Children and adults with attention-deficit/hyperactivity disorder (ADHD) show greater improvement in symptoms compared to treatment with extended-release viloxazine (ER). Atomoxetinesuggests a new study.
The researchers studied patients who started taking atomoxetine and started treatment with viloxazine after a washout period. Participants’ ADHD symptoms were assessed before and 4 weeks after starting each treatment.
Children and adults showed greater improvement in inattention and hyperactivity/impulsivity when taking viloxazine and atomoxetine, with almost all patients preferring the former to the latter.
Additionally, nearly half of the study participants had been pre-screened. stimulation, 85% were able to taper stimulant treatment. The effect of viloxazine was also more rapid than that of atomoxetine.
“Given the recent stimulant shortage and the new FDA, it is timely for both children and adults to have fast-acting and highly effective non-stimulant options across the full spectrum of ADHD symptoms.” [US Food and Drug Administration] We’ve boxed a warning about the increased mortality associated with stimulant overuse,” said researcher Maxwell Z. Price, a medical student at Hackensack Meridian Medical College. Medscape Medical News.
Non-irritating treatment options
Study co-author Richard L. Price, M.D., said: Medscape Medical News He said the study was done to find a more acceptable alternative to psychostimulant drug treatment for ADHD, which is now considered the “gold standard.”
Price said they are effective but have side effects such as appetite suppression. insomniamood disorders, anxiety, tics, or worsening of misuse.
A non-stimulant option, atomoxetine, has been around for decades and is often used in combination with stimulants. But the drug’s effects are mild, require frequent dose adjustments, take a long time to work, and people are “dissatisfied” with its usefulness, Price added.
Like atomoxetine, viloxazine is selective. Noradrenaline An inhibitor that has been used as an antidepressant in Europe for 30 years. It was recently reformulated as an extended-release drug and approved by the FDA for pediatric and pediatric use. ADHD in adults.
However, unlike atomoxetine, viloxazine is a prefrontal cortex 5-hydroxytritamine, norepinephrine, and dopamine in vivo level.
There have been no direct trials comparing the two drugs. However, even in head-to-head trials of ADHD drugs, the drugs under study are usually compared in matched patients. The current researchers wanted to compare the two drugs in the same patients for whom insurance companies mandated trials of generic atomoxetine before applying branded viloxazine.
“We wanted to know if patients with ADHD combined and taking atomoxetine experienced an improvement in ADHD symptoms after an open-label voluntary switch to viloxazine,” said Professor Price.
Investigators studied 50 patients who presented with the ADHD complex and had no other psychiatric, medical, substance-related comorbidities, or exposure to atomoxetine or viloxazine.
The study included 35 children (mean age, 11.9 ± 2.9 years, 94.3% male) and 15 adults (mean age, 29.3 ± 9.0 years, 73.3% male). Of these, 42.9% and 73.3%, respectively, were taking stimulants at the same time.
Patients received the average dose of atomoxetine once daily, followed by a 5-day washout period between the two drugs, followed by once daily viloxazine. Participants visited weekly for titration and monitoring.
At baseline, the Pediatric ADHD Rating Scale-5 (ADHD-RS-5) and the Adult Investigator Symptom Rating Scale (AISRS) were completed, then after 4 weeks of treatment with atomoxetine (or discontinuation due to early response or side effects, whichever came first), and again 5 days after discontinuation of atomoxetine to “re-establish baseline scores.” The same protocol was then repeated using viloxazine.
“Paradigm Shift”
At baseline, the ADHD-RS-5 total mean score was 40.3 ± 10.3. Improvement after 4 weeks was greater for viloxazine and atomoxetine, with scores of 13.9 ± 10.2 vs. 33.1 ± 12.1 (t = -10.12, P. < .00001). In inattention and hyperactivity/impulsivity, t The values were -8.57 and -9.87 respectively (both P.s < .0001).
Similarly, from a baseline total AISRS mean score of 37.3 ± 11.8, improvement was greater for viloxazine and atomoxetine, scores of 11.9 ± 9.4 vs. 28.8 ± 14.9, respectively (t = −4.18, P. = .0009 overall; t = −3.50, P. >.004 for hyperactivity/impulsivity; t = 3.90, P. > .002).
By 2 weeks, 86% of patients taking viloxazine reported a positive response compared to 14% of patients taking atomoxetine.
Side effects were lower for viloxazine and atomoxetine, with a total of 36% of patients discontinuing treatment with atomoxetine due to side effects such as gastrointestinal upset, irritability, fatigue, and insomnia, compared with 4% of patients discontinuing viloxazine due to fatigue.
Nearly all participants (96%) preferred viloxazine to atomoxetine, and 85% were able to taper off stimulant treatment after stabilization on viloxazine.
“These were no small differences,” commented Richard Price. “These were clinically and statistically meaningful differences.”
“We always think of starting ADHD treatment with stimulants, but perhaps treatment with viloxazine could help patients avoid stimulants altogether,” he suggested, so the results of the study could represent a “paradigm shift in this field.”
real world research
To comment Medscape Medical NewsGreg Mattingly, M.D., associate clinical professor at Washington University in St. Louis, Missouri, called this “a timely addition to the clinical literature as the first two non-stimulant drug options approved for adults with ADHD.”
The actual clinical study “provides a lot of answers,” said Mattingly, who is also president-elect of the American Association of ADHD and Related Disorders Professionals (APSARD), but was not involved in the study.
“Briefly, this real-life study of 50 clinic patients found that viloxazine ER had a faster onset, was significantly more effective than atomoxetine, and was preferred by 96% of patients,” he said.
“Another interesting part of the study, which is of great interest to both patients and healthcare professionals, is that 85% of patients who were initially treated with stimulants and viloxazine ER simultaneously were able to discontinue their stimulant medications,” added Mattingly.
This study received no special grant from Funding Agencies in the public, commercial and non-profit sectors.of Op Access fees were covered by investigators. Maxwell Z. Price Proves No Contradictions High interest with financial institutions regarding this material discussed in the manuscript.Mr. Richard L. Price received honorarium AbbVie, Alkermes, Idolusia, Intracellular Therapy, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, Supernas .Mattingly reports being a consultant AbbVie, Alkermes, Axsum, Biogen, Corium, Eisai, Intracellular, Ironshore, Janssen, Lundbeck, Neos, Neuroclin Bioscience, Noven, Otsuka, Redux, Revive, Roche, Rose, sage Therapeutics, Sky Therapeutics, Sunovion, Supernas, Takeda, Teva, Trispharma. are on the speaker station of AbbVie, Alkermes, Corium, Eisai, Intracellular, Ironshore, Janssen, Lundbeck, Neuroclin, Noven, Otsuka, Sunovion, Supernas, Takeda, Granted research/support from Trispharma AbbVie, Acadia, Alkermes, Akiri, Axome, Boehringer, Biogen, Eisai, Emalex, Idolusia, Intracellular, Janssen, Carna, Lumos Labs, Megenix, NLS-1 Plama AG, Redux, Lermada, Roche, Sage, Sirsei, Sunovion, Supernas, Takeda, and Teva.
Drugs for the central nervous system. It will be published online on July 10, 2023. full text
Bhatia Swift Yasgar Massachusetts LSW is a freelance writer with a counseling practice in Teaneck, New Jersey. She is a regular contributor to numerous medical publications, including Medscape and her WebMD, and is the author of consumer health books and books. Behind the Burqa: Our Life in Afghanistan and Our Escape to Freedom (The memoirs of two brave Afghan sisters who told her their stories).
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