Objective: This systematic review and meta-analysis aimed to assess the safety profile of pimavanserin in Parkinson’s disease psychosis (PDP) patients from the available randomized controlled trials (RCTs).

Background: Parkinson’s disease psychosis is a common phenomenon in Parkinson’s disease (PD) patients andis associated with increased morbidity and mortality. Patients with PDP treated with atypical anti-psychotic drugs (e.g., pimavanserin) have shown clinical benefits and good tolerability, however inconclusive safety profile of pimavanserin in PDP patients has not yet been fully elucidated.

Method: We searched PubMed/Medline, the Cochrane Library, and ClinicalTrials.gov from inception through January 2023 to identify RCTs that evaluated the safety profile of pimavanserin compared with placebo or other active drugs in PDP patients. Pooled risk ratio (RR) and 95% confidence interval (CI) were calculated using a random-effect model. Statistical analysis was performed by R Software 4.2.2 using the “meta” package.

Results: A total of four eligible RCTs comparing pimavanserin with placebo were included in this study. Of 680 participants, 417 patients received pimavanserin, and 263 were in the placebo group. Patients’ age and duration of study follow-up ranged from 69-72.4 years and 4-6 weeks, respectively.

Results from the pooled pair wise meta-analysis of safety assessment suggested no significant association between risk of orthostatic hypotension(RR, 95% CI: 0.45, 0.08-2.65;P=0.38; I2=51%), hallucinations(RR, 95% CI: 1.81, 0.75-4.34;P=0.19; I2=0%), and falls(RR, 95% CI: 1.51, 0.84-2.72;P=0.17; I2=0%)compared to placebo in PDP patients. Similarly, no significant influence of pimavanserin was observed on confusion state (RR, 95% CI: 2.13, 0.72-6.33;P=0.17; I2=0%) and headaches(RR, 95% CI: 1, 0.14-6.99; P=1.00; I2=47%)compared to placebo in PDP patients.

Conclusion: Pimavanserin treatment did not show any safety challenges considering orthostatic hypotension, hallucination, fall, confusion state, and headache; and appears to be safe for PDP patients. However, the lower number of studies, small sample size and presence of heterogeneity could influence results. Further long-term RCTs with large sample sizes are required to confirm the present findings.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-assessment-of-pimavanserin-in-parkinsons-disease-psychosis-patients-evidence-from-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials/