Abstract: BAckground: Aripiprazole and risperidone are two of the most widely used and best-considered second-generation antipsychotics (SGAs) for the treatment of schizophrenia spectrum disorders (SSD) attending to their effectiveness. Nonetheless, there is a still lack of head-to-head studies comparing these treatments, especially for the long-term treatment. Current evidence suggests that continued antipsychotic treatment is key for preventing relapse in people with SSD, but evidence-based recommendations for the choice of the individual antipsychotic for maintenance treatment are lacking. In this sense, differential adverse effect profiles may be considered as a key item to lead a personalized approach to SGA selection after a first-episode of psychosis (FEP). Aim of the study: In this study, we compared aripiprazole and risperidone adverse effect profiles for the long-term use after a FEP. Methods: This is an open-label, prospective, randomized clinical trial comparing aripiprazole and risperidone for the treatment of antipsychotic-naïve FEP subjects. Patients were enrolled from February 2014 to October 2018 in an early intervention program for psychosis (PAFIP) at the Marqués de Valdecilla University Hospital (Santander, Spain). The final sample consisted of 266 patients who were randomly assigned to treatment with aripiprazole (n = 136) or risperidone (n = 130) and followed-up for one year. Intention-to-treat principle was used for the analyses. Results: Adverse effects occurred in 228 patients of the total sample (85.7%) after 1-year follow-up. The incidence of adverse effects was similar between treatment groups; aripiprazole group (N = 117/136; 86.0%) vs risperidone group (N = 111/130; 85.4%). Adverse effects analyses revealed weight gain (17.3% of the total sample), sleepiness (9.4% of the total sample) and increased fatigability (9% of the total sample) as the most frequent adverse effects on the long-term, although no statistically significant differences were found between treatment groups. We observed weight gain on each treatment group (?2 = 0.17; p = 0.68) and similarly to extrapyramidal symptoms (EPS), no differences were found between treatment groups during the 1-year follow-up. The incidence of parkinsonism was the same in both groups (?2 = 0.04; p = 0.85) and akathisia was similar (?2 = 0.03; p = 0.87). At the endpoint, both parkinsonism (F = 1.14; p = 0.36) and akathisia (F = 0.80; p = 0.44) were more likely to affect the risperidone group compared to the aripiprazole group, although no significant differences were detected. Akathisia reports were more likely to be communicated during the first months after initiating treatment on each treatment group. However, other EPS were more frequently registered during the last months of the follow-up period. Conclusions: The emergence of adverse effects related to either aripiprazole or risperidone after a FEP represented a major concern on each group. Weight gain was a major issue, and EPS were similarly distributed between treatment groups as well, albeit non-statistically significant differences were registered regarding these items. Interestingly, we found different patterns of akathisia and EPS presentation which may be acknowledged for SGA treatment making-decision process on the long-term maintenance phase after a FEP.

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