Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Atomoxetin

Klassificering: A

Preparat: Atomoxetin Actavis, Atomoxetin Glenmark, Atomoxetin Medical Valley, Atomoxetin Mylan, Atomoxetin Orion, Atomoxetine Accord, Atomoxetine Sandoz, Atomoxetine STADA, Audalis, Strattera

ATC kod: N06BA09

Substanser: atomoxetin, atomoxetinhydroklorid

Sammanfattning

Atomoxetin förbättrar ADHD-relaterade svårigheter och ökar livskvaliteten hos både pojkar och flickor även om en meta-analys har visat att atomoxetin minskade ADHD-symptom mer hos flickor än hos pojkar.

Lägsta effektiva dos ska eftersträvas vid behandling med atomoxetin. De funna skillnaderna motiverar dock ingen generell differentiering i behandling mellan flickor/kvinnor och pojkar/män.

Additional information

Pharmacokinetics and dosing

No differences in atomoxetine pharmacokinetics have been seen between men and women, and no sex differentiation in dosing has been recommended by the manufacturer [6].

Effects

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 [7].

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 [8].

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 [9]. 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 [10].

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of atomoxetine have been found.

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Other information

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 [1]. 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 [2]. In Sweden, the ratio of boys to girls receiving license prescriptions for AHDH medications is 4:1 [3].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 [4].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 [5].

Försäljning på recept

Fler män än kvinnor hämtade ut läkemedel innehållande atomoxetin (ATC-kod N06BA09) på recept i Sverige år 2015, totalt 9 054 män och 5 429 kvinnor. Det motsvarar 1,9 respektive 1,1 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 10-19 år hos båda könen. I genomsnitt var läkemedel innehållande atomoxetin 1,5 gånger vanligare hos män [11].

ADHD är 2-3 gånger vanligare bland pojkar än bland flickor i Sverige [2] men skillnaden mellan könen jämnas ut med stigande ålder. Fler flickor/kvinnor får diagnosen som ungdomar och vuxna, vilket kan bero på att flickor oftare än pojkar har ADHD med huvudsakligen uppmärksamhetsstörning och mer sällan tydliga hyperaktivitet/impulsivitets problem och därför vara svårare att känna igen [12].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2014-10-28

Referenser

  1. Cornforth C, Sonuga-Barke E, Coghill D. Stimulant drug effects on attention deficit/hyperactivity disorder: a review of the effects of age and sex of patients. Curr Pharm Des. 2010;16:2424-33. PubMed
  2. Nøvik TS, Hervas A, Ralston SJ, Dalsgaard S, Rodrigues Pereira R, Lorenzo MJ et al. Influence of gender on attention-deficit/hyperactivity disorder in Europe--ADORE. Eur Child Adolesc Psychiatry. 2006;15 Suppl 1:I15-24. PubMed
  3. SBU. ADHD hos flickor. Statens beredning för medicinsk utvärdering.
  4. Zetterqvist J, Asherson P, Halldner L, Långström N, Larsson H. Stimulant and non-stimulant attention deficit/hyperactivity disorder drug use: total population study of trends and discontinuation patterns 2006-2009. Acta Psychiatr Scand. 2013;128:70-7. PubMed
  5. Garbe E, Mikolajczyk RT, Banaschewski T, Petermann U, Petermann F, Kraut AA et al. Drug treatment patterns of attention-deficit/hyperactivity disorder in children and adolescents in Germany: results from a large population-based cohort study. J Child Adolesc Psychopharmacol. 2012;22:452-8. PubMed
  6. Strattera (atomoxetine). DailyMed [www]. US National Library of Medicine. [updated 2014-02-01, cited 2014-10-28]. länk
  7. Cheng JY, Chen RY, Ko JS, Ng EM. Efficacy and safety of atomoxetine for attention-deficit/hyperactivity disorder in children and adolescents-meta-analysis and meta-regression analysis. Psychopharmacology (Berl). 2007;194:197-209. PubMed
  8. Marchant BK, Reimherr FW, Halls C, Williams ED, Strong RE, Kondo D et al. Long-term open-label response to atomoxetine in adult ADHD: influence of sex, emotional dysregulation, and double-blind response to atomoxetine. Atten Defic Hyperact Disord. 2011;3:237-44. PubMed
  9. Wehmeier PM, Schacht A, Escobar R, Hervas A, Dickson R. Health-related quality of life in ADHD: a pooled analysis of gender differences in five atomoxetine trials. Atten Defic Hyperact Disord. 2012;4:25-35. PubMed
  10. Wehmeier PM, Schacht A, Dittmann RW, Banaschewski T. Minor differences in ADHD-related difficulties between boys and girls treated with atomoxetine for attention-deficit/hyperactivity disorder. Atten Defic Hyperact Disord. 2010;2:73-85. PubMed
  11. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-30.] länk
  12. Socialstyrelsen. Stöd till barn, ungdomar och vuxna med adhd. Socialstyrelsen.

Författare: Linnéa Karlsson Lind, Desirée Loikas

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson