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Paliperidone extended-release tablets in schizophrenia patients previously treated with risperidone
Carla M Canuso1, Eriene A Youssef, Cynthia A Bossie
1Ortho-McNeil Janssen Scientific Affairs LLC, Titusville, NJ, USA. CCanuso@OMJUS.JNJ.com
Paliperidone extended-release (ER) tablets effectively treated acute symptoms in patients previously on risperidone. This study found paliperidone ER improved symptom scores and daily functioning compared to placebo.
Area of Science:
- Psychiatry
- Pharmacology
Background:
- Schizophrenia treatment often involves antipsychotic medications.
- Patients previously treated with risperidone may require alternative or optimized therapies.
- Paliperidone extended-release (ER) is an active metabolite of risperidone, offering a different pharmacokinetic profile.
Purpose of the Study:
- To evaluate the efficacy of paliperidone ER in patients with acute schizophrenia symptoms who had prior exposure to risperidone.
- To compare the effects of paliperidone ER versus placebo in this specific patient population.
Main Methods:
- Post-hoc analysis of pooled data from three 6-week, double-blind, placebo-controlled trials.
- Inclusion criteria required prior risperidone treatment (> or =4 weeks within 2 weeks of study entry).
- Efficacy assessed using the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impressions-Severity (CGI-S), and Personal and Social Performance (PSP) scale.
Main Results:
- 198 patients met criteria (142 paliperidone ER, 56 placebo).
- Paliperidone ER showed statistically significant improvements (P<0.05) in PANSS, CGI-S, and PSP scores compared to placebo.
- Study completion rates were higher for paliperidone ER (61.3%) versus placebo (42.9%).
- Adverse events like headache and insomnia were comparable; agitation was slightly lower with paliperidone ER.
Conclusions:
- Paliperidone ER is a significantly more effective treatment than placebo for patients with acute symptoms who have previously been treated with risperidone.
- Paliperidone ER demonstrates efficacy in improving both symptom reduction and functional gains in this patient group.
- The findings support the use of paliperidone ER as a therapeutic option for patients transitioning from risperidone therapy.
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