Long term effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a meta-analysis

Grunsven, P.M. van; Schayck, C.P. van; Jp, Derenne; Kerstjens, Huib A. M.; Renkema, Tej; Postma, Dirkje S.; Similowski, Thomas; Akkermans, Reinier; Jong, P.C.M. Pasker-de; Dekhuijzen, P.N.R.; Herwaarden, C.L.A. van; Weel, Chris van

doi:10.1136/thx.54.1.7

Cited by 136 publications

(55 citation statements)

References 14 publications

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“…On the other hand, a meta-analysis of three studies published between 1983 and 1996 showed a significant beneficial effect of inhaled corticosteroids over placebo on the course of the prebronchodilator FEV 1 during 2 years of treatment. 34 From our analysis of the MEFV curves, we hypothesise that the anatomical location of the anti-inflammatory effect of inhaled steroids is in the smaller airways. Significant changes were observed in MEF 50 and MEF 25 .…”

Section: Discussionmentioning

confidence: 96%

Effects of fluticasone propionate in COPD patients with bronchial hyperresponsiveness

Verhoeven

Hegmans²,

Mulder³

et al. 2002

Thorax

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Background: Treatment of chronic obstructive pulmonary disease (COPD) with inhaled corticosteroids does not appear to be as effective as similar treatment of asthma. It seems that only certain subgroups of patients with COPD benefit from steroid treatment. A study was undertaken to examine whether inhaled fluticasone propionate (FP) had an effect on lung function and on indices of inflammation in a subgroup of COPD patients with bronchial hyperresponsiveness (BHR). Methods: Twenty three patients with COPD were studied. Patients had to be persistent current smokers between 40 and 70 years of age. Non-specific BHR was defined as a PC 20 for histamine of <8 mg/ ml. Patients received either 2 × 500 µg FP or placebo for 6 months. Expiratory volumes were measured at monthly visits, BHR was determined at the start of the study and after 3 and 6 months, and bronchial biopsy specimens were taken at the start and after 6 months of treatment. Biopsy specimens from asymptomatic smokers served as controls. Results: In contrast to asthma, indices of BHR were not significantly influenced by treatment with FP. Forced expiratory volume in 1 second (FEV 1 ) showed a steep decline in the placebo group but remained stable in patients treated with FP. FEV 1 /FVC, and maximal expiratory flows at 50% and 25% FVC (MEF 50 , MEF 25 ) were significantly increased in the FP treated patients compared with the placebo group. Biopsy specimens were analysed for the presence of CD3+, CD4+, CD8+, MBP+, CD15+, CD68+, CD1a, and tryptase cells. FP treatment resulted in marginal reductions in these indices of inflammation. Conclusion: In patients with COPD and BHR, FP has a positive effect on indices of lung function compared with placebo. Bronchial inflammation analysed in bronchial biopsy specimens is only marginally reduced.

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Section: Discussionmentioning

confidence: 96%

Effects of fluticasone propionate in COPD patients with bronchial hyperresponsiveness

Verhoeven

Hegmans²,

Mulder³

et al. 2002

Thorax

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“…Grunsven et al 9 reported no signifi cant differences in exacerbation rates between the group on inhaled corticosteroids and the group on placebo. Results of a meta-analysis by Sin et al 12 are consistent with our fi ndings.Point estimates from our analyses, however, are more precise because of the greater number of component studies.…”

Section: Inhaled Corticosteroids and Copdmentioning

confidence: 96%

“…Most published studies and systematic reviews [8][9][10] 11 Only one meta-analysis focused primarily on health outcomes 12 ; none of these systematic reviews took observational evidence for adverse events into consideration. Limiting adverse events assessment to randomized controlled trials (RCTs) risks missing rare but potentially severe adverse events, such as osteoporotic fractures, glaucoma, or cataract, which RCTs cannot reliably assess because of limitations of sample sizes and study durations.…”

Section: 4 Inhaled Corticosteroids and Copdmentioning

confidence: 99%

Efficacy and Safety of Inhaled Corticosteroids in Patients With COPD: A Systematic Review and Meta-Analysis of Health Outcomes

