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Efficacy, safety, and impact on hospitalizations of paliperidone palmitate in recent-onset schizophrenia.

Zhang F, Si T, Chiou CF, Harris AW, Kim CY, Jahagirdar P, Ascher S - Neuropsychiatr Dis Treat (2015)

Bottom Line: Positive and Negative Syndrome Scale (PANSS) total score improved significantly from baseline to month 18 (mean [standard deviation, SD] change: -11.3 [21.38], P<0.0001, primary endpoint).In mirror analyses set (N=474), PP significantly (P<0.0001) reduced mean number of hospitalization days/person/year (12-month: 74.3 vs 19.7; 18-month: 74.3 vs 18.9) as well as percentage of patients requiring hospitalization in past 12 months (12-month: 39.7% vs 24.6%; 18-month: 39.7% vs 25%), and PP treatment increased the proportion of patients not requiring hospitalization (12-month: 60.3% vs 75.4%; 18-month: 60.3% vs 75%) from retrospective to prospective period.PP was efficacious and generally tolerable with significant reductions observed in both number of hospitalizations and days spent in hospital.

View Article: PubMed Central - PubMed

Affiliation: Xian Janssen Pharmaceuticals, Beijing, People's Republic of China.

ABSTRACT

Objective: To evaluate the efficacy, safety, and impact on hospitalizations of long-acting injectable paliperidone palmitate (PP) treatment, in patients with recent-onset schizophrenia who had not responded satisfactorily to oral antipsychotics.

Methods: In this 18-month, open-label, Phase-IIIb study from Asia-Pacific region, patients (18-50 years) with recent-onset (≤5 years) schizophrenia unsatisfactorily treated with previous oral antipsychotics were initiated on PP 150 mg eq on day 1, 100 mg eq on day 8, followed by flexible once monthly maintenance doses of 50-150 mg eq. The number and duration of hospitalizations were compared using a mirror analysis method between two periods: retrospective (12 months before PP initiation) and prospective (12 and 18 months after PP treatment) periods.

Results: A total of 303 out of 521 (58%) patients (mean age, 28.7 years; 65.5% men, 92.5% Asian) completed the study. Positive and Negative Syndrome Scale (PANSS) total score improved significantly from baseline to month 18 (mean [standard deviation, SD] change: -11.3 [21.38], P<0.0001, primary endpoint). Subgroup analysis revealed greater improvements among patients with worse disease severity at baseline: PANSS ≥70 versus <70 (mean [SD] change: -23.1 [24.62] vs -4.7 [15.98], P<0.0001 each). Secondary efficacy endpoints such as Clinical Global Impression of Schizophrenia (CGI-SCH), Medication Satisfaction Questionnaire (MSQ) scores showed significant improvements (P<0.0001) from baseline; 33.3% patients achieved symptom remission. In mirror analyses set (N=474), PP significantly (P<0.0001) reduced mean number of hospitalization days/person/year (12-month: 74.3 vs 19.7; 18-month: 74.3 vs 18.9) as well as percentage of patients requiring hospitalization in past 12 months (12-month: 39.7% vs 24.6%; 18-month: 39.7% vs 25%), and PP treatment increased the proportion of patients not requiring hospitalization (12-month: 60.3% vs 75.4%; 18-month: 60.3% vs 75%) from retrospective to prospective period. Adverse events (≥15%) were extrapyramidal symptoms-related (31.3%), injection-site pain (18.6%), and insomnia (15.2%).

Conclusion: PP was efficacious and generally tolerable with significant reductions observed in both number of hospitalizations and days spent in hospital.

No MeSH data available.


Related in: MedlinePlus

Change from baseline to month 18 in PANSS total score by PANSS baseline total score categories (intent-to-treat population; LOCF)Notes: **Compared with baseline, P<0.0001. P-value is from one-sided paired t-test for the  hypothesis that change is ≥−3.Abbreviations: LOCF, last observation carried forward; PANSS, Positive and Negative Syndrome Scale.
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f2-ndt-11-657: Change from baseline to month 18 in PANSS total score by PANSS baseline total score categories (intent-to-treat population; LOCF)Notes: **Compared with baseline, P<0.0001. P-value is from one-sided paired t-test for the hypothesis that change is ≥−3.Abbreviations: LOCF, last observation carried forward; PANSS, Positive and Negative Syndrome Scale.

Mentions: There was a significant (P<0.0001) and clinically meaningful improvement in mean (SD) PANSS total score of −11.3 (21.38) from baseline to endpoint (one-sided 95% CI: [-infinity; −9.7]) (Figure 1). A subgroup analyses of PANSS baseline total score categories (Figure 2) revealed that the improvement was significantly (P<0.0001) more pronounced among patients with worse disease severity at baseline: PANSS baseline total score ≥70 compared with <70 (mean [SD] change: −23.1 [24.62] vs −4.7 [15.98]).


