Comparative safety of prescribed Esketamine and ketamine in relation to renal and urinary disorders: A pharmacovigilance perspective.

Autor: Chiappini S; UniCamillus University of Medical Sciences, Via di S. Alessandro 8, Rome, Italy., Guirguis A; Pharmacy, Swansea University Medical School, The Grove, Swansea University, SA2 8PP, Swansea, Wales, UK. Electronic address: amira.guirguis@swansea.ac.uk., Schifano N; Department of Urology, ASST Sette Laghi, Varese, Italy; Circolo & Fondazione Macchi Hospital; University of Insubria, Varese, Italy., Corkery JM; Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, AL10 9AB Hertfordshire, UK. Electronic address: j.corkery@herts.ac.uk., Semeraro F; Department of Neuroscience, Imaging and Clinical Sciences, 'G. D'Annunzio' University, 66100 Chieti, Italy., Mosca A; Department of Neuroscience, Imaging and Clinical Sciences, 'G. D'Annunzio' University, 66100 Chieti, Italy., D'Andrea G; Department of Neuroscience, Imaging and Clinical Sciences, 'G. D'Annunzio' University, 66100 Chieti, Italy., Duccio Papanti G; Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, AL10 9AB Hertfordshire, UK; Tolmezzo Community Mental Health Centre, ASUFC Mental Health and Addiction Department, via Bonanni 2, 33028 Tolmezzo, UD, Italy., Arillotta D; Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, AL10 9AB Hertfordshire, UK; Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Viale G. Pieraccini, 6, 50139 Florence, Italy., Floresta G; Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, AL10 9AB Hertfordshire, UK; Department of Drug and Health Sciences, University of Catania, Catania, Italy. Electronic address: giuseppe.floresta@unict.it., Martinotti G; Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, AL10 9AB Hertfordshire, UK; Department of Neuroscience, Imaging and Clinical Sciences, 'G. D'Annunzio' University, 66100 Chieti, Italy., Schifano F; Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, AL10 9AB Hertfordshire, UK. Electronic address: f.schifano@herts.ac.uk.
Jazyk: angličtina
Zdroj: Progress in neuro-psychopharmacology & biological psychiatry [Prog Neuropsychopharmacol Biol Psychiatry] 2024 Dec 06; Vol. 136, pp. 111213. Date of Electronic Publication: 2024 Dec 06.
DOI: 10.1016/j.pnpbp.2024.111213
Abstrakt: Intranasal esketamine, approved with oral antidepressants for adults with treatment-resistant depression (TRD), is the S-enantiomer of ketamine and has higher potency and affinity for N-Methyl-d-Aspartate receptors. Administered intranasally, it offers rapid absorption and onset, essential for severe depressive symptoms or suicidal impulses. Comparative studies on esketamine and ketamine's urological safety profiles show esketamine has lower or comparable risks of renal and urinary disorders. Ketamine, however, has documented cases of nephrotoxicity and severe urological issues in recreational users. The study aims to further evaluate and compare these profiles against other antidepressants and antipsychotics using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) data. ADR cases were reported to the FDA up to May 12, 2024, being drugs listed including esketamine, ketamine, quetiapine, aripiprazole, olanzapine, risperidone, citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine, amitriptyline, and clomipramine. Risperidone showed the highest ADRs (107,418) and serious cases (71,515), with significant renal and urinary disorders reported, including acute kidney injury and urinary incontinence. Olanzapine, quetiapine, and aripiprazole also had high serious ADRs. Venlafaxine and fluoxetine were notable among antidepressants for acute kidney injury. Esketamine and ketamine were associated with lower urinary tract symptoms and nephrolithiasis. Disproportionality analysis revealed ketamine had higher odds of renal and urinary disorders compared to other drug classes, while esketamine had lower or comparable odds. The data suggest a relatively favorable tolerability profile for these drugs, especially esketamine. However, the results highlight the necessity for more extensive studies to evaluate long-term safety and optimize treatment protocols.
Competing Interests: Declaration of competing interest F.S. was a member of both the UK Advisory Council on the Misuse of Drugs (ACMD; 2011–2019) and of the EMA Advisory Board (2011–2023; Psychiatry). J.M.C. is a member of the ACMD's Novel Psychoactive Substances and Technical Committees. G.M. has been a consultant and/or a speaker and/or has received research grants from Angelini, Doc Generici, Janssen-Cilag, Lundbeck, Otsuka, Pfizer, Servier, and Recordati. A.G., S.C., R.V.-S., D.H.: declare no conflict of interest.
(Copyright © 2024. Published by Elsevier Inc.)
Databáze: MEDLINE
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