Safety and tolerability of once-daily tiotropium Respimat(®) as add-on to at least inhaled corticosteroids in adult patients with symptomatic asthma: A pooled safety analysis.
Identifieur interne : 001956 ( PubMed/Corpus ); précédent : 001955; suivant : 001957Safety and tolerability of once-daily tiotropium Respimat(®) as add-on to at least inhaled corticosteroids in adult patients with symptomatic asthma: A pooled safety analysis.
Auteurs : Ronald Dahl ; Michael Engel ; Daniel Dusser ; David Halpin ; Huib A M. Kerstjens ; Liliana Zaremba-Pechmann ; Petra Moroni-Zentgraf ; William W. Busse ; Eric D. BatemanSource :
- Respiratory medicine [ 1532-3064 ] ; 2016.
Abstract
Tiotropium, a long-acting anticholinergic bronchodilator, has demonstrated efficacy and safety as add-on therapy to inhaled corticosteroids (ICS), with or without other maintenance therapies, in patients with symptomatic asthma.
DOI: 10.1016/j.rmed.2016.07.001
PubMed: 27578478
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Safety and tolerability of once-daily tiotropium Respimat(®) as add-on to at least inhaled corticosteroids in adult patients with symptomatic asthma: A pooled safety analysis.</title><author><name sortKey="Dahl, Ronald" sort="Dahl, Ronald" uniqKey="Dahl R" first="Ronald" last="Dahl">Ronald Dahl</name><affiliation><nlm:affiliation>Odense University Hospital, University of Southern Denmark, Sdr Boulevard, DK 5000, Odense C, Denmark. Electronic address: ronald.dahl2@rsyd.dk.</nlm:affiliation></affiliation></author><author><name sortKey="Engel, Michael" sort="Engel, Michael" uniqKey="Engel M" first="Michael" last="Engel">Michael Engel</name><affiliation><nlm:affiliation>TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Str. 173, 55216, Ingelheim, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Dusser, Daniel" sort="Dusser, Daniel" uniqKey="Dusser D" first="Daniel" last="Dusser">Daniel Dusser</name><affiliation><nlm:affiliation>Pulmonary Department and Adult Cystic Fibrosis Center, Paris Descartes University, Sorbonne Paris Cité, Cochin Hospital, 27 Rue du Fg St Jacques, 75014, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Halpin, David" sort="Halpin, David" uniqKey="Halpin D" first="David" last="Halpin">David Halpin</name><affiliation><nlm:affiliation>Royal Devon & Exeter Hospital, Barrack Rd, Exeter, Devon, EX2 5DW, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Kerstjens, Huib A M" sort="Kerstjens, Huib A M" uniqKey="Kerstjens H" first="Huib A M" last="Kerstjens">Huib A M. Kerstjens</name><affiliation><nlm:affiliation>University of Groningen, Department of Pulmonary Medicine, and Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, Postbox 30.001, 9700 RB, Groningen, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Zaremba Pechmann, Liliana" sort="Zaremba Pechmann, Liliana" uniqKey="Zaremba Pechmann L" first="Liliana" last="Zaremba-Pechmann">Liliana Zaremba-Pechmann</name><affiliation><nlm:affiliation>Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstrasse 65, 88397, Biberach an der Riss, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Moroni Zentgraf, Petra" sort="Moroni Zentgraf, Petra" uniqKey="Moroni Zentgraf P" first="Petra" last="Moroni-Zentgraf">Petra Moroni-Zentgraf</name><affiliation><nlm:affiliation>TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Str. 173, 55216, Ingelheim, Germany; Boehringer Ingelheim Pty Limited, Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Busse, William W" sort="Busse, William W" uniqKey="Busse W" first="William W" last="Busse">William W. Busse</name><affiliation><nlm:affiliation>University of Wisconsin School of Medicine and Public Health, 600 Highland Ave, Madison, WI 53792, Wisconsin, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Bateman, Eric D" sort="Bateman, Eric D" uniqKey="Bateman E" first="Eric D" last="Bateman">Eric D. Bateman</name><affiliation><nlm:affiliation>Department of Medicine, University of Cape Town, Mowbray, 7700, Cape Town, South Africa.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27578478</idno><idno type="pmid">27578478</idno><idno type="doi">10.1016/j.rmed.2016.07.001</idno><idno type="wicri:Area/PubMed/Corpus">001956</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001956</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Safety and tolerability of once-daily tiotropium Respimat(®) as add-on to at least inhaled corticosteroids in adult patients with symptomatic asthma: A pooled safety analysis.</title><author><name sortKey="Dahl, Ronald" sort="Dahl, Ronald" uniqKey="Dahl R" first="Ronald" last="Dahl">Ronald Dahl</name><affiliation><nlm:affiliation>Odense University Hospital, University of Southern Denmark, Sdr Boulevard, DK 5000, Odense C, Denmark. Electronic address: ronald.dahl2@rsyd.dk.