A Prospective Flexible-Dose Study of Paliperidone Palmitate in Nonacute But Symptomatic Patients With Schizophrenia Previously Unsuccessfully Treated With Oral Antipsychotic Agents

Basit Öğe Kaydı
dc.contributor.authorSchreiner, Andreas
dc.contributor.authorBergmans, Paul
dc.contributor.authorCherubin, Pierre
dc.contributor.authorKeim, Sofia
dc.contributor.authorRancans, Elmars
dc.contributor.authorBez, Yasin
dc.contributor.authorParellada, Eduard
dc.date.accessioned2024-04-24T16:11:05Z
dc.date.available2024-04-24T16:11:05Z
dc.date.issued2014
dc.departmentDicle Üniversitesien_US
dc.description.abstractPurpose: The goal of this study was to explore the tolerability, safety, and treatment response of flexible doses of once-monthly paliperidone palmitate (PP) in the subset of nonacute but symptomatic adult patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents in the PALMFlexS (Paliperidone Palmitate Flexible Dosing in Schizophrenia) study. Methods: This was an interventional, single-arm, international, multicenter, unblinded, 6-month study performed in patients with schizophrenia. Patients were categorized according to reasons for switching. In patients switching because of lack of efficacy or for other reasons, primary efficacy outcomes were the proportion achieving treatment response (defined as >= 20% improvement in Positive and Negative Syndrome Scale [PANSS] total score from baseline to last-observation-carried-forward end point) and maintained efficacy (defined as noninferiority in the change in PANSS total score at end point versus baseline [Schuirmann's test]), respectively. Findings: A total of 593 patients (intention-to-treat population) were enrolled: 63.1% were male; their mean (SD) age was 38.4 (11.8) years; and 78.6% had paranoid schizophrenia. The main reasons for transition to PP were patient's wish (n = 259 [43.7%]), lack of efficacy (n = 144 [24.3%]), lack of compliance (n = 138 [23.3%]), and lack of tolerability (n = 52 [8.8%]) with the previous oral antipsychotic medication. The recommended PP initiation regimen (150 milligram equivalents [mg eq] day 1 and 100 mg eq day 8) was administered in 93.9% of patients. Mean PANSS total score decreased from 71.5 (14.6) at baseline to 59.7 (18.1) at end point (mean change, -11.7 [15.9]; 95% CI, -13.0 to -10.5; P < 0.0001). Sixty-four percent of patients showed an improvement of >= 20% in PANSS total score, and the percentage of patients rated mildly ill or less in Clinical Global Impression Severity increased from 31.8% to 63.2%. Mean personal and social performance total score (SD) increased (ie, improved) significantly for all patients from baseline to end point (58.1 [13.4] to 66.1 [15.7]; P < 0.0001). (C) 2014 The Authors. Published by Elsevier HS Journals, Inc.en_US
dc.description.sponsorshipAstraZeneca; GlaxoSmithKline; Janssen-Cilag; Lundbeck; Pfizer; Sanofi Synthlabo; Servier; Sanovel; Sanofi-Aventis; Bilim; Fondo de Investigacion Sanitaria of the Spanish Ministry of Science and Innovation [PI080055]; Fundacio la Marato de TV3 of Catalonia; Janssen; Otsuka; Angelini; Eli Lilly; French Health Ministry; French Education and Research Ministry; University Hospital of Strasbourg, Franceen_US
dc.description.sponsorshipDr. Schreiner, Mr. Bergmans and Ms. Keim are full-time employees of Janssen-Cilag and shareholders of Johnson & Johnson. Dr. Rancans participated in advisory boards for and cooperated in clinical trials with AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Janssen-Cilag, Lundbeck, M's Science Corporation, Otsuka, Pfizer and Servier, has received speaker's fees from AstraZeneca, GlaxoSmithKline, Janssen-Cilag, Lundbeck, Pfizer, Sanofi Synthlabo and Servier and was Principal Investigator for one site in the PALMFlexS study. Dr. Bez has received speaker honoraria from Nobel, Bilim and Janssen-Cilag, travel grants from Sanovel, Sanofi-Aventis, Janssen-Cilag and Bilim, and is member of advisory panels for Nobel and Janssen-Cilag. Dr. Parellada has received honoraria and/or research grants from the Fondo de Investigacion Sanitaria (registered number PI080055) of the Spanish Ministry of Science and Innovation, Fundacio la Marato de TV3 of Catalonia, Janssen-Cilag and GlaxoSmithKline. Dr. Carpiniello has received financial support as a participant to scientific boards or as a speaker in congresses or courses and grants for research from AstraZeneca, Janssen, Pfizer, Otsuka, Lundbeck, Angelini and Eli Lilly. Dr. Vidailhet has received investigation fees for the PALMFlexS study, speaker's honoraria and is member of advisory panels for Janssen, Lundbeck, Bristol-Myers Squibb, Eli Lilly, Roche, and research grants from the French Health Ministry, the French Education and Research Ministry and the University Hospital of Strasbourg, France. Dr. Cherubin is a full-time employee of Janssen-Cilag. Ludger Hargarter is a full-time employee and a member of Medical Affairs EMEA at Janssen-Cilag GmbH, Neuss, Germany.; This study was sponsored by Janssen-Cilag. Medical writing support was provided by apothecom scopemedical ltd and funded by Janssen-Cilag. Janssen-Cilag had a role in the study design; in the analysis, and interpretation of data in the writing of the manuscript; and in the decision to submit the manuscript for publication.en_US
dc.identifier.doi10.1016/j.clinthera.2014.08.014
dc.identifier.endpage1388en_US
dc.identifier.issn0149-2918
dc.identifier.issn1879-114X
dc.identifier.issue10en_US
dc.identifier.pmid25444566
dc.identifier.scopus2-s2.0-84908297790
dc.identifier.scopusqualityQ2
dc.identifier.startpage1372en_US
dc.identifier.urihttps://doi.org/10.1016/j.clinthera.2014.08.014
dc.identifier.urihttps://hdl.handle.net/11468/15258
dc.identifier.volume36en_US
dc.identifier.wosWOS:000344426500009
dc.identifier.wosqualityQ2
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.relation.ispartofClinical Therapeutics
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectLong-Acting Antipsychoticen_US
dc.subjectNonacuteen_US
dc.subjectPaliperidone Palmitateen_US
dc.subjectSchizophreniaen_US
dc.titleA Prospective Flexible-Dose Study of Paliperidone Palmitate in Nonacute But Symptomatic Patients With Schizophrenia Previously Unsuccessfully Treated With Oral Antipsychotic Agentsen_US
dc.titleA Prospective Flexible-Dose Study of Paliperidone Palmitate in Nonacute But Symptomatic Patients With Schizophrenia Previously Unsuccessfully Treated With Oral Antipsychotic Agents
dc.typeArticleen_US

Dosyalar

Koleksiyon

WoS İndeksli Yayınlar Koleksiyonu
PubMed İndeksli Yayın Koleksiyonu
Scopus İndeksli Yayınlar Koleksiyonu