BACKGROUND: The Remission in Schizophrenia Working Group (RSWG) has defined criteria for symptomatic remission based on achieving and maintaining a consistently low symptom threshold for at least six consecutive months. This analysis examined symptomatic remission in acutely ill patients with schizophrenia receiving eitheraripiprazole or haloperidolfor one year. METHODS: Pooled data from two 52-week, randomized, double-blind, multicenter, comparative trials of aripiprazole and haloperidol in acutely ill patients with schizophrenia were analyzed. Measures of symptomatic remission were calculated according to RSWG criteria. RESULTS:Remission rates were significantly higher for patients treated with aripiprazole compared with haloperidol (32% vs 22%, respectively; p<0.001, LOCF). Among remitters, aripiprazole-treated patients achieved symptom criteria in a significantly shorter time than haloperidol-treated patients (log rank p=0.0024). For trial completers, remission rates were similarly high in both groups (aripiprazole, 77%; haloperidol, 74%). Regardless of treatment type, remitters received significantly higher global clinical ratings than nonremitters (p<0.0001). Aripiprazole was associated with a significantly lower rate of discontinuations due to adverse events (AEs) than haloperidol (8.0% vs 18.4%, respectively; p<0.001) as well as lower concomitant medication use for extrapyramidal symptoms (EPS) (23% vs 57%, respectively; p<0.001). CONCLUSION:Acutely ill schizophrenia patients treated with aripiprazole demonstrated a significantly higher rate of symptomatic remission across 52 weeks compared with haloperidol-treated patients. The similar remission rates among trial completers in both treatment groups, combined with fewer AE-related discontinuations and lower EPS medication use in the aripiprazole group, suggest that better tolerability with aripiprazole may have contributed to superior overall remission rates.
RCT Entities:
BACKGROUND: The Remission in Schizophrenia Working Group (RSWG) has defined criteria for symptomatic remission based on achieving and maintaining a consistently low symptom threshold for at least six consecutive months. This analysis examined symptomatic remission in acutely ill patients with schizophrenia receiving either aripiprazole or haloperidol for one year. METHODS: Pooled data from two 52-week, randomized, double-blind, multicenter, comparative trials of aripiprazole and haloperidol in acutely ill patients with schizophrenia were analyzed. Measures of symptomatic remission were calculated according to RSWG criteria. RESULTS: Remission rates were significantly higher for patients treated with aripiprazole compared with haloperidol (32% vs 22%, respectively; p<0.001, LOCF). Among remitters, aripiprazole-treated patients achieved symptom criteria in a significantly shorter time than haloperidol-treated patients (log rank p=0.0024). For trial completers, remission rates were similarly high in both groups (aripiprazole, 77%; haloperidol, 74%). Regardless of treatment type, remitters received significantly higher global clinical ratings than nonremitters (p<0.0001). Aripiprazole was associated with a significantly lower rate of discontinuations due to adverse events (AEs) than haloperidol (8.0% vs 18.4%, respectively; p<0.001) as well as lower concomitant medication use for extrapyramidal symptoms (EPS) (23% vs 57%, respectively; p<0.001). CONCLUSION: Acutely ill schizophreniapatients treated with aripiprazole demonstrated a significantly higher rate of symptomatic remission across 52 weeks compared with haloperidol-treated patients. The similar remission rates among trial completers in both treatment groups, combined with fewer AE-related discontinuations and lower EPS medication use in the aripiprazole group, suggest that better tolerability with aripiprazole may have contributed to superior overall remission rates.
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