Long-term safety and tolerability of asenapine: A double-blind, uncontrolled, long-term extension trial in adults with an acute manic or mixed episode associated with bipolar I disorder

JOURNAL OF AFFECTIVE DISORDERS

卷:207

Article

Ketter, Terence A.¹  Durgam, Suresh²  Landbloom, Ronald³  Mackle, Mary³  Wu, Xiao²  Mathews, Maju⁴ 

[1] Stanford Univ, Sch Med, Stanford, CA 94305 USA

[2] Allergan, Jersey City, NJ USA

[3] Merck, Whitehouse Stn, NJ USA

[4] Forest Res Inst, Jersey City, NJ USA

关键词: Bipolar disorder;    Mania;    Mixed episodes;    Asenapine;    Safety;    Tolerability;   

DOI  :  10.1016/j.jad.2016.09.037

来源: Elsevier

【 摘 要 】

Background: Asenapine (ASN) is approved in the United States as monotherapy and adjunctive therap y (to lithium or valproate) in adults with bipolar mania, and as monotherapy in pediatric patients with bipolar mania. This is the first long-term study evaluating safety and tolerability of ASN fixed doses in this population. Methods: After completing a 3-week, randomized, placebo (PBO)-controlled acute trial, patients could enroll in this 26-week, fixed-dose (5 or 10 mg twice daily), double-blind extension study. Select predefined treatment emergent adverse events (TEAEs) and metabolic parameters were reported. Results: Overall, 164 patients were treated; 88 completed the study. The incidence of TEAE was greater for PBO/ASN 5 mg (68.3%) versus ASN 5 mg/ASN 5 mg (54.7%) and ASN 10 mg/ASN 10 mg (51.0%) with sedation, headache, somnolence, akathisia, and dizziness occurring as the most prevalent TEAEs. Predefine, TEAEs were more common for PBO/ASN 5 mg (33.3%) versus ASN 5 mg/ASN 5 mg (15.1%) and ASN 10 mgt ASN 10 mg (15.7%). Weight gain (>= 7% increase from baseline to endpoint) was more frequent for ASN 10 mgt ASN 10 mg (16.3%) versus ASN 5 mg/ASN 5 mg (13.7%) and PBO/ASN 5 mg (8.9%). No clinically significance metabolic changes were observed. The incidence of serious AEs was low and primarily related to underlying bipolar I disorder. Limitations: This study lacked a comparator group and was not powered for direct comparisons of ASIA regimens. Results may not be applicable to the general bipolar population. Conclusions: ASN was generally safe and well tolerated in adults with an acute manic or mixed episode associated with bipolar I disorder.

【 授权许可】

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