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Indacaterol/glycopyrronium in symptomatic patients with COPD (GOLD B and GOLD D) versus salmeterol/fluticasone: ILLUMINATE/LANTERN pooled analysis
Indacaterol/glycopyrronium (IND/GLY) is approved for maintenance treatment of adult patients with COPD. This post hoc analysis explored the efficacy and safety of IND/GLY versus salmeterol/fluticasone (SFC) in symptomatic (Global Initiative for Chronic Obstructive Lung Disease [GOLD] B and GOLD D) p...
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| Published in: | International journal of chronic obstructive pulmonary disease 2016-01, Vol.11, p.3189-3197 |
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| container_title | International journal of chronic obstructive pulmonary disease |
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| creator | Vogelmeier, Claus Zhong, Nanshan Humphries, Michael J Mezzi, Karen Fogel, Robert Bader, Giovanni Patalano, Francesco Banerji, Donald |
| description | Indacaterol/glycopyrronium (IND/GLY) is approved for maintenance treatment of adult patients with COPD. This post hoc analysis explored the efficacy and safety of IND/GLY versus salmeterol/fluticasone (SFC) in symptomatic (Global Initiative for Chronic Obstructive Lung Disease [GOLD] B and GOLD D) patients with moderate-to-severe COPD.
Data from LANTERN and ILLUMINATE studies were pooled and analyzed. In both studies, symptomatic COPD patients were randomized to once-daily IND/GLY 110 μg/50 μg or twice-daily SFC 50 μg/500 μg. End points were pre-dose trough forced expiratory volume in one second (FEV
), standardized area under the curve for FEV
from 0 to 12 hours (FEV
AUC
hours), peak FEV
, peak forced vital capacity (FVC), pre-dose trough FVC, Transition Dyspnea Index (TDI) total score, St George's Respiratory Questionnaire total score, rescue medication use and safety.
A total of 1,263 patients were classified as either GOLD B (n=809) or GOLD D (n=454). At week 26, IND/GLY demonstrated statistically significant improvement in all lung function parameters versus SFC in patients in both the GOLD B and GOLD D subgroups. TDI total score and rescue medication use were significantly improved with IND/GLY versus SFC in the overall population and in the GOLD B (TDI total score only) and GOLD D (rescue medication only) subgroups. IND/GLY also reduced the rate of exacerbations in the pooled population. Overall safety profile was comparable with a higher incidence of pneumonia in the SFC-treated group.
In this pooled analysis, IND/GLY demonstrated superior efficacy compared with SFC in patients in the GOLD B and GOLD D subgroups and supported its use in symptomatic COPD patients. |
| doi_str_mv | 10.2147/COPD.S116786 |
| format | article |
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Data from LANTERN and ILLUMINATE studies were pooled and analyzed. In both studies, symptomatic COPD patients were randomized to once-daily IND/GLY 110 μg/50 μg or twice-daily SFC 50 μg/500 μg. End points were pre-dose trough forced expiratory volume in one second (FEV
), standardized area under the curve for FEV
from 0 to 12 hours (FEV
AUC
hours), peak FEV
, peak forced vital capacity (FVC), pre-dose trough FVC, Transition Dyspnea Index (TDI) total score, St George's Respiratory Questionnaire total score, rescue medication use and safety.
A total of 1,263 patients were classified as either GOLD B (n=809) or GOLD D (n=454). At week 26, IND/GLY demonstrated statistically significant improvement in all lung function parameters versus SFC in patients in both the GOLD B and GOLD D subgroups. TDI total score and rescue medication use were significantly improved with IND/GLY versus SFC in the overall population and in the GOLD B (TDI total score only) and GOLD D (rescue medication only) subgroups. IND/GLY also reduced the rate of exacerbations in the pooled population. Overall safety profile was comparable with a higher incidence of pneumonia in the SFC-treated group.
