The LAI formulation of risperidone, which was the first injectable atypical antipsychotic, was developed in response to the need for new and better-tolerated LAI antipsychotics and to decrease relapse ( Taylor et al, 2004). Long-acting injectable (LAI) antipsychotics offer the potential to improve adherence, and to provide additional benefits, such as improving long-term treatment outcomes ( Kane et al, 2003). General dissatisfaction with oral antipsychotic therapy was underscored by results from the CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) study, which indicated that although 10–18% of patients discontinued initial treatment because of adverse events, ∼30% discontinued for reasons unrelated to tolerability, safety, or efficacy ( Lieberman et al, 2005). The adverse effects of antipsychotic treatment, as well as restrictive dosing regimens (such as the requirement to take drugs with food or multiple times a day), are a few of several factors that may compromise oral antipsychotic treatment adherence ( Cooper et al, 2007 Gianfrancesco et al, 2006 Keith and Kane, 2003). Tolerability, in some patients, remains a concern ( Lieberman et al, 2005).Īdherence to therapy is also an important challenge in the management of schizophrenia. Although considered a significant advancement over older drugs, atypical antipsychotics still have limited efficacy in many patients ( Stroup et al, 2006), particularly with respect to negative and cognitive symptoms. These agents are generally viewed as having efficacy at least equivalent to that of older neuroleptics, with a lower risk for extrapyramidal symptoms (EPSs) and associated anhedonia and apathy, impaired cognition, and dysphoria ( Lieberman et al, 2005 Tandon, 2002 Tandon and Jibson, 2002).
Paliperidone palmitate offers the potential to improve outcomes in adults with symptomatic schizophrenia.Ītypical antipsychotics are the mainstay of therapy for patients with schizophrenia. All doses of once-monthly paliperidone palmitate were efficacious and generally tolerated, both locally and systemically. Investigator-evaluated injection-site pain, swelling, redness, and induration were similar across treatment groups scores for patient-evaluated injection-site pain (visual analog scale) were similar across groups and diminished with time. The mean body mass index and mean weight showed relatively small dose-related increases during paliperidone palmitate treatment. Parkinsonism, the most frequently reported extrapyramidal symptom, was reported at similar rates for placebo (5%) and paliperidone palmitate (5–6% across doses). The overall incidence of treatment-emergent adverse events was similar between groups.
The Personal and Social Performance scale showed no significant difference between treatment groups. All paliperidone palmitate dose groups showed significant improvement vs placebo in the Positive and Negative Syndrome Scale (PANSS) total score (primary efficacy measure 25 and 50 mg equiv., p=0.02 100 mg equiv., p<0.001), as well as Clinical Global Impression Severity scores ( p ⩽0.006) and PANSS negative and positive symptom Marder factor scores ( p ⩽0.04). The intent-to-treat analysis set ( N=514) was 67% men and 67% White, with a mean age of 41 years. This 13-week, multicenter, randomized (1 : 1 : 1 : 1), double-blind, parallel-group study evaluated the efficacy, safety, and tolerability of fixed 25, 50, and 100 milligram equivalent (mg equiv.) doses of paliperidone palmitate vs placebo administered as gluteal injections on days 1 and 8, then every 4 weeks (days 36 and 64) in 518 adult patients with schizophrenia.
Paliperidone palmitate is a long-acting injectable antipsychotic agent.
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