Drug products: Spiolto Respimat, Striverdi Respimat
ATC code: R03AC19, R03AL06
Substances: olodaterol, olodaterol hydrochloride
Controlled studies on differences between men and women in oledaterol´s efficacy and pharmacokinetic properties are lacking Most studies had more male patients than female. A meta-analysis showed that no dose adjustment of olodaterol was necessary based on patient’s sex.
COPD (Chronic obstructive pulmonary disease) affects more women than men and women often get a more serious and rapidly progressive disease . However, it should be noted that most studies included more men than women, limiting the applicability to female patients . In a systematic review, the distribution varied from 50 to 93% men .
A pharmacokinetic meta-analysis based on two controlled trials (n=405 with COPD, n=296 with asthma) showed that no dose adjustment was necessary based on patient’s sex, with systemic exposure of olodaterol .
A study showed tiotropium+ olodaterol FDC (fixed-dose combination) to improve lung function over monocomponents in patients with COPD GOLD 2 -4 disease (3761 men, 1397 women), irrespective of prior treatment with LAMA (long-acting muscarinic antagonist) or LABA (long-acting β2-agonist). Pooled data for patient’s sex may indicate monotherapy with olodaterol being more effective for women compared to men in a forest plot, but FDC was superior in both groups. No statistical comparisons were made between subgroups. The low number of female patients in the pooled analysis is insufficient to draw any conclusions on sex differences . No other studies with a clinically relevant sex analysis regarding the effects of olodaterol alonehave been found.
No studies with a clinically relevant sex analysis regarding the adverse effects of olodaterol have been found.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2020-08-03
Reviewed by: Diana Rydberg, Carl-Olav Stiller
Approved by: Karin Schenck-Gustafsson