PMID- 26329980 OWN - NLM STAT- MEDLINE DCOM- 20151125 LR - 20150908 IS - 1941-9260 (Electronic) IS - 0032-5481 (Linking) VI - 127 IP - 7 DP - 2015 TI - Time-to-onset and -resolution of adverse events before/after atomoxetine discontinuation in adult patients with ADHD. PG - 677-85 LID - 10.1080/00325481.2015.1083394 [doi] AB - BACKGROUND: Adults with attention-deficit/hyperactivity disorder treated with atomoxetine were examined for time-to-onset and -resolution of common treatment-emergent adverse events (TEAEs) and male sexual dysfunction, and for changes in blood pressure (BP) and heart rate (HR) upon atomoxetine discontinuation. METHODS: 12-week open-label atomoxetine (40-100 mg/day) was followed by 12-week double-blind maintenance treatment (atomoxetine 80 or 100 mg/day). Responders were then randomized to atomoxetine (n = 266) or placebo (n = 258) for 25-week randomized withdrawal. Examined were (1) median time-to-onset and -resolution of TEAEs during atomoxetine treatment, and (2) within group, visitwise mean changes for sitting HR, systolic BP, and diastolic BP for the postrandomization placebo group. RESULTS: Common adverse events (AEs) appeared early, within week 1 of atomoxetine treatment. Some AEs resolve relatively rapidly, whereas others have a more lingering course of resolution (including male sexual side effects); median resolution times were 3 - 53 days. BP and HR increases during atomoxetine treatment returned to baseline upon atomoxetine discontinuation. CONCLUSION: Atomoxetine is associated with common AEs, with 3- to 53-day median resolution times. TRIAL REGISTRATION: ClincialTrials.gov - NCT00700427. FAU - Upadhyaya, Himanshu AU - Upadhyaya H AD - a 1 Lilly Research Laboratories, Lilly Corporate Center , Indianapolis, IN, USA. FAU - Tanaka, Yoko AU - Tanaka Y FAU - Lipsius, Sarah AU - Lipsius S FAU - Kryzhanovskaya, Ludmila A AU - Kryzhanovskaya LA FAU - Lane, Jeannine R AU - Lane JR FAU - Escobar, Rodrigo AU - Escobar R FAU - Trzepacz, Paula T AU - Trzepacz PT FAU - Allen, Albert J AU - Allen AJ LA - eng SI - ClinicalTrials.gov/NCT00700427 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20150902 PL - England TA - Postgrad Med JT - Postgraduate medicine JID - 0401147 RN - 0 (Adrenergic Uptake Inhibitors) RN - 57WVB6I2W0 (Atomoxetine Hydrochloride) SB - IM MH - Adrenergic Uptake Inhibitors/administration & dosage/adverse effects MH - Adult MH - *Atomoxetine Hydrochloride/administration & dosage/adverse effects MH - Attention Deficit Disorder with Hyperactivity/*drug therapy MH - Blood Pressure/drug effects MH - *Cardiovascular Diseases/chemically induced/diagnosis/physiopathology MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - *Drug-Related Side Effects and Adverse Reactions/diagnosis/etiology/physiopathology MH - *Erectile Dysfunction/chemically induced/diagnosis MH - Female MH - Heart Rate/drug effects MH - Humans MH - Male MH - Time Factors MH - Treatment Outcome MH - Withholding Treatment OTO - NOTNLM OT - Atomoxetine OT - adult OT - adverse events OT - attention-deficit hyperactivity disorder OT - cardiovascular changes OT - male sexual dysfunction EDAT- 2015/09/04 06:00 MHDA- 2015/12/15 06:00 CRDT- 2015/09/03 06:00 PHST- 2015/09/03 06:00 [entrez] PHST- 2015/09/04 06:00 [pubmed] PHST- 2015/12/15 06:00 [medline] AID - 10.1080/00325481.2015.1083394 [doi] PST - ppublish SO - Postgrad Med. 2015;127(7):677-85. doi: 10.1080/00325481.2015.1083394. Epub 2015 Sep 2.