Drug products: Atomoxetin Actavis, Atomoxetin Glenmark, Atomoxetin Medical Valley, Atomoxetin Mylan, Atomoxetin Orion, Atomoxetine Accord, Atomoxetine Sandoz, Atomoxetine STADA, Audalis, Strattera
ATC code: N06BA09
Substances: atomoxetine, atomoxetine hydrochloride
Atomoxetin has been shown to improve ADHD-related difficulties and increase quality of life in both boys and girls. Howerver, meta-analyses have shown atomoxetin to reduce ADHD-sympthoms more amongst girls than boys.
The lowest effective dose should always be used. Despite the identified sex differences, there is generally no reason to differentiate treatment between boys/men and girls/women.
No differences in atomoxetine pharmacokinetics have been seen between men and women, and no sex differentiation in dosing has been recommended by the manufacturer .
A meta-analysis of nine studies including 1150 patients on atomoxetine and 678 patients on placebo (sex ratio not specified) evaluating efficacy and safety of atomoxetine in children and adolescents showed that male sex was associated with a smaller reduction in ADHD symptoms. This suggests that atomoxetine may be more efficacious in female ADHD patients .
Long-term response to atomoxetine in adult ADHD was analysed in a double-blind trial followed by a three-year open-label study (247 men, 137 women). During the double-blind phase, sex had an impact on treatment effect. Women showed the greatest difference in improvement versus men on emotional dysregulation. In the end on the open-label phase, women had greater improvement on the hyperactivity/impulsivity section of both outcome measure scales WRAADDS and CAARS .
Pooled data from five atomoxetine clinical trials (658 boys, 136 girls) showed that atomoxetine was effective in improving some aspects of patient-reported HR-QoL (health-related quality of life) in both sexes. Sex did not influence treatment outcome . Also, another study (338 boys, 83 girls) showed that atomoxetine improved ADHD-related difficulties (and hence the quality of life) as perceived by patients, parents and physicians was similar in boys and girls .
No studies with a clinically relevant sex analysis regarding adverse effects of atomoxetine have been found.
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Even though earlier studies of ADHD treatment included few females, recent RCTs to demonstrate efficacy in the newer ER preparations have enrolled reasonable numbers of females . In a large European observational study, fewer girls than boys were referred for ADHD treatment, but they were as likely as boys to receive stimulant medication as an initial treatment for ADHD . In Sweden, the ratio of boys to girls receiving license prescriptions for AHDH medications is 4:1 .A study on prescription patterns of medications for ADHD in Sweden from 2006 to 2009 (methylphenidate, atomoxetine, amphetamine or dexamphetamine) showed that the prescribing prevalence increased more among women than men over the years (prevalence ratio 2.92 vs. 2.19). There were no differences in treatment discontinuation between men and women .Drug treatment of ADHD in children and youth in Germany was evaluated in a study. Time until first prescription of methylphenidate or atomoxetine was different between sexes: > 50 % of males received treatment within 30 months of diagnosis, while the corresponding time for > 50 % of females was 48 months .
Date of litterature search: 2014-10-28
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson