Drug products: Bretaris Genuair, Duaklir Genuair, Eklira Genuair
ATC code: R03AL05, R03BB05
Substances: aclidinium, aclidinium bromide
Clinical trials have shown, in subgroup analyses, that the effect of aclidinium on FEV1 among patients with chronic obstructive pulmonary disease (COPD) is similar in men and women. A somewhat higher percentage of women, compared to men, experienced at least one adverse effect with aclidinium treatment.
COPD (chronic obstructive pulmonary disease) affects more women than men and women often get a more serious and rapidly progressive disease .
The clearance of aclidinium in a subgroup analysis in one clinical study was shown to be similar between men and women (n=30) and it is also mentioned that the exposure appeared to be similar between men and women (data not shown) . Apart from that, no studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of aclidinium have been found. No sex differentiation in dosing has been recommended by the manufacturer [2, 3].
A subgroup analysis of pooled data from three efficacy and safety trials demonstrated a statistically significant change in trough FEV1 (morning pre-dose) from baseline with aclidinium 400 µg compared to placebo at week 12 (primary endpoint), for both men and women with COPD (1136 men, 783 women). The treatment difference from placebo in least squares mean was 0.096 L (95% CI 0.065-0.127) for men and 0.106 L (95% CI 0.068-0.143) for women .
The effect of aclidinium/formoterol combination therapy was compared to monotherapy with aclidinium, formoterol or placebo for men and women with COPD in subgroup analyses in a post hoc analysis with pooled data from two phase III clinical trials (1610 men, 1074 women). A statistically significant change from baseline in trough FEV1 and morning 1-hour post-dose FEV1 (co-primary endpoints) with aclidinium/formoterol compared to formoterol or placebo at week 24 was seen for both men and women, respectively . Women had lower baseline FEV1 levels than men in this pooled data set (1.135 vs 1.554 L) . For the secondary endpoints, a statistically significant improvement in transition dyspnea index (TDI) was seen for aclidinium/formoterol compared to placebo in both men and women but no statistically significant difference in exacerbation rates were found, in general, for two exacerbation rate scales with the different therapies, neither for men nor women. The only significant difference in exacerbation rates was a lower EXACT-exacerbation rate (a patient symptom rating scale) with aclidinium/formoterol compared to placebo in men .
A somewhat higher percentage of women experienced at least one adverse effect with aclidinium 400 µg in the twice-daily placebo-controlled trials, compared to what was seen in men (in total 1137 men, 784 women). The percentages were 54.7% for women compared to 46.9% for men with aclidinium 400 µg and 56.6% for women compared to 51.7% for men with placebo .
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2021-03-25
Reviewed by: Diana Rydberg
Approved by: Karin Schenck-Gustafsson