New Starting Dose Approved for Daliresp to Treat Severe COPD

The Food and Drug Administration (FDA) has approved Daliresp (roflumilast; AstraZeneca) 250mcg to be used as a starting dose once daily for the first 4 weeks of treatment followed by 500mcg thereafter to help reduce the rate of treatment discontinuation in some chronic obstructive pulmonary disease (COPD) patients. Daliresp is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

The tolerability of Daliresp was assessed in a 12-week randomized, double-blind, parallel group trial in patients with severe COPD associated with chronic bronchitis (N=1,323). Patients were randomized to received Daliresp 500mcg once daily for 12 weeks, Daliresp 500mcg every other day for 4 weeks followed by Daliresp 500mcg once daily for 8 weeks, or Daliresp 250mcg once daily for 4 weeks followed by Daliresp 500mcg once daily for 8 weeks.

Over the study period, the percentage of patients who discontinued treatment was 6.2% lower in those who initially received Daliresp 250mcg once daily for 4 weeks followed by Daliresp 500mcg once daily for 8 weeks compared to those receiving Daliresp 500mcg once daily for 12 weeks. (odds ratio [OR] 0.66; 95% CI: 0.47–0.93; P=0.017). However, due to the limited duration of the trial, whether the 250mcg dose improves long term tolerability of Daliresp 500mcg has not been determined.   

Daliresp, a selective phosphodiesterase-4 inhibitor, is supplied as 250mcg tablets in a blister pack of 28 tablets; the 500mcg strength is available in 30- and 90- count bottles. Daliresp 250mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.

For more information visit Astrazeneca-us.com.