</nlm:affiliation></affiliation></author><author><name sortKey="Engel, Michael" sort="Engel, Michael" uniqKey="Engel M" first="Michael" last="Engel">Michael Engel</name><affiliation><nlm:affiliation>TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Str. 173, 55216, Ingelheim, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Dusser, Daniel" sort="Dusser, Daniel" uniqKey="Dusser D" first="Daniel" last="Dusser">Daniel Dusser</name><affiliation><nlm:affiliation>Pulmonary Department and Adult Cystic Fibrosis Center, Paris Descartes University, Sorbonne Paris Cité, Cochin Hospital, 27 Rue du Fg St Jacques, 75014, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Halpin, David" sort="Halpin, David" uniqKey="Halpin D" first="David" last="Halpin">David Halpin</name><affiliation><nlm:affiliation>Royal Devon & Exeter Hospital, Barrack Rd, Exeter, Devon, EX2 5DW, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Kerstjens, Huib A M" sort="Kerstjens, Huib A M" uniqKey="Kerstjens H" first="Huib A M" last="Kerstjens">Huib A M. Kerstjens</name><affiliation><nlm:affiliation>University of Groningen, Department of Pulmonary Medicine, and Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, Postbox 30.001, 9700 RB, Groningen, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Zaremba Pechmann, Liliana" sort="Zaremba Pechmann, Liliana" uniqKey="Zaremba Pechmann L" first="Liliana" last="Zaremba-Pechmann">Liliana Zaremba-Pechmann</name><affiliation><nlm:affiliation>Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstrasse 65, 88397, Biberach an der Riss, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Moroni Zentgraf, Petra" sort="Moroni Zentgraf, Petra" uniqKey="Moroni Zentgraf P" first="Petra" last="Moroni-Zentgraf">Petra Moroni-Zentgraf</name><affiliation><nlm:affiliation>TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Str. 173, 55216, Ingelheim, Germany; Boehringer Ingelheim Pty Limited, Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Busse, William W" sort="Busse, William W" uniqKey="Busse W" first="William W" last="Busse">William W. Busse</name><affiliation><nlm:affiliation>University of Wisconsin School of Medicine and Public Health, 600 Highland Ave, Madison, WI 53792, Wisconsin, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Bateman, Eric D" sort="Bateman, Eric D" uniqKey="Bateman E" first="Eric D" last="Bateman">Eric D. Bateman</name><affiliation><nlm:affiliation>Department of Medicine, University of Cape Town, Mowbray, 7700, Cape Town, South Africa.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Respiratory medicine</title><idno type="eISSN">1532-3064</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Tiotropium, a long-acting anticholinergic bronchodilator, has demonstrated efficacy and safety as add-on therapy to inhaled corticosteroids (ICS), with or without other maintenance therapies, in patients with symptomatic asthma.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">27578478</PMID><DateCreated><Year>2016</Year><Month>08</Month><Day>31</Day></DateCreated><DateRevised><Year>2017</Year><Month>07</Month><Day>11</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1532-3064</ISSN><JournalIssue CitedMedium="Internet"><Volume>118</Volume><PubDate><Year>2016</Year><Month>Sep</Month></PubDate></JournalIssue><Title>Respiratory medicine</Title><ISOAbbreviation>Respir Med</ISOAbbreviation></Journal><ArticleTitle>Safety and tolerability of once-daily tiotropium Respimat(®) as add-on to at least inhaled corticosteroids in adult patients with symptomatic asthma: A pooled safety analysis.</ArticleTitle><Pagination><MedlinePgn>102-111</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0954-6111(16)30148-2</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.rmed.2016.07.001</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Tiotropium, a long-acting anticholinergic bronchodilator, has demonstrated efficacy and safety as add-on therapy to inhaled corticosteroids (ICS), with or without other maintenance therapies, in patients with symptomatic asthma.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To evaluate safety and tolerability of tiotropium delivered via the Respimat(®) device, compared with placebo, each as add-on to at least ICS therapy, in a pooled sample of adults with symptomatic asthma at different treatment steps.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Data were pooled from seven Phase II and III, randomised, double-blind, parallel-group trials of 12-52 weeks' treatment duration, which investigated once-daily tiotropium Respimat(®) (5 μg, 2.5 μg) versus placebo as add-on to different background maintenance therapy including at least ICS. Adverse events (AEs) including serious AEs were assessed throughout treatment + 30 days after the last dose of trial medication.