An analysis published in International Clinical Psychopharmacology found that paliperidone palmitate once-monthly (PP1M) had a more favorable benefit-risk profile compared to oral paliperidone extended-release (ER) in the maintenance treatment of schizophrenia through Week 40. 

Study authors performed a post-hoc benefit-risk assessment of PP1M injectable vs. oral paliperidone ER for schizophrenia. The analysis was based on patient-level data from two double-blind, placebo-controlled relapse studies. Efficacy outcomes included relapse, psychiatric hospitalization, Clinical Global Impression-Severity scale, Personal and Social Performance (PSP) scale, and Positive and Negative Syndrome Scale (PANSS). Safety outcomes included extrapyramidal symptom-related adverse events, weight gain, prolactin-related adverse events, somnolence, orthostatic hypotension, anticholinergic use, fasting plasma glucose, and total cholesterol/HDL. 

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The data indicated most efficacy outcomes significantly favored PP1M vs. paliperidone ER for the first 8 weeks of maintenance treatment. There were 165 fewer cases of PSP worsening, 115 fewer cases of relapse, 85 fewer cases of PANSS worsening, and 53 fewer cases of hospitalizations, per 1000 patients. 

For the first 40 weeks, there were 140 fewer cases of PSP worsening with PP1M treatment. While PP1M was consistently favored with regards to relapse, PANSS, hospitalizations, and Clinical Global Impression-Severity scale, these outcomes were not considered significant. Researchers noted no statistically significant differences in safety outcomes for both 8- and 40-week periods.

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