Evidence map›Paper›PMID 38824626›Full record

ArticleJournal of managed care & specialty pharmacy2024

Assessment of centanafadine in adults with attention-deficit/hyperactivity disorder: A matching-adjusted indirect comparison vs lisdexamfetamine dimesylate, atomoxetine hydrochloride, and viloxazine extended-release.

Jeff Schein, Martin Cloutier, Marjolaine Gauthier-Loiselle, Maryaline Catillon, Chunyi Xu, Deborah Chan, Ann Childress

5 registry-linked trialsAbstract readComparative Study
In one paragraph

Article in Journal of managed care & specialty pharmacy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00190736 phase4completednot on this map

Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months); With a Brief Evaluation of Executive Cognition

TypeinterventionalSponsorEli Lilly and CompanyRan2004 to 2006Enrolled440ConditionsADHDArmsAtomoxetine Hydrochloride, placebo
NCT00334880 phase3completednot on this map

A Phase III, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group, Forced Dose Titration, Safety and Efficacy Study of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

TypeinterventionalSponsorNew River PharmaceuticalsRan2006 to 2006Enrolled420ConditionsAttention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity, Attention Deficit Hyperactivity DisordersArmsNRP104
NCT03605680 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2019 to 2020Enrolled604ConditionsAttention Deficit Disorder, Attention Deficit Hyperactivity DisorderArmsCentanafadine SR, Placebo
NCT03605836 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2019 to 2020Enrolled590ConditionsAttention Deficit Disorder, Attention Deficit Hyperactivity DisorderArmsCentanafadine SR, Placebo
NCT04016779 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Flexible-Dose Study of the Efficacy and Safety of SPN-812 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

TypeinterventionalSponsorSupernus Pharmaceuticals, Inc.Ran2019 to 2020Enrolled374ConditionsAttention-Deficit/Hyperactivity Disorder (ADHD)ArmsPlacebo, SPN-812
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Jeff ScheinOtsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ.
Martin CloutierAnalysis Group, Inc., Montréal, QC, Canada.
Marjolaine Gauthier-LoiselleAnalysis Group, Inc., Montréal, QC, Canada.
Maryaline CatillonAnalysis Group, Inc., New York, NY.
Chunyi XuAnalysis Group, Inc., Montréal, QC, Canada.
Deborah ChanAnalysis Group, Inc., Montréal, QC, Canada.
Ann ChildressCenter for Psychiatry and Behavioral Medicine, Las Vegas, NV.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHead-to-head trials comparing centanafadine, an investigational therapy for adults with attention-deficit/hyperactivity disorder (ADHD), with other treatment options are lacking.

objectiveTo compare safety and efficacy outcomes of centanafadine sustained-release vs lisdexamfetamine dimesylate (lisdexamfetamine), atomoxetine hydrochloride (atomoxetine), and viloxazine extended-release (viloxazine ER), respectively, using matching-adjusted indirect comparison (MAIC).

methodsThis MAIC included patient-level data pooled from 2 centanafadine trials (NCT03605680 and NCT03605836) and published aggregate data from comparable trials of 3 comparators-lisdexamfetamine (NCT00334880), atomoxetine (NCT00190736), and viloxazine ER (NCT04016779)-in adult patients with ADHD. Propensity score weighting was used to match characteristics of individual patients from the centanafadine trials to aggregate baseline characteristics from the respective comparator trials. Safety outcomes were rates of adverse events for which information was available in the centanafadine and respective comparator trials. Efficacy outcome was mean change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) score (ADHD Rating Scale [ADHD-RS] was used as proxy in the comparison with lisdexamfetamine). Anchored indirect comparisons were conducted across matched populations of the centanafadine and respective comparator trials.

resultsAfter matching, baseline characteristics in the centanafadine trials were the same as those in the respective comparator trials. Compared with lisdexamfetamine, centanafadine was associated with a significantly lower risk of lack of appetite (risk difference [RD] in percentage points: 23.42), dry mouth (19.27), insomnia (15.35), anxiety (5.21), nausea (4.90), feeling jittery (3.70), and diarrhea (3.47) (all

conclusionsIn an anchored MAIC, centanafadine showed a significantly better short-term safety profile than lisdexamfetamine, atomoxetine, and viloxazine ER; efficacy was lower than with lisdexamfetamine and comparable (ie, nondifferent) with atomoxetine and viloxazine ER. This MAIC provides important insights on the relative safety and efficacy of common treatment options to help inform treatment decisions in adults with ADHD. Safety assessment was limited to rates of adverse events reported in both trials of a given comparison. STUDY REGISTRATION NUMBERS: NCT03605680, NCT03605836, NCT00334880, NCT00190736, and NCT04016779.

Indexed as

Atomoxetine HydrochlorideAttention Deficit Disorder with HyperactivityDelayed-Action PreparationsLisdexamfetamine DimesylateViloxazineAdolescentAdrenergic Uptake InhibitorsAdultCentral Nervous System StimulantsClinical Trials, Phase III as TopicFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultAdrenergic Uptake InhibitorsAtomoxetine HydrochlorideCentral Nervous System StimulantsDelayed-Action PreparationsLisdexamfetamine DimesylateViloxazine

Identifiers

PMID38824626
PMCPMC11145007

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.