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Of 3474 patients analysed, 2157 received tiotropium. The percentage of patients with AEs was comparable between treatment groups: tiotropium 5 μg, 60.8%; placebo 5 μg pool, 62.5%; tiotropium 2.5 μg, 57.1%; placebo 2.5 μg pool, 55.1%. Consistent with the disease profile, the most frequent AEs overall were asthma, decreased peak expiratory flow rate (both less frequent with tiotropium) and nasopharyngitis. Overall incidence of dry mouth, commonly associated with use of anticholinergics, was low: tiotropium 5 μg, 1.0%; placebo 5 μg pool, 0.5%; tiotropium 2.5 μg, 0.4%; placebo 2.5 μg pool, 0.5%. The percentage of cardiac disorder AEs was comparable between tiotropium and placebo: tiotropium 5 μg, 1.4%; placebo 5 μg pool, 1.4%; tiotropium 2.5 μg, 1.4%; placebo 2.5 μg pool, 1.1%. The proportions of patients with serious AEs were balanced across groups: tiotropium 5 μg, 4.0%; placebo 5 μg pool, 4.9%; tiotropium 2.5 μg, 2.0%; placebo 2.5 μg pool, 3.3%.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Tiotropium Respimat(®) demonstrated safety and tolerability comparable with those of placebo, as add-on to at least ICS therapy, at different treatment steps in adults with symptomatic asthma.</AbstractText><CopyrightInformation>Copyright © 2016 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Dahl</LastName><ForeName>Ronald</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Odense University Hospital, University of Southern Denmark, Sdr Boulevard, DK 5000, Odense C, Denmark. Electronic address: ronald.dahl2@rsyd.dk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Engel</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Str. 173, 55216, Ingelheim, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dusser</LastName><ForeName>Daniel</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Pulmonary Department and Adult Cystic Fibrosis Center, Paris Descartes University, Sorbonne Paris Cité, Cochin Hospital, 27 Rue du Fg St Jacques, 75014, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Halpin</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Royal Devon & Exeter Hospital, Barrack Rd, Exeter, Devon, EX2 5DW, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kerstjens</LastName><ForeName>Huib A M</ForeName><Initials>HAM</Initials><AffiliationInfo><Affiliation>University of Groningen, Department of Pulmonary Medicine, and Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, Postbox 30.001, 9700 RB, Groningen, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zaremba-Pechmann</LastName><ForeName>Liliana</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstrasse 65, 88397, Biberach an der Riss, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Moroni-Zentgraf</LastName><ForeName>Petra</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Str. 173, 55216, Ingelheim, Germany; Boehringer Ingelheim Pty Limited, Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Busse</LastName><ForeName>William W</ForeName><Initials>WW</Initials><AffiliationInfo><Affiliation>University of Wisconsin School of Medicine and Public Health, 600 Highland Ave, Madison, WI 53792, Wisconsin, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bateman</LastName><ForeName>Eric D</ForeName><Initials>ED</Initials><AffiliationInfo><Affiliation>Department of Medicine, University of Cape Town, Mowbray, 7700, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>07</Month><Day>02</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Respir Med</MedlineTA><NlmUniqueID>8908438</NlmUniqueID><ISSNLinking>0954-6111</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Asthma</Keyword><Keyword MajorTopicYN="N">Respimat(®)</Keyword><Keyword MajorTopicYN="N">Safety</Keyword><Keyword MajorTopicYN="N">Tiotropium</Keyword><Keyword MajorTopicYN="N">Tolerability</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>03</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>06</Month><Day>10</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>07</Month><Day>01</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>9</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>9</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>9</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27578478</ArticleId><ArticleId IdType="pii">S0954-6111(16)30148-2</ArticleId><ArticleId IdType="doi">10.1016/j.rmed.2016.07.001</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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