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Paliperidone Palmitate 3-Monthly Versus 1-Monthly Injectable in Patients With Schizophrenia With or Without Prior Exposure to Oral Risperidone or Paliperidone: A Post Hoc, Subgroup Analysis

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Background and ObjectivePaliperidone palmitate 3-monthly (PP3M) injectable formulation offers an advantage of improved medication adherence and lower relapse risk in patients with schizophrenia. This post hoc analysis compared outcomes following… Click to show full abstract

Background and ObjectivePaliperidone palmitate 3-monthly (PP3M) injectable formulation offers an advantage of improved medication adherence and lower relapse risk in patients with schizophrenia. This post hoc analysis compared outcomes following PP3M versus paliperidone palmitate 1-monthly (PP1M) treatment in patients with schizophrenia treated/untreated with oral risperidone/paliperidone (RIS/PALI).MethodsPatients were treated with PP1M (50, 75, 100, or 150 mg equivalent [eq.]) for 17 weeks during an open-label (OL) phase and randomized (1:1) to PP3M (175, 263, 350, or 525 mg eq.) or PP1M (50, 75, 100, or 150 mg eq.) during a 48-week double-blind phase. Efficacy outcomes were compared based on prior oral RIS/PALI exposure: recent (≥ 28 days of oral RIS/PALI exposure with last dose within 14 days before study entry); or no (no oral RIS/PALI exposure within 60 days before study entry).ResultsA total of 452 OL patients received recent oral RIS/PALI (n = 323 [71%], randomized to PP3M = 166; PP1M = 157), and 709 OL patients were without recent oral RIS/PALI (n = 506 [71%], randomized to PP3M = 254; PP1M = 252). Improvements in Positive and Negative Syndrome Scale (PANSS) scores (OL baseline-to-endpoint) were similar in recent-RIS/PALI (mean [standard deviation]:18.3 [17.96]) and no-RIS/PALI (− 21.1 [16.40]) subgroups. Relapse-free rates were comparable between recent-RIS/PALI (relapse-free rate [95% confidence interval for difference]: 2.6 [− 4.7 to 10.0]; PP3M: 90%; PP1M: 87%) and no-RIS/PALI subgroups (0.8 [− 4.5 to 6.0]; PP3M: 92%; PP1M: 91%). Weight gain was the most common (> 5% incidence) treatment-emergent adverse event in both subgroups irrespective of the prior treatment.ConclusionPatients with schizophrenia, irrespective of prior treatment with RIS/PALI, had comparable treatment outcomes and tolerability following PP3M or PP1M treatment.RegistrationThis study is registered at the EU clinical trial registry (EudraCT Number: 2011-004889-15) and ClinicalTrials.gov (identifier: NCT01515423).

Keywords: ris pali; treatment; pali; exposure; paliperidone

Journal Title: Clinical Drug Investigation
Year Published: 2018

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