Elicit: What are the adverse effects of Abilify Maintena in adult patients with schizophrenia over a 12-month treatment period? (1 public)
What are the adverse effects of Abilify Maintena in adult patients with schizophrenia over a 12-month treatment period?
The primary adverse effects of 12-month Abilify Maintena treatment included mild-to-moderate symptoms (insomnia, headache, anxiety), weight gain in up to 25.7% of patients, neurological effects in 7.2-14.3%, and serious adverse events in 14.6% of cases.
Abstract
This systematic review examined the adverse effects of Abilify Maintena (aripiprazole once-monthly) in adult patients with schizophrenia over a 12-month treatment period. The review included 40 studies of various designs, including randomized controlled trials, observational studies, and systematic reviews, with sample sizes ranging from 15 to over 3,000 participants and study durations from 12 weeks to 6 years.
The most commonly reported adverse events were insomnia, headache, anxiety, akathisia, weight changes, and injection site pain. The frequency of these events varied across studies, with most being reported as mild to moderate in severity. Serious adverse events were relatively rare, with one study reporting serious adverse drug reactions in 14.6% of patients.
Metabolic effects, particularly weight changes and alterations in lipid profiles, were observed but generally less pronounced compared to some other antipsychotics. Clinically significant weight gain (≥7% increase) was reported in 11.2% to 25.7% of patients across different studies. Neurological effects, including akathisia and extrapyramidal symptoms, were reported at rates ranging from 7.2% to 14.3%.
Overall, the evidence suggests that Abilify Maintena has a generally favorable safety and tolerability profile in adult patients with schizophrenia over a 12-month treatment period. However, clinicians should monitor patients for a range of potential side effects, particularly weight changes, metabolic parameters, and neurological effects.
Methods
We analyzed 40 sources from an initial pool of 490, using 7 screening criteria.
- Papers included for extraction: 46
Safety and Adverse Effects
Treatment-Emergent Adverse Events
| Study | Common Adverse Events | Frequency | Severity | Time of Onset |
|---|---|---|---|---|
| Dawood et al., 2020 | Sexual disinhibition, aggression, deliberate self-harm, impulsive behavior, Parkinsonism, tardive dyskinesia, gambling | Sexual disinhibition (3.5%), aggression (7%), impulsive behavior (<10%), Parkinsonism (10.5%), tardive dyskinesia (1.8%), gambling (1.8%) | Generally not severe | Not specified |
| Fleischhacker et al., 2013 | Insomnia, headache, anxiety, akathisia, increase in weight, injection-site pain, tremor | >5% for each listed adverse effect | Not mentioned | Not specified in abstract |
Serious Adverse Events
- Mustafa et al. (2019) reported serious adverse drug reactions (ADRs) in 14.6% of patients.
- Peters-Strickland et al. (2015) reported serious treatment-emergent adverse events (TEAEs) in 8.8% of patients.
- Nature of serious adverse events included psychotic disorders and exacerbation of existing psychiatric conditions.
Metabolic Effects
- Weight gain is significant in several studies, with clinically relevant weight gain (≥7% increase) occurring in approximately 11-26% of patients.
- Changes in lipid profiles and glucose metabolism were reported but specific data on glucose changes were limited.
Neurological Effects
- Significant rates of akathisia and extrapyramidal symptoms were recorded, with akathisia occurring in 7.2%-11% of patients.
Treatment Discontinuation Patterns
- Discontinuation rates varied widely across studies, generally lower than or comparable to oral antipsychotics when direct comparisons were made.
- Common reasons for discontinuation included lack of efficacy, adverse events, and patient/caregiver choice.