A Randomized, Double-Blind, Placebo-Controlled Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients With Alzheimer's, Vascular, or Mixed Dementia
To evaluate the tolerability of intramuscular (IM) aripiprazole in patients with agitation associated with dementia.
A 24-hour, double-blind, placebo-controlled, randomized study.
Sixteen healthcare facilities in the United States.
A total of 129 patients with acute agitation associated with Alzheimer's, vascular or mixed dementia in healthcare facilities.
Patients were randomized to IM aripiprazole (5 mg, 10 mg, or 15 mg) or IM placebo administered in divided doses 2 hours apart.
Safety assessments included adverse event (AE) reporting, vital signs, and electrocardiograms. Preliminary efficacy analyses used the Positive and Negative Syndrome Scale-Excited Component (PEC) scores and Agitation-Calmness Evaluation Scale (ACES).
There was greater incidence of AEs with IM aripiprazole (50% to 60%) than IM placebo (32.0%), but over 90% were mild or moderate in severity. The incidence of oversedation was low. PEC scores showed greater improvements in agitation with IM aripiprazole 10 mg and 15 mg compared with IM placebo.
A total of 10 mg or 15 mg of IM aripiprazole administered in divided doses was safe and well tolerated for treatment of agitation associated with Alzheimer's, vascular, or mixed dementia in long-term care. Preliminary analysis showed greater efficacy compared with IM placebo.
Available from: Mark J Rapoport
- "The median trial duration was 56 days (range = 1–90 days). A variety of outcome measures were reported in studies including composite measures of NPS (Barnes et al., 1982; Cantillon et al., 1996; Tariot et al., 1998; 2001; 2005; 2006; De Deyn et al., 1999; 2004; Katz et al., 1999; Street et al., 2000; Porsteinsson et al., 2001; Fontaine et al., 2003; Peskind et al., 2005; Gehrman et al., 2009; Sommer et al., 2009; Wang et al., 2009), agitation (Gaber et al., 2001; Ballard et al., 2005; Verhey et al., 2006; Holmes et al., 2007; Zhong et al., 2007; Rappaport et al., 2009,), aggression (Kyomen et al., 1999; Brodaty et al., 2003; Hall et al., 2005; Huertas et al., 2007), or psychosis (Mintzer et al., 2006; 2007; Streim et al., 2008). "
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ABSTRACT: Background: Medications are frequently prescribed for neuropsychiatric symptoms (NPS) associated with dementia, although information on the efficacy and safety of medications for NPS specifically in long-term care (LTC) settings is limited. The objective of this study was to provide a current review of the efficacy and safety of pharmacological treatments for NPS in LTC.
Methods: We searched MEDLINE, EMBASE, PsychINFO, and the Cochrane Library for randomized controlled trials comparing medications with either placebo or other interventions in LTC. Study quality was described using the Cochrane collaboration risk of bias tool. The efficacy of medications was evaluated using NPS symptom rating scales. Safety was evaluated through rates of trial withdrawals, trial withdrawals due to adverse events, and mortality.
Results: A total of 29 studies met inclusion criteria. The most common medications evaluated in studies were atypical antipsychotics (N = 15), typical antipsychotics (N = 7), anticonvulsants (N = 4), and cholinesterase inhibitors (N = 3). Statistically significant improvements in NPS were noted in some studies evaluating risperidone, olanzapine, and single studies of aripiprazole, carbamazepine, estrogen, cyproterone, propranolol, and prazosin. Study quality was difficult to rate in many cases due to incomplete reporting of details. Some studies reported higher rates of trial withdrawals, adverse events, and mortality associated with medications.
Conclusions: We conclude that there is limited evidence to support the use of some atypical antipsychotics and other medications for NPS in LTC populations. However, the generally modest efficacy and risks of adverse events highlight the need for the development of safe and effective pharmacological and non-pharmacological interventions for this population.
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ABSTRACT: We have demonstrated error-free DEMUX operation in a monolithic photodiode electroabsorption modulator (PD-EAM) at a data-rate of up to 160 Gbit/s. A high on/off ratio (low interchannel crosstalk) of more than 17 dB and a receiver sensitivity of -23.3 dBm are obtained. The error-free operation at a data rate of 160 Gbit/s is the highest bit rate ever achieved by using EO device. These results clearly indicate that PD-EAM optical gate has the potential for practical use in future high-bit-rate optical communication systems.
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