Drug products: Flutivate®
ATC code: D07AC17
There are some studies with analyses of sex differences in effect of fluticasone cream/ointment but the results are contradictory and the clinical relevance is unclear.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
No studies with a clinically relevant sex analysis regarding pharmacokinetics and dosing of fluticasone have been found.
A placebo controlled study in patients with atopic eczema (156 male, 216 female) a reduction in the risk of flare development and lengthening of the time to the first flare after application of fluticasone 0.05% cream was demonstrated and subgroup analyses showed no difference between men and women regarding the primary efficacy parameter .
In an another placebo controlled study (29 boys, 46 girls) assessing the efficacy and safety of fluticasone 0.005% ointment in the maintenance treatment of children with atopic dermatitis, a highly statistically significant treatment effect was observed in girls (p < 0.001) . The authors suggested that compliance factors and treatment preferences (i.e. perhaps boys do not like ointment-based formulations) may have influenced the results. However, the total number of boys was small and there was an imbalance in ratio of boys/girls between treatment groups; 13 (33%): 26 (67%) in the fluticasone group and 16 (44%):20 (56%) respectively in the placebo group.
Both men and women have been included in most of the safety studies of topical fluticasone cream/ointment. However, no analysis of sex differences have been found and sex-divided data is lacking [2, 3].
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2016-12-13
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson