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Efficacy of tiotropium–olodaterol fixed-dose combination in COPD

Authors Derom E, Brusselle GG, Joos GF

Received 9 July 2016

Accepted for publication 20 October 2016

Published 13 December 2016 Volume 2016:11(1) Pages 3163—3177

DOI https://doi.org/10.2147/COPD.S92840

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Amy Norman

Peer reviewer comments 6

Editor who approved publication: Dr Richard Russell


Eric Derom, Guy G Brusselle, Guy F Joos

Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium

Abstract: Tiotropium–olodaterol, formulated in the Respimat soft-mist inhaler, is an inhaled fixed-dose combination (FDC) of a long-acting muscarinic antagonist (LAMA) and a long-acting β2-agonist (LABA), commercialized under the name of Spiolto or Stiolto. The efficacy of tiotropium–olodaterol 5–5 µg once daily in adult patients with COPD was documented in eleven large, multicenter trials of up to 52 weeks duration. Tiotropium–olodaterol 5–5 µg not only improved spirometric values to a significantly greater extent than placebo but also resulted in statistically significant beneficial effects on dyspnea, markers of hyperinflation, use of rescue medication, health-related quality of life, and exercise endurance. Improvements exceeded the minimal clinically important difference (MCID) for forced expiratory volume in 1 second (FEV1), dyspnea, and quality of life. Differences between tiotropium–olodaterol 5–5 µg and the respective monocomponents were statistically significant for FEV1, dyspnea, markers of hyperinflation, use of rescue medication, and health-related quality of life, but did not reach the MCID. However, dual bronchodilatation significantly increased the number of patients who exceeded the MCID for dyspnea and quality of life. Moreover, tiotropium–olodaterol 5–5 µg was significantly more effective than salmeterol–fluticasone (FDC) twice daily at improving pulmonary function. Differences between tiotropium–olodaterol and other LAMA/LABA FDCs were not observed for FEV1 or other efficacy markers. Therefore, tiotropium–olodaterol is a valuable option in the treatment of COPD patients who remain symptomatic under monotherapy.

Keywords: COPD, bronchodilatation, dyspnea, exacerbation, exercise tolerance, LABA, LAMA, spirometry

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