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    FLEXIBLY DOSED PALIPERIDONE PALMITATE IN NON-ACUTE PATIENTS WITH SCHIZOPHRENIA SWITCHED FROM PREVIOUSLY UNSUCCESSFUL MONOTHERAPY WITH ORAL ATYPICAL ANTIPSYCHOTICS
    (Elsevier Science Bv, 2014) Hargarter, Ludger; Bergmans, Paul; Cherubin, Pierre; Rancans, Elmars; Bez, Yasin; Parellada, Eduardo; Carpiniello, Bernado
    [Abstract Not Available]
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    Intramuscular long-acting paliperidone palmitate in acute patients with schizophrenia unsuccessfully treated with oral antipsychotics
    (Pergamon-Elsevier Science Ltd, 2015) Hargarter, Ludger; Cherubin, Pierre; Bergmans, Paul; Keim, Sofia; Rancans, Elmars; Bez, Yasin; Parellad, Eduard
    In this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosing in Schizophrenia [PALMFlexS]), tolerability, safety and treatment response with paliperidone palmitate (PP) were explored in patients with acute symptoms of schizophrenia following switching from previously unsuccessful treatment with oral antipsychotics. This pragmatic study was conducted in a large, more representative sample of the general schizophrenia population compared to randomized controlled pivotal trials, to specifically mimic real-world clinical situations. After initiation on Day 1 and Day 8, patients received PP once monthly at flexible doses (50-150mg eq.) intramuscularly. The primary efficacy outcome was defined as the percentage of patients achieving >= 30% improvement in PANSS total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and treatment-emergent adverse events (TEAEs). Overall, 212 patients received PP at least once after switching from oral antipsychotics, primarily due to lack of efficacy (45.8%). Significant improvements from BL in mean (SD) PANSS total score were observed from Day 8 onwards (BL to LOCF EP: - 31.0 [29.0]; p < 0.0001). At endpoint, two-thirds (66.7%) and 43.5% of patients achieved a >= 30% and >= 50% improvement in mean PANSS total score, respectively. PP was associated with significant improvements across secondary measures of symptom severity, subjective well-being, medication satisfaction, illness-related disorders of activity and participation, and patient functioning (p < 0.0001; BL to LOCF EP). PP was generally well tolerated, with significant reductions in ESRS total score (p < 0.0001) and mainly mild-to-moderate TEAEs. TEAEs reported in >= 5% of patients were injection-site pain (13.7%), insomnia (10.8%), psychotic disorder (10.4%), headache and anxiety (both 6.1%). The PALMFlexS study findings provide valuable pragmatic clinical data on PP treatment in patients with acute schizophrenia previously unsuccessfully treated with oral antipsychotics. (C) 2014 The Authors. Published by Elsevier Inc.
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    ONCE MONTHLY PALIPERIDONE PALMITATE - TOLERABILITY AND TREATMENT RESPONSE IN RECENTLY DIAGNOSED VERSUS CHRONIC NON-ACUTE SCHIZOPHRENIA PATIENTS SWITCHED FROM PREVIOUSLY UNSUCCESSFUL TREATMENT WITH ORAL ANTIPSYCHOTICS
    (Elsevier Science Bv, 2014) Hargarter, Ludger; Bergmans, Paul; Cherubin, Pierre; Rancans, Elmars; Bez, Yasin; Parellada, Eduardo; Carpiniello, Bernardo
    [Abstract Not Available]
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    PALIPERIDONE PALMITATE - IMPACT ON NEGATIVE, DISORGANIZED AND DEPRESSIVE SYMPTOMS, SUBJECTIVE WELL-BEING AND PATIENT SATISFACTION IN PATIENTS WITH SCHIZOPHRENIA PREVIOUSLY UNSUCCESSFULLY TREATED WITH ORAL ANTIPSYCHOTICS
    (Elsevier Science Bv, 2014) Schreiner, Andreas; Hargarter, Ludger; Bergmans, Paul; Cherubin, Pierre; Rancans, Elmars; Bez, Yasin; Parellada, Eduardo
    [Abstract Not Available]
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    PALIPERIDONE PALMITATE IN ACUTE PATIENTS WITH SCHIZOPHRENIA TREATMENT RESPONSE, SAFETY AND TOLERABILITY: A PROSPECTIVE FLEXIBLE DOSE STUDY IN PATIENTS PREVIOUSLY UNSUCCESSFULLY TREATED WITH ORAL ANTIPSYCHOTICS
    (Elsevier Science Bv, 2014) Schreiner, Andreas; Bergmans, Paul; Cherubin, Pierre; Rancans, Elmars; Bez, Yasin; Parellada, Eduardo; Carpiniello, Bernado
    [Abstract Not Available]
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    A Prospective Flexible-Dose Study of Paliperidone Palmitate in Nonacute But Symptomatic Patients With Schizophrenia Previously Unsuccessfully Treated With Oral Antipsychotic Agents
    (Elsevier, 2014) Schreiner, Andreas; Bergmans, Paul; Cherubin, Pierre; Keim, Sofia; Rancans, Elmars; Bez, Yasin; Parellada, Eduard
    Purpose: 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.