Efficacy, safety, and tolerability of xanomeline for schizophrenia spectrum disorders: a systematic review

We systematically reviewed extant studies evaluating the efficacy and tolerability of xanomeline and xanomeline-trospium (KarXT) for treatment of adults with schizophrenia. In accordance with PRISMA guidelines, articles were systematically searched for in databases and clinical trial registries. A t...

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Published inExpert opinion on pharmacotherapy Vol. 25; no. 4; p. 467
Main Authors Leber, Alexia, Ramachandra, Ranuk, Ceban, Felicia, Kwan, Angela T H, Rhee, Taeho Greg, Wu, Jie, Cao, Bing, Jawad, Muhammad Youshay, Teopiz, Kayla M, Ho, Roger, Le, Gia Han, Ramachandra, Diluk, McIntyre, Roger S
Format Journal Article
LanguageEnglish
Published England 03.03.2024
Subjects
Adult
Animals
Antipsychotic Agents - adverse effects
Antipsychotic Agents - therapeutic use
Humans
Psychiatric Status Rating Scales
Randomized Controlled Trials as Topic
Schizophrenia - drug therapy
Animal model
muscarinic agonist
negative
xanomeline
antipsychotics
positive
schizophrenia
randomized controlled trial
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Summary:We systematically reviewed extant studies evaluating the efficacy and tolerability of xanomeline and xanomeline-trospium (KarXT) for treatment of adults with schizophrenia. In accordance with PRISMA guidelines, articles were systematically searched for in databases and clinical trial registries. A total of 4 preclinical trials and 3 randomized controlled trials (RCTs) were included in this review. A 4-week RCT observed a difference of 24.0 points (SD 21.0) in the Positive and Negative Syndrome Scale (PANSS) total score between xanomeline and placebo groups (  = 0.039). A 5-week RCT observed PANSS total score changes from baseline to week 5, including -17.4 and -5.9 points in KarXT and placebo groups, respectively (LSMD -11.6 points; 95% CI -16.1 to -7.1;  < 0.001; d = 0.75). Another 5-week RCT observed PANSS total score changes from baseline to week 5, including -21.2 (SE 1.7) and -11.6 (SE 1.6) points in KarXT and placebo groups, respectively (LSMD -9.6; 95% CI -13.9 to -5.2;  < 0.0001; d = 0.61). Side effects include constipation, nausea, vomiting, dyspepsia, and dry mouth. KarXT offers an innovative non-D2 blocking approach, representing a promising treatment avenue for schizophrenia.
ISSN:1744-7666
DOI:10.1080/14656566.2024.2334424