Intramuscular olanzapine versus intramuscular aripiprazole for the treatment of agitation in patients with schizophrenia: A pragmatic double-blind randomized trial

Kittipeerachon, Mantana; Chaichan, Warawat

doi:10.1016/j.schres.2016.07.017

Cited by 14 publications

(7 citation statements)

References 42 publications

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“…Previous clinical trials reported a significant improvement from baseline in PANSS-EC scores 2 hours after IM olanzapine. 17 , 28 , 30 Similar results were seen in this PMS study, where there was an improvement in the PANSS-EC total score and in all 5 subitems when comparing changes from baseline to 2 hours after the IM olanzapine injection.…”

Section: Discussionsupporting

confidence: 84%

“…Previous studies have shown that IM olanzapine is effective without the addition of benzodiazepines 22 and that coadministration of IM olanzapine with benzodiazepine may increase the risk of somnolence. 28 It is reported that a Lilly-maintained safety database (estimated worldwide patient exposure to IM olanzapine, N=539,000) was searched for all spontaneous adverse events reported in temporal association with olanzapine IM treatment. 29 The report found 83 cases that were considered as serious, including 29 fatalities, and in these fatalities, concomitant benzodiazepines were reported in 66% of cases and indicated that clinicians should use caution when using IM olanzapine and parenteral benzodiazepines simultaneously.…”

Section: Discussionmentioning

confidence: 99%

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Safety and effectiveness of rapid-acting intramuscular olanzapine for agitation associated with schizophrenia – Japan postmarketing surveillance study

Katagiri¹,

Taketsuna

Kondo³

et al. 2018

NDT

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ObjectiveThe objective of this study was to evaluate the safety and effectiveness of rapid-acting intramuscular (IM) olanzapine in the treatment of acute agitation associated with schizophrenia in real-world clinical settings in Japan.MethodsIn this multicenter, postmarketing surveillance (PMS) study, patients with acute agitation associated with schizophrenia were treated with IM olanzapine daily in a daily clinical setting. The observational period ranged from 1 to 7 days, including the day of initial administration. Safety was assessed by reporting treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs). The Positive and Negative Syndrome Scale – Excited Component (PANSS-EC) score was used to evaluate effectiveness at baseline and at 2 hours (after each administration), 2 days, and 3 days (end of the observational period) from the last administration of the IM olanzapine injection.ResultsThe safety analysis set included 999 patients, and the initial dose of 10 mg was administered to 955 patients. TEAEs were reported in 28 patients (36 events), the most common of which were dyslalia (5 patients), akathisia and somno lence (4 patients each), hepatic function abnormal (3 patients), and constipation and dehydration (2 patients each). One serious adverse event of akathisia occurred during the observation period. The PANSS-EC score (mean ± standard deviation) was 23.3±6.4 (n=625) at baseline, 16.9±7.0 (n=522) at 2 hours after initial injection, and 14.9±6.5 (n=650) at the last observation carried forward.ConclusionThe results of this Japanese PMS study demonstrated that IM olanzapine is safe and has a favorable effectiveness profile in the treatment of schizophrenia patients with acute agitation.

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Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

Safety and effectiveness of rapid-acting intramuscular olanzapine for agitation associated with schizophrenia – Japan postmarketing surveillance study

Katagiri¹,

Taketsuna

Kondo³

et al. 2018

NDT

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“…Previous studies have reported an improvement in PANSS-EC scores after treatment of acute agitation with intramuscular olanzapine 10 , 11 , 19 , 20 and after treatment with oral olanzapine. 20 Our report showed that acute agitation can improve as early as 2 hours after treatment with RAIM, and this improvement was maintained for 7 days after administration of RAIM in patients who transitioned to oral olanzapine.…”

Section: Discussionmentioning

confidence: 89%

“…It is well known that intramuscular olanzapine has a generally favorable extrapyramidal symptoms safety profile, and a similar efficacy compared to the parenteral typical antipsychotics. 8 , 9 Previous clinical trials have reported a significant improvement from baseline in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) scores 2 hours after intramuscular olanzapine 10 , 11 in patients with agitation associated with schizophrenia. In addition, previous studies have shown minimal to no incidences of treatment-emergent extrapyramidal symptoms with intramuscular olanzapine.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine for agitation associated with schizophrenia

Katagiri

Taketsuna

Kondo

et al. 2018

NDT

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ObjectiveTo assess the effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine (RAIM) in patients with acute agitation associated with schizophrenia in a real-world clinical setting.MethodsThe postmarketing surveillance study with a 3-day observational period after the last RAIM administration was conducted (original study). Following this, an extended study was added for patients who received oral olanzapine after RAIM administration during the original study period, in order to additionally observe them for 7 days after initial RAIM administration. Effectiveness and safety from initial RAIM administration were evaluated using the Positive and Negative Syndrome Scale-Excited Component score and treatment-emergent adverse events (TEAEs), respectively.ResultsThe effectiveness and safety analysis set included a total of 521 and 522 patients, respectively. A majority of patients received 10 mg of RAIM (475/522 patients, 91.0%). The mean ± SD total Positive and Negative Syndrome Scale-Excited Component score was 23.6±6.2 (n=318) at baseline (before initial RAIM administration), 17.4±6.8 (n=280) at 2 hours after initial administration, 16.2±6.8 (n=246) 2 days after final administration, 14.9±6.2 (n=248) 3 days after final administration, 13.8±5.9 (n=242) 4 days after final administration, 13.2±5.8 (n=221) 7 days after initial administration, and 13.4±6.2 (n=351) at final observation (with the last observation carried forward approach), showing that reduction in agitation seen with RAIM was sustained with oral dose of olanzapine. The most common TEAEs were dyslalia and somnolence (each event occurred in four patients), and abnormal hepatic function and constipation (occurred in three patients). One serious adverse event of sudden cardiac death occurred after transitioned to oral olanzapine with many other antipsychotic drugs.ConclusionIn the treatment of acute agitation associated with schizophrenia, RAIM could be generally transitioned to oral olanzapine without exacerbating adverse events or losing treatment effect.

