Efficacy and Safety of Aclidinium/Formoterol versus Tiotropium in COPD: Results of an Indirect Treatment Comparison
Identifieur interne : 000066 ( Main/Exploration ); précédent : 000065; suivant : 000067Efficacy and Safety of Aclidinium/Formoterol versus Tiotropium in COPD: Results of an Indirect Treatment Comparison
Auteurs : Goran Medic [Pays-Bas] ; Leandro Lindner [Espagne] ; Miriam Van Der Weijden [Pays-Bas] ; Andreas Karabis [Pays-Bas]Source :
- Advances in Therapy [ 0741-238X ] ; 2016.
Abstract
The objective of this study was to estimate the relative efficacy and safety of fixed-dose combination aclidinium/formoterol 400/12 μg twice daily compared to tiotropium 18 μg once daily in adult patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
A systematic literature review performed in March 2014, using a predefined search strategy in MEDLINE, EMBASE and Cochrane Library, identified 17 randomized placebo-controlled trials, (tiotropium
Regarding bronchodilation, aclidinium/formoterol was found to be more efficacious than tiotropium at peak FEV1, with mean difference in change from baseline (DCFB) 143 mL [95% credible interval (CrI): 112, 174] and at trough FEV1 [DCFB 26 mL (95% CrI −2, 55)]. Aclidinium/formoterol is expected to be more efficacious than tiotropium in improving dyspnea symptoms measured by TDI [DCFB 0.54 points (95% CrI 0.09, 0.99); odds ratio (OR) of responders 1.51 (95% CrI 1.11, 2.06)]. SGRQ results are comparable for aclidinium/formoterol versus tiotropium [DCFB −0.52 (95% CrI −2.21, 1.17); OR of responders 1.16 (95% CrI 0.47, 2.87)]. The ITC results suggest similar safety profiles regarding AEs, SAEs and hospitalization.
Based on the ITC, aclidinium/formoterol is expected to be more efficacious than tiotropium in terms of lung function and symptom control while providing comparable HRQoL results and safety profile.
AstraZeneca.
The online version of this article (doi:10.1007/s12325-016-0299-4) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1007/s12325-016-0299-4
PubMed: 26883661
PubMed Central: 4833795
Affiliations:
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type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Van Der Weijden, Miriam" sort="Van Der Weijden, Miriam" uniqKey="Van Der Weijden M" first="Miriam" last="Van Der Weijden">Miriam Van Der Weijden</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Real World Strategy and Analytics, Mapi Group, Houten, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Real World Strategy and Analytics, Mapi Group, Houten</wicri:regionArea><wicri:noRegion>Houten</wicri:noRegion></affiliation></author><author><name sortKey="Karabis, Andreas" sort="Karabis, Andreas" uniqKey="Karabis A" first="Andreas" last="Karabis">Andreas Karabis</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Real World Strategy and Analytics, Mapi Group, Houten, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Real World Strategy and Analytics, Mapi Group, 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xml:lang="en" level="a" type="main">Efficacy and Safety of Aclidinium/Formoterol versus Tiotropium in COPD: Results of an Indirect Treatment Comparison</title><author><name sortKey="Medic, Goran" sort="Medic, Goran" uniqKey="Medic G" first="Goran" last="Medic">Goran Medic</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Real World Strategy and Analytics, Mapi Group, Houten, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Real World Strategy and Analytics, Mapi Group, Houten</wicri:regionArea><wicri:noRegion>Houten</wicri:noRegion></affiliation></author><author><name sortKey="Lindner, Leandro" sort="Lindner, Leandro" uniqKey="Lindner L" first="Leandro" last="Lindner">Leandro Lindner</name><affiliation wicri:level="3"><nlm:aff id="Aff2">AstraZeneca, Barcelona, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>AstraZeneca, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Van Der Weijden, Miriam" sort="Van Der Weijden, Miriam" uniqKey="Van Der Weijden M" first="Miriam" last="Van Der Weijden">Miriam Van Der Weijden</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Real World Strategy and Analytics, Mapi Group, Houten, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Real World Strategy and Analytics, Mapi Group, Houten</wicri:regionArea><wicri:noRegion>Houten</wicri:noRegion></affiliation></author><author><name sortKey="Karabis, Andreas" sort="Karabis, Andreas" uniqKey="Karabis A" first="Andreas" last="Karabis">Andreas Karabis</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Real World Strategy and Analytics, Mapi Group, Houten, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Real World Strategy and Analytics, Mapi Group, Houten</wicri:regionArea><wicri:noRegion>Houten</wicri:noRegion></affiliation></author></analytic><series><title level="j">Advances in Therapy</title><idno type="ISSN">0741-238X</idno><idno type="eISSN">1865-8652</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Introduction</title><p>The objective of this study was to estimate the relative efficacy and safety of fixed-dose combination aclidinium/formoterol 400/12 μg twice daily compared to tiotropium 18 μg once daily in adult patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).