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Psych Congress  

Once-Monthly Paliperidone Palmitate Compared With Conventional Oral Antipsychotic Treatment in Patients With Schizophrenia

Authors  
Larry Alphs, MD, PhD
Cynthia A. Bossie, PhD
Lian Mao, PhD
H. Lynn Starr, MD, FAAP
Sponsor  
Janssen Scientific Affairs, LLC

Background: Advantages of atypical antipsychotics compared with older conventional agents are a topic of controversy. This exploratory analysis from the Paliperidone palmitate Research in Demonstrating Effectiveness (PRIDE) study compared once-monthly paliperidone palmitate (PP) with conventional oral antipsychotics (OAs).

Methods: 15-month prospective, randomized, open-label, event-monitoring board-blinded study, randomly assigned 444 subjects with schizophrenia to PP or daily OAs (from a preselected group of 7 commonly prescribed medications). Primary endpoint was time to first treatment failure: arrest/incarceration, psychiatric hospitalization, suicide, discontinuation due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services to prevent psychiatric hospitalization. Event-free probabilities estimated using Kaplan-Meier method. This exploratory analysis reported randomization-based individual comparisons of PP versus the conventional OA haloperidol (n=89 and n=15, respectively), and perphenazine (n=132 and n=20, respectively).

Results: Compared with PP, risk for first treatment failure was 95% higher with haloperidol (HR: 1.95 [95% CI, 0.97-3.91]); the comparison to perphenazine yielded an HR of 1.01 (0.50-2.04). Mean (SD) daily dose of prescribed haloperidol and perphenazine: 8.2 (5.3) and 16.5 (8.8) mg, respectively. Mean (SD) monthly PP dose for haloperidol and perphenazine comparisons: 173.8 (34.5) and 177.1 (33.7) mg, respectively. Subjects reporting extrapyramidal symptom-related adverse events (AEs): 53.3% haloperidol, 40% perphenazine, and 23.9% PP. Subjects reporting prolactin-related AEs: 13.3%, 0%, and 23.5%, respectively. Subjects with ≥7% weight increase: 20.0%, 5.0%, and 32.4%, respectively.

Conclusions: Exploratory analyses suggest differential treatment effects and side effect profiles of once-monthly PP compared with conventional oral antipsychotics.

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