Roflumilast Improves Breathlessness and Lung Function
13 Trials of Roflumilast Analyzed in 14,563 Subjects
Background:Roflumilast (brand name is Daliresp) is non-steroid anti-inflammatory medication approved to reduce “flare ups” (exacerbations) in those with COPD who have:
♦ chronic bronchitis
♦ severe disease as measured by amount of air exhaled in one second (FEV1) below 50% of predicted
♦ a history of “flare ups”
It is different than other approved treatments for COPD which include bronchodilators (relax muscle around breathing tubes to increase air flow) and a combination of long-acting bronchodilator and inhaled corticosteroid. The dose is 500 mg taken once daily.
Study:The analysis examined 13 different studies that compared roflumilast with placebo (sham or pretend) treatment in those with moderate to severe COPD. Dr. Luo of Sichuan University is the first author. The report was published in the journal Respiratory Research, 2016, open access.
Results:There were overall significant benefits showing:
⇒ increased breathing tests FEV1 and FVC (total volume of air exhaled after a deep breath in)
⇒ reduced breathlessness as measured on the Transition Dyspnea Index – a questionnaire about shortness of breath with daily activities
⇒ reduced number of “flare ups” (exacerbations) by 14%
There were also more side effects with roflumilast compared with placebo. Most were related to the gastrointestinal tract.
Conclusion:The authors concluded that “roflumilast can be considered as an alternative therapy is selective patients with moderate to severe COPD.”
My Comments:The package information that is included with the medication states that the most common side effects include diarrhea, weight loss, nausea, headache, back pain, flu-like symptoms, problems sleeping (insomnia), dizziness, and decreased appetite. Some people taking roflumilast may develop mood or behavior problems, including thoughts of suicide.
In my practice, I have prescribed roflumilast for those who have repeated “flare ups” of their COPD despite use of other medications that reduce the risk on an exacerbation. Unfortunately, only about one-half of those who were started on roflumilast were able to tolerate the medication and continued it. Nausea and upset stomach were the most common complaints in my practice.
Certainly, both you and your health care provider should consider possible benefits along with possible side effects before prescribing any medication.
Donald A. Mahler, M.D. is Emeritus Professor of Medicine at Geisel School of Medicine at Dartmouth in Hanover, New Hampshire. He works as a pulmonary physician at Valley Regional Hospital in Claremont, NH, where he is Director of Respiratory Services.