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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.
Paliperidone Palmitate 3-month formulation (PP3M) has shown a significantly longer time to relapse compared to placebo, with similar efficacy and safety to Paliperidone Palmitate 1-month (PP1M). However, studies of longer duration are required.
Objectives
The main objective of this study is to determine the effectiveness of PP3M in the prevention of hospitalizations in patients with non-acute schizophrenia in a naturalistic outpatient psychiatric setting.
Methods
Sample: 30 patients diagnosed with schizophrenia (DSM 5) that started treatment with PP3M after being stabilized with PP1M (the treatment dose was not changed in the four months before study inclusion) The mean dose of PP3M was 401. 55 mg Quarterly basis, the following evaluations were performed during a follow-up period of 60 months: The Clinical Global Impression-Schizophrenia scale (CGI-SCH) Treatment adherence, concomitant medication, and the number of hospitalizations. Efficacy values: Percentage of patients who remained free of admissions at the end of 60 months of follow-up. Other evaluation criteria: Average change from baseline visit to the final evaluation as assessed by score obtained on the following scale: GSI-SCH; percentage of patients on antipsychotic monotherapy, and treatment adherence rate.
Results
The percentage of patients who remained free of admissions at the end of the 60 months was 83.25%. Mean variations from baseline scores at 60 months were: (-0.36 ±0-37) on the GCI-SCH. The rate of adherence to treatment with PP3M after 60 months was 86.58%.
Conclusions
In our study, we found that paliperidone palmitate 3-month formulation effectively prevents admissions under daily clinical practice conditions.
Disclosure
No significant relationships.
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