Olodaterol is a long-acting beta2-adrenoceptor agonist (LABA). By activating β2-adrenoceptors, LABAs cause relaxation of smooth muscle in the airways, resulting in bronchodilation.1
Olodaterol (administered via the Respimat inhaler) was compared with formoterol (administered via an Aeroliser dry powder inhaler) in two 48-week, randomised, double-blind, placebo-controlled trials in patients with moderate to very severe COPD (post-bronchodilator FEV1 less than 80% predicted normal and post-bronchodilator FEV1 to FVC ratio less than 70%). Participants continued to receive their usual background therapy, including long- and short-acting anticholinergics, inhaled corticosteroids and xanthines.1–3
CO-PRIMARY EFFICACY ENDPOINTS
Lung function was assessed on the basis of two co-primary endpoints: initial FEV1 response (area under the curve from 0–3 hours) and trough FEV1 response.2
Overall, 459 patients were treated with olodaterol 5 microgram daily, 460 with formoterol 12 microgram twice daily and 460 with placebo.2
Increased initial and trough FEV1
After 24 weeks, patients receiving olodaterol showed a significant improvement in lung function, with increases in initial FEV1 response of 0.15L and 0.13L (p<0.0001 for both) and increases in trough FEV1 response of 0.08L (p<0.001) and 0.05L (p<0.01) compared with placebo. The increases were comparable to those seen in patients treated with formoterol (initial FEV1 responses +0.18L and +0.15L, p<0.0001 for both; trough FEV1 responses +0.05L and +0.04L, p<0.01 and p<0.05, respectively). Improvements were sustained over 48 weeks.2
Rapid onset of action
Olodaterol had a rapid onset of action, comparable to formoterol. In both studies, FEV1 increased within 5 minutes of first dosing, and increased further after 15 and 30 minutes.2
Reduction in rescue medication use
Symptomatic benefits were also seen. The olodaterol and formoterol groups showed significant reductions in weekly mean daytime and night-time rescue medication use over 48 weeks compared with the placebo group (p<0.01).2
Two six-week trials (total n=199) showed that the significant effect of once-daily olodaterol compared with placebo on FEV1 response (p<0.0001) was sustained over the full 24-hour dosing interval, comparable to twice-daily formoterol.1
Increased endurance time
In two additional six-week studies (total n=301), olodaterol significantly increased endurance time as assessed by constant work-rate cycle ergometry to symptom limitation performed at 75% maximal work capacity. At week 6, mean log-transformed endurance times in the two studies were 14% and 11% greater with olodaterol than with placebo (p≤0.0003 and p≤0.002, respectively).5
Pooled analysis of the two 48-week studies and two further placebo-controlled 48-week studies in patients with moderate to very severe COPD (total n=3104) showed that the safety profile of olodaterol 5 microgram once daily was comparable to that of formoterol 12 microgram twice daily and placebo.4
The adverse events reported with olodaterol were nasopharyngitis, dizziness, hypertension, rash and arthralgia, all of which were seen rarely or uncommonly.1
- Striverdi Respimat Summary of Product Characteristics, October 2013.
- Koch A et al. Poster presented at European Respiratory Society Annual Congress, Barcelona, Spain, September 2013; P764.
- Koch A et al. Poster presented at European Respiratory Society Annual Congress, Barcelona, Spain, September 2013; P763.
- McGarvey L et al. Poster presented at European Respiratory Society Annual Congress, Barcelona, Spain, September 2013; P3633.
- Maltais F et al. Poster presented at 79th Annual Meeting of the American College of Chest Physicians, Chicago, October 2013; P13-14109.