Risk of pneumonia and exacerbations with single inhaler extrafine triple therapy compared to indacaterol/glycopyrronium: Post-hoc Analysis of the TRIBUTE Study

Scuri, Mario; Singh, Dave; Fabbri, Leonardo M.; Guasconi, Alessandro; Vezzoli, Stefano; Prunier, H; Muraro, Annamaria; Petruzzelli, Stefano; Papi, Alberto

doi:10.1055/s-0039-1678328

Cited by 2 publications

(3 citation statements)

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“…More recently (in 2018), the incidence of pneumonia associated with single-inhaler triple therapies has been compared with that associated to treatment with ICS/LABA, LABA/LAMA or LAMA [17,18,75,76]. In IMPACT, the incidence of pneumonia was higher in patients treated with FF/VI/UMEC than UMEC/VI (8% versus 5%; figure 2a) [17] whereas, in TRIBUTE, BDP/FF/G was not associated with a higher incidence of pneumonia when compared with IND/GLY (4% with each; figure 2b) [18,77]. Likewise, in SUMMIT, the risk of pneumonia was not increased by ICS therapy [16,78].…”

Section: Pneumoniamentioning

confidence: 99%

“…Effect of different pharmacological combinations on exacerbations of chronic obstructive pulmonary disease (ECOPD) and pneumonia both in the a) IMPACT[17] and b) TRIBUTE[77] studies (reproduced with permission from the authors). Note that in panel a, all bars indicate the incidence of events (as events per patient per year) but ECOPD results are shown as RR values, whereas those of pneumonia are shown as HR values for time to first event.…”

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confidence: 99%

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Inhaled corticosteroids in COPD: friend or foe?

et al. 2018

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The efficacy, safety and positioning of inhaled corticosteroids (ICS) in the treatment of patients with chronic obstructive pulmonary disease (COPD) is much debated, since it can result in clear clinical benefits in some patients ("friend") but can be ineffective or even associated with undesired side effects, pneumonia, in others ("foe"). After critically reviewing the evidence for and against ICS treatment in patients with COPD, we propose that: 1) ICS should not be used as a single, stand-alone therapy in COPD; 2) patients most likely to benefit from the addition of ICS to long-acting bronchodilators include those with history of multiple or severe exacerbations despite appropriate maintenance bronchodilator use, particularly if blood eosinophils are>300 cells·µL, and those with a history of and/or concomitant asthma; and 3) the risk of pneumonia in COPD patients using ICS is higher in those with older age, lower body mass index, greater overall fragility, receiving higher ICS doses and those with blood eosinophils <100 cells·µL All these factors must be carefully considered and balanced in any individual COPD patient before adding ICS to her/his maintenance bronchodilator treatment. Further research is needed to clarify some of these issues and firmly establish these recommendations.

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Section: Pneumoniamentioning

confidence: 99%

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confidence: 99%

Inhaled corticosteroids in COPD: friend or foe?

et al. 2018

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“…These results were consistent with those observed in TRINITY, where BDP/FF/G delayed CID compared to tiotropium, and reduced the rate of moderate/severe exacerbations in GOLD Group B patients 75,76. In TRIBUTE, in addition to confirming the delay of CID,77 and the benefits in GOLD Group B patients,78 BDP/FF/G demonstrated a favorable benefit/risk ratio compared with the dual bronchodilator combination IND/GLY;3 in particular, there was a reduced rate of moderate/severe exacerbations together with comparable rates of pneumonia events, as shown in Figure 1 79…”

Section: Review Of Triple Therapy Studiesmentioning

confidence: 65%

Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal

Vanfleteren¹,

Fabbri²,

Papi³

et al. 2018

COPD

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Recently, two “fixed triple” single-inhaler combinations of an inhaled corticosteroid (ICS), a long-acting β2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA) have become available for patients with COPD. This review presents the clinical evidence that led to the approval of these triple therapies, discusses the role of ICS in patients with COPD, and presents data on the relative efficacy of “fixed triple” (ICS/LAMA/LABA) therapy vs LAMA, ICS/LABA, and LAMA/LABA combinations, and summarizes studies in which ICS/LABAs were combined with LAMAs to form “open triple” combinations. Of the five main fixed triple studies completed so far, three evaluated the efficacy and safety of an extrafine formulation of beclometasone dipropionate, formoterol fumarate, and glycopyrronium; the other two studies evaluated fluticasone furoate, vilanterol, and umeclidinium. Overall, compared to LAMA, ICS/LABA, or LAMA/LABA, triple therapy decreased the risk of exacerbations and improved lung function and health status, with a favorable benefit-to-harm ratio. Furthermore, triple therapy showed a promising signal in terms of improved survival. The evidence suggests that triple therapy is the most effective treatment in moderate/severe symptomatic patients with COPD at risk of exacerbations, with marginal if any risk of side effects including pneumonia. Ongoing studies are examining the role of triple therapy in less severe symptomatic patients with COPD and asthma–COPD overlap.

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Risk of pneumonia and exacerbations with single inhaler extrafine triple therapy compared to indacaterol/glycopyrronium: Post-hoc Analysis of the TRIBUTE Study

Cited by 2 publications

References 0 publications

Inhaled corticosteroids in COPD: friend or foe?

Inhaled corticosteroids in COPD: friend or foe?

Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal

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