In this pooled analysis, IND/GLY demonstrated superior efficacy compared with SFC in patients in the GOLD B and GOLD D subgroups and supported its use in symptomatic COPD patients.</description><identifier>ISSN: 1178-2005</identifier><identifier>ISSN: 1176-9106</identifier><identifier>EISSN: 1178-2005</identifier><identifier>DOI: 10.2147/COPD.S116786</identifier><identifier>PMID: 28008244</identifier><language>eng</language><publisher>New Zealand: Dove Medical Press Ltd</publisher><subject><![CDATA[Adrenergic beta-2 Receptor Agonists - administration & dosage ; Adrenergic beta-2 Receptor Agonists - adverse effects ; Aged ; Bronchodilator Agents - administration & dosage ; Bronchodilator Agents - adverse effects ; Chronic obstructive pulmonary disease ; Clinical medicine ; Clinical trials ; Clinical Trials, Phase III as Topic ; COPD ; Dyspnea ; exacerbation ; Female ; Fluticasone-Salmeterol Drug Combination - administration & dosage ; Fluticasone-Salmeterol Drug Combination - adverse effects ; Forced Expiratory Volume ; Glycopyrrolate - administration & dosage ; Glycopyrrolate - adverse effects ; Humans ; Indans - administration & dosage ; Indans - adverse effects ; LABA/ICS ; LABA/LAMA ; Lung - drug effects ; Lung - physiopathology ; Lung diseases ; lung function ; Male ; Middle Aged ; Muscarinic Antagonists - administration & dosage ; Muscarinic Antagonists - adverse effects ; Original Research ; Patients ; Pulmonary Disease, Chronic Obstructive - complications ; Pulmonary Disease, Chronic Obstructive - diagnosis ; Pulmonary Disease, Chronic Obstructive - drug therapy ; Pulmonary Disease, Chronic Obstructive - physiopathology ; Quinolones - administration & dosage ; Quinolones - adverse effects ; Randomized Controlled Trials as Topic ; Recovery of Function ; Severity of Illness Index ; Spirometry ; Statistical analysis ; Steroids ; Surveys and Questionnaires ; Time Factors ; Treatment Outcome ; Values ; Vital Capacity]]></subject><ispartof>International journal of chronic obstructive pulmonary disease, 2016-01, Vol.11, p.3189-3197</ispartof><rights>2016. This work is licensed under https://creativecommons.org/licenses/by-nc/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2016 Vogelmeier et al. This work is published and licensed by Dove Medical Press Limited 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c478t-92447b343c9c8d41820d532e8c728462581f8025f90a66a3435218b3a121859f3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2680094093/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2680094093?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,44590,53791,53793,75126</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28008244$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vogelmeier, Claus</creatorcontrib><creatorcontrib>Zhong, Nanshan</creatorcontrib><creatorcontrib>Humphries, Michael J</creatorcontrib><creatorcontrib>Mezzi, Karen</creatorcontrib><creatorcontrib>Fogel, Robert</creatorcontrib><creatorcontrib>Bader, Giovanni</creatorcontrib><creatorcontrib>Patalano, Francesco</creatorcontrib><creatorcontrib>Banerji, Donald</creatorcontrib><title>Indacaterol/glycopyrronium in symptomatic patients with COPD (GOLD B and GOLD D) versus salmeterol/fluticasone: ILLUMINATE/LANTERN pooled analysis</title><title>International journal of chronic obstructive pulmonary disease</title><addtitle>Int J Chron Obstruct Pulmon Dis</addtitle><description>Indacaterol/glycopyrronium (IND/GLY) is approved for maintenance treatment of adult patients with COPD. This post hoc analysis explored the efficacy and safety of IND/GLY versus salmeterol/fluticasone (SFC) in symptomatic (Global Initiative for Chronic Obstructive Lung Disease [GOLD] B and GOLD D) patients with moderate-to-severe COPD.
Data from LANTERN and ILLUMINATE studies were pooled and analyzed. In both studies, symptomatic COPD patients were randomized to once-daily IND/GLY 110 μg/50 μg or twice-daily SFC 50 μg/500 μg. End points were pre-dose trough forced expiratory volume in one second (FEV
), standardized area under the curve for FEV
from 0 to 12 hours (FEV
AUC
hours), peak FEV
, peak forced vital capacity (FVC), pre-dose trough FVC, Transition Dyspnea Index (TDI) total score, St George's Respiratory Questionnaire total score, rescue medication use and safety.
