Effect of inhaled formoterol and budesonide on exacerbations of asthma
CommentThis study examined the effect of adding a long-acting inhaled beta-agonist (formoterol) to two different doses of an inhaled steroid (budesonide). The addition of formoterol significantly decreased the rate of mild and severe exacerbations and also improved indices of symptoms. Increasing the dose of the steroid was additive, was more effective in controlling severe exacerbations and equally effective in controlling mild exacerbations. Other indices of symptomatology, which were not primary endpoints, were better controlled with formoterol than with increasing the dose of the steroid.
Given the inflammatory nature of asthma, the use of an inhaled steroid is considered a mainstay of therapy in patients with moderate to severe, persistent asthma. No claim can be made based on this study for using formoterol or any other long-acting beta-agonist without an inhaled steroid. However, asthma is a chronic disease, many patients will be treated starting at a young age, and inhaled steroids have at least a theoretical potential for causing systemic side-effects. If the addition of a long-acting beta-agonist inhaler will allow a reduction in steroid dose, this could conceivably be advantageous in patients with mild to moderate disease who require continuous treatment.
November 28, 1997
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Reader CommentsDate: Wed, 3 Dec 1997
From: "Mark Leber" <email@example.com>
Several questions need to be asked before we can accept the results of this study and apply them to our patient population. First, were these patients true asthma patients? Did they exhibit reversibility using beta agonists? How many smoked or had other comorbid conditions such as diabetes, hypertension, kidney disease or copd? What was the racial and ethnic character of the experimental group? The population group may not be the same as the patients you treat. How many patients displayed multiple allergies or eosinophilia?
Second, I noticed that the patients only used diaries to detail their asthma attacks. Was there a trend in using more formoterol over the course of the study? Did any of these patients end up being seen in an emergency department or hospitalized? The main goals of treatment should be to reduce the long term deterioration in pulmonary function observed in asthma patients without the steroid side effects not how to treat mild asthmatics which I believe is fairly easy to do as demonstrated in this study.
Formoterol dosage was specified a priori and was not to change during the study. There were 11 hospitalizations for asthma: 1 in the low-dose budesonide plus formoterol group, 2 in the high-dose budesonide plus formoterol group, 3 in the low-dose budesonide only group and 5 in the high dose budesonide only group. -- mj
May 4, 1998
to the editor about this article, from the April 9, 1998 New England
Journal of Medicine.
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