SESSION TYPE: COPD: Safety and Effectiveness of Newer Therapies
PRESENTED ON: Tuesday, October 23, 2012 at 02:45 PM - 04:15 PM
PURPOSE: Roflumilast is approved to reduce the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Improvement in lung function has also been noted with roflumilast treatment. This analysis examined changes in lung function among COPD subjects from a pool of seven 6-month roflumilast studies.
METHODS: Data were pooled from seven 6-month randomized, placebo-controlled studies in subjects with moderate-to-severe COPD treated with roflumilast 500μg. Efficacy was assessed as pre- and postbronchodilator FEV1 following 6 months of treatment; subgroups of subjects with either moderate or severe COPD were also analyzed. Adverse event (AE) frequencies were examined.
RESULTS: A total of 4746 subjects were randomized to roflumilast (pooled intent-to-treat [ITT], n= 2511; moderate COPD, n=1184; severe COPD, n=1217) or placebo (pooled ITT, n=2235; moderate COPD, n=1098; severe COPD, n=1062). Baseline demographics were similar between treatment groups. At 6 months, roflumilast increased pre- and postbronchodilator FEV1 by 66 mL and 67 mL, respectively, compared with placebo (both P<0.0001). Roflumilast, compared with placebo, also increased pre- and postbronchodilator FEV1 in subjects with moderate (73 mL and 63 mL, respectively, both P<0.0001) and severe (58 mL and 71 mL, respectively, both P<0.0001) COPD. AEs were reported by 61.1% and 55.8% of subjects receiving roflumilast and placebo, respectively. AEs with frequencies ≥5% were diarrhea (roflumilast, 10.3% vs placebo, 2.3%), nasopharyngitis (6.6% vs 6.1%) and nausea (5.9% vs 1.2%). Frequencies of serious AEs were similar between groups (roflumilast, 7.7% vs placebo, 7.5%).
CONCLUSIONS: Roflumilast was associated with significant improvements in lung function, as measured by FEV1, in both moderate and severe COPD subjects after 6 months of treatment compared with placebo.
CLINICAL IMPLICATIONS: Roflumilast consistently improved lung function over 6 months. Adverse events were similar to those reported previously in pivotal roflumilast trials. The results in moderate or severe COPD patients suggest that similar benefits on lung function are observed with roflumilast treatment regardless of COPD severity.
DISCLOSURE: Nicola Hanania: Consultant fee, speaker bureau, advisory committee, etc.: Advisory Board for Forest Research Institute, Grant monies (from industry related sources): Research grant support from Forest Research Institute
Jill Karpel: Grant monies (from industry related sources): Research funds from Forest, Boeringher-Ingelheim, Novartis, Genentech, Consultant fee, speaker bureau, advisory committee, etc.: Speaker Bureau for Merck, Genentech, Astra-Zeneca, Boeringher-Ingelheim
Udo-Michael Goehring: 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: Employe of Forest Research Institute
Paul Rowe: Employee: Employee of Forest Research Institute
Leonardo Fabbri: Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca, Boehringer Ingelheim, Chiesi International, GlaxoSmithKline Beech, Merck Sharp Dohme, Novartis, Nycomed, Pearl Therapeutics, Sterna, Peer Voice Europe, OM Pharma Sa, Schering Plough, Sigma-Tau, Roche, German Aerospace Center, Mundipharma Int., Genetech Inc., Elevation Pharmaceutical, Ferrer Group, Grant monies (from industry related sources): Institution grants AstraZeneca, Boehringer Ingelheim, Schering-Plough, Pfizer, Nycomed, Menarini, Chiesi Farmaceutici, GlaxoSmithKline Beech, Merck Sharp Dohme, Roche, Sigma-Tau, Italian Ministry for University Research, and Italian Ministry of Health
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