Mortality Rates in Extrafine ICS-Containing vs ICS-Free Medications in COPD

Asthma inhaler
Asthma inhaler
The pooled safety analysis included data from the TRILOGY, TRINITY, and TRIBUTE studies.

This article is part of Pulmonology Advisor‘s coverage of the American Thoracic Society’s International Conference, taking place in San Diego, California. Our staff will report on medical research related to asthma and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from ATS 2018.

SAN DIEGO — According to a presentation at the American Thoracic Society 2018 International Conference held May 18-23 in San Diego, California, extrafine inhaled corticosteroid (ICS)-containing medications may be tied to a lower mortality rate vs ICS-free medications in symptomatic patients with chronic obstructive pulmonary disease (COPD) at risk for exacerbations. 

Extrafine ICS-containing medications are known to lower the risk for COPD exacerbations but their efficacy in lowering mortality in these patients “has been debated based on randomized trials and real-world data, leaving the question still unanswered,” the researchers wrote. 

A total of 3 multicenter, randomized, double-blind, active-controlled, 52-week studies enrolled patients with symptomatic COPD who had severe airflow limitation and exacerbation history.

In TRILOGY, patients were randomly assigned to a fixed triple combination of extrafine beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G) 100/6/12.5 mcg 2 actuations twice daily via pressurized metered dose inhaler (pMDI) or a fixed combination of extrafine BDP/FF 100/6 mcg 2 actuations twice daily.

In TRINITY, patients were randomly assigned to receive BDP/FF/G, tiotropium (TIO) 18 mcg once daily via single-dose dry powder inhaler, or extrafine BDP/FF + TIO.

In TRIBUTE, patients were randomly assigned to receive extrafine BDP/FF/G or indacaterol/glycopyrronium bromide 85/43 mcg once daily.

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The investigators assessed mortality rates, taking into account all events leading to a fatal outcome during the study periods. They compared all extrafine ICS-containing regimens vs ICS-free regimens. In addition, they compared the extrafine BDP/FF/G with ICS-free treatments.

ICS-containing combinations (BDP/FF/G, BDP/FF, BDP/FF + TIO) demonstrated a decreased risk for a fatal event compared with ICS-free combinations (TIO, IND/GLY; hazard ratio [HR] 0.72; 95% CI, 0.50-1.02; P =.066). Similarly, there was a reduced risk seen with only BDP/FF/G when compared with ICS-free treatments (HR 0.72; 95% CI, 0.49-1.06; P =.096).

In general, there was a lower rate of mortality observed with extrafine ICS-containing medications vs ICS-free medications in patients with symptomatic COPD at risk for exacerbations. The researchers added, “Notably, these results are confirmed when referring specifically to the extrafine triple combination BDP/FF/G.”

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Scuri M, Fabbri LM, Singh D, et al. Reduction in fatal events with ICS-containing medications: results of safety pooled analysis from the TRILOGY, TRINITY and TRIBUTE studies. Presented at: American Thoracic Society 2018 International Conference; May 18-23, 2018; San Diego, CA. Abstract 7725.