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“…Nonetheless, ziprasidone is not yet commonly used in psychiatric emergency care, presumably because of its minimal sedating effect and only mild antipsychotic action (19). Compared with aripiprazole, olanzapine was superior initially, probably because of its sedating effect; 24 hours later, there was no longer any significant difference (12,13,20,21).…”

Section: Second-generation Antipsychoticsmentioning

confidence: 99%

The Use of Rapid Tranquilization in Aggressive Behavior

Hirsch¹,

Steinert²

2019

Deutsches Ärzteblatt International

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ggressive behavior can be considered pathological only when it arises in the context of disease. It is thus not necessarily an indication for medical treatment. Not only emergency medical personnel and psychiatrists, but also family physicians are often confronted with the question of how to treat aggressive behavior. In one study, psychiatric emergencies accounted for 11.8% of all emergency medical interventions outside the hospital. Psychomotor agitation made up 28% of all psychiatric emergencies, second only to alcohol intoxication (33%) (1). Psychomotor agitation in the context of mental illness and intoxication constitutes a medical emergency. Affected patients can injure themselves or others. In a retrospective survey of six German psychiatric hospitals, 1.7 to 5 aggressive attacks per patient-year were reported (2). In one hospital in the federal state of North Rhine-Westphalia, 171 of the 2210 patients admitted within a 1-year period were involved in aggressive attacks, and a total of 441 episodes of aggressive behavior were reported (3). Psychomotor agitation carries the risk of somatic complications, including electrolyte disturbances, rhabdomyolysis, and lactic acidosis (4, 5). The goal of pharmacotherapy is to calm the patient. Amnesia and deep sedation should be avoided in order not to compromise the patient's ability to participate in joint decision-making about further treatment. Deep sedation also puts patients at risk of cardiorespiratory depression, aspiration, and other complications. No data on this topic are available from Germany, but an Australian study has shown that 16 agitated patients who were pharmacologically sedated (9% of the patients so treated) sustained complications such as hypotension and hypoxemia (6). The health-related causes of aggressive behavior include nearly all kinds of mental disorders, and various somatic illnesses as well. In an emergency, the history should be rapidly obtained from someone who has observed the behavior, and an initial, orienting physical examination should be performed. Intoxications, withdrawal syndromes, a postictal state, and rapidly reversible causes such as hypoglycemia should be ruled out (7). The patient's permission for pharmacotherapy should be obtained whenever possible. In Germany, when the patient refuses treatment, the physician must determine whether coercive emergency treatment is permissible and required, as per the concept of a Summary Background: Psychomotor agitation and aggressiveness in the context of mental illness are medical emergencies. In a survey of six German psychiatric hospitals, 1.7 to 5 aggressive attacks per patient-year were reported. If talking to the patient has no calming effect, intervention with drugs is required. In this article, we review the evidence on tranquilizing drugs and discuss clinically relevant ethical and practical questions, e.g., with respect to involuntary medication. Method: This review is based on pertinent articles retrieved by a selective search in MEDLINE, supplemented by a reference sear...

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Intramuscular olanzapine versus intramuscular aripiprazole for the treatment of agitation in patients with schizophrenia: A pragmatic double-blind randomized trial

Cited by 14 publications

References 42 publications

Safety and effectiveness of rapid-acting intramuscular olanzapine for agitation associated with schizophrenia – Japan postmarketing surveillance study

Safety and effectiveness of rapid-acting intramuscular olanzapine for agitation associated with schizophrenia – Japan postmarketing surveillance study

Effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine for agitation associated with schizophrenia

The Use of Rapid Tranquilization in Aggressive Behavior

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Intramuscular olanzapine versus intramuscular aripiprazole for the treatment of agitation in patients with schizophrenia: A pragmatic double-blind randomized trial

Cited by 14 publications

References 42 publications

Safety and effectiveness of rapid-acting intramuscular olanzapine for agitation associated with schizophrenia &ndash; Japan postmarketing surveillance study

Safety and effectiveness of rapid-acting intramuscular olanzapine for agitation associated with schizophrenia &ndash; Japan postmarketing surveillance study

Effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine for agitation associated with schizophrenia

The Use of Rapid Tranquilization in Aggressive Behavior

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Product

Resources

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Safety and effectiveness of rapid-acting intramuscular olanzapine for agitation associated with schizophrenia – Japan postmarketing surveillance study

Safety and effectiveness of rapid-acting intramuscular olanzapine for agitation associated with schizophrenia – Japan postmarketing surveillance study