Triple fixed-dose regimens of an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β2-agonist (LABA) for chronic obstructive pulmonary disease (COPD) have been studied at single dose levels of inhaled glucocorticoid, but studies at two dose levels are lacking.
Triple therapy with twice-daily budesonide (at either the 160-μg or 320-μg dose), glycopyrrolate, and formoterol resulted in a lower rate of moderate or severe COPD exacerbations than glycopyrrolate–formoterol or budesonide–formoterol.
Triple therapy, including glucocorticoid at either of two dose levels, is beneficial for moderate-to-very severe chronic obstructive pulmonary disease (COPD), according to a study published online June 24 in the New England Journal of Medicine.
Klaus F. Rabe, M.D., Ph.D., from the German Center for Lung Research in Grosshansdorf, and colleagues conducted a 52-week, phase 3 trial to assess the efficacy and safety of triple therapy at two dose levels of inhaled glucocorticoid in patients with moderate-to-very severe COPD and at least one exacerbation in the previous year. A total of 8,509 patients were randomly assigned to receive either twice-daily inhaled doses of triple therapy (inhaled glucocorticoid [320 or 160 µg], a long-acting muscarinic antagonist [LAMA; glycopyrrolate], and a long-acting β2-agonist [LABA; formoterol]) or one of two dual therapies (glycopyrrolate plus formoterol or budesonide plus formoterol) in a 1:1:1:1 ratio.
The researchers found that the annual rates of moderate or severe exacerbations were 1.08 and 1.07 in the 320- and 160-µg budesonide triple therapy groups, respectively; 1.42 in the glycopyrrolate-formoterol group; and 1.24 in the budesonide-formoterol group. Compared with glycopyrrolate-formoterol or budesonide-formoterol, the rate was significantly lower with 320-µg glucocorticoid triple therapy (rate ratios, 0.76 and 0.87, respectively). Similarly lower rates were seen with 160-µg glucocorticoid triple therapy (rate ratios, 0.75 and 0.86, respectively).
"Our findings show the benefits of triple therapy with a budesonide-glycopyrrolate-formoterol combination over dual therapy with a LAMA-LABA or an inhaled glucocorticoid-LABA combination," the authors write.
The study was funded by AstraZeneca.
Not for me I can't even do dual /combi.
I still take all my meds individually. I can control dose better that way avoiding side affects that can occur with combi.
Its the formeterol I can only take one dose a day to avoid excessive muscle cramps.
Good for those that can tolerate the triple therapy.
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