A total of 1,263 patients were classified as either GOLD B (n=809) or GOLD D (n=454). At week 26, IND/GLY demonstrated statistically significant improvement in all lung function parameters versus SFC in patients in both the GOLD B and GOLD D subgroups. TDI total score and rescue medication use were significantly improved with IND/GLY versus SFC in the overall population and in the GOLD B (TDI total score only) and GOLD D (rescue medication only) subgroups. IND/GLY also reduced the rate of exacerbations in the pooled population. Overall safety profile was comparable with a higher incidence of pneumonia in the SFC-treated group.
In this pooled analysis, IND/GLY demonstrated superior efficacy compared with SFC in patients in the GOLD B and GOLD D subgroups and supported its use in symptomatic COPD patients.</description><subject>Adrenergic beta-2 Receptor Agonists - administration & dosage</subject><subject>Adrenergic beta-2 Receptor Agonists - adverse effects</subject><subject>Aged</subject><subject>Bronchodilator Agents - administration & dosage</subject><subject>Bronchodilator Agents - adverse effects</subject><subject>Chronic obstructive pulmonary disease</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>COPD</subject><subject>Dyspnea</subject><subject>exacerbation</subject><subject>Female</subject><subject>Fluticasone-Salmeterol Drug Combination - administration & dosage</subject><subject>Fluticasone-Salmeterol Drug Combination - adverse effects</subject><subject>Forced Expiratory Volume</subject><subject>Glycopyrrolate - administration & dosage</subject><subject>Glycopyrrolate - adverse effects</subject><subject>Humans</subject><subject>Indans - administration & dosage</subject><subject>Indans - adverse effects</subject><subject>LABA/ICS</subject><subject>LABA/LAMA</subject><subject>Lung - drug effects</subject><subject>Lung - physiopathology</subject><subject>Lung diseases</subject><subject>lung function</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Muscarinic Antagonists - administration & dosage</subject><subject>Muscarinic Antagonists - adverse effects</subject><subject>Original Research</subject><subject>Patients</subject><subject>Pulmonary Disease, Chronic Obstructive - complications</subject><subject>Pulmonary Disease, Chronic Obstructive - diagnosis</subject><subject>Pulmonary Disease, Chronic Obstructive - drug therapy</subject><subject>Pulmonary Disease, Chronic Obstructive - physiopathology</subject><subject>Quinolones - administration & dosage</subject><subject>Quinolones - adverse effects</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Recovery of Function</subject><subject>Severity of Illness Index</subject><subject>Spirometry</subject><subject>Statistical analysis</subject><subject>Steroids</subject><subject>Surveys and Questionnaires</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Values</subject><subject>Vital Capacity</subject><issn>1178-2005</issn><issn>1176-9106</issn><issn>1178-2005</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNpVkkFv0zAUxyMEYmNw44wscQGJrrbjOPYOSKUtI1JoEXRny7WdLpUTBzsZytfgE-OuZdoufs_237_39P5OkrcIXmJE8ul8_WNx-QshmjP6LDlHKGcTDGH2_FF-lrwKYR8TmufoZXKGGYQME3Ke_C1aLZXsjXd2urOjct3ovWvroQF1C8LYdL1rZF8r0MXVtH0Af-r-FhzKgg_X63IBvgDZanCfLj6CO-PDEECQtjFHbGWH-F4G15orUJTlzfdiNdssp-VstVn-XIHOOWt0hEg7hjq8Tl5U0gbz5hQvkpuvy83826RcXxfzWTlRJGf9hMf-821KUsUV0wQxDHWWYsNUjhmhOGOoYhBnFYeSUhmFGUZsm0oUQ8ar9CIpjlzt5F50vm6kH4WTtbg_cH4npI-NWyOgQoZDnmNOUkKR5DqVWNOMwkrpuImsz0dWN2wbo1Wck5f2CfTpTVvfip27E1n0LRIj4P0J4N3vwYRe7N3g40SCwDS6xQnkhzKfjirlXQjeVA8VEBSH3yAOtojTb4jyd4-7ehD_tz_9B7aYri4</recordid><startdate>20160101</startdate><enddate>20160101</enddate><creator>Vogelmeier, Claus</creator><creator>Zhong, Nanshan</creator><creator>Humphries, Michael J</creator><creator>Mezzi, Karen</creator><creator>Fogel, Robert</creator><creator>Bader, Giovanni</creator><creator>Patalano, Francesco</creator><creator>Banerji, Donald</creator><general>Dove Medical Press Ltd</general><general>Dove Medical Press</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>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20160101</creationdate><title>Indacaterol/glycopyrronium in symptomatic patients with COPD (GOLD B and GOLD D) versus salmeterol/fluticasone: