| 1. Is formoterol as safe as a traditional, short-acting bronchodilator? |
Repeated high doses of formoterol given over a 3-day period in doses up
to 90µg/day are as well-tolerated as high doses of the short-acting
ß2-agonist terbutaline (Tötterman et al, 1998). Increases in the QTc
interval on ECG and reductions in serum potassium that occur after
inhalation of high doses of ß2-agonist are less marked with high doses
of formoterol than with high doses of terbutaline.
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| 2. Does the formoterol component of Symbicort mask exacerbations of asthma? |
No, formoterol does not mask exacerbations.
A one-year study showed that the changes in PEF and symptom score during
a severe exacerbation are similar in patients taking budesonide and
formoterol in separate inhalers, as in patients taking budesonide alone
(Tattersfield et al, 1999).
The addition of formoterol to budesonide reduces the number of exacerbations
without changing their time-course or severity. Thus exacerbations can
still be detected and treated as needed.
Change in morning PEF before, during and after an exacerbation
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| 3. Does formoterol mask the underlying inflammation of asthma? |
Formoterol does not mask the underlying inflammation of asthma.
Kips et al (2000) compared the effects of low dose budesonide (100µg bid)
+ formoterol (12µg bid) with high dose budesonide (400µg bid) alone over a
12-month period. No significant differences in underlying airway inflammation
were seen, as measured by the proportion of eosinophils and EG2+ cells found
in induced sputum.
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| 4. Is long-term treatment with budesonide safe? |
The long-term use of budesonide in asthma patients is supported by reassuring
safety data. The START study (Pauwels et al, 2003) showed that in over
7,000 patients with mild persistent asthma, treatment with Pulmicort Turbuhaler 400µg (200µg in children) over
three years was well tolerated. A similar number of adverse events were
reported in the budesonide group as in the placebo group.
Budesonide is the only inhaled corticosteroid that has a pregnancy category
rating of B in the US (all other ICS are category C). This reflects the wide body of experience and reassuring safety records of budesonide and indicates that
budesonide is regarded as more suitable for pregnant women than other inhaled
corticosteroids.
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| 5. Is long-term treatment with Symbicort well tolerated? |
Symbicort has an excellent safety profile. Several large, long-term studies
have shown that Symbicort is well-tolerated in the long-term maintenance
treatment of asthma in patients aged six years and above, at a wide range
of doses (Ställberg et al 2003, Rosenhall et al 2003, Tal et al 2002).
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| 6. What happens if a patient occationally takes high doses of Symbicort? |
The tolerability of a high dose of Symbicort (10 extra inhalations of
Symbicort 160/4.5 µg) has been investigated in asthmatic patients already
receiving maintenance treatment with two inhalations twice daily Symbicort
160/4.5 (Ankerst et al, 2001). The study was designed to resemble the
situation where a patient uses Symbicort instead of a short-acting ß2-agonist
to relieve the symptoms of an asthma attack.
The high dose of Symbicort was associated with ß2-agonist class effects.
However, neither individual nor mean effects constituted any safety concerns.
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