Efficacy, safety, and impact on hospitalizations of paliperidone palmitate in recent-onset schizophrenia.

Zhang F, Si T, Chiou CF, Harris AW, Kim CY, Jahagirdar P, Ascher S - Neuropsychiatr Dis Treat (2015)

Change from baseline to month 18 in PANSS total score by PANSS baseline total score categories (intent-to-treat population; LOCF)Notes: **Compared with baseline, P<0.0001. P-value is from one-sided paired t-test for the  hypothesis that change is ≥−3.Abbreviations: LOCF, last observation carried forward; PANSS, Positive and Negative Syndrome Scale.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4362974&req=5

f2-ndt-11-657: Change from baseline to month 18 in PANSS total score by PANSS baseline total score categories (intent-to-treat population; LOCF)Notes: **Compared with baseline, P<0.0001. P-value is from one-sided paired t-test for the hypothesis that change is ≥−3.Abbreviations: LOCF, last observation carried forward; PANSS, Positive and Negative Syndrome Scale.
Mentions: There was a significant (P<0.0001) and clinically meaningful improvement in mean (SD) PANSS total score of −11.3 (21.38) from baseline to endpoint (one-sided 95% CI: [-infinity; −9.7]) (Figure 1). A subgroup analyses of PANSS baseline total score categories (Figure 2) revealed that the improvement was significantly (P<0.0001) more pronounced among patients with worse disease severity at baseline: PANSS baseline total score ≥70 compared with <70 (mean [SD] change: −23.1 [24.62] vs −4.7 [15.98]).

Bottom Line: Positive and Negative Syndrome Scale (PANSS) total score improved significantly from baseline to month 18 (mean [standard deviation, SD] change: -11.3 [21.38], P<0.0001, primary endpoint).In mirror analyses set (N=474), PP significantly (P<0.0001) reduced mean number of hospitalization days/person/year (12-month: 74.3 vs 19.7; 18-month: 74.3 vs 18.9) as well as percentage of patients requiring hospitalization in past 12 months (12-month: 39.7% vs 24.6%; 18-month: 39.7% vs 25%), and PP treatment increased the proportion of patients not requiring hospitalization (12-month: 60.3% vs 75.4%; 18-month: 60.3% vs 75%) from retrospective to prospective period.PP was efficacious and generally tolerable with significant reductions observed in both number of hospitalizations and days spent in hospital.

View Article: PubMed Central - PubMed

Affiliation: Xian Janssen Pharmaceuticals, Beijing, People's Republic of China.

ABSTRACT

Objective: To evaluate the efficacy, safety, and impact on hospitalizations of long-acting injectable paliperidone palmitate (PP) treatment, in patients with recent-onset schizophrenia who had not responded satisfactorily to oral antipsychotics.

Methods: In this 18-month, open-label, Phase-IIIb study from Asia-Pacific region, patients (18-50 years) with recent-onset (≤5 years) schizophrenia unsatisfactorily treated with previous oral antipsychotics were initiated on PP 150 mg eq on day 1, 100 mg eq on day 8, followed by flexible once monthly maintenance doses of 50-150 mg eq. The number and duration of hospitalizations were compared using a mirror analysis method between two periods: retrospective (12 months before PP initiation) and prospective (12 and 18 months after PP treatment) periods.

Results: A total of 303 out of 521 (58%) patients (mean age, 28.7 years; 65.5% men, 92.5% Asian) completed the study. Positive and Negative Syndrome Scale (PANSS) total score improved significantly from baseline to month 18 (mean [standard deviation, SD] change: -11.3 [21.38], P<0.0001, primary endpoint). Subgroup analysis revealed greater improvements among patients with worse disease severity at baseline: PANSS ≥70 versus <70 (mean [SD] change: -23.1 [24.62] vs -4.7 [15.98], P<0.0001 each). Secondary efficacy endpoints such as Clinical Global Impression of Schizophrenia (CGI-SCH), Medication Satisfaction Questionnaire (MSQ) scores showed significant improvements (P<0.0001) from baseline; 33.3% patients achieved symptom remission. In mirror analyses set (N=474), PP significantly (P<0.0001) reduced mean number of hospitalization days/person/year (12-month: 74.3 vs 19.7; 18-month: 74.3 vs 18.9) as well as percentage of patients requiring hospitalization in past 12 months (12-month: 39.7% vs 24.6%; 18-month: 39.7% vs 25%), and PP treatment increased the proportion of patients not requiring hospitalization (12-month: 60.3% vs 75.4%; 18-month: 60.3% vs 75%) from retrospective to prospective period. Adverse events (≥15%) were extrapyramidal symptoms-related (31.3%), injection-site pain (18.6%), and insomnia (15.2%).

Conclusion: PP was efficacious and generally tolerable with significant reductions observed in both number of hospitalizations and days spent in hospital.

No MeSH data available.


Related in: MedlinePlus