Roflumilast effective in reducing COPD exacerbation rate

Roflumilast is effective when it comes to enhancing lung function and preventing exacerbations in patients with COPD with chronic bronchitis and severe airflow obstruction, as per a large 12-month randomized trial.

Results of the 1,568-patient, double-blind, placebo-controlled study known as the M2-125 trial suggest that the drug is an important potential advance in the treatment of a subset of patients with COPD, Dr. Andrew McIvor said at the annual meeting of the American College of Chest Physicians.

From Internalmedicinenews.com:

Participants in the eight-nation M2-125 trial had to have at least one documented moderate or severe COPD exacerbation during the year prior to enrollment. They were randomized to roflumilast 500 mcg once daily or placebo for 1 year, on top of background long-acting beta2-agonist or short-acting anticholinergic therapy at stable doses, along with short-acting beta2-agonists as needed. Long-acting anticholinergics and inhaled corticosteroids were not permitted.
The rate of moderate to severe COPD exacerbations requiring systemic steroids and/or treatment in a hospital—one of two co-primary study end points—was 1.21 cases per patient per year in the roflumilast group and 1.49 in controls, for a highly significant 18.5% relative risk reduction.
The other primary end point was improvement in lung function as reflected in mean change from baseline in forced expiratory volume in 1 second (FEV1) prior to administration of a bronchodilator.
Again, roflumilast showed a highly significant advantage, with a 33-mL increase in FEV1 as compared to a 25-mL decrease with placebo over the course of 12 months.

Roflumilast (Daxas) is an investigational selective phosphodiesterase 4 inhibitor that targets inflammation that is a hallmark of the disease when taken daily in an oral form, as per Dr. McIvor of St. Joseph's Healthcare Hamilton (Ont.).