Nebenwirkungen · Trelegy Ellipta
Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed · Abschnitt 4.8 · PDF-Seite 9
HOS-138238 · Präparat HOS-098164
In a 52-week study, with a total of 10 355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Trelegy Ellipta (n = 4 151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4 134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2 070). Fatal pneumonia occurred in 12 of 4 151 patients (3.5 per 1 000 patient- years) receiving Trelegy Ellipta, 5 of 4 134 patients (1.7 per 1 000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2 070 patients (2.9 per 1 000 patient-years) receiving umeclidinium/vilanterol.
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Version 2026-05-08T12:00:00Z · SHA-256 da8a456ad1e55d2f32bd6c089e4b8c46019bb784e9ff1f604d031e5d487eea91 · Passage 5ed50e18f90617c876c836759310807a5fe452443010e2c2e0f9a3eb1e818ccb · Zeichen 4672–5394 im Abschnitt