Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary diseaseReportar como inadecuado




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Respiratory Research

, 12:55

First Online: 01 December 2011Received: 22 December 2010Accepted: 26 April 2011

Abstract

BackgroundThe long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease COPD.

MethodsIn two double-blind, 52-week studies, ACCLAIM-COPD I n = 843 and II n = 804, patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second FEV1-forced vital capacity ratio of ≤70% and FEV1 <80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George-s Respiratory Questionnaire SGRQ and time to first moderate or severe COPD exacerbation.

ResultsAt 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM-COPD I by 61 and 67 mL; both p < 0.001 and ACCLAIM-COPD II by 63 and 59 mL; both p < 0.001. More patients had a SGRQ improvement ≥4 units at 52 weeks with aclidinium versus placebo in ACCLAIM-COPD I 48.1% versus 39.5%; p = 0.025 and ACCLAIM-COPD II 39.0% versus 32.8%; p = 0.074. The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM-COPD II hazard ratio HR 0.7; 95% confidence interval CI 0.55 to 0.92; p = 0.01, but not ACCLAIM-COPD I HR 1.0; 95% CI 0.72 to 1.33; p = 0.9. Adverse events were minor in both studies.

ConclusionAclidinium is effective and well tolerated in patients with moderate to severe COPD.

Trial registrationClinicalTrials.gov: NCT00363896 ACCLAIM-COPD I and NCT00358436 ACCLAIM-COPD II.

KeywordsAclidinium bromide anticholinergic chronic obstructive pulmonary disease long-acting muscarinic antagonist List of abbreviations usedAEadverse event

ANCOVAanalysis of covariance

ATSAmerican Thoracic Society

BDIBaseline Dyspnoea Index

CIconfidence interval

COPDchronic obstructive pulmonary disease

ECGelectrocardiogram

ERSEuropean Respiratory Society

FEV1forced expiratory volume in 1 second

FVCforced vital capacity

HRhazard ratio

MCIDminimal clinically important difference

SAEserious adverse event

SGRQSt George-s Respiratory Questionnaire

TDITransitional Dyspnoea Index

Electronic supplementary materialThe online version of this article doi:10.1186-1465-9921-12-55 contains supplementary material, which is available to authorized users.

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Autor: Paul W Jones - Stephen I Rennard - Alvar Agusti - Pascal Chanez - Helgo Magnussen - Leonardo Fabbri - James F Donohue -

Fuente: https://link.springer.com/







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