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Characterisation and impact of reported and unreported exacerbations: results from ATTAIN

Paul W. Jones, Rosa Lamarca, Ferran Chuecos, Dave Singh, Alvar Agustí, Eric D. Bateman, Gonzalo de Miquel, Cynthia Caracta, Esther Garcia Gil
European Respiratory Journal 2014; DOI: 10.1183/09031936.00038814
Paul W. Jones
1Division of Clinical Science, St George’s, University of London, London, UK
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Rosa Lamarca
2R&D Centre, Almirall, Barcelona, Spain
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Ferran Chuecos
2R&D Centre, Almirall, Barcelona, Spain
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Dave Singh
3Medicines Evaluation Unit, University Hospital of South Manchester, Manchester, UK
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Alvar Agustí
4Thorax Institute, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain
5FISIB, Centro de Investigación Biomédica en Red Enfermedades Respiratorias (CIBERES), Mallorca, Spain
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Eric D. Bateman
6Dept of Medicine, University of Cape Town, Cape Town, South Africa
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Gonzalo de Miquel
2R&D Centre, Almirall, Barcelona, Spain
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Cynthia Caracta
7Forest Research Institute, Forest Laboratories Inc., Jersey City, NJ, USA
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Esther Garcia Gil
2R&D Centre, Almirall, Barcelona, Spain
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Abstract

The frequency and impact of exacerbations identified using healthcare resource utilisation (HCRU) or the EXAcerbations of Chronic pulmonary disease Tool (EXACT) were compared prospectively in a 24-week, phase III trial (ATTAIN). Patients with moderate-to-severe chronic obstructive pulmonary disease received twice-daily aclidinium 200 μg, aclidinium 400 μg or placebo. All HCRU events were reported to physicians. “EXACT-identified” events were categorised as “EXACT-reported” (detected by EXACT and reported to the physician) and “EXACT-unreported” (detected but not reported). Health status was measured using the St George’s Respiratory Questionnaire (SGRQ).

Annualised EXACT-identified event rates were higher in all study arms (placebo 1.39, aclidinium 200 μg 1.00 and aclidinium 400 μg 0.98 per patient per year) versus HCRU (placebo 0.60, aclidinium 200 μg 0.43 and aclidinium 400 μg 0.40 per patient per year). Concordance between methods was low (kappa 0.16). Aclidinium reduced EXACT-identified events (rate ratio versus placebo: aclidinium 200 μg 0.72 and aclidinium 400 μg 0.71; both p<0.05); HCRU events were similarly reduced.

At week 24, SGRQ scores improved (-6.6 versus baseline) in patients with no event during weeks 1–12; improvements were significantly smaller in patients with HCRU events (-3.4; p = 0.036) or EXACT-unreported events (-3.0; p = 0.002).

Unreported events were more frequent than reported events. Both had similar negative impact on health status. Aclidinium reduced the frequency of both types of event.

Abstract

There are twice as many unreported exacerbation events as reported events; both have similar impact on health status http://ow.ly/AwJVf

  • Received February 26, 2014.
  • Accepted August 11, 2014.
  • ©ERS
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Characterisation and impact of reported and unreported exacerbations: results from ATTAIN
Paul W. Jones, Rosa Lamarca, Ferran Chuecos, Dave Singh, Alvar Agustí, Eric D. Bateman, Gonzalo de Miquel, Cynthia Caracta, Esther Garcia Gil
European Respiratory Journal Jan 2014, erj00388-2014; DOI: 10.1183/09031936.00038814

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Characterisation and impact of reported and unreported exacerbations: results from ATTAIN
Paul W. Jones, Rosa Lamarca, Ferran Chuecos, Dave Singh, Alvar Agustí, Eric D. Bateman, Gonzalo de Miquel, Cynthia Caracta, Esther Garcia Gil
European Respiratory Journal Jan 2014, erj00388-2014; DOI: 10.1183/09031936.00038814
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