PMID- 38397275 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240227 IS - 2227-9067 (Print) IS - 2227-9067 (Electronic) IS - 2227-9067 (Linking) VI - 11 IP - 2 DP - 2024 Jan 26 TI - Atomoxetine Treatment of Attention Deficit/Hyperactivity Disorder Symptoms in 3-6-Year-Old Children with Autism Spectrum Disorder: A Retrospective Cohort Study. LID - 10.3390/children11020163 [doi] LID - 163 AB - Atomoxetine is indicated for the management of attention deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 18 years. Few studies have assessed the safety and tolerability of atomoxetine in younger patients. This retrospective cohort study included 133 children aged 3-6 years who were diagnosed with ADHD comorbid with autism spectrum disorder (ASD). The primary endpoint was the evaluation of the safety profile of atomoxetine. In total, 50 patients (37.6%) experienced adverse events (AEs), which led to treatment discontinuation in 23 patients (17.3%). The most common AEs were gastrointestinal (24.1%), aggression or hostility (12.8%), and increased hyperactivity (9.0%). In the 23 patients who discontinued treatment, all the AEs resolved after treatment ceased. Among the 110 patients who completed at least 6 months' treatment, atomoxetine titrated to a dose of 1.2-1.8 mg/kg/day appeared to be well tolerated and effective. The Clinical Global Impression-Improvement score improved to 1 ("very much improved") and 2 ("much improved") in 62.4% and 20.3% of children, respectively, at their last visit. Overall, atomoxetine appeared to be well tolerated in younger children with comorbid ADHD and ASD. Nevertheless, close patient monitoring remains essential, and the study limitations necessitate caution in generalizing these findings to broader populations. Long-term prospective studies are required. FAU - Alsayouf, Hamza A AU - Alsayouf HA AUID- ORCID: 0000-0002-3646-7599 AD - Dr Hamza Alsayouf Clinic, Amman 11181, Jordan. FAU - Alsarhan, Osama AU - Alsarhan O AD - Dr Hamza Alsayouf Clinic, Amman 11181, Jordan. FAU - Khreisat, Wael AU - Khreisat W AD - Royal Medical Services, Amman 11855, Jordan. FAU - Daoud, Azhar AU - Daoud A AD - The Specialty Hospital, Amman 11942, Jordan. LA - eng PT - Journal Article DEP - 20240126 PL - Switzerland TA - Children (Basel) JT - Children (Basel, Switzerland) JID - 101648936 PMC - PMC10887200 OTO - NOTNLM OT - adverse events OT - atomoxetine OT - attention deficit/hyperactivity disorder OT - autism spectrum disorder OT - safety COIS- The authors declare no conflicts of interest. EDAT- 2024/02/24 11:44 MHDA- 2024/02/24 11:45 PMCR- 2024/01/26 CRDT- 2024/02/24 01:06 PHST- 2023/12/20 00:00 [received] PHST- 2024/01/21 00:00 [revised] PHST- 2024/01/24 00:00 [accepted] PHST- 2024/02/24 11:45 [medline] PHST- 2024/02/24 11:44 [pubmed] PHST- 2024/02/24 01:06 [entrez] PHST- 2024/01/26 00:00 [pmc-release] AID - children11020163 [pii] AID - children-11-00163 [pii] AID - 10.3390/children11020163 [doi] PST - epublish SO - Children (Basel). 2024 Jan 26;11(2):163. doi: 10.3390/children11020163.