</p></sec><sec><title>Methods</title><p>A systematic literature review performed in March 2014, using a predefined search strategy in MEDLINE, EMBASE and Cochrane Library, identified 17 randomized placebo-controlled trials, (tiotropium <italic>n</italic> = 15; aclidinium/formoterol <italic>n</italic> = 2). Outcomes of interest were: bronchodilation (peak and trough forced expiratory volume in 1 s (FEV<sub>1</sub>)), COPD symptoms [Transition Dyspnea Index (TDI) focal score and % of responders (>1 unit improvement)] and Health Related Quality of Life (HRQoL) [St. George’s Respiratory Questionnaire (SGRQ) total score and % responders (>4 unit improvement)], % of patients with ≥1 exacerbations, adverse events (AE), serious adverse events (SAE), hospitalization and mortality, all at 24 weeks. In the absence of head-to-head trials between aclidinium/formoterol and tiotropium, a Bayesian indirect treatment comparison (ITC) was used with placebo as common control.</p></sec><sec><title>Results</title><p>Regarding bronchodilation, aclidinium/formoterol was found to be more efficacious than tiotropium at peak FEV<sub>1</sub>, with mean difference in change from baseline (DCFB) 143 mL [95% credible interval (CrI): 112, 174] and at trough FEV<sub>1</sub> [DCFB 26 mL (95% CrI −2, 55)]. Aclidinium/formoterol is expected to be more efficacious than tiotropium in improving dyspnea symptoms measured by TDI [DCFB 0.54 points (95% CrI 0.09, 0.99); odds ratio (OR) of responders 1.51 (95% CrI 1.11, 2.06)]. SGRQ results are comparable for aclidinium/formoterol versus tiotropium [DCFB −0.52 (95% CrI −2.21, 1.17); OR of responders 1.16 (95% CrI 0.47, 2.87)]. The ITC results suggest similar safety profiles regarding AEs, SAEs and hospitalization.</p></sec><sec><title>Conclusion</title><p>Based on the ITC, aclidinium/formoterol is expected to be more efficacious than tiotropium in terms of lung function and symptom control while providing comparable HRQoL results and safety profile.</p></sec><sec><title>Funding</title><p>AstraZeneca.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1007/s12325-016-0299-4) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Bhowmik, A" uniqKey="Bhowmik A">A Bhowmik</name></author><author><name sortKey="Seemungal, Ta" uniqKey="Seemungal T">TA Seemungal</name></author><author><name sortKey="Sapsford, Rj" uniqKey="Sapsford R">RJ Sapsford</name></author><author><name sortKey="Wedzicha, Ja" uniqKey="Wedzicha J">JA 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sortKey="Decramer, M" uniqKey="Decramer M">M Decramer</name></author><author><name sortKey="Anzueto, A" uniqKey="Anzueto A">A Anzueto</name></author><author><name sortKey="Kerwin, E" uniqKey="Kerwin E">E Kerwin</name></author><author><name sortKey="Kaelin, T" uniqKey="Kaelin T">T Kaelin</name></author><author><name sortKey="Richard, N" uniqKey="Richard N">N Richard</name></author><author><name sortKey="Crater, G" uniqKey="Crater G">G Crater</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Maleki Yazdi, Mr" uniqKey="Maleki Yazdi M">MR Maleki-Yazdi</name></author><author><name sortKey="Kaelin, T" uniqKey="Kaelin T">T Kaelin</name></author><author><name sortKey="Richard, N" uniqKey="Richard N">N Richard</name></author><author><name sortKey="Zvarich, M" uniqKey="Zvarich M">M Zvarich</name></author><author><name sortKey="Church, A" uniqKey="Church A">A Church</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jones, Pw" uniqKey="Jones P">PW Jones</name></author><author><name sortKey="Beeh, Km" uniqKey="Beeh K">KM Beeh</name></author><author><name sortKey="Chapman, Kr" uniqKey="Chapman K">KR Chapman</name></author><author><name sortKey="Decramer, M" uniqKey="Decramer M">M Decramer</name></author><author><name sortKey="Mahler, Da" uniqKey="Mahler D">DA Mahler</name></author><author><name sortKey="Wedzicha, Ja" uniqKey="Wedzicha J">JA Wedzicha</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Espagne</li><li>Pays-Bas</li></country><region><li>Catalogne</li></region><settlement><li>Barcelone</li></settlement></list><tree><country name="Pays-Bas"><noRegion><name sortKey="Medic, Goran" sort="Medic, Goran" uniqKey="Medic G" first="Goran" last="Medic">Goran Medic</name></noRegion><name sortKey="Karabis, Andreas" sort="Karabis, Andreas" uniqKey="Karabis A" first="Andreas" last="Karabis">Andreas Karabis</name><name sortKey="Van Der Weijden, Miriam" sort="Van Der Weijden, Miriam" uniqKey="Van Der Weijden M" first="Miriam" last="Van Der Weijden">Miriam Van Der Weijden</name></country><country name="Espagne"><region name="Catalogne"><name sortKey="Lindner, Leandro" sort="Lindner, Leandro" uniqKey="Lindner L" first="Leandro" last="Lindner">Leandro Lindner</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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