Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study

Progress and Prospects for Long-Acting Β 2 -Agonists in the Treatment of Chronic Obstructive Pulmonary Disease (Copd)

“…In particular, in the INVIGORATE study tiotropium produced a small (absolute difference 11 ml) and likely not of clinical significance, but statistically greater, improvement in trough FEV 1 than indacaterol. Even though indacaterol reduced the rescue medication use, numerically fewer exacerbations occurred among the participants taking tiotropium [67].…”

“…In particular, in the INVIGORATE study tiotropium produced a small (absolute difference 11 ml) and likely not of clinical significance, but statistically greater, improvement in trough FEV 1 than indacaterol. Even though indacaterol reduced the rescue medication use, numerically fewer exacerbations occurred among the participants taking tiotropium [67].On the other hand, in general even the prescribing behaviour of specialists does not seem to favour the use of LABAs as monotherapy in the treatment of COPD. The Adelphi Respiratory Disease Specific Programme, a cross-sectional survey of consulting patients in five European countries and in the US, showed a conflict between the current real-world practice and the GOLD 2011 updated treatment recommendations, documenting that even large proportions of patients in the low risk groups were currently receiving ICS/ LABA, either alone or in combination with a LAMA [68].…”

“…In a pooled analysis of data from three randomized, double blind, placebo-controlled studies, both indacaterol doses, 150 and 300 μg, were associated with significant reductions in exacerbations versus placebo [29]. However, the Indacaterol: providing opportunity to re-engage patients with life (INVIGORATE) study showed that tiotropium offered greater protection from exacerbations than indacaterol [30], but the absolute number of events was small and the difference between treatments was of uncertain clinical importance.…”

“…In a pooled analysis of data from three randomized, double blind, placebo-controlled studies, both indacaterol doses, 150 and 300 μg, were associated with significant reductions in exacerbations versus placebo [29]. However, the Indacaterol: providing opportunity to re-engage patients with life (INVIGORATE) study showed that tiotropium offered greater protection from exacerbations than indacaterol [30], but the absolute number of events was small and the difference between treatments was of uncertain clinical importance.A post hoc analysis has shown that blood eosinophil count ≥2%, which is a promising biomarker of response to ICSs in patients with COPD [31], does not appear to predict bronchodilator response to β 2 -agonists in either ICS users or non-users [32].It is remarkable to point out that a UK-based cost-utility analysis of indacateroldemonstrated that indacaterol can produce better outcomes at a lower cost to the healthcare system compared with both tiotropium and salmeterol and is likely to remain cost-effective under a range of assumptions [33]. In particular, the proportion of patients in each of the COPD stages and the mortality rate associated with very severe COPD are the variables with the largest impact on the results.…”

Individualized Care in COPD: Updated Guidelines from Revised GOLD 2017 Report

“…LAMA (Tiotropium) has been shown to have greater effect on reducing exacerbations compared to LABA treatment [38,39]. Because of concerns regarding adverse cardiovascular effects associated with this class, FDA conducted a review in 2009 and concluded that LAMA (Tiotropium) added to other standard therapies had no effect on cardiovascular risk [40].…”