Arformoterol tartrate ( Arformoterol, 15 mcg bid; Brovana ) is a nebulized long-acting β2-agonist approved for maintenance treatment of COPD ( chronic obstructive pulmonary disease ).
This was a multicenter, double-blind, randomized, placebo-controlled study. Patients ( aged greater than or equal to 40 years with baseline FEV1 less than or equal to 65% predicted, FEV1 more than 0.50 L, FEV1/FVC less than or equal to 70%, and greater than or equal to 15 pack-year smoking history ) received Arformoterol ( n = 420 ) or placebo ( n = 421 ) for 1 year.
The primary assessment was time from randomization to respiratory death or first COPD exacerbation-related hospitalization.
Among 841 patients randomized, 103 had greater than or equal to 1 primary event ( 9.5% vs 15.0%, for Arformoterol vs placebo, respectively ).
Patients who discontinued treatment for any reason ( 39.3% vs 49.9%, for Arformoterol vs placebo, respectively ) were followed for up to 1 year postrandomization to assess for primary events.
Fewer patients receiving Arformoterol than placebo experienced COPD exacerbation-related hospitalizations ( 9.0% vs 14.3%, respectively ). Twelve patients ( 2.9% ) receiving Arformoterol and 10 patients ( 2.4% ) receiving placebo died during the study.
Risk for first respiratory serious adverse event was 50% lower with Arformoterol than placebo ( P = 0.003 ). Numerically more patients on Arformoterol ( 13; 3.1% ) than placebo ( 10; 2.4% ) experienced cardiac serious adverse events; however, time-to-first cardiac serious adverse event was not significantly different.
Improvements in trough FEV1 and FVC were greater with Arformoterol ( least-squares mean change from baseline vs placebo: 0.051 L, P = 0.030 and 0.075 L, P = 0.018, respectively ).
Significant improvements in quality of life ( overall St. George’s Hospital Respiratory Questionnaire and Clinical COPD Questionnaire ) were observed with Arformoterol versus placebo ( P less than 0.05 ).
In conclusion, Arformoterol has showen an approximately 40% lower risk of respiratory death or COPD exacerbation-related hospitalization over 1 year vs placebo.
Arformoterol was well-tolerated and improved lung function vs placebo. ( Xagena )
Donohue JF et al, Chest 2014;146:1531-1542