Roflumilast has been approved by the FDA as a first in class new drug to be marketed under the brand name Dalilresp by Forrest Pharmaceuticals. As a brand new drug that is marketed to prevent exacerbations of COPD, but not to reduce day-to-day symptoms of COPD, the question is whether patients and physicians are going to see a benefit in using this drug. It may be a hard sell to take a $200./ month medication that may reduce the incidence of COPD exacerbations by 40-50% but does not make you feel any better in between episodes. In a given individual it may take a long time to decide if the medication helps or not. Still if you have been, or cared for, a COPD patient struggling for each breath and feeling like they are drowning the value of avoiding an episode like this may be pretty high.
Roflumilast is a selective long lasting (14 hour half-life) inhibitor of the enzyme Phosphodiseterase-4 (PDE-4) that is a part of the inflammatory process in the lungs. Roflumilast is approved for use at a fixed dose of 500 mg for the prevention of exacerbations of chronic obstructive lung disease with sputum production, what is commonly called chronic bronchitis. It is not felt to be effective for patients with emphysema without sputum production.
Roflumilast appears to a drug that will fill a niche in management of the severe chronic bronchitis patient who continue to have acute exacerbations despite aggressive treatment with established medications like inhaled corticosteroids, inhaled long acting anticholinergics like tiotropium (Spireva), beta agonists bronchodialators, and episodic burst courses of prednisone. In those patients who have fairly frequent exacerbations of COPD, especially if they result in hospitalizations, a drug to reduce the frequency of these episodes would be very valuable. Even avoiding one ER visit for a COPD exacerbation is going to more than pay for a couple of years of roflumilast therapy, and if a several day hospitalization is avoided a lifetime of therapy may be a bargain.
Good news is that Roflumilast appears to be something that most patients are going to be able to tolerate. Rofluvilast side effects seem to be infrequent and moderate. The most frequent side effects noted in the larger trial of roflumilast were diarrhea 6% of patients, nausea 6%, abdominal pain 3%, weight loss 2%, and dizziness 2% and headache 2%. In addition there seems to be no difference in absorption when taken with food or on an empty stomach, and with a 14 hour half life once daily dosing is a nice plus for patient compliance. Drug interactions seem to not be a big issue either with no effect on warfarin, erythromycin or the usual inhaled COPD medications.
Unfortunately the measured improvement in FEV 1.0 and FVC (the commonly used measurements of lung function) with roflumilast is very minimal, and there does not appear to be significant improvement in how a patient on romfluvilast feels or in their functional ability.
So where does this leave physicians and patients regarding whether to use roflumilast? It is a bit hard to say, but I would consider using roflumilast in a patient with chronic bronchitis who is on a good regimen of medications including an high dose of an inhaled corticosteroid with or without a long-acting beta agonist, tiotropium, a rescue beta agonist inhaler, and still has one or more severe exacerbations of COPD a year that results in either a hospital or ER visit, or significant morbidity to the patient.
Resource: Prednisone side effects