A safety evaluation of aripiprazole in the treatment of schizophrenia

ABSTRACT

Introduction

Aripiprazole is a third generation antipsychotic approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia. Aripiprazole is available as oral and long-acting injectable (LAI) depot formulations, with a unique mechanism of action comprising partial D₂ and serotonin 5-HT_1A agonism and antagonism at serotonin 5-HT_2A receptors.

Areas covered

We review short-and-long-term clinical trials, meta-analyses of clinical trials and product information pertaining to the safety and efficacy of aripiprazole in adults with schizophrenia. Formulations of aripiprazole reviewed include oral aripiprazole, Aripiprazole monohydrate LAI (Abilify Maintena©) and Aripiprazole lauroxil LAI (Aristada©). Clinical studies and product information were collected from PubMed, Psychinfo, Embase, and other web sources.

Expert opinion

Aripiprazole is a generally well-tolerated third-generation antipsychotic with low rates of motor side effects and metabolic adverse effects that occur commonly with several alternative antipsychotics. Akathisia and tremor appear to occur at higher rates with aripiprazole compared to placebo but are still generally uncommon with incidences of 10–11% or less. Uniquely, aripiprazole treatment is associated with reduced serum prolactin levels and QT_c interval. A variety of LAI options with dosing intervals as infrequent as every 8 weeks provide a compelling reason to select aripiprazole in patients with limited oral treatment adherence.

KEYWORDS:

• Antipsychotic
• neuroleptic
• aripiprazole
• adverse event
• safety
• tolerability

Acknowledgments

Manufacturers of aripiprazole products were not involved in the writing of the contents of the manuscript.

Drug summary box

Declaration of interest

A Preda has received honoraria from Boehringer-Ingelheim, GLG, and Guidepoint.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

A reviewer on this manuscript has disclosed that they have been a member of advisory boards and have received research and travel grants as well as honoraria from Bristol Myers Squibb, Otsuka, and Lundbeck. All other peer reviewers on this manuscript have no relevant financial or other relationships to disclose.