An assessment of injection site reaction and injection site pain of 1-month and 3-month long-acting injectable formulations of paliperidone palmitate.
Perspect Psychiatr Care
; 54(4): 530-538, 2018 Oct.
Article
em En
| MEDLINE
| ID: mdl-29446084
ABSTRACT
PURPOSE:
To evaluate injection site reactions and pain following paliperidone palmitate 1-month (PP1M) and 3-month (PP3M) administration using safety data of double-blind (DB), noninferiority study.METHODS:
Patients (n = 1,429) with schizophrenia, treated with PP1M (50-150 mg-eq, 17-week open-label [OL] phase) were randomized to PP1M or PP3M in 48-week DB phase.FINDINGS:
PP1M and PP3M injections were well tolerated. Incidence of induration, redness, and swelling were low in both phases (OL 9-12%; DB 7-13%), and were mostly mild in both groups. Mean (SD) visual analog scale scores decreased from OL-baseline (22.0 [21.6]) to DB-baseline (19.5 [20.6] vs. 18.4 [20.4]) and DB-endpoint (15.6 [17.9] vs. 15.5 [18.3]). PRACTICE IMPLICATIONS Injection site reactions and pain were low and similar between both treatments, regardless of administration site and dose.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Dor
/
Esquizofrenia
/
Antipsicóticos
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Palmitato de Paliperidona
/
Reação no Local da Injeção
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Perspect Psychiatr Care
Ano de publicação:
2018
Tipo de documento:
Article