SESSION TYPE: COPD Posters II
PRESENTED ON: Wednesday, October 24, 2012 at 01:30 PM - 02:30 PM
PURPOSE: Clinical studies in COPD have shown that use of anti-inflammatory therapies such as inhaled corticosteroids are associated with adverse events (AEs; eg, pneumonia). Roflumilast, an oral phosphodiesterase-4 inhibitor approved to reduce the risk of exacerbations in severe COPD patients associated with chronic bronchitis and a history of exacerbations, also has demonstrated preclinical anti-inflammatory activity in COPD patient airways. This analysis examined the roflumilast COPD safety pool to determine whether treatment with roflumilast is associated with any similar change in respiratory AEs, such as infections.
METHODS: Patients in 14 studies were treated with roflumilast 500μg (n=5766), roflumilast 250μg (n=797),or placebo (n=5491) in moderate-to-very severe COPD patients. Only pooled data from patients treated with the approved roflumilast dose (500μg) or placebo were considered for this analysis. Frequencies of AEs, serious AEs, and AEs leading to discontinuation due to infections/infestations or respiratory disorders system organ classes (SOC) are reported.
RESULTS: By SOC, infections/infestations occurred in 25.9% and 27.5% of roflumilast- and placebo-treated patients, respectively; respiratory disorders occurred in 25.6% and 29.3% of patients, respectively. Common AEs (≥1% of patients in either treatment group) included COPD exacerbations (roflumilast, 19.8% vs placebo, 23.1%), nasopharyngitis (both 6.3%), upper respiratory tract infection (3.8% vs 4.3%), bronchitis (3.1% vs 3.5%), influenza (2.5% vs 2.4%), dyspnea (1.5% vs 2.2%), pneumonia (1.8% vs 2.0%), sinusitis (both 1.8%), cough (1.7% vs 1.8%), urinary tract infection (1.3% vs 1.0%), rhinitis (1.2% vs 0.9%), pharyngitis (1.1% vs 1.3%), and lower respiratory tract infection (both 1.0%). Common serious AEs (≥0.5% of patients) included COPD exacerbations (5.8% vs 7.1%) and pneumonia (both 1.1%). Common AEs leading to discontinuation (≥0.2% of patients) included COPD exacerbations (3.2% vs 3.8%), pneumonia (0.3% vs 0.5%), dyspnea (0.3% vs 0.6%), respiratory failure (0.2% vs 0.1%), and acute respiratory failure (0.1% vs 0.2%).
CONCLUSIONS: The percentages of patients treated with roflumilast experiencing respiratory AEs, infections, and COPD exacerbations were either similar or lower than those treated with placebo in this large safety pool.
CLINICAL IMPLICATIONS: Compared with placebo, treatment with roflumilast does not increase the risk of infections or respiratory disorders and reduces exacerbations reported as adverse events in COPD patients.
DISCLOSURE: Gary Ferguson: Consultant fee, speaker bureau, advisory committee, etc.: Consultant for Boehringer-Ingelheim, GlaxoSmithKline, Novartis and Pearl, Consultant fee, speaker bureau, advisory committee, etc.: Speaker for Boehringer-Ingelheim, GlaxoSmithKline and Pfizer, Grant monies (from industry related sources): Grant support from Boehringer- Ingelheim, Forest, GlaxoSmithKline, Novartis and Pearl
Nicola Hanania: Consultant fee, speaker bureau, advisory committee, etc.: Advisory Board for Forest Research Institute, Grant monies (from industry related sources): Institution received research grant support from Forest Research Institute
Udo-Michael Goehring: Employee: Employee of Takeda Pharmaceuticals International GmbH
Hans Mosberg: Employee: Employee of Takeda Pharmaceuticals International GmbH
Manja Brose: Employee: Employee of Takeda Pharmaceuticals International GmbH
Dirk Bredenbroker: Employee: Employee of Takeda Pharmaceuticals International GmbH
Hassan Lakkis: Employee: Employee of Forest Research Institute
Paul Rowe: Employee: Employee of Forest Research Institute
No Product/Research Disclosure InformationPulmonary Research Institute of Southeast Michigan, Livonia, MI