TORONTO — Patients with chronic obstructive pulmonary disease treated with a combination of formoterol and tiotropium required less rescue medication than did those treated with tiotropium alone.
In a 12-week double-blind trial sponsored by Schering-Plough, Dr. Donald P. Tashkin of the University of California, Los Angeles, and colleagues, tested a combination of the long-acting anticholinergic tiotropium plus the long-acting β2-agonist formoterol to improve symptom control and lessen the need for rescue albuterol to a greater degree than the anticholinergic alone.
The 255 participating patients were aged 40 years or older and had at least a 10 pack-year history of smoking. Postbronchodilator forced expiratory volume in 1 second (FEV1) was 30%–70% of predicted normal, or 0.75 L, and the ratio of FEV1 to forced vital capacity was less than 70%.
Spirometric measurements were performed weekly, and the number of puffs of rescue medication was recorded in patient diaries. The majority of patients were white men, and the average age was 64 years.
Overall daily rescue medication use was reduced by 0.81 puffs/day in the combination group, which was significantly greater than the reduction in the monotherapy group of 0.53 puffs/day, Dr. Tashkin reported in a poster session at an international conference of the American Thoracic Society.
Daytime albuterol puffs were reduced by 1.16/day in the combination group, which also was significantly greater than the reduction of 0.76 in the monotherapy group.
Overall nighttime albuterol use was reduced by 0.44 puffs/day and 0.28 puffs/day in the combination and monotherapy groups, respectively.
Both treatments were generally well tolerated. Four patients in the monotherapy group experienced serious adverse events that were considered to be treatment related, whereas no patients in the combination group experienced serious adverse events.
The rationale for combining an anticholinergic with a β-agonist to relieve the impaired lung function in COPD derives from the drugs' different mechanisms of bronchodilation, Dr. Tashkin wrote in a recent review (Chest 2004;125:249–59).