Tiotropium/Olodaterol Delays Clinically Important Deterioration Compared with Tiotropium Monotherapy in Patients with Early COPD: a Post Hoc Analysis of the TONADO ® Trials.
| Autor: | Rabe KF; LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany. k.f.rabe@lungenclinic.de.; Christian Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Kiel, Germany. k.f.rabe@lungenclinic.de., Chalmers JD; Tayside Respiratory Research Group, University of Dundee, Dundee, UK., Miravitlles M; Pneumology Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.; CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain., Kocks JWH; General Practitioners Research Institute, Groningen, The Netherlands.; Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.; Observational and Pragmatic Research Institute, Singapore, Singapore., Tsiligianni I; Health Planning Unit, Department of Social Medicine, Faculty of Medicine, University of Crete, Crete, Greece., de la Hoz A; Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany., Xue W; Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA., Singh D; Medicines Evaluation Unit (MEU), University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK., Ferguson GT; Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA., Wedzicha J; Respiratory Division, National Heart and Lung Institute, Imperial College London, London, UK. |
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| Jazyk: | angličtina |
| Zdroj: | Advances in therapy [Adv Ther] 2021 Jan; Vol. 38 (1), pp. 579-593. Date of Electronic Publication: 2020 Nov 11. |
| DOI: | 10.1007/s12325-020-01528-2 |
| Abstrakt: | Introduction: Since chronic obstructive pulmonary disease (COPD) is a heterogeneous condition, a composite endpoint of clinically important deterioration (CID) may provide a more holistic assessment of treatment efficacy. We compared long-acting muscarinic antagonist/long-acting β Methods: Data were analysed from 2055 patients treated with either tiotropium/olodaterol 5/5 μg or tiotropium 5 μg (delivered via Respimat ® ) in two replicate, 52-week, parallel-group, double-blind studies (TONADO ® 1/2). CID was defined as a decline of at least 0.1 L from baseline in trough forced expiratory volume in 1 s, increase from baseline of at least 4 units in St. George's Respiratory Questionnaire score, or moderate/severe exacerbation. Time to first occurrence of one of these events was recorded as time to first CID. Results: Overall, treatment with tiotropium/olodaterol significantly increased the time to, and reduced the risk of, CID versus tiotropium (median time to CID 226 versus 169 days; hazard ratio [HR] 0.76 [95% confidence interval 0.68, 0.85]; P < 0.0001). Significant reductions were also observed in patients with low exacerbation history (241 versus 170; HR 0.73 [0.64, 0.83]; P < 0.0001), GOLD 2 patients (241 versus 169; 0.72 [0.61, 0.84]; P < 0.0001) and maintenance-naïve patients (233 versus 171; 0.75 [0.62, 0.91]; P = 0.0030). Conclusion: In patients with COPD, including patients with low exacerbation history, GOLD 2 patients and maintenance-naïve patients, tiotropium/olodaterol reduced the risk of CID versus tiotropium. These results demonstrate the advantages of treatment optimisation with tiotropium/olodaterol over tiotropium monotherapy. Trial Registration: ClinicalTrials.gov identifier: TONADO ® 1 and 2 (NCT01431274 and NCT01431287, registered 8 September 2011). |
| Databáze: | MEDLINE |
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