Efficacy and safety of bifeprunox in patients with an acute exacerbation of schizophrenia: results from a randomized, double-blind, placebo-controlled, multicenter, dose-finding study |
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Authors: | Daniel E Casey Earl E Sands Jens Heisterberg Hwa-Ming Yang |
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Institution: | (1) UHN 80 Department of Psychiatry, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA;(2) Solvay Pharmaceuticals, Inc., Marietta, GA, USA;(3) H. Lundbeck A/S, Valby, Copenhagen, Denmark |
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Abstract: | Rationale Bifeprunox is a partial dopamine agonist with a unique receptor-binding profile and potential antipsychotic properties.
Objectives The current study evaluated the efficacy and safety of bifeprunox in patients with an acute exacerbation of schizophrenia.
Materials and methods In this 6-week, double-blind, placebo-controlled study, 589 patients were randomly assigned to once-daily treatment with bifeprunox
5, 10, or 20 mg, placebo, or risperidone 6 mg. Efficacy was assessed by changes in symptom rating scales Positive and Negative
Syndrome Scale (PANSS) total and subscale scores; PANSS-derived BPRS scores; Clinical Global Impression—Severity (CGI—S) and
Clinical Global Impression—Improvement (CGI—I) scores]. Safety and tolerability were assessed by monitoring adverse events,
extrapyramidal symptoms (EPS), laboratory values, electrocardiograms, prolactin levels, and weight.
Results Compared with placebo, bifeprunox 20 mg produced a statistically significantly greater reduction from baseline to last assessment
in the primary efficacy variable (PANSS total score; effect size = −0.339), as well as most secondary efficacy measures. No
statistically significant differences in efficacy were seen with lower doses of bifeprunox. The most common treatment-emergent
adverse events (TEAEs) noted with bifeprunox were gastrointestinal; no clear dose-related trend in the incidence of any TEAE
was observed in the bifeprunox groups. Compared to placebo, treatment with bifeprunox led to small but statistically significant
decreases in weight and prolactin levels. EPS were comparable between bifeprunox and placebo. The active reference in this
study, risperidone 6 mg, showed statistically significant differences from placebo for the primary efficacy parameter (effect
size = −0.628) and all secondary efficacy parameters.
Conclusions These data suggest that 20 mg of bifeprunox may be efficacious in improving symptoms in patients with an acute exacerbation
of schizophrenia. Bifeprunox appeared to be safe and well tolerated by patients in this 6-week study.
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Keywords: | Bifeprunox Schizophrenia Partial dopamine agonist Atypical antipsychotic Symptoms Metabolic Extrapyramidal symptoms Weight Prolactin |
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