Gartlehner¹

2006

The Annals of Family Medicine

111

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PURPOSE We wanted to review systematically the effi cacy, effectiveness, and safety of inhaled corticosteroids with respect to health outcomes in patients with chronic obstructive pulmonary disease (COPD). METHODSWe searched MEDLINE, EMBASE, The Cochrane Library, and the International Pharmaceutical Abstracts to identify relevant articles. We limited evidence to double-blinded randomized controlled trials (RCTs) for effi cacy, but we also reviewed observational evidence for safety. Outcomes of interest were overall mortality, exacerbations, quality of life, functional capacity, and respiratory tract symptoms. When possible, we pooled data to estimate summary effects for each outcome.RESULTS Thirteen double-blinded RCTs determined the effi cacy of an inhaled corticosteroid compared with placebo; 11 additional studies assessed the safety of inhaled corticosteroid treatment in patients with asthma or COPD. Overall, COPD patients treated with inhaled corticosteroids experienced signifi cantly fewer exacerbations than patients taking placebo (relative risk [RR] = 0.67; 95% CI, 0.59-0.77). No signifi cant difference could be detected for overall mortality (RR = 0.81; 95% CI, 0.60-1.08). Evidence on quality of life, functional capacity, and respiratory tract symptoms is mixed. Adverse events were generally tolerable; pooled discontinuation rates did not differ signifi cantly between inhaled corticosteroid and placebo treatment groups (RR = 0.92; 95% CI, 0.74-1.14). Observational evidence, however, indicates a dose-related risk of cataract and open-angle glaucoma. Severe adverse events, such as osteoporotic fractures, are rare; the clinical importance of the additional risk is questionable.CONCLUSIONS Overall, the risk-benefi t ratio appears to favor inhaled corticosteroid treatment in patients with moderate to severe COPD. Existing evidence does not indicate a treatment benefi t for patients with mild COPD. INTRODUCTIONC hronic obstructive pulmonary disease (COPD) is among the leading causes of morbidity and mortality worldwide.1 In 2000 COPD accounted for approximately 20.7 million outpatient visits, 3.4 million emergency department visits, 6.3 million hospitalizations, and 116,513 deaths in the United States. 2 The World Health Organization estimates that by the year 2020, COPD will be the third-leading cause of death and the fi fth-leading cause of disability worldwide. COPD is characterized by a progressive, irreversible limitation of airfl ow associated with an abnormal infl ammatory response to noxious particles or gases. It is caused primarily by smoking. 3,4 Gerald Gartlehner, MD 254 INHALED CORTICOSTEROIDS AND COPDThe benefi cial effect of inhaled corticosteroid treatment for COPD remains controversial, 3,5 in part because only smoking cessation is reliably shown to slow the rate of decline in lung function. 4 Although the Food and Drug Administration (FDA) has not approved inhaled corticosteroids as monotherapy for the treatment of COPD, they are frequently prescribed to reduce or alleviate symptoms...

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“…Also a recent metaanalysis points to a positive effect on the lung function in COPD [9]. But most studies show that this positive effect is no more than an initial effect during the first months of use.…”

mentioning

confidence: 99%

Is lung function really a good parameter in evaluating the long-term effects of inhaled corticosteroids in COPD?

Schayck¹

2000

Eur Respir J

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Recently several large trials evaluating the effects of long-term medication in chronic obstructive pulmonary disease (COPD) have appeared and there are still several which will be published in the coming years. The primary outcome of these trials was the decline in lung function. The long-term medication investigated was mainly inhaled corticosteroids. In contrast to asthma, COPD is a progressive and, to a large extent, irreversible pulmonary disease. One of the consequences is that the effectiveness of (for instance) inhaled corticosteroids in COPD can probably be measured to a limited extent on the basis of the lung function. Which parameters should be used to evaluate whether or not long-term medication in COPD is justified?Effects of inhaled corticosteroids on chronic obstructive pulmonary diseaseIn one of the first prospective studies investigating the long-term use of inhaled corticosteroids, no distinction was made between asthma and COPD [1]. This study can therefore not provide the actual answer to the above-mentioned questions. Moreover, the selection criteria used in this study were such that more patients with asthma than with COPD were selected.The study of DOMPELING et al. [2] showed that the administration of inhaled corticosteroids to COPD patients did lead to a clear improvement in lung function during the first 6 months (beclomethasone 800 mg daily), but also that there was no change in the subsequent annual decline of the lung function. In asthma, however, this change did clearly occur [2]. Asthma patients can gain much more from the treatment with inhaled corticosteroids than COPD patients. Not only is the initial peak effect (the effect of the inhaled corticosteroids during the first 3±6 months) in COPD less strong, but, because the subsequent annual decline of lung function (expressed in the decline of the forced expiratory volume in one second (FEV1) per year) does not show any change, the final long-term effect of inhaled corticosteroids on COPD with regard to this variable is also limited [3]. On the basis of extrapopulation of these data, the gain in time because of the use of inhaled steroids until the patients reach the 0.5 L level (a lung function usually indicating severe disability or death) is <1.5 yrs in COPD, whereas in asthma it is almost 9 yrs [2].These findings in COPD were confirmed by subsequent studies. In 58 COPD patients who were treated with 1,600 mg budesonide for 2 yrs, RENKEMA et al.[4] observed some decrease in symptoms. They found no clear improvement in the annual decline of the lung function [4]. The study of PAGGIARO et al.[5] involving 281 COPD patients also showed that fluticasone 500 mg twice a day during 6 months resulted in only a slight decrease in symptoms, a slight improvement of the peak flow and a small shift from severe to moderate exacerbations [5]. The most relevant finding in this study of COPD patients was the clear improvement in the outcome of the 6-min walking test, which probably means an improvement in the functioning of COPD patients [5].As...

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Long term effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a meta-analysis

Abstract: Conclusions-This meta-analysis in patients with clearly defined moderately severe COPD showed a beneficial course of FEV 1 during two years of treatment with relatively high daily dosages of inhaled corticosteroids.

Cited by 136 publications

References 14 publications

Effects of fluticasone propionate in COPD patients with bronchial hyperresponsiveness

Effects of fluticasone propionate in COPD patients with bronchial hyperresponsiveness

Efficacy and Safety of Inhaled Corticosteroids in Patients With COPD: A Systematic Review and Meta-Analysis of Health Outcomes

Is lung function really a good parameter in evaluating the long-term effects of inhaled corticosteroids in COPD?

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