Roflumilast is a selective, highly potent phosphodiesterase 4 inhibitor with greater affinity for PDE4 than other PDE4 inhibitors.
Oral agent indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe disease associated with chronic bronchitis and a history of exacerbations.
Roflumilast (Daliresp) is an oral phosphodiesterase-4 inhibitor that inhibits the breakdown of cyclic AMP and may improve FEV1 when taken with bronchodilators.
Roflumilast (Daliresp) reduces exacerbations in patients treated with corticosteroids by 15-20% in severe to very severe COPD and a history of exacerbations.
Roflumilast (Daliresp) side effects include nausea diarrhea, anorexia, headache, weight loss, and alterations in sleep.
Not a bronchdilator agent.
Contraindicated in patients with moderate to severe liver disease (Child-Pugh B or C).
May be associated with insomnia, anxiety, depression, suicidal ideation and other mood changes.
Psychiatric adverse reactions in controlled clinical trials 5.9% versus such reactions in 3.3% of placebo patients.
Weight loss a common adverse reaction, 7.5% versus 2.1% in placebo patients.
Use with strong cytochrome P450 agents is not recommended, and includes phenytoin, carbamazine, phenobarbital and rifampin.
Most common clinical adverse reactions are diarrhea (9.5%), weight loss (7.5%), nausea (4.7%), headache (4.4%), an back pain (3.2%).