Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the cases of death were varied, most of the deaths appeared to be cardiovascular (e.g., heart failure, Sudden death) or infections (e.g., pneumonia) in nature. Observational studies suggest that similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Loxapine is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines.
Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine succinate capsules in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
Media Articles Related to Loxapine
An evolutionary approach reveals new clues toward understanding the roots of schizophrenia
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Is mental illness simply the evolutionary toll humans have to pay in return for our unique and superior cognitive abilities when compared to all other species?
Schizophrenia: Impaired activity of the selective dopamine neurons
Source: Schizophrenia News From Medical News Today [2015.02.19]
German-American team of researchers finds neurophysiological correlates for cognitive and emotional symptoms in a Schizophrenia mouse model.
Schizophrenia and weight gain: A new explanation?
Source: Schizophrenia News From Medical News Today [2015.02.06]
Cannabinoids may be involved in the weight gain that occurs in people with schizophrenia who are treated with the antipsychotic olanzapine, according to a pilot study published in the Journal of...
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Source: Schizophrenia News From Medical News Today [2015.02.05]
Researchers from the universities of Granada and Washington in St Louis break new ground in what could be an important first step towards better diagnosis and treatment of this diseaseScientists...
"Spark", a new public-private project created to develop a drug to fight the cognitive impairment associated with schizophrenia
Source: Schizophrenia News From Medical News Today [2015.01.28]
A public-private consortium led by the biotech Iproteos - based at Parc CientÃfic de Barcelona (PCB), and comprised by the biopharmaceutical company Ascil-Biopharma, the Institute for Biomedical...
Published Studies Related to Loxapine
Rapid acute treatment of agitation in patients with bipolar I disorder: a
multicenter, randomized, placebo-controlled clinical trial with inhaled loxapine. 
of agitation in patients with bipolar I disorder... CONCLUSIONS: Inhaled loxapine provided a rapid, non-injection, well-tolerated
Off-label medication use. 
Prescribing medications for off-label uses is not illegal. Off-label prescribing
includes using medications for unapproved indications; using a drug outside of
the recommended dosage range or duration of use; using a drug in certain
unapproved patient populations, such as those defined by age, sex, or particular
clinical parameters; or intentionally using a medication in a patient who has a
Efficacy and safety of loxapine for inhalation in the treatment of agitation in patients with schizophrenia: a randomized, double-blind, placebo-controlled trial. [2011.10]
CONCLUSIONS: Inhaled loxapine was generally safe and well tolerated and produced rapid improvement in agitated patients with psychotic disorders. Statistically significant differences in efficacy were found for the 10-mg dose compared with placebo, with results suggesting 5 mg may be effective. The delivery of loxapine by inhalation may provide a rapid, well-tolerated option for treating acute psychotic agitation that allows patients to avoid the aversive effects and loss of autonomy often associated with use of intramuscular medications. Further investigation of this new loxapine formulation is warranted. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00369577. (c) Copyright 2011 Physicians Postgraduate Press, Inc.
Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. [2011.01]
CONCLUSIONS: Inhaled loxapine provided a rapid, well-tolerated acute treatment for agitation in people with schizophrenia.
Efficacy and safety of loxapine for inhalation in the treatment of agitation in
patients with schizophrenia: a randomized, double-blind, placebo-controlled
CONCLUSIONS: Inhaled loxapine was generally safe and well tolerated and produced
Clinical Trials Related to Loxapine
Multidose PK Study of Staccato Loxapine [Completed]
Staccato® Loxapine Treatment of Schizophrenic Patients With Agitation [Completed]
Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning [Recruiting]
This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming
patients down in a situation of restlessness during mechanical ventilation weaning. This
drug is used for several years to quieten restless patients. Its purpose is to restore
spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical
Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan loxapine succinate
25 mg capsules to Watson Loxitane 25 mg capsules following a single, oral 25 mg (1 x 25 mg)
dose administration under fasting conditions.
Staccato® Loxapine for Inhalation in Schizophrenia [Completed]
Staccato Loxapine is being developed for the treatment of acute agitation in patients with
schizophrenia. A 50 patient, dose escalation Phase I clinical trial was completed in November
Reports of Suspected Loxapine Side Effects
Cardiogenic Shock (25),
Disseminated Intravascular Coagulation (17),
Neuroleptic Malignant Syndrome (16),
Extremity Necrosis (13),
Toxicity TO Various Agents (11),
Blood Pressure Decreased (7),
Multiple Drug Overdose (6),
Blood Glucose Increased (6), more >>
Page last updated: 2015-02-26