Striverdi Respimat (olodaterol)
Striverdi Respimat (olodaterol) is the fourth authorised bronchodilator in the group of long-acting beta 2-agonists for inhalation. The registered indication is maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Thus, olodaterol is not approved for the treatment of asthma. The recommended dose is 5 microgram (two puffs) once daily.
The long-term effect has been demonstrated in 4 largely identical randomised, double-blind, 48-weeks studies, in which olodaterol was compared with placebo and placebo + formoterol 12 microgram twice daily. Compared with placebo, statistically significant improvement in various lung function measurements was maintained; there was no effect on dyspnoea, but a modest effect was seen on health-related quality of life. The average improvements of lung function measurements compared with placebo were not clinically relevant (lower than Minimum Clinically Important Difference, MCID), but 5 out of the 6 enrolled patients were in concomitant treatment with at least one other bronchodilator. Another possible interpretation of the results is that in most cases combination therapy of COPD is not better than treatment with one single drug. As such, olodaterol was found comparable to formoterol monotherapy.
It is IRF’s overall assessment that Striverdi Respimat can be used equally with other long-acting beta 2-agonists for inhalation to treat COPD, but currently several less expensive alternatives are available. It is important to note that only a minority of COPD patients will be free of symptoms despite treatment with the maximum recommended dose. When starting on a new drug, the patient and the prescriber should agree on a plan for the relevant degree of alleviation of symptoms. If the objective is not achieved, the treatment should be discontinued. Otherwise, the patient may end up in ineffective polypharmacy.
Striverdi Respimat was marketed on 3 March 2014. General reimbursement is currently granted.