The pharmacology and safety of paliperidone extended-release in the treatment of schizophrenia. Exp Opin Drug Safety 6: 651-662, 2007.
Articolo
Data di Pubblicazione:
2007
Abstract:
Paliperidone extended-release (ER) is a newly commercialised antipsychotic
formulated using the principal active metabolite of risperidone,
9-hydroxyrisperidone. It has been developed as an osmotic controlled-release
oral delivery system that minimizes peak-trough fluctuations in plasma
concentrations, allowing once-daily administration and theoretically leading
to a decreased incidence of adverse effects. Available data from
preregistration, multicenter, short-term, double-blind, placebo-controlled
studies indicate that paliperidone ER, at dosages of 3 – 15 mg/day,
is relatively safe and well tolerated in adult patients with schizophrenia.
As with risperidone, paliperidone may cause extrapyramidal symptoms and
hyperprolactinemia in a dose-dependent manner. Preliminary long-term
studies (up to 52 weeks) appear to confirm the findings from short-term
trials indicating a low liability for paliperidone ER to cause metabolic effects
(i.e., weight gain, hyperglycaemia and lipid dysregulation). Safety data
from elderly patients appear to be promising. Due to negligible hepatic
biotransformation, paliperidone ER is unlikely to be involved in clinically
significant metabolic drug – drug interactions.
formulated using the principal active metabolite of risperidone,
9-hydroxyrisperidone. It has been developed as an osmotic controlled-release
oral delivery system that minimizes peak-trough fluctuations in plasma
concentrations, allowing once-daily administration and theoretically leading
to a decreased incidence of adverse effects. Available data from
preregistration, multicenter, short-term, double-blind, placebo-controlled
studies indicate that paliperidone ER, at dosages of 3 – 15 mg/day,
is relatively safe and well tolerated in adult patients with schizophrenia.
As with risperidone, paliperidone may cause extrapyramidal symptoms and
hyperprolactinemia in a dose-dependent manner. Preliminary long-term
studies (up to 52 weeks) appear to confirm the findings from short-term
trials indicating a low liability for paliperidone ER to cause metabolic effects
(i.e., weight gain, hyperglycaemia and lipid dysregulation). Safety data
from elderly patients appear to be promising. Due to negligible hepatic
biotransformation, paliperidone ER is unlikely to be involved in clinically
significant metabolic drug – drug interactions.
Tipologia CRIS:
14.a.1 Articolo su rivista
Elenco autori:
Spina, Edoardo; Cavallaro, R.
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