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A comparison of serum prolactin concentrations after administration of paliperidone extended-release and risperidone tablets in patients with schizophrenia.
J Psychopharmacol. 2010 Jul; 24(7):1011-8.JP

Abstract

Increases in serum prolactin concentrations after administration of risperidone have been attributed, by some, to the availability of paliperidone in plasma. This double-blind, randomized, parallel-group study in patients with schizophrenia compared serum prolactin concentrations following the administration of paliperidone extended-release and risperidone immediate-release tablets. At steady state, the doses administered resulted in a similar exposure to paliperidone and the pharmacologically active fraction of risperidone (i.e. risperidone + paliperidone), respectively. Eligible patients were randomized to either paliperidone extended-release 12 mg on days 1-6 or risperidone immediate-release 2 mg on day 1 and 4 mg on days 2-6. Mean serum prolactin concentrations increased on day 1 (C(max): 71.8 ng/ml and 89.7 ng/ml reached at 6.5 hours and 2.6 hours for paliperidone extended-release and risperidone immediate-release, respectively). On day 6, serum prolactin concentration-time profiles were similar for both treatments, with overall higher serum prolactin concentrations than on day 1 (AUC(0-24 h): 1389 and 842 ng h/ml, and 1306 and 741 ng.h/ml on day 6 and day 1 for paliperidone extended-release and risperidone immediate-release, respectively). These results indicate that paliperidone extended-release 12 mg and risperidone immediate-release 4 mg, administered over a period of 6 days, lead to similar elevations in serum prolactin concentrations.

Authors+Show Affiliations

Johnson & Johnson Pharmaceutical Research and Development, Titusville, NJ 08560, USA. JBerwaer@its.jnj.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase I
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19825908

Citation

Berwaerts, Joris, et al. "A Comparison of Serum Prolactin Concentrations After Administration of Paliperidone Extended-release and Risperidone Tablets in Patients With Schizophrenia." Journal of Psychopharmacology (Oxford, England), vol. 24, no. 7, 2010, pp. 1011-8.
Berwaerts J, Cleton A, Rossenu S, et al. A comparison of serum prolactin concentrations after administration of paliperidone extended-release and risperidone tablets in patients with schizophrenia. J Psychopharmacol. 2010;24(7):1011-8.
Berwaerts, J., Cleton, A., Rossenu, S., Talluri, K., Remmerie, B., Janssens, L., Boom, S., Kramer, M., & Eerdekens, M. (2010). A comparison of serum prolactin concentrations after administration of paliperidone extended-release and risperidone tablets in patients with schizophrenia. Journal of Psychopharmacology (Oxford, England), 24(7), 1011-8. https://doi.org/10.1177/0269881109106914
Berwaerts J, et al. A Comparison of Serum Prolactin Concentrations After Administration of Paliperidone Extended-release and Risperidone Tablets in Patients With Schizophrenia. J Psychopharmacol. 2010;24(7):1011-8. PubMed PMID: 19825908.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparison of serum prolactin concentrations after administration of paliperidone extended-release and risperidone tablets in patients with schizophrenia. AU - Berwaerts,Joris, AU - Cleton,Adriaan, AU - Rossenu,Stefaan, AU - Talluri,Krishna, AU - Remmerie,Bart, AU - Janssens,Luc, AU - Boom,Sandra, AU - Kramer,Michelle, AU - Eerdekens,Mariëlle, Y1 - 2009/10/13/ PY - 2009/10/15/entrez PY - 2009/10/15/pubmed PY - 2010/9/18/medline SP - 1011 EP - 8 JF - Journal of psychopharmacology (Oxford, England) JO - J Psychopharmacol VL - 24 IS - 7 N2 - Increases in serum prolactin concentrations after administration of risperidone have been attributed, by some, to the availability of paliperidone in plasma. This double-blind, randomized, parallel-group study in patients with schizophrenia compared serum prolactin concentrations following the administration of paliperidone extended-release and risperidone immediate-release tablets. At steady state, the doses administered resulted in a similar exposure to paliperidone and the pharmacologically active fraction of risperidone (i.e. risperidone + paliperidone), respectively. Eligible patients were randomized to either paliperidone extended-release 12 mg on days 1-6 or risperidone immediate-release 2 mg on day 1 and 4 mg on days 2-6. Mean serum prolactin concentrations increased on day 1 (C(max): 71.8 ng/ml and 89.7 ng/ml reached at 6.5 hours and 2.6 hours for paliperidone extended-release and risperidone immediate-release, respectively). On day 6, serum prolactin concentration-time profiles were similar for both treatments, with overall higher serum prolactin concentrations than on day 1 (AUC(0-24 h): 1389 and 842 ng h/ml, and 1306 and 741 ng.h/ml on day 6 and day 1 for paliperidone extended-release and risperidone immediate-release, respectively). These results indicate that paliperidone extended-release 12 mg and risperidone immediate-release 4 mg, administered over a period of 6 days, lead to similar elevations in serum prolactin concentrations. SN - 1461-7285 UR - https://www.unboundmedicine.com/medline/citation/19825908/A_comparison_of_serum_prolactin_concentrations_after_administration_of_paliperidone_extended_release_and_risperidone_tablets_in_patients_with_schizophrenia_ L2 - https://journals.sagepub.com/doi/10.1177/0269881109106914?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -