ORIGINAL RESEARCH

FUNDING: No funding was received for the preparation of this manuscript. FINANCIAL DISCLOSURES: The authors have no conflicts of interest relevant to the content of this article. ADDRESS CORRESPONDENCE TO: Masaru Nakamura, MD, PhD, 10-1, KusatsuUmegadai, Nishi Ward, Hiroshima City, Japan; Phone: 082-277-1001; Fax: 082-277-1008; E-mail: [email protected] KEY WORDS: Paliperidone palmitate, paliperidone-ER, risperidone long-acting injectable, switching, prolactin

Prolactin Levels After Switching to Paliperidone Palmitate in Patients with Schizophrenia by MASARU NAKAMURA, MD, PhD; TAKAHIKO NAGAMINE, MD, PhD; GORO SATO, MD, PhD; AND KAZUE BESHO, Phc Dr. Nakamura is with the Department of Psychiatric Internal Medicine, Kosekai-Kusatsu Hospital, Hiroshima, Japan; Dr. Nagamine is with the Department of Psychiatric Internal Medicine, Shinseikai-Ishii Memorial Hospital, Iwakuni, Japan; Dr. Sato is with the Department of Psychiatry, Kosekai-Kusatsu Hospital, Hiroshima, Japan; and PhC. Besho is with the Department of Pharmacy, Kosekai-Kusatsu Hospital, Hiroshima, Japan. Innov Clin Neurosci. 2016;13(5–6):28–30

ABSTRACT Objective: The aim of this study was to investigate the tolerability and efficacy of paliperidone palmitate and its effect on the levels of prolactin in patients with schizophrenia. Method: A prospective study was carried out in 22 Japanese middle-aged patients with schizophrenia who were switched from paliperidone-extended release or risperidone long-acting injectable to paliperidone palmitate for a minimum of 12 months. Psychotic symptoms using the 18-item Brief Psychiatric Rating Scale, extrapyramidal symptoms using 9-item Drug-induced Extrapyramidal Symptoms Scale, and plasma prolactin levels using fasting blood samples were assessed at Baseline, and one, three, six, and 12 months. Results: There were significant reductions in prolactin levels at one, three, and six months relative to baseline in the male subjects switched from risperidone long-acting injectable,

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Innovations in CLINICAL NEUROSCIENCE

[VOLUME 13, NUMBER 5–6, MAY–JUNE 2016]

while prolactin levels in male subjects switched from paliperidone-extended release and the female subjects switched from risperidone long-acting injectable or paliperidone-extended release were largely unchanged. No time-sequential changes were observed in total scores of Brief Psychiatric Rating Scale and Druginduced Extrapyramidal Symptoms Scale, irrespective of previous antipsychotics treatment. Conclusion: Switching from paliperidone-extended release or risperidone long-acting injectable to paliperidone palmitate did not result in any observed time-sequential changes in psychotic symptoms in study subjects, and prolactin levels decreased in male subjects switched from risperidone long-acting injectable. As measurement of paliperidone concentrations is limited in routine practice, a fluctuation range of prolactin levels may be a useful marker for confirmation of safety maintenance

treatment with long-acting injectables in clinical settings.

INTRODUCTION Schizophrenia is a chronic and recurrent psychiatric disorder that requires long-term treatment with antipsychotics. The use of long-acting preparations has been shown to increase adherence in patients with schizophrenia, reduce their risks of relapse, and improve their global outcomes.1 Paliperidone extended release (PAL) and risperidone longacting injection (RLAI) provide constant medication delivery offering low peak-to-trough fluctuations and significant clinical effect.2,3 Paliperidone palmitate (PP) is a recently developed LAI with efficacy and tolerability that have been demonstrated in randomized, double-blind, controlled studies.4,5 Among several oral antipsychotics, a significant association between dopamine D2 receptor occupancy levels and serum prolactin concentration has been demonstrated in previous studies.6,7 Here, we investigate changes in prolactin levels after switching from PAL or RLAI to PP, in a 12-month, prospectivedesigned study of Japanese middleaged patients with schizophrenia. The ethics committee of Kusatsu Hospital approved this study.

METHODS Inclusion criteria. Patients with a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)8 that were switched from PAL or RLAI to PP based on a psychiatrist’s recommendation were enrolled consecutively in our study from December 2013 to May 2014 at Kusatsu Hospital in Hiroshima. Those patients who agreed to participate via written informed consent were eligible to enter the study. Inclusion criteria were 1) being treated with PAL or RLAI for at least six months previously and ongoing treatment with PP for 12 months or more, 2) not having changed antipsychotic treatment (neither introduction of

FIGURE 1. Changes in the levels of PRL at baseline and 1, 3, 6, and 12 months after switching from PAL or RLAI to PP, divided by sex and previously treated status (PAL or RLAI) *p

Prolactin Levels After Switching to Paliperidone Palmitate in Patients with Schizophrenia.

Objective: The aim of this study was to investigate the tolerability and efficacy of paliperidone palmitate and its effect on the levels of prolactin ...
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