P.3.c.041 A randomized, double-blind study of paliperidone palmitate and risperidone long-acting therapy in schizophrenia

Pandina, Gahan; Lane, Rosanne; Gopal, Srihari; Gassmann-Mayer, Cristiana; Hough, David M.; Remmerie, Bart; Simpson, G.M.

doi:10.1016/s0924-977x(10)70711-2

Cited by 2 publications

(11 citation statements)

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“…In the first study, rates of TEAEs were 76% in the paliperidone group and 79% in the RLAI group,22 whereas in the second study, rates of TEAEs were 57.9% in the paliperidone group and 52.8% in the RLAI group 23. Therefore, neither drug can be associated with a higher incidence of adverse effects based on these results.…”

Section: Safety and Tolerabilitymentioning

confidence: 73%

“…With regard to weight changes, weight actually decreased in the paliperidone palmitate group in the first study compared with RLAI (which caused a slight weight increase), whereas in the second study, mean body weight increases were similar at the endpoint between the two treatment groups (see Table 4). In addition, in the second study, there were no clinically relevant changes in vital signs or ECG, and the incidence of glucose-related TEAEs, as well as investigator assessments of the injection site, were similar in both treatment groups 23. Overall, it appears that both paliperidone palmitate and RLAI have comparable adverse effect profiles.…”

Section: Safety and Tolerabilitymentioning

confidence: 74%

“…Unlike the previous study, the lower limit of the 95% CI of the treatment difference for the change in PANSS total score did exceed the prespecified protocol noninferiority margin of −5, and therefore paliperidone was shown to be noninferior to RLAI (point estimate [95% CI] 0.4 [−1.62; 2.38]). In addition, both groups showed similar improvements in CGI-S and PSP, as well as other secondary measures 23. Limitations of this study include its relatively short duration, lasting only 13 weeks compared with 53 weeks in the previous one, and therefore the longer-term efficacy of paliperidone palmitate cannot be compared with RLAI from these findings.…”

Section: Efficacy In Schizophreniamentioning

confidence: 82%

“…Paliperidone palmitate’s efficacy as maintenance therapy in schizophrenia has also been evaluated in a 52-week recurrence prevention study20 and a further 52-week, open-label extension phase of this study 21. In addition, two studies compared its clinical efficacy with intramuscular long-acting risperidone injection 22,23. Many of these studies are currently only available as poster presentations.…”

Section: Efficacy In Schizophreniamentioning

confidence: 99%

“…Consequently, another noninferiority study between paliperidone palmitate and RLAI was performed, acknowledging the optimized initiation dosing regimen for paliperidone 23. This was a randomized (1:1), double-blind, double-dummy, active- controlled, parallel-group, 13-week comparative Phase III study.…”

Section: Efficacy In Schizophreniamentioning

confidence: 99%

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Once-monthly paliperidone injection for the treatment of schizophrenia

Bishara¹

2010

NDT

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Paliperidone palmitate is a new long-acting antipsychotic injection for the treatment of acute and maintenance therapy in schizophrenia. Paliperidone (9-hydroxyrisperidone) is the major active metabolite of risperidone and acts at dopamine D2 and serotonin 5HT2A receptors. As with other atypical antipsychotics, it exhibits a high 5HT2A:D2 affinity ratio. It also has binding activity as an antagonist at α1-and α2 adrenergic receptors and H1 histaminergic receptors, but has virtually no affinity for cholinergic receptors. Paliperidone palmitate has been shown to be effective in reducing Positive and Negative Syndrome Scale total scores in four short-term trials in acute schizophrenia. It was also effective as maintenance therapy in a long-term trial in which time to recurrence of symptoms was significantly longer in paliperidone-treated patients compared with placebo. In addition, paliperidone was shown to be noninferior to risperidone long-acting injection in one study, but this noninferiority was not established in another longer study comparing the two drugs. Treatment should be initiated with 234 mg on day 1 and 156 mg on day 8, followed by a recommended monthly maintenance dose of 39–234 mg based on efficacy and tolerability. Paliperidone palmitate is generally well tolerated, although it can cause weight gain and a rise in prolactin levels, which is generally greater in women than in men. Overall, paliperidone palmitate may have advantages over other currently available long-acting injections, and therefore may be a useful alternative for the treatment of schizophrenia, although further long-term trials comparing it with active treatments are warranted.

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Section: Safety and Tolerabilitymentioning

confidence: 73%

Section: Safety and Tolerabilitymentioning

confidence: 74%

Section: Efficacy In Schizophreniamentioning

confidence: 82%