Abstract
BackgroundIn this study, the treatment of schizophrenia patients with aripiprazole once-monthly (AOM) was evaluated under real-life conditions in a naturalistic setting.MethodsThis multicenter, prospective, non-interventional study included 242 patients (age = 43.1 ± 15.1 years, 55.0% male) who were monitored during 6 months of AOM treatment. Endpoints included measurements of psychopathology (Brief Psychiatric Rating Scale, BPRS) and severity of illness scales (Clinical Global Impressions-Severity, CGI-S, and -Improvement, CGI-I). Furthermore, treatment-related adverse events (TRAEs) were recorded.ResultsAt baseline, the mean BPRS total score was 54.1 ± 15.6, the mean CGI-S was 4.8 ± 0.8 and the most frequent illness category was ‘markedly ill’ (41.7%). Patients had been pretreated with oral aripiprazole for a mean duration of 9.7 months (SD: 22.3) and 87.9% were deemed by their clinician as “clinically stable” and for a mean of 5.9 months. The difference in global BPRS after 6 months was − 13.8 (SD: 16.0; 95% CI: [− 15.9; − 11.7]; p < 0.001). The proportion of patients with high CGI-S scores decreased and the proportion of patients with low scores increased significantly (p < 0.001, respectively). BPRS scores improved numerically especially well in younger patients ≤35 years, CGI-S scores decreased significantly more in this population. TRAEs were rare, with low incidences of extrapyramidal symptoms (2.9%) or weight increase (0.4%).ConclusionsTreatment with AOM showed satisfying effectiveness in outpatients with further improvement of psychopathology after oral aripiprazole treatment for a considerable duration and even after having achieved clinically judged “stability”. Our findings indicate a robust therapeutic effect of AOM and substantiate previous results from randomized controlled trials under real-world routine conditions.
Highlights
In this study, the treatment of schizophrenia patients with aripiprazole once-monthly (AOM) was evaluated under real-life conditions in a naturalistic setting
Improving adherence to medication may be achieved by using long-acting injectable antipsychotics (LAIs) which may in turn reduce the risk of relapse and improve patient functioning [12,13,14]
All patients had been previously treated with oral aripiprazole for a mean duration of 9.7 months (SD 22.3 months), with 33.3% of patients having received oral aripiprazole for < 1 month, 39.9% for 1–6 months, and 26.8% for more > 6 months
Summary
The treatment of schizophrenia patients with aripiprazole once-monthly (AOM) was evaluated under real-life conditions in a naturalistic setting. Improving adherence to medication may be achieved by using long-acting injectable antipsychotics (LAIs) which may in turn reduce the risk of relapse and improve patient functioning [12,13,14]. Aripiprazole once-monthly (AOM) is an atypical LAI with a unique pharmacological profile: aripiprazole shows partial agonist activity at dopamine D2/D3 receptors [15, 16], the risk of adverse effects, such as parkinsonism, hyperprolactinemia and sexual dysfunction [17] is low. In the European study, Kaplan– Meier estimated impending relapse rates at week 26 from randomization were 7.1% for AOM 400 mg, 7.8% for oral aripiprazole (10–30 mg/day) and 21.8% for aripiprazole once-monthly at a subtherapeutic dose (50 mg) [21]. AOM 400 mg has a long half-life of 46.5 days [22], which potentially can provide long-term relapse protection for patients
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