Comparative effectiveness of antipsychotics available in the Unified Health System (SUS) for the treatment of the main psychological and behavioral symptoms of dementia: systematic review

• Grant number: 23/07086-0
• Support Opportunities: Regular Research Grants
• Start date: November 01, 2023
• End date: October 31, 2025
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Paulo José Fortes Villas Bôas
• Grantee: Paulo José Fortes Villas Bôas
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

Dementia is considered a major global health problem, with a prevalence rate of 8% among individuals over the age of 65 in Brazil, estimated to be 1.5 million cases in 2010. Dementia is a syndrome characterized by progressive and global cognitive impairment and encompasses a group of neurodegenerative diseases characterized by a progressive loss of cognitive function and the ability to perform activities of daily living. It may be accompanied by various types and severities of neuropsychiatric and behavioral symptoms. Behavioral and psychological symptoms of dementia (BPSD) occur in 50% of dementia patients and impact the quality of life of both the patient and the caregiver. The most frequent manifestations include agitation, aggression, irritability, depression, anxiety, apathy, behavioral disturbances, sleep disturbances, delusions, and hallucinations, which have an impact on the patient and the family. In addition to non-pharmacological measures, pharmacological treatment may be necessary, with atypical antipsychotics being the first-line treatment. Despite being widely prescribed, atypical antipsychotics are not licensed for use in BPSD. Objective To evaluate the effectiveness of atypical antipsychotics in the treatment of the main psychological and behavioral symptoms of dementia through a systematic literature review. Methods This will be a systematic review (SR) of randomized controlled trials, conducted following the guidelines and standardizations of the Cochrane Collaboration, including published and unpublished randomized controlled trials. This SR will follow the PICO acronym, where P = Population: Older adults (individuals aged 65 years or older) with dementia; I = Intervention: Use of atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine, and ziprasidone) as provided in the Clinical Protocol and Therapeutic Guidelines - Refractory Schizophrenia (Brazil, Ministry of Health 2012); C = Comparison: Placebo or no intervention; O = Outcome: Treatment of the main psychological and behavioral symptoms of dementia. Potentially eligible studies will be selected from the following databases: MEDLINE, CENTRAL, EMBASE, LILACS, SCIELO. The PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analyses) guidelines and the Cochrane Collaboration's MECIR recommendations will be followed, including data analysis and collection, study selection, data management and extraction, assessment of risk of bias in included studies, treatment effect measures, analysis units, handling of missing data, assessment of heterogeneity, assessment of reporting biases, data synthesis (summarized using the Review Manager statistical software), sensitivity analysis, and evaluation of the quality of evidence (grading the strength of evidence for each outcome using the Grading of Recommendations Assessment, Development, and Evaluation - GRADE. (AU)