Date of Award

2017

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department

Physician Assistant Studies

Department Chair

John Cavenagh, MBA, PhD, PA-C

Abstract

OBJECTIVE: The objective of this selective EBM review is to determine whether or not “Is Aristada (aripiprazole lauroxil) a safe and effective treatment for schizophrenia in adult patients?”

STUDY DESIGN: Review of three randomized controlled studies. All three trials were conducted between 2014 and 2015.

DATA SOURCES: One randomized, controlled trial and two randomized, controlled, doubleblind trials found via Cochrane Library and PubMed.

OUTCOMES MEASURED: The outcomes that were measured include adverse events (pain at injection site, insomnia, headache, toothache, abdominal discomfort, constipation, diarrhea, akathisia, back pain, dyskinesia, dystonia, nasopharyngitis) measured by vital signs, physical examination, and clinical laboratory tests. Improvement in psychotic symptoms measured by PANSS (Positive and Negative Syndrome Scale) and CGI-I scale (Clinical Global Impressions- Improvement Scale). Also, effect on agitation and hostility measured by PANSS, Personal and Social Performance Scale, and disturbing and aggressive behavior.

RESULTS: The three randomized, controlled trials showed that the use of aripiprazole lauroxil was effective at reducing symptoms of schizophrenia including hostility and agitation, based on PANSS, CGI-I, and PSP scores. Results in reducing symptoms were seen as early as 8 days after initial administration in some cases. Aripiprazole lauroxil was also found for be safe in the trials with, only a limited number of mild to moderate adverse events occurring among certain participants in the studies, mostly injection site pain.

CONCLUSIONS: Based on these three trials, Aristada (aripiprazole lauroxil) is a safe and effective treatment option for schizophrenia in adult patients.

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