Drug products: Alvesco
ATC code: R03BA08
Controlled studies on sex differences in efficacy and safety of ciclesonide are lacking. No clinically relevant pharmacokinetic sex differences have been reported.
In our opinion, the present evidence does not motivate differentiation in dosing or treatment between men and women.
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 [5, 6].
The pharmacokinetics and pharmacodynamics of the active metabolite of ciclesonide (desisobutyryl-ciclesonide) was analyzed in a population study consisting of asthma patients (12 men, 20 women). Women had larger peripheral volume of distribution of desisobutyryl-ciclesonide. The maximum cortisol release rate was higher in women, but it’s unknown whether this is clinically relevant . However, pooled from 12 phase I and three phase III studies in adults and two phase III studies in children (in total 300 males, 310 females) showed no clinically relevant sex differences in the pharmacokinetics of desisobutyryl-ciclesonide . The manufacturer report no differences in pharmacokinetic of desisobutyryl-ciclesonide due to patient’s sex, age or race [9, 10].
No studies with a clinically relevant sex analysis of the effects of ciclesonide has been found.
The manufacturer reports no sex differences in adverse effects from short-term trials in children and adults using ciclesonide nasal spray . No studies on sex differences in adverse events in ciclesonide inhalation spray have been found.
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
In a study on inhalation technique using metered dose inhalers (33 men, 26 women), 75% of the participants had an incorrect inhalation technique, especially women, regardless of age. Only 4% of women and 43% of men had an acceptable inhalation technique. The authors speculate that this may add to the worse asthma prognosis in women, shown in a meta-analysis of six trials of randomly assigned asthma treatment .
Several studies have shown worse prognosis for women with asthma. In an observational registry study (416 men, 498 women), women were found to have more asthmatic symptoms, worse quality of life and require more health care due to their asthma . In a Danish prospective study on hospitalization due to asthma (6104 men of whom 2.5% had asthma, 7436 women of whom 2.2% had asthma), women had a 1.7 higher relative risk to be hospitalized . An observational study from Singapore found hospitalization due to asthma to be more common in boys than girls aged 0-4 years (boys/girls ratio 1.69). In adults aged 35-64 years, women were more hospitalized (men/women ratio 0.81) .
Date of litterature search: 2017-06-21
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson