Sublingual Dexmedetomidine for Agitation Associated with Schizophrenia or Bipolar Disorder: A Post Hoc Analysis of Number Needed to Treat, Number Needed to Harm, and Likelihood to be Helped or Harmed

Citrome, Leslie; Risinger, Robert; Rajachandran, Lavanya; Robison, Heather

doi:10.1007/s12325-022-02274-3

Cited by 9 publications

(3 citation statements)

References 27 publications

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“…In emergency situations where an injectable antipsychotic is indicated (e.g., for a highly agitated patient), an anticholinergic medication is often administered in combination with an antipsychotic and benzodiazepine for rapid control [ 49 ]. Alternative approaches for the emergency treatment of agitation include an injectable SGA that has reduced risk of dystonia (e.g., olanzapine, ziprasidone) or sublingual dexmedetomidine [ 50 , 51 ].…”

Section: Differentiation Of Drug-induced Movement Disorders and Their...mentioning

confidence: 99%

An Evidence-Based Update on Anticholinergic Use for Drug-Induced Movement Disorders

Vanegas-Arroyave,

Caroff,

Citrome

et al. 2024

CNS Drugs

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Drug-induced movement disorders (DIMDs) are associated with use of dopamine receptor blocking agents (DRBAs), including antipsychotics. The most common forms are drug-induced parkinsonism (DIP), dystonia, akathisia, and tardive dyskinesia (TD). Although rare, neuroleptic malignant syndrome (NMS) is a potentially life-threatening consequence of DRBA exposure. Recommendations for anticholinergic use in patients with DIMDs were developed on the basis of a roundtable discussion with healthcare professionals with extensive expertise in DIMD management, along with a comprehensive literature review. The roundtable agreed that “extrapyramidal symptoms” is a non-specific term that encompasses a range of abnormal movements. As such, it contributes to a misconception that all DIMDs can be treated in the same way, potentially leading to the misuse and overprescribing of anticholinergics. DIMDs are neurobiologically and clinically distinct, with different treatment paradigms and varying levels of evidence for anticholinergic use. Whereas evidence indicates anticholinergics can be effective for DIP and dystonia, they are not recommended for TD, akathisia, or NMS; nor are they supported for preventing DIMDs except in individuals at high risk for acute dystonia. Anticholinergics may induce serious peripheral adverse effects (e.g., urinary retention) and central effects (e.g., impaired cognition), all of which can be highly concerning especially in older adults. Appropriate use of anticholinergics therefore requires careful consideration of the evidence for efficacy (e.g., supportive for DIP but not TD) and the risks for serious adverse events. If used, anticholinergic medications should be prescribed at the lowest effective dose and for limited periods of time. When discontinued, they should be tapered gradually. Graphical Abstract

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Section: Differentiation Of Drug-induced Movement Disorders and Their...mentioning

confidence: 99%

An Evidence-Based Update on Anticholinergic Use for Drug-Induced Movement Disorders

Vanegas-Arroyave,

Caroff,

Citrome

et al. 2024

CNS Drugs

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“…49,50 A post hoc analysis of combined study results reported the NNT for response versus placebo was 3 (95% CI, 3-3). 51 Across both studies, the most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) are somnolence (23% for the 180-µg group, 22% for the 120-µg group, 6% with placebo), oral paresthesia or oral hypoesthesia (7%, 6%, 1%), dizziness (6%, 4%, 1%), dry mouth (4%, 7%, 1%), hypotension (5%, 5%, 0%), and orthostatic hypotension (5%, 3%, <1%). 24 The cost of a dose of sublingual dexmedetomidine is higher than alternative IM formulations, which may impact uptake.…”

Section: Citrome Et Almentioning

confidence: 99%

Alternative Approaches for Addressing Acute Agitation in Schizophrenia and Bipolar Disorder

Citrome,

Correll,

San

et al. 2024

Prim. Care Companion CNS Disord.

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Importance:The prompt effective treatment of acute agitation among patients with schizophrenia or bipolar disorder can alleviate distressing symptoms for the patient and decrease the risk of escalation to aggression and the potential for serious harm to the patient, health care providers, and others.Observations: A commonly used approach for the management of acute agitation has been the intramuscular administration of antipsychotic medications and/or benzodiazepines. However, US Food and Drug Administration-approved treatments with alternative routes of delivery now include inhaled loxapine powder and, more recently, dexmedetomidine sublingual film. Two formulations of intranasal olanzapine for acute agitation are in development. Conclusions and Relevance:Intranasal formulations offer the potential for favorable pharmacokinetics and onset of action combined with ease of delivery obviating the need for injections and are thus consistent with patient-centered factors such as preference and selfadministration. In this review, alternative methods of medication delivery are discussed, with an emphasis on the potential for intranasal administration to treat acute agitation in adult patients with schizophrenia or bipolar disorder.

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“…A post hoc analysis of the two phase 3 trials with sublingual dexmedetomidine was conducted to calculate the numbers needed to treat (NNT), numbers needed to harm (NNH), and likelihood to be helped or harmed (LHH) [ 17 ]. The NNT was calculated based on the PEC response rate defined as a 40% or greater reduction in PEC score from baseline.…”

Section: Post Hoc Analysismentioning

confidence: 99%

Sublingual Dexmedetomidine for the Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder

Smith

Santalucia

Bunn

et al. 2023

Clin Psychopharmacol Neurosci

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Acute agitation is common amongst individuals with bipolar disorder and schizophrenia and represents a medical emergency. Commonly used medications for agitation, such as benzodiazepines and antipsychotics, are often delivered intramuscularly and may cause adverse effects. Non-invasive, effective, and safe alternative treatment options are needed. The purpose of this review article is to describe the efficacy and safety of sublingual formulation of dexmedetomidine (Igalmi), a selective α2-adrenergic receptor agonist, U.S. Food and Drug Administration approved for the treatment of acute agitation in adults with schizophrenia or bipolar I and II disorder. In two phase 3 trials, two dose strengths of sublingual dexmedetomidine 180 μg and 120 μg were safe and effective in managing acute agitation in patients with bipolar disorder or schizophrenia. Both doses significantly reduced Positive and Negative Syndrome Scale-Exited Component scores two hours after receiving a single dose as compared to placebo, indicating a substantial improvement in agitation. The beneficial effects of sublingual dexmedetomidine were achieved without serious adverse events with the most common side effect being mild somnolence. The clinical trial data suggest that sublingual dexmedetomidine represents a safe and effective treatment option in the armamentarium for acute agitation for people with schizophrenia or bipolar disorder.

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Sublingual Dexmedetomidine for Agitation Associated with Schizophrenia or Bipolar Disorder: A Post Hoc Analysis of Number Needed to Treat, Number Needed to Harm, and Likelihood to be Helped or Harmed

Cited by 9 publications

References 27 publications

An Evidence-Based Update on Anticholinergic Use for Drug-Induced Movement Disorders

An Evidence-Based Update on Anticholinergic Use for Drug-Induced Movement Disorders

Alternative Approaches for Addressing Acute Agitation in Schizophrenia and Bipolar Disorder

Sublingual Dexmedetomidine for the Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder

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