Non-pulmonary effects induced by the addition of formoterol to budesonide therapy in patients with mild or moderate persistent asthma

Objective: The present study was designed to assess the non-pulmonary effec ts of a 2-week treatment with the addition of formoterol to budesonide ther apy in 10 patients with mild or moderate asthma. Methods: Each patient was invited to perform a screening visit which included spirometry before and a fter inhalation of 12 mu g formoterol with a metered dose inhaler (MDI), me asurement of arterial blood pressure, baseline electrocardiography and 24-h our Holter monitoring, and a test for evaluating upper limb tremor. Patient s then began bronchodilating therapy with 12 mu g formoterol MDI and 400 mu g budesonide Turbuhaler b.i.d. Each patient was also given a peak flowmete r and a diary in which he had to record the morning and evening values meas ured before taking inhaled drugs. Two weeks later, the patients repeated th e same examinations; the diary card was returned 2 months after the beginni ng of the study. Results: Adding formoterol to budesonide therapy caused a significant improvement in lung function, but neither induced any statistic ally significant effect on mean heart rate, nor altered the circadian rhyth m of autonomic regulation nor elicited significant alterations in cardiac m orphology. However, the evaluation of upper limb tremor revealed a statisti cally significant increase (p = 0.02). Conclusions: This study shows that a dding the recommended dose of formoterol to an inhaled corticosteroid thera py does not induce significant cardiac undesirable effects, although tremor , surely due to stimulation of beta(2) receptors of the skeletal muscles, m ay sometimes be a limiting effect. Copyright (C) 2000 S. Karger AG, Basel.