The effect of differences in trial design on estimates of efficacy of olanzapine in randomized studies.
Antipsychotics
Meta-analysis
Pharmacotherapy
Schizophrenia
Journal
Psychiatry research
ISSN: 1872-7123
Titre abrégé: Psychiatry Res
Pays: Ireland
ID NLM: 7911385
Informations de publication
Date de publication:
12 Apr 2024
12 Apr 2024
Historique:
received:
03
06
2023
revised:
03
04
2024
accepted:
05
04
2024
medline:
20
4
2024
pubmed:
20
4
2024
entrez:
20
4
2024
Statut:
aheadofprint
Résumé
Differences in trial design may affect estimates of efficacy of psychotropic drugs. The purpose of this meta-analysis is to evaluate whether the use of Olanzapine (OLZ) as either investigational or control drug affects the observed efficacy of OLZ. We performed a search for Randomized-Controlled Trials (RCTs) in which the efficacy of OLZ is assessed in patients with schizophrenia or schizoaffective disorder. We assessed overall efficacy of OLZ and performed subgroup analyses of studies with OLZ as intervention or comparator. Mixed-effect meta-regression analyses were performed. Of the 25 RCTs included, OLZ was considered as investigational drug or active control in 13 and 12 studies, respectively. The reduction of PANSS score was greater in trials in which OLZ was used as investigational drug. Multivariate meta-regression models showed that a higher PANSS score at baseline and trial duration were the main predictors of greater PANSS score reduction. Trials with OLZ used as investigational drug differ from those of trials with OLZ as comparator for baseline PANSS scores and study duration; these differences may produce differences in estimates of efficacy. As a consequence, the severity of illness at enrollment and trial duration should be carefully considered to ensure the reliability of indirect comparisons among antipsychotics.
Sections du résumé
BACKGROUND
BACKGROUND
Differences in trial design may affect estimates of efficacy of psychotropic drugs. The purpose of this meta-analysis is to evaluate whether the use of Olanzapine (OLZ) as either investigational or control drug affects the observed efficacy of OLZ.
METHODS
METHODS
We performed a search for Randomized-Controlled Trials (RCTs) in which the efficacy of OLZ is assessed in patients with schizophrenia or schizoaffective disorder. We assessed overall efficacy of OLZ and performed subgroup analyses of studies with OLZ as intervention or comparator. Mixed-effect meta-regression analyses were performed.
RESULTS
RESULTS
Of the 25 RCTs included, OLZ was considered as investigational drug or active control in 13 and 12 studies, respectively. The reduction of PANSS score was greater in trials in which OLZ was used as investigational drug. Multivariate meta-regression models showed that a higher PANSS score at baseline and trial duration were the main predictors of greater PANSS score reduction.
CONCLUSIONS
CONCLUSIONS
Trials with OLZ used as investigational drug differ from those of trials with OLZ as comparator for baseline PANSS scores and study duration; these differences may produce differences in estimates of efficacy. As a consequence, the severity of illness at enrollment and trial duration should be carefully considered to ensure the reliability of indirect comparisons among antipsychotics.
Identifiants
pubmed: 38642423
pii: S0165-1781(24)00180-X
doi: 10.1016/j.psychres.2024.115895
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
115895Informations de copyright
Copyright © 2024 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest Valdo Ricca received fees from agencies for speaking in symposia sponsored by Angelini, Janssen, Lundbeck, Otsuka, Viatris. Psychiatric Unit received fees from ArcaPharma and LundBeck. Edoardo Mannucci has received consultancy fees from Merck and Novartis, speaking fees from Abbott, Astra Zeneca, Bristol Myers Squibb, Boehringer-Ingelheim, Eli-Lilly, Merck, Novo Nordisk, Sanofi, and Novartis, and research grants from Merck, Novartis, and Takeda. Diabetology received fees from Astra Zeneca, Bayer, Boehringer-Ingelheim, Eli-Lilly, Janssen, Merck, Novartis and Novo Nordisk. Francesco Rotella, Emanuele Cassioli, Andrea Falone and Francesco Del Monaco declare no conflict of interests.