| 1. What is Symbicort? |
Symbicort®
is a combination product delivering through the dry powder inhaler,
Turbuhaler®, the
inhaled corticosteroid, budesonide, together with the rapid- and
long-acting ß2-agonist
bronchodilator, formoterol. One dose of Symbicort contains
80 or 160
µg budesonide together with
4.5 µg formoterol, or 320 µg
budesonide with 9 µg
formoterol. These doses are labelled as delivered doses leaving the
inhaler (not doses metered in the inhaler as is the case for
Pulmicort Turbuhaler).
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| 2. Pulmicort vs. Symbicort
in asthma |
Efficacy of budesonide
(Pulmicort) has been evaluated in comparison with budesonide plus
formoterol delivered via two inhalers in patients with mild
persistent asthma (OPTIMA)(1) and moderate persistent asthma (FACET)
(2). These studies showed that patients with mild persistent asthma
not previously treated with inhaled corticosteroids benefited
significantly from Pulmicort alone, whereas patients not well
controlled in their asthma and already using inhaled corticosteroids
improved significantly when formoterol was added.
Clinical studies with the
combination product (Symbicort) vs. Pulmicort alone have shown a
similar pattern (3-5).
Morning PEF in a study comparing
budesonide and formoterol administered via one or two inhalers
Morning PEF in 362 patients
with moderate-to-severe asthma treated for 12 weeks with two
inhalations of Symbicort 160/4.5 µg
twice daily. Pulmicort Turbuhaler 200 µg
twice daily plus Oxis Turbuhaler 4.5 µg
twice daily. Combination treatment with Pulmicort and Oxis produced
significantly greater increases in PEF than Pulmicort alone; the
effect of Symbicort tended to be faster than that of Pulmicort and
Oxis given via separate inhalers
References:
1. O´Byrne et al.: Low dose
inhaled budesonide and formoterol in mild persistent asthma. Am J
Respir Crit Care Med 2001; 164: 1392-1397.
2. Pauwels RA et al.: Effect of
inhaled formoterol and budesonide on exacerbations of asthma. N
Engl J Med 1997; 337: 1405-1411.
3. Zetterström O et al.:
Improved asthma control with budesonide/formoterol in a single
inhaler, compared with budesonide alone. Eur
Respir J 2001; 18: 1-7.
4. Tal A et
al. Budesonide/formoterol in a single
inhaler versus inhaled corticosteroids alone in
the
treatment of asthma. Ped Pulmonol 2002; 34: 342-350.
5.
Kuna P, Kuprys I. Symbicort Turbuhaler: a new concept in asthma
management. Int J Clin
Pract
2002; 56: 797-803.
6.
Buhl R. Budesonide/formoterol for the treatment of asthma. Expert
Opin Pharmacother 2003; 4 (8): 1393-1406.
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| 3. Pulmicort vs. Symbicort
in COPD |
Two placebo-controlled clinical
studies in patients with moderate-to-severe COPD comparing the
monocomponents (budesonide; formoterol) with Symbicort have shown
Symbicort treatment to result in fewer severe exacerbations, less
symptoms and use of rescue medication, better lung function and
quality of life (1,2).
Treatment with Pulmicort alone
also resulted in statistically significant reductions of severe
exacerbations and improvements in symptoms and quality of life, but
not in airway function.
Exacerbation
rates in patients with moderate-to-severe COPD treated with Symbicort
(budesonide/formoterol), the monocomponents or placebo
The
absolute number of severe exacerbations in the two studies (1,2) was
significantly reduced by Symbicort treatment. The beneficial effect
on exacerbations is not due to the bronchodilatory component of
Symbicort, and it is also larger than the steroid effect alone.
References:
1. Szafranski W et al.: Efficacy
and safety of budesonide/formoterol in the management of chronic
obstructive pulmonary disease. Eur Respir J 2003; 21: 74-81.
2. Calverley
PM, et al. Maintenance therapy with
budesonide and formoterol in chronic obstructive pulmonary disease.
Eur Respir J 2003; 22 (6): 912-9.
Symbicort
Pulmicort in COPD
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