Background: The evaluation of long-term effectiveness and tolerability of aripiprazole once-monthly (AOM) is yet scarce, and severely ill patients have not been specifically studied.
Objective: The aim of the study was to explore the long-term adherence, effectiveness and tolerability of AOM in the treatment of patients with severe (Clinical Global Impression-Severity, CGI-S ≥ 5) schizophrenia, and whether high-dose therapy may benefit patients inadequately controlled on standard doses.
Methods: Six-year mirror-image study, with a 36-month prospective follow-up, was conducted on patients with severe schizophrenia who underwent treatment with AOM (n = 60). The assessment included the CGI-S, the WHO Disability Assessment Schedule (WHO- DAS), the Medication Adherence Report Scale (MARS), the laboratory tests, the assessment of weight and adverse effects reported. Reasons for treatment discontinuation, hospital admissions and psychiatric medications in the previous three years and during the follow-up were recorded.
Results: The average dose was found to be 780 (120) mg/28 days. Tolerability was good, with fewer side effects or biological parameters alterations reported. There were three discharges due to adverse effects, two due to lack of effectiveness and one treatment abandoning. Weight and prolactin levels were decreased. CGI-S and WHO-DAS were decreased (p < 0.001), and MARS increased (p < 0.001). There were less treatment abandoning, hospital admissions (p < 0.0001) and concomitant medication (p < 0.01) observed than during the previous 36 months.
Conclusion: Treatment adherence and tolerability of AOM were found to be remarkable, even in those patients on high doses. AOM showed effectiveness in patients with severe schizophrenia, who recorded less hospitalizations and clinical severity and disability, although a considerable percentage of them required higher doses than labeled.
Keywords: Schizophrenia; adherence; aripiprazole once-monthly; doses.; effectiveness; tolerability.
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