The
efficacy of Symbicort in COPD patients has been studied in two
12-month clinical trials: Calverley et al
(2003) and Szafranski et al
(2003). These studies showed that Symbicort significantly
reduces the risk of exacerbations requiring medical intervention and
provides rapid and sustained improvement in lung function and symptom
relief.
Maintenance therapy with Symbicort compared with budesonide and formoterol, in chronic obstructive pulmonary disease
Calverley et al, 2003
The
Calverley et al study (2003) involved 1022 patients with
severe COPD (FEV1 < 50% predicted normal
prebronchodilator) and a history of exacerbations. Initially
treatment was intensified with the oral steroid prednisolone (30mg
once daily) and inhaled formoterol Turbuhaler (9µg twice daily)
for two weeks, in an attempt to optimise patients’ health
status. Following the intensification period, patients were
randomised to receive Symbicort (320/9µg, twice daily), budesonide
Turbuhaler alone (400µg, twice daily), formoterol alone (9µg,
twice daily), or placebo for one year. All treatments were delivered
via Turbuhaler.
After
the intensification period, the improvement in FEV1
achieved during run-in was maintained with Symbicort throughout the
study. In contrast, FEV1 declined greatly and rapidly
with all other treatments. Symbicort was also associated with higher
morning PEF (through value) compared with budesonide alone, formoterol alone and
placebo.
Furthermore, Symbicort
significantly reduced the risk of having an exacerbation, prolonging
the time to first exacerbation
requiring medical intervention by 158 days more than placebo, 100
days more than formoterol alone, and 76 days more than budesonide
alone. Symbicort also reduced the rate of oral
steroid courses given due to exacerbations by 28%, 30% and 45% versus
budesonide, formoterol and placebo, respectively.
Symbicort
provided a superior improvement in quality of Life (St. George’s
Respiratory Questionnaire) compared with budesonide and formoterol
alone. The improvement of 7.5 for Symbicort vs placebo (a change of 4
is consider clinically meaningful) was both highly statistically
significant as well as being a change that patients will notice.
Symbicort was also associated with significant imporvements vs. budesonide and formoterol alone by 4.5 and 3.4 units respectively.
Calverley study summary
Szafranski et al, 2003
The
Szafranski et al (2003) study involved 812 patients with
severe COPD (FEV1 < 50% predicted normal) and a
history of exacerbations. Patients were randomised to receive
Symbicort (320/9µg, twice daily), budesonide alone
(400µg, twice daily), formoterol alone (9µg, twice daily), or placebo for one year, after a two week
run-in period where maintenance medication was withdrawn and only
terbutaline was allowed as rescue. All treatments were provided in
Turbuhaler.
Symbicort
was seen to reduce the number of severe exacerbations by 23% compared
to formoterol alone and by 24% compared to placebo. Symbicort significantly improved FEV1 by 9% compared to budesonide and by 15% compared to placebo. Symbicort
improved and maintained morning and evening PEF (through value) compared with
placebo, budesonide alone and formoterol alone within a week and
versus budesonide and placebo within a day. This improvement was
sustained throughout the 12-month study period without any signs of
tachyphylaxis. Symbicort significantly reduced total symptom scores
(breathlessness, cough, chest tightness and night-time awakenings)
within the first week of treatment versus budesonide, formoterol and
placebo. This effect was sustained for 12 months, versus budesonide
and placebo. Symbicort was superior to formoterol alone in terms of
night-time awakenings throughout the study period, approximately
equivalent to one extra nights sleep per week.
Szafranski study summary
|