ILLUMINATE/LANTERN pooled analysis</title><author>Vogelmeier, Claus ; Zhong, Nanshan ; Humphries, Michael J ; Mezzi, Karen ; Fogel, Robert ; Bader, Giovanni ; Patalano, Francesco ; Banerji, Donald</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c478t-92447b343c9c8d41820d532e8c728462581f8025f90a66a3435218b3a121859f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adrenergic beta-2 Receptor Agonists - administration & dosage</topic><topic>Adrenergic beta-2 Receptor Agonists - adverse effects</topic><topic>Aged</topic><topic>Bronchodilator Agents - administration & dosage</topic><topic>Bronchodilator Agents - adverse effects</topic><topic>Chronic obstructive pulmonary disease</topic><topic>Clinical medicine</topic><topic>Clinical trials</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>COPD</topic><topic>Dyspnea</topic><topic>exacerbation</topic><topic>Female</topic><topic>Fluticasone-Salmeterol Drug Combination - administration & dosage</topic><topic>Fluticasone-Salmeterol Drug Combination - adverse effects</topic><topic>Forced Expiratory Volume</topic><topic>Glycopyrrolate - administration & dosage</topic><topic>Glycopyrrolate - adverse effects</topic><topic>Humans</topic><topic>Indans - administration & dosage</topic><topic>Indans - adverse effects</topic><topic>LABA/ICS</topic><topic>LABA/LAMA</topic><topic>Lung - drug effects</topic><topic>Lung - physiopathology</topic><topic>Lung diseases</topic><topic>lung function</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Muscarinic Antagonists - administration & dosage</topic><topic>Muscarinic Antagonists - adverse effects</topic><topic>Original Research</topic><topic>Patients</topic><topic>Pulmonary Disease, Chronic Obstructive - complications</topic><topic>Pulmonary Disease, Chronic Obstructive - diagnosis</topic><topic>Pulmonary Disease, Chronic Obstructive - drug therapy</topic><topic>Pulmonary Disease, Chronic Obstructive - physiopathology</topic><topic>Quinolones - administration & dosage</topic><topic>Quinolones - adverse effects</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Recovery of Function</topic><topic>Severity of Illness Index</topic><topic>Spirometry</topic><topic>Statistical analysis</topic><topic>Steroids</topic><topic>Surveys and Questionnaires</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Values</topic><topic>Vital Capacity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vogelmeier, Claus</creatorcontrib><creatorcontrib>Zhong, Nanshan</creatorcontrib><creatorcontrib>Humphries, Michael J</creatorcontrib><creatorcontrib>Mezzi, Karen</creatorcontrib><creatorcontrib>Fogel, Robert</creatorcontrib><creatorcontrib>Bader, Giovanni</creatorcontrib><creatorcontrib>Patalano, Francesco</creatorcontrib><creatorcontrib>Banerji, Donald</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Alumni)</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</collection><collection>Publicly Available Content Database</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>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>International journal of chronic obstructive pulmonary disease</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vogelmeier, Claus</au><au>Zhong, Nanshan</au><au>Humphries, Michael J</au><au>Mezzi, Karen</au><au>Fogel, Robert</au><au>Bader, Giovanni</au><au>Patalano, Francesco</au><au>Banerji, Donald</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Indacaterol/glycopyrronium in symptomatic patients with COPD (GOLD B and GOLD D) versus salmeterol/fluticasone: ILLUMINATE/LANTERN pooled analysis</atitle><jtitle>International journal of chronic obstructive pulmonary disease</jtitle><addtitle>Int J Chron Obstruct Pulmon Dis</addtitle><date>2016-01-01</date><risdate>2016</risdate><volume>11</volume><spage>3189</spage><epage>3197</epage><pages>3189-3197</pages><issn>1178-2005</issn><issn>1176-9106</issn><eissn>1178-2005</eissn><abstract>Indacaterol/glycopyrronium (IND/GLY) is approved for maintenance treatment of adult patients with COPD. This post hoc analysis explored the efficacy and safety of IND/GLY versus salmeterol/fluticasone (SFC) in symptomatic (Global Initiative for Chronic Obstructive Lung Disease [GOLD] B and GOLD D) patients with moderate-to-severe COPD.
