Takashi Ohnishi1,2, Hisanori Kobayashi1,2, Toshio Yamaoka1,2, Tokiko Toma1,2, Keiko Imai1,2, Akihide Wakamatsu1,2, Kenichi Noguchi1,2. 1. Drs. Ohnishi, Kobayashi, and Noguchi and Mr. Wakamatsu are with the Medical Affairs Division of Janssen Pharmaceutical K.K. in Tokyo, Japan. 2. Mr. Yamaoka, Ms. Toma, and Ms. Imai are with the Drug Safety Surveillance Department, Japan Safety & Surveillance Division of Janssen Pharmaceutical K.K. in Tokyo, Japan.
Abstract
Objective: We sought to evaluate the effects of a one-month paliperidone palmitate formulation (PP1M) on employment status, social function, symptomatology, and safety and conducted a two-year postmarketing surveillance study of Paliperidone Palmitate 1 Month (PP1M). Methods: Patients diagnosed with schizophrenia participated in the study. Employment status was recorded at baseline and changes were measured at one and two years. Social functioning and symptomatology were assessed using the Social and Occupational Functioning Assessment Scale (SOFAS) and the Clinical Global Impression-Schizophrenia (CGI-SCH). Data on adverse events were also collected. Results: A total of 1,319 patients were enrolled in this investigation, including 1,306 who were evaluable for safety and 1,279 who were evaluable for efficacy. The maintenance rate during the observation period was 49.4 percent. During the observation period, the percentages of patients reporting employment significantly increased: 24.3 percent of patients were employed in some capacity at baseline, 32.5 percent of patients were employed at one year, and 34.6 percent of patients were employed at two years. Significant improvements were observed in both SOFAS and CGI-SCH scores during the observation period. The percentage of patients with socially functional remission also significantly increased. A strong association between the improvement of social function, gender, and monotherapy versus polypharmacy and the improvement of employment status was observed. A total of 29.3 percent of patients experienced at least one adverse event. There were no unexpected findings from long-term treatment and a safety profile, including mortality. Conclusion: PP1M treatment appears to improve not only schizophrenic symptoms but also functional outcomes.
Objective: We sought to evaluate the effects of a one-month paliperidone palmitate formulation (PP1M) on employment status, social function, symptomatology, and safety and conducted a two-year postmarketing surveillance study of Paliperidone Palmitate 1 Month (PP1M). Methods:Patients diagnosed with schizophrenia participated in the study. Employment status was recorded at baseline and changes were measured at one and two years. Social functioning and symptomatology were assessed using the Social and Occupational Functioning Assessment Scale (SOFAS) and the Clinical Global Impression-Schizophrenia (CGI-SCH). Data on adverse events were also collected. Results: A total of 1,319 patients were enrolled in this investigation, including 1,306 who were evaluable for safety and 1,279 who were evaluable for efficacy. The maintenance rate during the observation period was 49.4 percent. During the observation period, the percentages of patients reporting employment significantly increased: 24.3 percent of patients were employed in some capacity at baseline, 32.5 percent of patients were employed at one year, and 34.6 percent of patients were employed at two years. Significant improvements were observed in both SOFAS and CGI-SCH scores during the observation period. The percentage of patients with socially functional remission also significantly increased. A strong association between the improvement of social function, gender, and monotherapy versus polypharmacy and the improvement of employment status was observed. A total of 29.3 percent of patients experienced at least one adverse event. There were no unexpected findings from long-term treatment and a safety profile, including mortality. Conclusion: PP1M treatment appears to improve not only schizophrenic symptoms but also functional outcomes.
Authors: Viviana R Carmona; Juana Gómez-Benito; Tania B Huedo-Medina; J Emilio Rojo Journal: Int J Occup Med Environ Health Date: 2017-04-26 Impact factor: 1.843
Authors: J M Haro; S A Kamath; S Ochoa; D Novick; K Rele; A Fargas; M J Rodríguez; R Rele; J Orta; A Kharbeng; S Araya; M Gervin; J Alonso; V Mavreas; E Lavrentzou; N Liontos; K Gregor; P B Jones Journal: Acta Psychiatr Scand Suppl Date: 2003
Authors: Robert Rosenheck; Douglas Leslie; Richard Keefe; Joseph McEvoy; Marvin Swartz; Diana Perkins; Scott Stroup; John K Hsiao; Jeffrey Lieberman Journal: Am J Psychiatry Date: 2006-03 Impact factor: 18.112