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DOI: 10.1055/s-2007-959286
© Georg Thieme Verlag KG Stuttgart · New York
β2-Sympathomimetika: Gefahren in der Asthmatherapie? Lehren aus der SMART1-Studie
Eine Stellungnahme der Deutschen AtemwegsligaSafety of long acting β2-agonists in the management of asthmaPublication History
eingereicht: 4.7.2006
akzeptiert: 5.10.2006
Publication Date:
22 December 2006 (online)
![](https://www.thieme-connect.de/media/dmw/20070102/lookinside/thumbnails/10.1055-s-2007-959286-1.jpg)
Zusammenfassung
Die moderne Therapie des Asthma bronchiale hat zu einer eindrucksvollen Abnahme von Mortalität, Asthmaanfällen und asthmabedingten Notfalleinweisungen geführt. Dies ist überwiegend auf die Anwendung inhalativer Kortikosteroide (ICS) zurückzuführen, für die auch ein mortalitätssenkender Effekt bewiesen ist. Langwirksame β2-Sympathomimetika führen in Kombination mit ICS zu einer Reduktion von Exazerbationen bei gleichzeitiger Verminderung der ICS-Dosis. Daher sollte die Kombinationstherapie aus beiden Substanzen fester Bestandteil der Asthmatherapie bei denjenigen Patienten sein, die unter alleiniger ICS-Therapie symptomatisch bleiben. Die Behandlung mit langwirksamen Symathomimetika ist in jüngster Zeit durch die kürzlich publizierte SMART-Studie (Salmeterol Multicenter Asthma Research Trial) in die Kritik geraten, da sich in der mit Salmeterol behandelten Patientengruppe eine Erhöhung der pulmonalen Todesfälle oder lebensbedrohlichen pulmonalen Ereignisse zeigte. Aufgrund früherer Studienergebnisse, in denen über eine erhöhte Komplikationsrate der jeweiligen, mit β2-Sympathomimetika behandelten Patientengruppen berichtet wurde, insbesondere aber wegen der SMART-Ergebnisse, wurde von der Federal Drug Administration in den USA (FDA) die Aufnahme eines entsprechenden Warnhinweises im Beipackzettel aller Salmeterol-haltigen Präparate, einschließlich der Salmeterol/Fluticason-Fixkombination und beim Formoterol verfügt. Welche Konsequenzen ergeben sich hieraus für die Behandlung von Asthmapatienten? Die Indikation für den Einsatz langwirksamer β2-Sympathomimetika ist gleichermaßen für Erwachsene und Kinder/Jugendliche kritisch zu stellen. Sie gehören unverändert erst ab dem Schweregrad III zur inhalativen Therapie des Asthma bronchiale und müssen, entsprechend der aktuellen Asthma-Therapieleitlinien, mit inhalativen Kortikosteroiden kombiniert werden.
Summary
Modern drug treatment of asthma has resulted in an impressive reduction of mortality, rates of exacerbation and the frequency of emergency treatment. This effect is in particular the result of the introduction of long-term therapy with inhaled corticosteroids (ICS), which have also been shown to significantly reduce the mortality rate from asthma. By combining long-acting beta2 agonists with ICS administration the exacerbation rate can be further reduced, even when the ICS dosage is reduced. For this reason combination therapy with long-acting beta2 agonists and ICS should always be prescribed in patients with unstable asthma when on appropriately dosed ICS administration alone. The recently published SMART study (Salmeterol Multicenter Asthma Research Trial) has again revitalized a long-lasting discussion about the increased risk of severe asthma exacerbations and of asthma-related death caused by beta2 agonist therapy. In this trial there was a small but significant increase in asthma-related deaths of patients receiving salmeterol compared with patients on placebo. Based on previous reports and as a result of this recent findings, the US Food and Drug Administration (FDA) imposed a „black box” warning for the use of the long-acting beta2 agonist salmeterol, including the fixed combination of salmeterol/fluticasone, as well as of formoterol. The warning appropriately alerts doctors to findings of which they should be aware. What are the consequences for clinicians prescribing long-acting beta2 agonists? Although such long-acting agonists provide sustained bronchodilation and improve asthma control, they should only be used in adults and children with stage III asthma who have not adequately responded to other asthma controlling medications, such as low-to-medium doses of inhaled corticosteroids (ICS). They must be prescribed only in combination with ICS.
Schlüsselwörter
Salmeterol - Formoterol - Asthma - Kortikosteroide - β2-Sympathomimetika - Therapie - Mortalität
Key words
Salmeterol - Fomoterol - Corticosteroids - β2-agonists - Asthma - Therapy - Mortality
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Prof. Dr. med. A. Gillissen
Robert Koch-Klinik, Thoraxzentrum des Klinikums St. Georg
Nikolai-Rumjanzew-Straße 100
04207 Leipzig
Phone: 0341/4231202
Fax: 0341/4231203
Email: adrian.gillissen@sanktgeorg.de
URL: http://www.rkk-leipzig.de