolism Humans Male Middle Aged Randomized Controlled Trials as Topic Sodium-Glucose Transporter 2 Inhibitors - adverse effects Sodium-Glucose Transporter 2 Inhibitors - therapeutic use Treatment Outcome |
| title | Efficacy of ertugliflozin in monotherapy or combination therapy in patients with type 2 diabetes: A pooled analysis of placebo-controlled studies |
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