Abstract
The use of novel drugs such as inhaled loxapine (LOXi) for schizophrenia and the off-label use of substances such as sodium nitroprusside (NIT) for the management of mental disorders require further investigation. We aimed to evaluate the efficacy and safety of LOXi and NIT for the treatment of agitation associated with schizophrenia. A systematic review of randomized controlled trials (RCTs) comparing the use of LOXi or NIT versus placebo or other antipsychotic agents was conducted, and we evaluated the efficacy (CGI-scale) and safety (adverse events) of the therapies. Altogether, 71 studies were identified, of which 2 (LOXi) were included in the meta-analysis, and 1 (NIT) was included in the systematic review only. The efficacy data showed superiority of LOXi against placebo, regardless of the dose (5 and 10 mg). No significant differences were observed concerning the safety results. Treatment with NIT showed favorable results, with significant reduction of the symptoms. The efficacy of these medications is difficult to assess because of the lack of RCTs. However, there is some information regarding the efficacy and safety of LOXi in the treatment of agitation in schizophrenic patients.
Highlights
Schizophrenia is a chronic and damaging mental disease that significantly affects patient and family quality of life while generating massive costs to patients and health care systems
According to the Pharmaceutical Research and Manufacturers of America (PHRMA, 2014), approximately 200 novel drugs for mental health disorders were under development in 2014, of which 30% were indicated for schizophrenia (PHRMA, 2014)
The aim of this paper is to present a systematic review with a meta-analysis of the efficacy and safety of two potential drugs, LOXi and NIT, for the treatment of agitation in schizophrenia
Summary
Schizophrenia is a chronic and damaging mental disease that significantly affects patient and family quality of life while generating massive costs to patients and health care systems. A staccato system of inhaled loxapine (LOXi) was developed, which shows a great capacity to generate loxapine aerosol This mechanism facilitates the treatment of patients through faster and less invasive action and presents pharmacokinetic profile that is similar to that of intravenous administration. The administration of LOXi was approved by the FDA in 2012 (it has been available on the US market since 2014) as a single dose for the treatment of agitation in schizophrenic or bipolar patients. This product was approved in 2013 by the European Medical Association for use in two doses (Gross et al, 2014; Citrome, 2012). This drug is not yet available in Brazil, the pharmaceutical industry is interested in its registration (Ferrer International, 2015)
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