PURPOSE: The ability to reduce and/or prevent exacerbations is an important characteristic of effective chronic obstructive pulmonary disease (COPD) treatment. Mometasone furoate (MF) and formoterol (F) have been investigated as COPD treatments in multiple studies. However, the therapeutic effect of their combined administration via a metered-dose inhaler (MDI) in reducing COPD exacerbations has not been well elucidated. We investigated the effect of MF/F on COPD exacerbations in subjects with moderate−very severe COPD using data from 2 clinical trials.
METHODS: The effect of MF/F on COPD exacerbations was assessed by measuring the time to first mild (≥12 inhalations or ≥2 nebulized treatments of rescue medication/day), moderate (treatment with antibiotics or oral steroids), or severe (emergency room treatment or hospitalization) exacerbation in 2 independent, 26-wk, multicenter, double-blind, placebo (PBO)-controlled trials conducted in adults (≥40 y) with moderate−very severe COPD. In each trial (prebronchodilator FEV1/forced vital capacity ratio ≤0.7 and postbronchodilator FEV1 ≤60% predicted), subjects were randomized to twice-daily (BID) MF/F 400/10µg (n1=217; n2=225), MF/F 200/10µg (n1=207; n2=239), MF 400µg (n1=210; n2=253), F 10µg (n1=209; n2=243), or PBO (n1=212; n2=236).
RESULTS: In Trial 1 (N=1055), significant reductions in moderate−severe exacerbations were observed in subjects treated with MF/F 400/10µg compared with those on PBO (8.8% vs 16.5%; P=0.009). In Trial 2 (N=1196), significant reductions in mild, moderate, or severe exacerbations were observed in the MF/F 400/10µg and MF/F 200/10µg groups compared with the PBO group (37.6% and 32.3% vs 45.7%; P≤0.027). Also in trial 2, significant reductions in moderate−severe exacerbations were observed in the MF/F 400/10µg and MF/F 200/10µg groups compared with the PBO group (15.4% and 12.8% vs 24.6%; P≤0.006). A pooled analysis of both studies indicated that MF/F 400/10µg and MF/F 200/10µg were associated with relative risk reductions in moderate−severe exacerbations of 41.5% and 34.6%, respectively..
CONCLUSIONS: Subjects with moderate−very severe COPD treated with the combination of MF/F administered via a MDI experienced significant reductions in the incidence of moderate−severe exacerbations.
CLINICAL IMPLICATIONS: MF/F treatment reduces exacerbations in patients with moderate−very severe COPD.
DISCLOSURE: Donald Tashkin: University grant monies: Merck, Consultant fee, speaker bureau, advisory committee, etc.: Merck
Dennis Doherty: University grant monies: Boehringer Ingelheim, Merck, Novartis, Pfizer, Grant monies (from sources other than industry): NIH-NHLBI, Department of Veterans Affairs, Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca, Boehringer-Ingelheim, Forest, Ikaria, Merck, Pfizer
Edward Kerwin: Grant monies (from industry related sources): Merck
Carlos Eduardo Matiz-Bueno: Other: Spouse is an employee at Merck
Tulin Shekar: Employee: Merck
Sibabrata Banerjee: Employee: Merck
Jonathan Sadeh: Employee: Merck
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