SynthesisCNS drugs2026
Multiple Adverse Outcomes Associated with Risperidone in People with Dementia: An Individual Participant Data Meta-Analysis.
Synthesis in CNS drugs, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
INTRODUCTION AND
objectivesRisperidone has modest efficacy for behaviours and psychological symptoms of dementia and is associated with many adverse events. Current guidelines limit its use to no longer than 12-16 weeks. This study aims to evaluate adverse outcomes over time, identify key predictors, and examine high-risk subgroups to inform safer prescribing.
methodA one-stage individual participant data meta-analysis of six randomised controlled trials (risperidone: n = 1009; placebo: n = 712) was conducted. Mixed-effect generalised linear models and proportional hazards mixed-effects models estimated treatment effects, predictors, and subgroup differences for adverse outcomes over varying time periods.
resultsRisperidone was associated with increased risks of cerebrovascular (hazard ratio [HR] 4.11; 95% confidence interval [CI] 1.77-9.51; p = 0.001) and major cardiovascular events (HR 2.00; 95% CI 1.23-3.26; p = 0.006), with median (interquartile range) onset at 4.3 (5.9) and 4.8 (6.8) weeks of treatment, respectively. Somnolence occurred consistently during treatment, whereas upper respiratory tract infections (odds ratio [OR] 2.31; 95% CI 1.24-4.32; p = 0.009) and extrapyramidal symptoms emerged (OR 2.93; 95% CI 1.68-5.08; p < 0.001) after week 4. Older age, male sex, and baseline cardiac pharmacotherapy use predicted serious adverse outcomes.
conclusionMost adverse effects occur after 4 weeks of treatment. Attention to baseline risk factors is essential to minimise harm. Risk-benefit calculators may guide individualised prescribing.
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