Abstract
Background and objectives
Short-term studies focused on once-monthly paliperidone palmitate (PP) at doses of 25 mg eq, 50 mg eq, 75 mg eq, 100 mg eq, or 150 mg eq have shown its efficacy and tolerability in the treatment of schizophrenia patients. However, few open-label and long-term studies are available regarding this new pharmacological formulation. Thus, our main aim was to review the scientific evidence on efficacy, safety, tolerability, and preference of PP in these populations.
Method
Electronic searches were conducted by using PubMed and ISI Web of Knowledge databases. All relevant studies published from 2009 until January 2015 were included without any language restriction if patients met diagnostic criteria for schizophrenia, and adequate information on efficacy, safety, and tolerability of once-monthly PP was available.
Results
Nineteen studies were identified irrespective of the study design and duration of the follow-up period. Randomized, double-blind, placebo-controlled trials found that schizophrenia patients receiving PP showed a significant improvement in psychotic symptoms and similar adverse events compared to placebo and suggested that all doses of PP were efficacious and well tolerated. Other studies demonstrated noninferiority of PP compared to risperidone long-acting injectable in recently diagnosed schizophrenia patients, chronically ill patients, as well as in acute and nonacute symptomatic schizophrenia patients, and a similar proportion of treatment-emergent adverse events between both groups were also noted.
Conclusion
Several studies have demonstrated that schizophrenia patients treated with PP show higher rates of improvement of psychotic symptoms compared to placebo, and similar efficacy and tolerability outcomes were noted when comparing PP to risperidone long-acting injectable or oral, paliperidone extended release.
Acknowledgments
This study was supported by the Ministerio de Economía y Competitividad. Instituto de Salud Carlos III- Fondo Europeo de Desarrollo Regional, Unión Europea, Un manera de hacer Europa, Centro de Investigación Biomédica en Red de salud Mental, CIBERSAM, by the Government of Catalonia, and Secretaria d’Universitats i Recerca del Departament d’Economia i Coneixement (2014SGR441). This work was developed (in part) at the Centro Esther Koplowitz (Barcelona).
Disclosure
Miquel Bernardo has been a consultant for, received grant/research support and honoraria from, and been on the speakers/advisory board of ABBiotics, Adamed, AMGEN, Eli Lilly, Ferrer, Forum Pharmaceuticals, Gedeon, Hersill, Janssen-Cilag, Lundbeck, Otsuka, Pfizer, Roche, and Servier. Alexandre González-Rodríguez has received honoraria or been paid for travels from Pfizer, Janssen, and Ferrer. Rosa Catalán has received honoraria or has been paid for travels from Lilly, Lundbeck, Janssen, Ferrer, Pfizer, and Bristol. Rafael Penadés has received honoraria or been paid for travels from Otsuka-Lundbeck. Clemente Garcia-Rizo has been a consultant for, received grant/research support, awards, honoraria from, and been on the speakers/advisory board of Bristol-Myers Squibb, Eli-Lilly, Ferrer, Janssen-Cilag, and Pfizer. Miquel Bioque has been a consultant for, received grant/research support, awards, honoraria from, and been on the speakers/advisory board of Ferrer, Janssen-Cilag, Lundbeck, Otsuka, and Pfizer. Eduard Parellada has received honoraria and/or research grants from Janssen-Cilag, Glaxo-Smith Kline, and Ferrer. The authors report no other conflicts of interest in this work.