Transition from Ziprasidone IM to Oral Formulation in Agitated Patients with Acute Exacerbation of Schizophrenia: An Open Trial

Mautone, A.; Scarone, Silvio

doi:10.1055/s-0031-1280794

Cited by 5 publications

(4 citation statements)

References 13 publications

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“…In total, 1428 patients had received IM ziprasidone treatment and 836 patients had received IM haloperidol treatment for agitation. The 19 reports included 12 RCTs (ziprasidone versus haloperidol) [1, 7, 9–12, 14–16, 19, 22, 25], 5 open-label perspective trials [13, 17, 18, 20, 21], and 2 individual case reports [2, 4]. After multiple discussions among the authors, it became clear that one trial had two studies [18] but one of them was also reported in a later larger study [19]; therefore, one of these two studies was excluded from Table 1, which summarizes the characteristics of the included 19 studies.…”

Section: Discussionmentioning

confidence: 99%

“…First, ziprasidone was associated with modest concentration-related QTc increases [20]. Second, an open-label perspective trial showed similar results including (a) one with only 3 subjects having >60 ms prolonged QTc interval [17] and (b) another [13] indicating that IM ziprasidone did not appear to influence atrial and ventricular electrical conduction in drug-free inpatients with schizophrenia. However, the diagnosis of schizophrenia might influence atrial conduction and even be associated with atrial fibrillation.…”

Section: Discussionmentioning

confidence: 99%

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QT Interval Prolongation Associated with Intramuscular Ziprasidone in Chinese Patients: A Case Report and a Comprehensive Literature Review with Meta-Analysis

Tang

Zheng

et al. 2014

Case Reports in Psychiatry

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Intramuscular (IM) ziprasidone has been associated with QTc interval prolongations in patients with preexisting risk factors. A 23-year-old male Chinese schizophrenia patient experienced an increase of QTc interval of 83 milliseconds (ms) after receiving 20 mg IM ziprasidone (baseline and increased QT/QTc were, respectively, 384/418 and 450/501). This was rated as a probable adverse drug reaction (ADR) by the Liverpool ADR causality assessment tool. A systematic review including all types of trials reporting the effect of IM ziprasidone on the QTc interval prolongation identified 19 trials with a total of 1428 patients. Mean QTc change from baseline to end of each study was −3.7 to 12.8 ms after IM ziprasidone. Four randomized trials (3 of 4 published in Chinese) were used to calculate a meta-analysis of QTc interval prolongation which showed no significant differences between IM ziprasidone and IM haloperidol groups (risk ratio 0.49 to 4.31, 95% confidence interval 0.09 to 19.68, P = 0.06 to 0.41). However, our review included two cases of patients who experienced symptoms probably related to QTc prolongation after IM ziprasidone. Thus, careful screening and close monitoring, including baseline ECG, should be considered in patients receiving IM ziprasidone for the first time.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

QT Interval Prolongation Associated with Intramuscular Ziprasidone in Chinese Patients: A Case Report and a Comprehensive Literature Review with Meta-Analysis

Tang

Zheng

et al. 2014

Case Reports in Psychiatry

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“…52 Furthermore, IM ziprasidone has been shown to be at least as effective, if not more effective than IM haloperidol in some studies, with similar risk for QTc prolongation but less EPS. [53][54][55][56] Olanzapine became available for IM use in 2004 and is supported by data from randomized controlled trials and a meta-analysis concluding it as a safe and effective option with comparable efficacy but less EPS than IM haloperidol. 3,57 It was also comparable in efficacy to haloperidol/ promethazine and haloperidol/benzodiazepine combinations.…”

Section: Parenteral Antipsychoticsmentioning

confidence: 99%

Section: Treatment Optionsmentioning

confidence: 99%

Managing acute agitation and aggression in the world of drug shortages

Miller¹

2021

Mental Health Clinician

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Acute agitation and aggression create safety risks for both patients and staff, often leading to psychiatric emergencies. Quick and appropriate treatment is necessary to achieve safe and effective outcomes. Unfortunately, there are several factors that hinder timely interventions, such as medication shortages and delay in staff preparedness. Ultimately, the goal of managing acute agitation and aggression in the clinical setting is to de-escalate the situation and prevent harm to patients and staff. This article will explore useful interventions in realizing treatment goals for the management of agitation and aggression in adults while navigating limitations faced in practice.

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The safety and efficacy of sequential intramuscular/oral ziprasidone treatment of acute episode in patients with schizophrenia: a multicenter, open-labeled study

Liang

et al. 2023

BMC Psychiatry

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Background Ziprasidone mesylate injection is an atypical antipsychotic drug which is recently approved in China. In combination with its oral formulation, sequential therapy with ziprasidone brings new interventions to patients with agitation in the acute phase of schizophrenia. The purpose of this 7-day multicenter study conducted in China was to evaluate the efficacy and safety of ziprasidone sequential treatment through intramuscular/oral routes in agitated patients with schizophrenia. Methods A total of 95 patients were enrolled from three centers in this study. The study duration was 7 days. In the first 3 days, subjects were administered an intramuscular injection of ziprasidone 10–40 mg daily and started sequentially with oral ziprasidone 40–80 mg at dinner (or lunch) from the day of the last intramuscular injection. In the following 4 days, according to the severity of the symptoms and the drug response, 120–160 mg of ziprasidone was orally administered daily. In total, six visits were scheduled to assess the Positive and Negative Syndrome Scale (PANSS), the Behavioral Activity Rating Scale (BARS), the Clinical Global Impression of Severity (CGI-S), and Improvement (CGI-I) scores throughout the procedure. Lastly, adverse events were recorded during treatment. Results Out of the 95 patients that were enrolled, 83 cases were effectively completed. Visits 3, 4, 6, PANSS, and PANSS-excited component (PANSS-EC) subscale points, and Visit 2–Visit 6 viewpoints, BARS scale points, and baseline scores denote a progressive downward trend (P < 0.001). In this study, 62 adverse events were reported. The most common adverse events were extrapyramidal symptoms (EPS) (23 cases) and excessive sedation(10 cases), and 13 cases of prolonged QTc interval were reported. Conclusions Ziprasidone IM demonstrated significant and rapid reduction in agitation, and sequential oral formulation keep stability and continuation of the treatment can further ensure efficacy. Ziprasidone sequential therapy may provide a new approach to acute agitation in schizophrenic patients. Trial registration The Chinese Clinical Trials Registry; URL: https://www.chictr.org.cn: ChiCTR-OIC-16007970.

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Transition from Ziprasidone IM to Oral Formulation in Agitated Patients with Acute Exacerbation of Schizophrenia: An Open Trial

Abstract: Even with the limitations of any non-comparative study, these results suggest that the IM/oral sequential administration of ziprasidone is an effective and well tolerated therapeutic option in the management of acute exacerbations of schizophrenia in agitated patients.

Cited by 5 publications

References 13 publications

QT Interval Prolongation Associated with Intramuscular Ziprasidone in Chinese Patients: A Case Report and a Comprehensive Literature Review with Meta-Analysis

QT Interval Prolongation Associated with Intramuscular Ziprasidone in Chinese Patients: A Case Report and a Comprehensive Literature Review with Meta-Analysis

Managing acute agitation and aggression in the world of drug shortages

The safety and efficacy of sequential intramuscular/oral ziprasidone treatment of acute episode in patients with schizophrenia: a multicenter, open-labeled study

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