科研之友
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摘要
Background: Atypical antipsychotics have broad-spectrum efficacy against core symptoms of acute mania/mixed states in bipolar disorder; however, they are associated with clinically significant adverse effects (AEs). Methods: This post hoc analysis evaluated the safety and tolerability of the atypical antipsychotic cariprazine in the treatment of adult patients with acute manic/mixed episodes of bipolar I disorder. Data were taken from three 3-week randomized, double-blind, placebo-controlled, flexible-dose trials of cariprazine 3-12 mg/d. Patient subgroups categorized by modal daily dose (3-6 mg/d; 9-12 mg/d) were used to assess dose response. Results: The pooled safety population comprised 1065 patients (placebo=442; cariprazine 3-6 mg/d=263; cariprazine 9-12 mg/d=360). More cariprazine- than placebo-treated patients reported double-blind treatment-emergent AEs; the overall AE incidence was similar among cariprazine-dose groups. AEs reported in >= 5% of cariprazine patients overall with at least twice the incidence of placebo were akathisia, extrapyramidal symptoms, restlessness, and vomiting. The incidence of SAES was low and similar between the placebo- and cariprazine-treatment groups. Metabolic parameter changes were small and generally similar between cariprazine and placebo groups; mean increases in fasting glucose levels were greater with cariprazine (3-6 mg/d=6.6 mg/dL; 9-12 mg/d=7.2 mg/dL) than placebo (1.7 mg/dL). Mean weight change was 0.54 kg and 0.17 kg for cariprazine and placebo, respectively; weight increase >= 7% was < 3% in all treatment groups. Cariprazine was not associated with clinically meaningful changes in electrocardiogram parameters. Limitations: Post hoc analysis, flexible-dose design, short trial duration. Conclusion: Cariprazine was generally safe and well-tolerated in patients with manic/mixed episodes associated with bipolar I disorder.
- 出版日期2017-6
