Medication Monitor

Generic Name (Trade Name—Company)
March 1, 2011


Reducing COPD exacerbations


Reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations

Roflumilast is an oral agent that has a unique mechanism of action because it and the active metabolite roflumilast N-oxide are selective inhibitors of phosphodiesterase 4, the main cyclic adenosine monophosphate–metabolizing enzyme in inflammatory and immune cells. FDA said that roflumilast, given as a 500 µg tablet once daily to patients with severe COPD associated with chronic bronchitis, resulted in a significant reduction in the rate of moderate or severe exacerbations compared with placebo-treated patients; long-acting beta-2–adrenergic receptor agonists and short-acting muscarinics was used by approximately 40% of patients in both groups. In addition, roflumilast was also shown to be more efficacious in improving lung function when used concomitantly with salmeterol (Serevent—GlaxoSmithKline) or tiotropium (Spiriva—Boehringer Ingelheim) over a 6-month period compared with these agents alone. Use of this agent has been associated with psychiatric adverse events.