ATC kod: R03BA08
Det saknas kontrollerade studier om könsskillnader i effekt och säkerhet av ciklesonid. Farmakokinetisk finns inga kliniskt relevanta könsskillnader rapporterade.
Vår bedömning är att nuvarande kunskapsunderlag inte motiverar skillnad i dosering eller behandling mellan kvinnor och män.
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 Janusmed Drugs and Birth Defects (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) .
Fler kvinnor än män hämtade ut inhalationsspray innehållande ciklesonid (ATC-kod R03BA08) på recept i Sverige år 2016, totalt 4 623 kvinnor och 2 605 män. Det motsvarar 0,9 respektive 0,5 personer per tusen invånare. I åldersgruppen 0-14 år var inhalationsspray innehållande ciklesonid i genomsnitt 1,3 gånger vanligare hos pojkar och i åldersgruppen 15 år och äldre 1,8 gånger vanligare hos kvinnor .
Faktagranskat av: Mia von Euler
Godkänt av: Karin Schenck-Gustafsson