Use of paliperidone palmitate in acute units: post-hoc analysis of the shadow study according to previous antipsychotic treatment

2016 ◽  
Author(s):  
Manuel Serrano
Keyword(s):  
Paliperidone Palmitate ◽  
Antipsychotic Treatment ◽  
Post Hoc Analysis ◽  
Post Hoc

Metabolic syndrome in schizophrenia patients observed in German clinical practice - how do untreated patients differ from patients with previous antipsychotic medication?

2011 ◽  
Vol 26 (S2) ◽  
pp. 1425-1425
Author(s):  
S. Kraemer ◽  
A. Minarzyk ◽  
S. Pamulapati ◽  
T. Forst ◽  
D. Kopf
Keyword(s):  
Metabolic Syndrome ◽  
Antipsychotic Medication ◽  
Prospective Observational Study ◽  
Fasting Glucose ◽  
Hdl Cholesterol ◽  
Antipsychotic Treatment ◽  
Physical Parameters ◽  
Antipsychotic Therapy ◽  
Post Hoc Analysis ◽  
Post Hoc

IntroductionFor antipsychotic therapy and for schizophrenia associations with increased prevalence of metabolic syndrome (MetS) have been reported. This post-hoc analysis of a German, prospective, observational study assessed MetS-prevalence at baseline and month-3 in adults with schizophrenia.MethodsPatients previously untreated (UT, N = 108; 60.2% females) or on different antipsychotic therapy (PT, N = 367; 47.7% females) were initiated or switched to new antipsychotic medication at baseline (choice unrestricted). Analyzed were patients with complete metabolic data (fasting blood samples, physical parameters, baseline/month-3) without medication change. Prevalence of MetS (AHA/NHLB-definition) and MetS-factors were determined; 95% confidence intervals (CI) were derived from exploratory ANCOVA analyses, adjusting for treatment group and sex.ResultsPT had significantly higher MetS prevalence at both visits than UT (baseline: 49.9% [CI 44.6;55.1] vs. 25.9% [18.0;35.3]; month-3: 54.5% [49.3;59.7] vs. 32.4% [23.7;42.1]); MetS prevalence increased by 4.6% in PT and 6.5% in UT. At baseline, UT had significantly better values than PT for triglycerides (p = 0.0048), HDL-cholesterol (p = 0.0044), blood pressure (SBP/ DBP; p = 0.0090/0.0067), fasting glucose (P = 0.0304), waist circumference (p=< .0001). At month-3 differences were no longer significant, except for DBP (p = 0.0227). ANCOVA for both groups pooled revealed a significant effect on change from baseline for DBP (p = 0.0227), and a sex effect for fasting triglycerides (p = 0.0006) and HDL-cholesterol (p = 0.0015 in favor of women.ConclusionPhysical and metabolic parameters initially were better in UT, compared to PT. At month-3, UT and PT values had converged, indicating that antipsychotic treatment may be associated with increased metabolic burden in an at-risk population.

scholarly journals 104 Long-term Efficacy of Lurasidone in Antipsychotic-naïve vs. Antipsychotic-exposed Adolescents with Schizophrenia: Analysis of a Two-Year Study

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 267-268
Author(s):  
Christoph U. Correll ◽  
Robert Goldman ◽  
Michael Tocco ◽  
Jay Hsu ◽  
Andrei Pikalov
Keyword(s):  
Extension Study ◽  
Fixed Dose ◽  
First Episode ◽  
Antipsychotic Treatment ◽  
Number Needed To Treat ◽  
Post Hoc Analysis ◽  
Term Efficacy ◽  
Treatment Naïve ◽  
Post Hoc

Abstract:Background:Early-onset schizophrenia is characterized by greater severity and more functional impairment than adult-onset schizophrenia. Few studies have prospectively evaluated short- or long-term antipsychotic efficacy in treatment-naïve (vs. previously treated) first-episode schizophrenia. The aim of this post-hoc analysis was to evaluate the long-term efficacy of lurasidone in antipsychotic-naïve adolescents with schizophrenia.Method:Patients aged 13-17 years with schizophrenia were randomized to 6 weeks of double-blind (DB), fixed-dose treatment with lurasidone (40 mg/day or 80 mg/day) or placebo. Six-week completers were eligible to enroll in an open-label (OL), flexible dose 2-year lurasidone treatment study. Efficacy over 104 weeks of OL treatment with lurasidone was evaluated for 2 patient groups based on treatment status prior to entering the initial DB study (treatment-naïve [TN] vs. treated previously [TP]). Treatment-naïve was defined as never having received antipsychotic treatment prior to randomization. Efficacy measures included the PANSS total score and the Clinical Global Impressions-Severity (CGI-S) score. Treatment response was defined as ≥20% reduction from baseline in PANSS total score.Results:A total of 50 TN and 221 TP patients completed the 6-week DB study and entered the extension study; and 30 (60.0%) TN and 126 (57.0%) TP patients completed 104 weeks. In the ITT population of the initial DB study, treatment with lurasidone (vs. placebo) yielded larger effects at DB endpoint on the PANSS total score in the TN group (-25.0 vs. -14.4; P<0.02; effect size [ES]=0.75) compared to the TP group (-17.3 vs. -10.0; P<0.001; ES=0.45); and in the CGI-S score in the TN group (-1.07 vs. -0.28; P=0.002; ES=0.97) compared to the TP group (-0.91 vs. -0.55; P=0.005; ES=0.38). During OL treatment with lurasidone, the magnitude of improvement from DB baseline continued to be somewhat larger in the PANSS total score for TN patients (n=38) vs. TP patients (151) at week 52 (-32.6 vs. -28.1) and week 104 (-33.6 vs. -29.2); and in the CGI-S score for TN vs. TP patients at week 52 (-2.1 vs. -1.5) and week 104 (-2.1 vs. -1.6). Responder rates during treatment with lurasidone were 72.0% (TN group) and 61.1% (TP group) at OL baseline (number-needed-to-treat [NNT]=10), 100% and 90.1% at week 52 [NNT=11], and 100% and 88.9% at week 104 [NNT=11]. During OL treatment, the most common adverse events for TN vs. TP patients were headache (26.0% vs. 23.5%), nasopharyngitis (24.0% vs. 5.4%), nausea (16.0% vs. 11.8%), and dizziness (16.0% vs. 4.1%).Conclusion:In this post-hoc analysis of a 2-year OL extension study, antipsychotic-naïve adolescents with schizophrenia responded well to treatment with lurasidone at doses of 40 mg/day or 80 mg/day. TN patients achieved greater improvement than TP patients during acute treatment; and these greater treatment effects were largely maintained during 2 years of continued treatment with lurasidone.Funding Acknowledgements:Supported by funding from Sunovion Pharmaceuticals Inc

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