Extrafine triple therapy reduces exacerbations in GOLD B COPD patients: post-hoc analysis of TRILOGY and TRINITY

Rationale: Current GOLD management strategy recommends the use of a triple combination only in group D patients. However, group B includes a significant portion of exacerbating subjects that may benefit from this treatment. In TRILOGY and TRINITY studies (Singh et al. Lancet 2016;Vestbo et al Lancet 2017) fixed triple combination of Beclometasone Dipropionate, Formoterol Fumarate and Glycopyrronium (BDP/FF/G) significantly reduced moderate/severe exacerbations vs. ICS/LABA (BDP/FF) and LAMA (Tiotropium) in symptomatic, severe/very severe COPD patients with an exacerbation history. We re-categorised the distribution of our study populations into current GOLD groups and conducted a post-hoc analysis where the effect of triple therapy was evaluated in the subgroup of GOLD B patients with 1 exacerbation in the previous year. Methods: In TRILOGY,1,367 patients of which 753 (55%) were classified as B vs. 614 (45%) as D were included. In TRINITY,out of 2,689 patients, 1,324 (49%) were group B whereas 1,365 (51%) were group D(≥2 mod exac and/or ≥1 hospital/ER admission). Results: In B patients, triple therapy significantly reduced moderate/severe exacerbations by 23% vs. ICS/LABA in TRILOGY (adj R/R 0.77, 95% CI:0.59 – 0.99, p = 0.042) and by 22% vs. LAMA in TRINITY (adj R/R 0.78,95% CI:0.62 – 0.97, p = 0.023). These findings were consistent with the overall populations. Conclusions: These results demonstrate that BDP/FF/G extrafine triple therapy reduces moderate/severe exacerbations also in GOLD B patients with 1 exacerbations in the previous year.