Despite several long-acting β2-adrenoceptor agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combinations (FDCs) are currently approved for the treatment of chronic obstructive pulmonary disease (COPD), there are limited findings concerning the direct comparison across the different LABA/LAMA FDCs. The aim of this study was to compare the efficacy/safety profile of approved LABA/LAMA FDCs in COPD. A network meta-analysis was performed by linking the efficacy (forced expiratory volume in 1 s, St' George Respiratory Questionnaire, transitional dyspnea index) and safety (cardiovascular serious adverse events) outcomes resulting from randomized controlled trials that directly compared LABA/LAMA FDCs with placebo and/or each other. The Surface Under the Cumulative Ranking Curve Analysis (SUCRA) was performed for each single outcome (SUCRA: 1 = best, 0 = worst). The combined efficacy/safety profile was reported via the novel Improved Bidimensional SUCRA score (IBiS: the higher the value the better the treatment). Data obtained from 12,136 COPD patients (79.50% LABA/LAMA FDCs vs. placebo; 20.50% direct comparison between different LABA/LAMA FDCs) were extracted from 22 studies published between 2013 and 2019. The IBiS score showed the following rank of efficacy/safety profile: tiotropium/olodaterol 5/5 μg (area 66.83%) » glycopyrronium/indacaterol 15.6/27.5 μg (area 40.43%)  >  umeclidinium/vilanterol 62.5/25 μg (area 30.48%)  ≈  aclidinium/formoterol 400/12 μg (area 28.44%)  >  glycopyrronium/indacaterol 50/110 μg (area 19.95%)  >  glycopyrronium/formoterol 14.4/9.6 μg (area 11.50%). Each available LABA/LAMA FDC has a specific efficacy/safety profile that needs to be considered for personalized therapy in COPD. Head-to-head studies aimed to assess the impact of different LABA/LAMA FDCs on the risk of COPD exacerbation are needed to further improve the information provided by this quantitative synthesis.

Rogliani, P., Matera, M.g., Ritondo, B.l., De Guido, I., Puxeddu, E., Cazzola, M., et al. (2019). Efficacy and cardiovascular safety profile of dual bronchodilation therapy in chronic obstructive pulmonary disease: A bidimensional comparative analysis across fixed-dose combinations. PULMONARY PHARMACOLOGY & THERAPEUTICS, 59, 101841 [10.1016/j.pupt.2019.101841].

Efficacy and cardiovascular safety profile of dual bronchodilation therapy in chronic obstructive pulmonary disease: A bidimensional comparative analysis across fixed-dose combinations

Rogliani P.
;
Puxeddu E.;Cazzola M.;Calzetta L.
2019-01-01

Abstract

Despite several long-acting β2-adrenoceptor agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combinations (FDCs) are currently approved for the treatment of chronic obstructive pulmonary disease (COPD), there are limited findings concerning the direct comparison across the different LABA/LAMA FDCs. The aim of this study was to compare the efficacy/safety profile of approved LABA/LAMA FDCs in COPD. A network meta-analysis was performed by linking the efficacy (forced expiratory volume in 1 s, St' George Respiratory Questionnaire, transitional dyspnea index) and safety (cardiovascular serious adverse events) outcomes resulting from randomized controlled trials that directly compared LABA/LAMA FDCs with placebo and/or each other. The Surface Under the Cumulative Ranking Curve Analysis (SUCRA) was performed for each single outcome (SUCRA: 1 = best, 0 = worst). The combined efficacy/safety profile was reported via the novel Improved Bidimensional SUCRA score (IBiS: the higher the value the better the treatment). Data obtained from 12,136 COPD patients (79.50% LABA/LAMA FDCs vs. placebo; 20.50% direct comparison between different LABA/LAMA FDCs) were extracted from 22 studies published between 2013 and 2019. The IBiS score showed the following rank of efficacy/safety profile: tiotropium/olodaterol 5/5 μg (area 66.83%) » glycopyrronium/indacaterol 15.6/27.5 μg (area 40.43%)  >  umeclidinium/vilanterol 62.5/25 μg (area 30.48%)  ≈  aclidinium/formoterol 400/12 μg (area 28.44%)  >  glycopyrronium/indacaterol 50/110 μg (area 19.95%)  >  glycopyrronium/formoterol 14.4/9.6 μg (area 11.50%). Each available LABA/LAMA FDC has a specific efficacy/safety profile that needs to be considered for personalized therapy in COPD. Head-to-head studies aimed to assess the impact of different LABA/LAMA FDCs on the risk of COPD exacerbation are needed to further improve the information provided by this quantitative synthesis.
2019
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO
English
Con Impact Factor ISI
Rogliani, P., Matera, M.g., Ritondo, B.l., De Guido, I., Puxeddu, E., Cazzola, M., et al. (2019). Efficacy and cardiovascular safety profile of dual bronchodilation therapy in chronic obstructive pulmonary disease: A bidimensional comparative analysis across fixed-dose combinations. PULMONARY PHARMACOLOGY & THERAPEUTICS, 59, 101841 [10.1016/j.pupt.2019.101841].
Rogliani, P; Matera, Mg; Ritondo, Bl; De Guido, I; Puxeddu, E; Cazzola, M; Calzetta, L
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/222247
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