Clinical relevance of Paliperidone Palmitate three-month intramuscular injection formulation: an Italian Real-World, Retrospective, one-year Mirror Image Study

Abstract

Introduction Paliperidone Palmitate 3-month (PP3M) formulation, introduced in Italy since 2017, is an effective and safety therapeutic option for patients with schizophrenia, clinically stable with 1-month formulation (PP1M). Only a few “Real World” studies investigated the clinical relevance of PP3M and the long-term clinical and health resource utilization outcomes. Objectives The aim of this retrospective, mirror image study was to evaluate the efficacy of PP3M in terms of continuity of care and number of hospitalizations. Methods Fifty outpatients treated with Paliperidone Palmitate (PP) were recruited from a Community Mental Health Centre (CMHC) in Milan. Statistical analysis were conducted with SPSS 26. Frequencies of hospitalization 6 months before and after the start of PP3M were compared using the McNemar test, setting the significance to p<0.05. Results This study involved 34 patients (68%) treated with PP1M and 16 (32%) treated with PP3M.The median time interval between PP1M and PP3M was 14 months. After the switch to PP3M, 69% of patients continued to visit the CMHC with an unchanged frequency (50% once/month, 6% more than once/month), while 31% with a decreased frequency (once/3 months). No patient increased the frequency of CMHC visits or started visiting it discontinuously. 44% of subjects had had at least one hospitalization prior to the switch and no hospitalizations after (p=0.016). Moreover, no patients showed increased hospitalizations Conclusions In this study PP3M clinical relevance was confirmed comparing pre-initiation and post-initiation 6-months time intervals: hospitalizations number significantly decreased, while the continuity of care was preserved. Further studies on a greater sample are necessary to support these preliminary data. Disclosure No significant relationships.

Keywords

• one-year Mirror Image Study
• clinical relevance
• psychopharmacology
• Paliperidone Palmitate 3-month formulation