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?
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%.
Treatment discontinuation rates varied across studies, ranging from 14.28% to 41%, but were generally lower than those reported for oral antipsychotics. Common reasons for discontinuation included lack of efficacy, patient/caregiver choice, and adverse events. Notably, several studies reported good long-term persistence with Abilify Maintena, with one study finding that 69.6% of patients continued treatment over a four-year follow-up period.
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. The variability in study designs, populations, and reporting methods highlights the need for further long-term, head-to-head comparisons with other antipsychotics to fully elucidate the safety profile of Abilify Maintena.
Methods
We analyzed 40 sources from an initial pool of 490, using 7 screening criteria. Each paper was reviewed for 5 key aspects that mattered most to the research question.
Paper search
Using your research question “What are the adverse effects of Abilify Maintena in adult patients with schizophrenia over a 12-month treatment period?”, we searched across over 126 million academic papers from the Semantic Scholar corpus. We retrieved the 490 papers most relevant to the query.
Screening
We screened in sources based on their abstracts that met these criteria:
- Population Age and Diagnosis: Does the study focus exclusively on adult patients (≥18 years) diagnosed with schizophrenia using standardized diagnostic criteria (DSM or ICD)?
- Intervention: Does the study examine treatment with Abilify Maintena (aripiprazole long-acting injectable)?
- Study Duration: Is the study duration greater than or equal to 12 months?
- Outcomes: Does the study report adverse effects or safety outcomes?
- Study Design: Is the study a randomized controlled trial, observational study, systematic review, or meta-analysis?
- Sample Size: Does the study include 10 or more patients?
- Study Type: Is the study a clinical study involving human subjects (not an animal study, in vitro study, or case report/series with <10 patients)?
Results
Characteristics of Included Studies
| Study | Full text retrieved | Study Design | Population Size | Duration | Primary Outcomes | Study Quality/Risk of Bias |
|---|---|---|---|---|---|---|
| “Efficacy and Tolerability of AOM,” [Missing] | No | Systematic review and meta-analysis of randomized controlled trials | 1,860 | Not specified in abstract | Efficacy and tolerability of aripiprazole once-monthly | Low risk of bias (systematic review methodology) |
| Chue and Chue, 2016 | No | Review of randomized controlled trials and observational studies | Not mentioned | 52 weeks, 38 weeks, and 6 months | Not mentioned | Not assessable (review article) |
| Dawood et al., 2020 | Yes | Non-interventional, retrospective observational study | 57 | Not uniformly specified | Effectiveness and safety of Aripiprazole Lauroxil | Moderate risk of bias (observational design) |
| De Hert et al., 2015 | No | Randomized, double-blind, active-controlled, noninferiority study | 662 | 38 weeks | Relapse rates | Low risk of bias (randomized, double-blind design) |
| Di Lorenzo et al., 2019 | No | Retrospective observational study | 217 | 6 and 12 months | Clinical and functioning improvement, urgent consultations, psychiatric hospitalizations, adverse effects, and dropout | Moderate risk of bias (observational design) |
Safety and Adverse Effects
Treatment-Emergent Adverse Events
| Study | Common Adverse Events | Frequency | Severity | Time of Onset |
|---|---|---|---|---|
| “Efficacy and Tolerability of AOM,” [Missing] | Weight gain | Not specified in abstract | Not specified in abstract | Not specified in abstract |
| Chue and Chue, 2016 | Not mentioned | Not mentioned | Not mentioned | Not mentioned |
| 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 |
Analysis of Treatment-Emergent Adverse Events
- Most Commonly Reported Adverse Events:
- Weight gain/changes (reported in 9 studies)
- Insomnia (reported in 8 studies)
- Akathisia (reported in 7 studies)
- Headache (reported in 5 studies)
- Injection site pain (reported in 4 studies)
- Anxiety (reported in 4 studies)
- Tremor (reported in 4 studies)
- Frequency of Adverse Events:
- Varied widely across studies
- Weight gain: ranged from 11.2% to 25.7% for clinically significant weight gain
- Akathisia: ranged from 7.2% to 10-11%
- Insomnia: ranged from 6.6% to 22%
- Headache: reported at 7.6% in one study
- Severity:
- Most studies reported mild to moderate severity for the majority of adverse events
- Serious adverse drug reactions were noted in 14.6% of patients in one study.
Treatment Discontinuation Patterns
| Study | Discontinuation Reason | Frequency | Timing | Patient Characteristics |
|---|---|---|---|---|
| Dawood et al., 2020 | Ineffectiveness, side effects, patient request | 25% of patients | By study end | Not specified |
| Di Lorenzo et al., 2019 | Not mentioned | 14.28% | Not specified in abstract | Not mentioned |
| Fagiolini et al., 2021 | Lack of efficacy, patient/caregiver choice, physician’s choice, non-adherence, inconvenience, tolerability issues | 30.4% overall | Mean 32.23 months for non-persistent individuals | Not specified |
These findings suggest that while discontinuation is a significant issue in the treatment of schizophrenia with aripiprazole once-monthly, it may offer advantages in terms of treatment persistence compared to oral antipsychotics. However, the variability in discontinuation rates and reasons across studies underscores the importance of individualized treatment approaches and close monitoring of patients, particularly in the early stages of treatment.