Long term effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a meta-analysis
a Department
of General Practice and Social Medicine, b Department of Epidemiology, c Department of Pulmonology,
Dekkerswald, d University
of Nijmegen, The Netherlands Department of
Pulmonology, Hospital Pitié-Salpêtrière, Paris, France, e Department of
Pulmonology, University of Groningen, The Netherlands
Correspondence to: Dr P M van Grunsven, Department of General Practice, University of Nijmegen, P O Box 9101, 6500 HB Nijmegen, The Netherlands.
Received 25 November 1997; Returned to authors 21 January 1998; Revised version received 27 April 1998; Accepted for publication 15 May 1998
BACKGROUND
The role of
inhaled corticosteroids in the long term management of chronic
obstructive pulmonary disease (COPD) is still unclear. A meta-analysis
of the original data sets of the randomised controlled trials published
thus far was therefore performed. The main question was: "Are inhaled
corticosteroids able to slow down the decline in lung function
(FEV1) in COPD?"
METHODS
A Medline
search of papers published between 1983 and 1996 was performed and
three studies were selected, two of which were published in full and
one in abstract form. Patients with "asthmatic features" were
excluded from the original data. Ninety five of the original 140 patients treated with inhaled corticosteroids (81 with 1500 µg
beclomethasone daily, six with 1600 µg budesonide daily, and eight
with 800 µg beclomethasone daily) and 88 patients treated with
placebo (of the initial 144 patients) were included in the analysis.
The effect on FEV1 was assessed by a multiple repeated
measurement technique in which points of time in the study and
treatment effects (inhaled corticosteroids compared with placebo) were investigated.
RESULTS
No baseline
differences were observed (mean age 61 years, mean FEV1
45% predicted). The estimated two year difference in prebronchodilator FEV1 was +0.034 l/year (95% confidence interval (CI)
0.005 to 0.063) in the inhaled corticosteroid group compared with
placebo. The postbronchodilator FEV1 showed a difference of
+0.039 l/year (95% CI -0.006 to 0.084). No beneficial effect was
observed on the exacerbation rate. Worsening of the disease was the
reason for drop out in four patients in the treatment group compared with nine in the placebo group. In the treatment group six of the 95 subjects dropped out because of an adverse effect which may have been
related to the treatment compared with two of the 88 patients in the
placebo group.
CONCLUSIONS
This
meta-analysis in patients with clearly defined moderately severe COPD
showed a beneficial course of FEV1 during two years of
treatment with relatively high daily dosages of inhaled corticosteroids.
© 1999 by Thorax
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