title: Efficacy and tolerability of paliperidone ER in patients with unsatisfactorily controlled schizophrenia by other antipsychotics: a flexible-dose approach.
abstract: This study evaluates the effectiveness of paliperidone ER in patients with symptomatic but not highly acute schizophrenia in terms of efficacy, safety, and patients' perception of their social functioning and well-being. This is a multicenter, open-label prospective study with a flexible-dose approach; 133 patients were enrolled and followed for 13 weeks after switching to paliperidone ER. Outcome efficacy measures were as follows: the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression-Severity (CGI-S) scale, and the Personal and Social Performance (PSP) scale; in addition, the Subjective Well-being under Neuroleptics (SWN-20) scale, the Drug Attitude Inventory (DAI-30), and the sleep evaluation scale were used. Symptom Rating Scale (ESRS), adverse events, and subjective side effects were recorded. 118/133(88.7%) patients completed the study. The mean PANSS score decreased (88.98 ± 10.09 to 66.52 ± 16.29; P < 0.001); 40.5% of the patients achieved improvement of at least 30%. PSP and CGI-S scores as well as DAI-30 and SWN-20 decreased (P < 0.001). ESRS (P < 0.001) decreased significantly from the baseline. Throughout the trial, no deaths occurred and only one serious adverse event was reported. Paliperidone ER has proved to be efficacious, safe, and well tolerated also with this approach more closely resembling actual clinical practice. Patient-relevant outcome parameters such as social functioning and quality of life improved, which is crucial for treatment adherence in clinical practice.
authors.affiliation: aPsychiatry Department, University of Pisa-AOUP Pisa, Pisa bClinical Psychiatry Department, Clinical Neuropsychopharmacology Unit, IRCCS Ospedale Maggiore Policlinico, Milan cMedical Affairs, Janssen-CilagSpA, Cologno Monzese, Milan dBiostatistic Unit, Medi Service, Genoa ePsychiatric Operative Unit - ASL Salerno-Ds 68, Salerno, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Mauri
authors.forename: Massimo C
authors.initials: MC
authors.lastname: Mauri
authors.forename: Marina
authors.initials: M
authors.lastname: Adami
authors.forename: Giorgio
authors.initials: G
authors.lastname: Reggiardo
authors.forename: Corrivetti
authors.initials: C
authors.lastname: Giulio
mesh_terms: D000284:Administration, Oral; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007398:Interpersonal Relations; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012559:Schizophrenia / Q000188:drug therapy*; D012720:Severity of Illness Index
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D000068882:Paliperidone Palmitate