Drug products: ANORO ELLIPTA, RELVAR ELLIPTA, Trelegy Ellipta
ATC code: R03AK10, R03AL03, R03AL08
Substances: vilanterol, vilanterol trifenatate
Limited data from controlled trials of vilanterol does not suggest any notable difference in the pharmacokinetics between men and women. Published controlled studies on differences between men and women regarding effect and safety of vilanterol are lacking.
COPD (chronic obstructive pulmonary disease) affects more women than men and women often get a more serious and rapidly progressive disease . Adult asthma is more common in women while childhood asthma is more common in boys. The reversal of this sex difference in prevalence occurs around puberty which suggests that sex hormones may play a role in the etiology of asthma . However, some studies suggest that there are sex differences in expression and diagnosing of asthma, and it has been discussed if women are under-treated for respiratory diseases or not [3, 4].
In a population pharmacokinetic analysis in asthma patients (356 men, 500 women) and COPD patients (751 men, 340 women), there was no evidence of a patient’s sex influencing the pharmacokinetics of vilanterol . In a population pharmacokinetics study of inhaled vilanterol in COPD patients (795 men, 327 women), there was no notable difference in vilanterol systemic exposure between the sexes . Population pharmacokinetic analysis (69% male) showed no evidence of a clinically significant effect of patient’s sex on systemic exposure of vilanterol .
In a multi-center, randomized, double-blind, placebo-controlled study with children aged 5-11 years, 18 boys and 10 girls with persistent asthma, inhaled vilanterol 25 µg showed similar pharmacokinetic profiles irrespective of sex. No relationship between patient’s sex and Cmax or AUC (0-t) was observed .
In a randomized, double-blind, repeated-dose, 2-way crossover study, with children with persistent asthma (15 boys, 11 girls, aged 5-11), the pharmacokinetic profile of the combination therapy with fluticasone furoate and vilanterol, did not seem to be affected by the patient’s sex .
No studies with a clinically relevant sex analysis regarding the effects of vilanterol have been found.
No studies with a clinically relevant sex analysis regarding the adverse effects of vilanterol have been found.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2020-08-07
Reviewed by: Diana Rydberg, Carl-Olav Stiller
Approved by: Karin Schenck-Gustafsson