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Autor     Marc Decramer, Marc Miravitlles, David Price, Miguel Román-Rodríguez, Carl Llor, Tobias Welte, Roland Buhl, Daniel Dusser, Katerina Samara, Nikolaus Siafakas
Titel    New horizons in early stage COPD - Improving knowledge, detection and treatment
Zeitschrift    Respiratory Medicine
Verlag    Elsevier
Ausgabe    105
Jahr    2011
Seiten    1576-1587
DOI    10.1016/j.rmed.2010.12.015
URL    http://www.resmedjournal.com/article/S0954-6111(10)00560-3/pdf

Literaturverz.   

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Fußnoten    no
Fragmente    1


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[1.] Analyse:Amm/Fragment 112 01 - Diskussion
Zuletzt bearbeitet: 2014-12-25 21:30:39 Hindemith
Amm, Decramer et al 2011, Fragment, SMWFragment, Schutzlevel, Verschleierung, ZuSichten

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Seite: 112, Zeilen: 1ff (entire page)
Quelle: Decramer et al 2011
Seite(n): 1581, Zeilen: r.col: 21ff
[In the Lung Health Study II, which compared triamcinolone acetonide 600 μg or placebo bid in] 1,116 patients with mild-to-moderate COPD, active treatment had, again, a non-significant effect on the rate of decline in FEV1. Nevertheless, there was a significant reduction in respiratory symptoms with triamcinolone acetonide and in visits to a physician due to respiratory illness (Group LHSR, 2000). A post-hoc analysis of the ISOLDE trial of 751 patients treated with fluticasone proprionate 500 μg or placebo bid showed that, in 391 patients with an FEV1 ≥ 50% predicted, fluticasone propionate had no impact on the number of exacerbations per patient per year, at 1.5 versus 1.8. However, the proportion of patients with more than one exacerbations/year treated with oral corticosteroids was reduced significantly with active treatment, at 8% versus 16% for placebo (Jones PW et al, 2003). In the ISOLDE trial as a whole, the annual rate of decline in FEV1 was similar in both groups (Burge PS et al, 2000).

The MISTRAL study, published in 2006, randomised 1,010 COPD patients to tiotropium 18 μg or placebo once daily for 1 year. Among 426 patients with an FEV1 > 50% predicted, tiotropium was associated with a significant reduction in the number of exacerbations per patient per year, at 1.2 versus 2, alongside which there was a nonsignificant reduction in the number of patients experiencing one or more exacerbations in patients with mild COPD (Dusser D et al, 2006). For the BRONCUS study, 523 COPD patients were randomly assigned to N-acetylcysteine 600 mg daily or placebo and followed-up for 3 years. N-acetylcysteine was found to have, compared with placebo, no significant effects on either the decline in FEV1 or the decline in vital capacity in 389 participants with GOLD stage II COPD (Decramer M et al, 2005).

In the Lung Health Study II, which compared triamcinolone acetonide 600 μg or placebo bid in 1116 patients with mild-to-moderate COPD, active treatment had, again, a non-significant effect on the rate of decline in FEV1. Nevertheless, there was a significant reduction in respiratory symptoms with triamcinolone acetonide, at 21.1 per 100 person-years versus 28.2 per 100 person-years for placebo (p = 0.005), and in visits to a physician due to respiratory illness, at 1.2 per 100 person-years versus 2.1 per 100 person-years for placebo (p Z 0.03).63

A post-hoc analysis of the ISOLDE trial of 751 patients treated with fluticasone proprionate 500 μg or placebo bid showed that, in 391 patients with an FEV1 ≥ 50% predicted, fluticasone propionate had no impact on the number of exacerbations per patient per year, at 1.47 versus 1.75 (p = 0.45). However, the proportion of patients with ≥1 exacerbations/year treated with oral corticosteroids was reduced significantly with active treatment, at 8% versus 16% for placebo (p = 0.02).64 In the ISOLDE trial as a whole, the annual rate of decline in FEV1 was 50 ml/year in the fluticasone propionate group and 59 ml/year in the placebo group (p Z 0.16). Again, the study was powered to detect only a difference of only 20 ml/year.65

For the BRONCUS study, 523 COPD patients were randomly assigned to N-acetylcysteine (NAC) 600 mg daily or placebo and followed-up for 3 years. NAC was found to have, compared with placebo, no significant effects on either the decline in FEV1 or the decline in vital capacity (VC) in 389 participants with GOLD Stage II COPD. Mean decline in FEV1 was 6 ml/year higher with NAC (p Z 0.589) and 12 ml/year higher in VC (p Z 0.538).66

The MISTRAL study, published in 2006, randomised 1010 COPD patients to tiotropium 18 μg or placebo once daily for 1 year. Among 426 patients with an FEV1 >50% predicted, tiotropium was associated with a significant reduction in the number of exacerbations per patient per year, at 1.21 versus 1.97 (p < 0.001), alongside which there was a nonsignificant reduction in the number of patients experiencing ≥1 exacerbation in patients with mild COPD.67


63. Lung Health Study Research Group. Effect of inhaled triamcinolone on the decline in pulmonary function in chronic obstructive pulmonary disease. N Engl J Med 2000;343:1902e9.

64. Jones PW, Willits LR, Burge PS, Calverley PM. Disease severity and the effect of fluticasone propionate on chronic obstructive pulmonary disease exacerbations. Eur Respir J 2003;21:68e73.

65. Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA, Maslen TK. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ 2000;320:1297e303.

66. Decramer M, Rutten-van Molken M, Dekhuijzen PN, Troosters T, van Herwaarden C, Pellegrino R, et al. Effects of N-acetylcysteine on outcomes in chronic obstructive pulmonary disease (Bronchitis Randomized on NAC Cost-Utility Study, BRONCUS): a randomised placebo-controlled trial. Lancet 2005;365:1552e60.

67. Dusser D, Bravo ML, Iacono P. The effect of tiotropium on exacerbations and airflow in patients with COPD. Eur Respir J 2006;27:547e55.

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