0
Obstructive Lung Diseases |

Respiratory-Associated Adverse Events in the Roflumilast COPD Safety Pool

Gary Ferguson*, MD; Nicola Hanania, MD; Udo-Michael Goehring, MD; Hans Mosberg, MD; Manja Brose, MS; Dirk Bredenbroker, MD; Hassan Lakkis, PhD; Paul Rowe, MD
Author and Funding Information

Pulmonary Research Institute of Southeast Michigan, Livonia, MI


Chest. 2012;142(4_MeetingAbstracts):665A. doi:10.1378/chest.1388392
Text Size: A A A
Published online

Abstract

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 Information

Pulmonary Research Institute of Southeast Michigan, Livonia, MI

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
PubMed Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543