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Three-month Injectable Paliperidone Palmitate for the Treatment of Adults with Schizophrenia: A Review of Clinical Effectiveness, Safety, and Guidelines

Last updated: August 31, 2017
Project Number: RC0917-000
Product Line: Rapid Response
Research Type: Drug
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness and safety of 3-month injectable paliperidone palmitate for the treatment of adults with schizophrenia?
  2. What are the evidence-based guidelines associated with the use of 3-month injectable paliperidone palmitate for the treatment of adults with schizophrenia?

Key Message

Evidence from one randomized controlled trial showed that patients with schizophrenia randomly assigned to placebo were almost four times more likely to have a relapse compared to 3-month injectable paliperidone palmitate, and the 3-month formulation was generally tolerable. Findings from another randomized study showed that 3-month injectable paliperidone palmitate was not inferior to the once-monthly injectable formulation in preventing relapse in adults with schizophrenia during 48 weeks of treatment. Tolerability profiles were similar between the two formulations. Indirect comparison from a post hoc analysis showed that patients remained relapse free for approximately six and 13 months following discontinuation of once-monthly injectable paliperidone palmitate and the 3-month injectable formulation, respectively. There were no evidence-based guidelines found associated with the use of 3-month injectable paliperidone palmitate for the treatment of adults with schizophrenia.