Efficacy and Safety of Paliperidone Extended Release in Schizophrenia Patients Requiring a Switch in Antipsychotic Medication by Switching Previous Antipsychotics to Paliperidone Extended Release.
- Author:
Young Seon MOON
1
;
Kyoung Sae NA
;
Chul Eung KIM
;
Yong Sik KIM
;
Jin Sang YOON
;
Yong Min AHN
;
Hee Yeon JUNG
;
Bum Hee YU
;
Yang Whan JEON
;
Sang Kyu LEE
;
Jeong Ho SEOK
;
Byoung Joo HAM
;
Doo Byung PARK
;
Hyun KIM
;
Byung Wook LEE
;
Chang Hyung HONG
;
Jong Woo KIM
;
Jin Hee HAN
Author Information
1. Department of Psychiatry, Inha University College of Medicine, Inha University Hospital, Incheon, Korea. kce320@inha.ac.kr
- Publication Type:Multicenter Study ; Original Article
- Keywords:
Schizophrenia;
Atypical antipsychotic;
Paliperidone ER;
Efficacy;
Tolerability
- MeSH:
Antipsychotic Agents;
Body Weight;
Follow-Up Studies;
Humans;
Isoxazoles;
Prolactin;
Prospective Studies;
Pyrimidines;
Schizophrenia;
Sleep Initiation and Maintenance Disorders;
Waist Circumference;
Weights and Measures
- From:Korean Journal of Psychopharmacology
2012;23(3):97-106
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
OBJECTIVE: This study aimed to evaluate the clinical efficacy, safety, and tolerability of paliperidone extended release (ER) in patients with schizophrenia by switching previous antipsychotics to paliperidone ER. METHODS: An open-label, 24 weeks, prospective, non-comparative, multi-center study evaluated total 387 patients with schizophrenia requiring a switch in antipsychotic medication due to suboptimal efficacy, intolerability, and non-compliance. Patients were switched to flexible-dose trial of paliperidone ER (3-12 mg/day). Efficacy was measured by Krawiecka Scale, Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S), Clinical Global Impression-Schizophrenia-Improvement (CGI-SCH-I), sleep visual analog scale (VAS), and Personal and Social Performance Scale (PSP). Safety assessments included adverse events (AEs), evaluation of extrapyramidal symptoms (EPS) using the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS), and laboratory tests. RESULTS: Data from a total of 321 subjects who took the paliperidone ER and had at least one follow-up assessment without a major protocol violation were analyzed. Switching to paliperidone ER led to a significant improvement in the Krawiecka, CGI-SCH-S, CGI-SCH-I, PSP, and DIEPSS scales. However, serum prolactin levels and metabolic parameters including body weight and waist circumference were significantly increased. Insomnia was the most common adverse event. CONCLUSION: This study suggested that patients with schizophrenia who showed insufficient response or intolerance to other previous antipsychotics can be switched to paliperidone ER, with efficacy, safety, and tolerability.
