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Efficacy of Tiotropium + Olodaterol in Patients with Chronic Obstructive Pulmonary Disease by Initial Disease Severity and Treatment Intensity: A Post Hoc Analysis.
Adv Ther. 2015 Jun; 32(6):523-36.AT

Abstract

INTRODUCTION

The once-daily long-acting muscarinic antagonist (LAMA) tiotropium and once-daily long-acting β2-agonist (LABA) olodaterol have been studied as a once-daily fixed-dose combination (FDC) in patients with chronic obstructive pulmonary disease (COPD). Two large, 52-week, double-blind, parallel-group studies in patients with moderate-very severe COPD demonstrated that tiotropium + olodaterol significantly improved lung function and symptoms versus the monocomponents. This post hoc analysis determined effects on lung function by prior LAMA or LABA maintenance treatment and initial disease severity.

METHODS

5162 patients were randomized and treated with olodaterol 5 µg, tiotropium 2.5 µg, tiotropium 5 µg, tiotropium + olodaterol 2.5/5 µg, or tiotropium + olodaterol 5/5 µg (all once daily via Respimat(®) inhaler). Primary efficacy (lung-function) end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0-3) and trough FEV1 responses (i.e., change from baseline). Pooled data are presented for the following subgroups: prior maintenance treatment with LAMA or LABA, Global initiative for chronic Obstructive Lung Disease (GOLD) 2 (predicted FEV1 50% to <80%) and 3 (30% to <50%)/4 (<30%), sex, age, and prior use of inhaled corticosteroids.

RESULTS

Tiotropium + olodaterol FDC improved lung function over the monocomponents in patients with GOLD 2 and 3-4 disease, irrespective of prior LAMA or LABA maintenance therapy; most comparisons between FDCs and their respective monocomponents were statistically significant (P < 0.05). FEV1 AUC0-3 and trough FEV1 responses for the individual treatments were generally greater in patients with less severe COPD at baseline.

CONCLUSIONS

Tiotropium + olodaterol 5/5 µg significantly improved FEV1 AUC0-3 and trough FEV1 in all GOLD severity groups compared to olodaterol 5 µg and tiotropium 5 µg alone, irrespective of whether patients had received prior LAMA or LABA maintenance treatment. Improvements from baseline in lung function were generally greater in patients with less severe disease.

FUNDING

Boehringer Ingelheim.

TRIAL REGISTRATION

ClinicalTrials.gov numbers, NCT01431274 and NCT01431287.

Authors+Show Affiliations

Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA, garytferguson@msn.com.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

26112656

Citation

Ferguson, Gary T., et al. "Efficacy of Tiotropium + Olodaterol in Patients With Chronic Obstructive Pulmonary Disease By Initial Disease Severity and Treatment Intensity: a Post Hoc Analysis." Advances in Therapy, vol. 32, no. 6, 2015, pp. 523-36.
Ferguson GT, Fležar M, Korn S, et al. Efficacy of Tiotropium + Olodaterol in Patients with Chronic Obstructive Pulmonary Disease by Initial Disease Severity and Treatment Intensity: A Post Hoc Analysis. Adv Ther. 2015;32(6):523-36.
Ferguson, G. T., Fležar, M., Korn, S., Korducki, L., Grönke, L., Abrahams, R., & Buhl, R. (2015). Efficacy of Tiotropium + Olodaterol in Patients with Chronic Obstructive Pulmonary Disease by Initial Disease Severity and Treatment Intensity: A Post Hoc Analysis. Advances in Therapy, 32(6), 523-36. https://doi.org/10.1007/s12325-015-0218-0
Ferguson GT, et al. Efficacy of Tiotropium + Olodaterol in Patients With Chronic Obstructive Pulmonary Disease By Initial Disease Severity and Treatment Intensity: a Post Hoc Analysis. Adv Ther. 2015;32(6):523-36. PubMed PMID: 26112656.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of Tiotropium + Olodaterol in Patients with Chronic Obstructive Pulmonary Disease by Initial Disease Severity and Treatment Intensity: A Post Hoc Analysis. AU - Ferguson,Gary T, AU - Fležar,Matjaž, AU - Korn,Stephanie, AU - Korducki,Lawrence, AU - Grönke,Lars, AU - Abrahams,Roger, AU - Buhl,Roland, Y1 - 2015/06/26/ PY - 2015/04/24/received PY - 2015/6/27/entrez PY - 2015/6/27/pubmed PY - 2016/1/14/medline SP - 523 EP - 36 JF - Advances in therapy JO - Adv Ther VL - 32 IS - 6 N2 - INTRODUCTION: The once-daily long-acting muscarinic antagonist (LAMA) tiotropium and once-daily long-acting β2-agonist (LABA) olodaterol have been studied as a once-daily fixed-dose combination (FDC) in patients with chronic obstructive pulmonary disease (COPD). Two large, 52-week, double-blind, parallel-group studies in patients with moderate-very severe COPD demonstrated that tiotropium + olodaterol significantly improved lung function and symptoms versus the monocomponents. This post hoc analysis determined effects on lung function by prior LAMA or LABA maintenance treatment and initial disease severity. METHODS: 5162 patients were randomized and treated with olodaterol 5 µg, tiotropium 2.5 µg, tiotropium 5 µg, tiotropium + olodaterol 2.5/5 µg, or tiotropium + olodaterol 5/5 µg (all once daily via Respimat(®) inhaler). Primary efficacy (lung-function) end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0-3) and trough FEV1 responses (i.e., change from baseline). Pooled data are presented for the following subgroups: prior maintenance treatment with LAMA or LABA, Global initiative for chronic Obstructive Lung Disease (GOLD) 2 (predicted FEV1 50% to <80%) and 3 (30% to <50%)/4 (<30%), sex, age, and prior use of inhaled corticosteroids. RESULTS: Tiotropium + olodaterol FDC improved lung function over the monocomponents in patients with GOLD 2 and 3-4 disease, irrespective of prior LAMA or LABA maintenance therapy; most comparisons between FDCs and their respective monocomponents were statistically significant (P < 0.05). FEV1 AUC0-3 and trough FEV1 responses for the individual treatments were generally greater in patients with less severe COPD at baseline. CONCLUSIONS: Tiotropium + olodaterol 5/5 µg significantly improved FEV1 AUC0-3 and trough FEV1 in all GOLD severity groups compared to olodaterol 5 µg and tiotropium 5 µg alone, irrespective of whether patients had received prior LAMA or LABA maintenance treatment. Improvements from baseline in lung function were generally greater in patients with less severe disease. FUNDING: Boehringer Ingelheim. TRIAL REGISTRATION: ClinicalTrials.gov numbers, NCT01431274 and NCT01431287. SN - 1865-8652 UR - https://www.unboundmedicine.com/medline/citation/26112656/Efficacy_of_Tiotropium_+_Olodaterol_in_Patients_with_Chronic_Obstructive_Pulmonary_Disease_by_Initial_Disease_Severity_and_Treatment_Intensity:_A_Post_Hoc_Analysis_ L2 - https://dx.doi.org/10.1007/s12325-015-0218-0 DB - PRIME DP - Unbound Medicine ER -