Medication Monitor



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

Roflumilast

(Daliresp—Forest)
Reducing COPD exacerbations

Uses:

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.