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Single Inhaler Extrafine Triple Therapy Vs Indacaterol/Glycopyrronium in COPD Patients Previously Treated with LABA/LAMA: Post-Hoc Analysis of the Tribute Study
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A3043 - Single Inhaler Extrafine Triple Therapy Vs Indacaterol/Glycopyrronium in COPD Patients Previously Treated with LABA/LAMA: Post-Hoc Analysis of the Tribute Study
Author Block: M. Scuri1, D. Singh2, L. M. Fabbri3, I. Valente1, A. Guasconi1, S. Vezzoli1, H. Prunier1, G. Cohuet4, A. Muraro1, S. Petruzzelli5, A. Papi6; 1GCD, Chiesi Farmaceutici, Parma, Italy, 2Univ Hosp Of South Manchester, Manchester M23 9QZ, United Kingdom, 3Internal and Respiratory Medicine, Univ of Ferrara, Ferrara, Italy, 4Laboratoires CHIESI SAS, COURBEVOIE, France, 5Chiesi Farmaceutici S.p.a., Parma, Italy, 6Univ Di Ferrara Centro Asma, Ferrara 44100, Italy.
Rationale: TRIBUTE was a 52-week randomized, parallel group, double-blind, active-controlled study, where twice daily fixed triple combination of extrafine beclometasone dipropionate, formoterol fumarate and glycopyrronium (BDP/FF/G 87/5/9 µg), via pressurized metered dose inhaler (pMDI) demonstrated a superior clinical benefit in reducing exacerbations and improving the quality of life compared to once daily indacaterol and glycopyrronium (IND/GLY 85/43 µg) DPI in symptomatic COPD patients at risk for exacerbations. To investigate whether previous therapy with LABA/LAMA had any differential impact on treatment response, we conducted a post-hoc analysis on the subgroup of patients treated with this medication at study entry. Methods: At study entry 383 out of 1532 patients (25.0%) had been previously treated with LABA/LAMA and were subsequently randomized to BDP/FF/G (n=184) or IND/GLY (n=199). Results: In the subgroup of patients treated with LABA/LAMA before screening, single inhaler extrafine triple therapy with BDP/FF/G reduced moderate/severe exacerbations by 24% (adjusted rate ratio: 0.76, 95% CI: 0.56 to 1.03, p=0.081) and improved SGRQ total score by -2.16 (CI 95%: -3.68 to -0.64, p=0.005) compared to IND/GLY. Conclusions: Although the limited sample size did not allow to achieve statistical significance in terms of exacerbation reduction, the findings of this analysis further confirm the superior clinical benefits provided by extrafine BDP/FF/G compared to IND/GLY and suggest a greater benefit (compared to the overall study population) in adding an ICS to double bronchodilator therapy in symptomatic patients at risk of exacerbations.
Author Block: M. Scuri1, D. Singh2, L. M. Fabbri3, I. Valente1, A. Guasconi1, S. Vezzoli1, H. Prunier1, G. Cohuet4, A. Muraro1, S. Petruzzelli5, A. Papi6; 1GCD, Chiesi Farmaceutici, Parma, Italy, 2Univ Hosp Of South Manchester, Manchester M23 9QZ, United Kingdom, 3Internal and Respiratory Medicine, Univ of Ferrara, Ferrara, Italy, 4Laboratoires CHIESI SAS, COURBEVOIE, France, 5Chiesi Farmaceutici S.p.a., Parma, Italy, 6Univ Di Ferrara Centro Asma, Ferrara 44100, Italy.
Rationale: TRIBUTE was a 52-week randomized, parallel group, double-blind, active-controlled study, where twice daily fixed triple combination of extrafine beclometasone dipropionate, formoterol fumarate and glycopyrronium (BDP/FF/G 87/5/9 µg), via pressurized metered dose inhaler (pMDI) demonstrated a superior clinical benefit in reducing exacerbations and improving the quality of life compared to once daily indacaterol and glycopyrronium (IND/GLY 85/43 µg) DPI in symptomatic COPD patients at risk for exacerbations. To investigate whether previous therapy with LABA/LAMA had any differential impact on treatment response, we conducted a post-hoc analysis on the subgroup of patients treated with this medication at study entry. Methods: At study entry 383 out of 1532 patients (25.0%) had been previously treated with LABA/LAMA and were subsequently randomized to BDP/FF/G (n=184) or IND/GLY (n=199). Results: In the subgroup of patients treated with LABA/LAMA before screening, single inhaler extrafine triple therapy with BDP/FF/G reduced moderate/severe exacerbations by 24% (adjusted rate ratio: 0.76, 95% CI: 0.56 to 1.03, p=0.081) and improved SGRQ total score by -2.16 (CI 95%: -3.68 to -0.64, p=0.005) compared to IND/GLY. Conclusions: Although the limited sample size did not allow to achieve statistical significance in terms of exacerbation reduction, the findings of this analysis further confirm the superior clinical benefits provided by extrafine BDP/FF/G compared to IND/GLY and suggest a greater benefit (compared to the overall study population) in adding an ICS to double bronchodilator therapy in symptomatic patients at risk of exacerbations.
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