Data from LANTERN and ILLUMINATE studies were pooled and analyzed. In both studies, symptomatic COPD patients were randomized to once-daily IND/GLY 110 μg/50 μg or twice-daily SFC 50 μg/500 μg. End points were pre-dose trough forced expiratory volume in one second (FEV
), standardized area under the curve for FEV
from 0 to 12 hours (FEV
AUC
hours), peak FEV
, peak forced vital capacity (FVC), pre-dose trough FVC, Transition Dyspnea Index (TDI) total score, St George's Respiratory Questionnaire total score, rescue medication use and safety.
A total of 1,263 patients were classified as either GOLD B (n=809) or GOLD D (n=454). At week 26, IND/GLY demonstrated statistically significant improvement in all lung function parameters versus SFC in patients in both the GOLD B and GOLD D subgroups. TDI total score and rescue medication use were significantly improved with IND/GLY versus SFC in the overall population and in the GOLD B (TDI total score only) and GOLD D (rescue medication only) subgroups. IND/GLY also reduced the rate of exacerbations in the pooled population. Overall safety profile was comparable with a higher incidence of pneumonia in the SFC-treated group.
In this pooled analysis, IND/GLY demonstrated superior efficacy compared with SFC in patients in the GOLD B and GOLD D subgroups and supported its use in symptomatic COPD patients.</abstract><cop>New Zealand</cop><pub>Dove Medical Press Ltd</pub><pmid>28008244</pmid><doi>10.2147/COPD.S116786</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1178-2005 |
| ispartof | International journal of chronic obstructive pulmonary disease, 2016-01, Vol.11, p.3189-3197 |
| issn | 1178-2005 1176-9106 1178-2005 |
| language | eng |
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| source | Taylor & Francis Open Access; Publicly Available Content Database; PubMed Central |
| subjects | Adrenergic beta-2 Receptor Agonists - administration & dosage Adrenergic beta-2 Receptor Agonists - adverse effects Aged Bronchodilator Agents - administration & dosage Bronchodilator Agents - adverse effects Chronic obstructive pulmonary disease Clinical medicine Clinical trials Clinical Trials, Phase III as Topic COPD Dyspnea exacerbation Female Fluticasone-Salmeterol Drug Combination - administration & dosage Fluticasone-Salmeterol Drug Combination - adverse effects Forced Expiratory Volume Glycopyrrolate - administration & dosage Glycopyrrolate - adverse effects Humans Indans - administration & dosage Indans - adverse effects LABA/ICS LABA/LAMA Lung - drug effects Lung - physiopathology Lung diseases lung function Male Middle Aged Muscarinic Antagonists - administration & dosage Muscarinic Antagonists - adverse effects Original Research Patients Pulmonary Disease, Chronic Obstructive - complications Pulmonary Disease, Chronic Obstructive - diagnosis Pulmonary Disease, Chronic Obstructive - drug therapy Pulmonary Disease, Chronic Obstructive - physiopathology Quinolones - administration & dosage Quinolones - adverse effects Randomized Controlled Trials as Topic Recovery of Function Severity of Illness Index Spirometry Statistical analysis Steroids Surveys and Questionnaires Time Factors Treatment Outcome Values Vital Capacity |
| title | Indacaterol/glycopyrronium in symptomatic patients with COPD (GOLD B and GOLD D) versus salmeterol/fluticasone: ILLUMINATE/LANTERN pooled analysis |
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