Roflumilast (brand name Daliresp) is a prescription medicine used in adults with severe COPD to decrease the number of exacerbations. It is in a class of medications called phosphodiesterase inhibitors and works by decreasing the swelling in the lungs.

How does roflumilast for COPD work?

Roflumilast inhibits an enzyme called phosphodiesterase 4 (PDE4), preventing the breakdown of cyclic adenosine monophosphate (cAMP) into its inactive state (called AMP).

In people with COPD, a four-week treatment with roflumilast reduced sputum neutrophils by 31 percent and eosinophils by 42 percent. The clinical significance of this is unknown, however.

Studies of roflumilast

In the two one-year pivotal studies, roflumilast reduced the rate of moderate or severe exacerbations when used with a bronchodilator compared a placebo used with a bronchodilator.

According to AstraZeneca, who manufactures roflumilast under its brand name Daliresp, “For every five patients treated, adding Daliresp could prevent one additional exacerbation per year.”

A post-marketing surveillance study of roflumilast (NCT02068456) is currently recruiting participants in South Korea and will evaluate the safety and effectiveness of roflumilast in real-use conditions.

Also, a randomized, double-blind Phase 2 clinical trial (NCT02671942) is evaluating the safety and drug properties of different doses of roflumilast in 120 people with COPD who live in China. Roflumilast has been approved by the U.S. Food and Drug Administration at a recommended dose of 500 mcg per day. This Phase 2 trial will study lower doses (250 mcg and 375 mcg once daily) vs. a placebo.

Indications and side effects

Roflumilast is a tablet to be taken orally once daily. This medicine may control COPD but won’t cure it, so it should be taken even if symptoms improve.

From the eight controlled studies of roflumilast and more than 4,400 people with COPD, the most common adverse reactions were diarrhea, weight loss, nausea, headache, back pain, flu-like symptoms, insomnia, dizziness, and decreased appetite.

Roflumilast may also cause insomnia, anxiety, and depression, and three patients in the studies experienced suicide-related adverse reactions. If patients, their families or caregivers notice mood changes, they should alert their healthcare providers right away.

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