Tags

Type your tag names separated by a space and hit enter

A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia.
J Psychopharmacol. 2011 May; 25(5):685-97.JP

Abstract

The safety and tolerability of paliperidone palmitate, an injectable atypical antipsychotic agent, were assessed in a 1-year open-label extension of a double-blind study in patients with schizophrenia. Patients from the double-blind study who experienced a recurrence, remained recurrence free until study end, or who were in the transition, maintenance or double-blind phases and had received at least one injection of paliperidone palmitate when enrollment was stopped, were eligible for the open-label extension. Patients received gluteal injections of paliperidone palmitate once every 4 weeks: starting dose 50 mg eq. followed by 25, 50, 75, or 100 mg eq. flexible dosing. Of the 388 patients enrolled, 288 completed the open-label extension. During the open-label extension, the median (range) duration of exposure to paliperidone palmitate was 338 days (10; 390), and 74% of patients received all 12 open-label injections of paliperidone palmitate. The most frequent (≥ 5% in total group) adverse events were insomnia (7%); worsening of schizophrenia; nasopharyngitis; headache; and weight increase (6% each). Potentially prolactin-related adverse events occurred in 13 (3%) patients, mostly women, and none resulted in study discontinuation. Extrapyramidal treatment-emergent adverse events were reported in 25 (6%) patients; tremor was the most frequently reported (n = 8, 2%). At open-label extension endpoint, investigator-rated redness at the injection site was observed in ≤ 4% of patients in each group. Injection-site pain was rated by investigators as absent in 82-87% of patients. Schizophrenia symptoms measured by Positive and Negative Syndrome Scale and personal and social performance changes improved during the open-label extension.

Authors+Show Affiliations

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey 08560, USA. sgopal2@its.jnj.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

20615933

Citation

Gopal, S, et al. "A 52-week Open-label Study of the Safety and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia." Journal of Psychopharmacology (Oxford, England), vol. 25, no. 5, 2011, pp. 685-97.
Gopal S, Vijapurkar U, Lim P, et al. A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia. J Psychopharmacol. 2011;25(5):685-97.
Gopal, S., Vijapurkar, U., Lim, P., Morozova, M., Eerdekens, M., & Hough, D. (2011). A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia. Journal of Psychopharmacology (Oxford, England), 25(5), 685-97. https://doi.org/10.1177/0269881110372817
Gopal S, et al. A 52-week Open-label Study of the Safety and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia. J Psychopharmacol. 2011;25(5):685-97. PubMed PMID: 20615933.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia. AU - Gopal,S, AU - Vijapurkar,U, AU - Lim,P, AU - Morozova,M, AU - Eerdekens,M, AU - Hough,D, Y1 - 2010/07/08/ PY - 2010/7/10/entrez PY - 2010/7/10/pubmed PY - 2011/8/13/medline SP - 685 EP - 97 JF - Journal of psychopharmacology (Oxford, England) JO - J Psychopharmacol VL - 25 IS - 5 N2 - The safety and tolerability of paliperidone palmitate, an injectable atypical antipsychotic agent, were assessed in a 1-year open-label extension of a double-blind study in patients with schizophrenia. Patients from the double-blind study who experienced a recurrence, remained recurrence free until study end, or who were in the transition, maintenance or double-blind phases and had received at least one injection of paliperidone palmitate when enrollment was stopped, were eligible for the open-label extension. Patients received gluteal injections of paliperidone palmitate once every 4 weeks: starting dose 50 mg eq. followed by 25, 50, 75, or 100 mg eq. flexible dosing. Of the 388 patients enrolled, 288 completed the open-label extension. During the open-label extension, the median (range) duration of exposure to paliperidone palmitate was 338 days (10; 390), and 74% of patients received all 12 open-label injections of paliperidone palmitate. The most frequent (≥ 5% in total group) adverse events were insomnia (7%); worsening of schizophrenia; nasopharyngitis; headache; and weight increase (6% each). Potentially prolactin-related adverse events occurred in 13 (3%) patients, mostly women, and none resulted in study discontinuation. Extrapyramidal treatment-emergent adverse events were reported in 25 (6%) patients; tremor was the most frequently reported (n = 8, 2%). At open-label extension endpoint, investigator-rated redness at the injection site was observed in ≤ 4% of patients in each group. Injection-site pain was rated by investigators as absent in 82-87% of patients. Schizophrenia symptoms measured by Positive and Negative Syndrome Scale and personal and social performance changes improved during the open-label extension. SN - 1461-7285 UR - https://www.unboundmedicine.com/medline/citation/20615933/A_52_week_open_label_study_of_the_safety_and_tolerability_of_paliperidone_palmitate_in_patients_with_schizophrenia_ L2 - https://journals.sagepub.com/doi/10.1177/0269881110372817?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -