New Starting Dose Approved for Daliresp to Treat Severe COPD

Percentage of patients discontinuing treatment significantly lower in those who initially received 250mcg daily
Percentage of patients discontinuing treatment significantly lower in those who initially received 250mcg daily

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.

Related Articles

For more information visit Astrazeneca-us.com.