Bodyplethysmographischer Wirkeintritt von Formoterol bei Patienten mit mittel- bis schwergradiger partiell reversibler Atemwegsobstruktion

Zusammenfassung

Hintergrund: Formoterol ist ein langwirksames, inhalatives β₂-Sympathomimetikum zur Behandlung obstruktiver Atemwegserkrankungen. Darüber hinaus zeichnet sich Formoterol gegenüber Salmeterol durch einen schnelleren Wirkeintritt aus. Bislang liegen nur wenige vergleichende Untersuchungen zum bodyplethysmographischen Wirkeintritt von Formoterol und Salmeterol bei mittel- bis schwergradiger, partiell reversibler Atemwegsobstruktion vor. Methode: In einer monozentrischen, einfach-blinden Parallelgruppen-Studie wurde der Wirkeintritt von Formoterol (2 × 12 µg/Tag via Foradil Aerolizer®) und Salmeterol (2 × 50 µg/Tag via Serevent Diskus®) vor und nach einer 14-tägigen Behandlung bodyplethysmographisch bei 60 Patienten mit mittel- bis schwergradiger Atemwegsobstruktion (Alter: 61,9 ± 12,8 Jahre, 65 % männlich, FEV₁ 40,6 ± 15,3 % des Sollwertes; Reversibilität > 15 %) untersucht. Ergebnisse: Nach Inhalation von Formoterol zeigte sich sowohl initial (Tag 1) als auch nach 14-tägiger Behandlung ein signifikant schnellerer Wirkungseintritt (Reduktion von sRAw um > 10 %) als in der Salmeterolgruppe (Visite 1: 1,4 ± 0,9 vs. 15,1 ± 34,5 min; Visite 3: 6,2 ± 21,6 vs. 51 ± 135 min., p < 0,0001, beide Vergleiche). In beiden Gruppen konnte nach 14-tägiger Behandlung eine deutliche Verbesserung der morgendlichen Lungenfunktion (FEV₁) gegenüber dem Ausgangswert beobachtet werden (Formoterol: 1,38 ± 0,64 l vs. 1 ± 0,41; Salmeterol: 1,43 ± 0,67 l vs. 1 ± 0,4, p < 0,05, beide Vergleiche). Sowohl Formoterol als auch Salmeterol waren gut verträglich. Zusammenfassung: Auch bei Patienten mit mittel- bis schwergradiger Atemwegsobstruktion lässt sich bodyplethysmographisch nach Inhalation von Formoterol aus dem Aerolizer® eine rasche Bronchodilatation erzielen. Dabei war Formoterol Salmeterol bezüglich der Geschwindigkeit des Wirkungseintritts überlegen. Die mit beiden Substanzen erzielte Kontrolle der obstruktiven Ventilationsstörung war dagegen vergleichbar. Neben der Unterscheidung lang- und kurzwirksamer β₂-Sympathomimetika erscheint eine Klassifizierung in schnell und verzögert wirksame β₂-Sympathomimetika sinnvoll.

Abstract

Background: Formoterol is a long acting β₂-agonist used for the treatment of obstructive airway diseases. Compared with Salmeterol, Formoterol has a rapid onset of bronchodilation. There are only scant data regarding the comparative onset of action using bodyplethysmography in moderate to severely obstructive patients. Methods: In a mono-center, single-blinded parallel group study 60 patients (age: 61.9 ± 12.8 years, 65 % male) with moderate to severe (mean FEV₁ 40.6 ± 15.3 % of predicted), partially reversible (FEV₁ post bronchodilator > 15 % from baseline) airway obstruction were treated with either formoterol 12 µg bid or salmeterol 50 µg bid over a period of two weeks. Onset of action was measured by airway resistance (sRaw) before and after two weeks of treatment. Results: Compared with Salmeterol, Formoterol had a significantly faster onset of action (10 % decrease of Raw) at baseline (F: 1.4 ± 0.9 vs. S: 15.1 ± 34.5 min., p < 0.0001) and after two weeks of treatment (F: 6.2 ± 21.6 vs. S: 51 ± 135 min., p < 0.0001). Morning FEV₁ improved similarily during treatment in both study groups, when compared with baseline lung function (F: 1.38 ± 0.64 vs. 1 ± 0.41 l; S: 1.43 ± 0.67 vs. 1 ± 0.4 l, p < 0.05, both comparisons). Both treatments were well tolerated. Conclusion: Formoterol produces a rapid improvement of airway resistance in patients with moderate to severe, partially reversible airway obstruction. The onset of bronchodilation was significantly faster for Formoterol compared with Salmeterol. Both drugs improved lung function similarily after two weeks of treatment. It is important to distinguish β₂-agonists not only into short- and long-acting but also into fast- and slow-acting.

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