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Asenapine: a review of its use in the management of mania in adults with bipolar I disorder.
CNS Drugs. 2011 Mar; 25(3):251-67.CD

Abstract

Asenapine is an atypical antipsychotic agent available in sublingual formulations (5 or 10 mg) and indicated in the US (Saphris) for the acute treatment, as monotherapy or adjunctive therapy, of manic and mixed episodes and in the EU (Sycrest) for the treatment of moderate to severe manic episodes, in adult patients with bipolar I disorder. In two large (both n = 480), well designed, 3-week trials in adult patients with bipolar I disorder, asenapine monotherapy was significantly more effective than placebo at improving mania symptoms, as assessed using the Young Mania Rating Scale total score (YMRS; primary endpoint), with significant differences between the asenapine and placebo groups occurring after 2 days of treatment. In both trials, Clinical Global Impression for Bipolar Disorder (CGI-BP) scale mania severity scores exceeded those of placebo. In one trial, response and remission rates exceeded those of placebo. In a 9-week extension study that recruited completers from the monotherapy trials, there were no significant differences between asenapine and olanzapine groups in terms in Montgomery-Åsberg Depression Rating Scale (MADRS) scores, CGI-BP mania severity scores, YMRS response rates or YMRS remission rates during the extension phase. In the extension study, the efficacy of asenapine monotherapy appeared to be maintained over 40 weeks (total treatment duration of 52 weeks). In a 12-week trial of asenapine as adjunctive therapy to lithium or valproate, asenapine was more effective than placebo in improving manic symptoms, based on the difference between groups in the YMRS total score at week 3 (primary endpoint). Most adverse events associated with asenapine were of mild to moderate severity, with <7% of asenapine recipients experiencing serious adverse events (vs 7% with placebo). In a pooled analysis of the monotherapy trials, the most common adverse events (occurring in ≥ 5% of patients and at twice the incidence of placebo) reported during acute phase asenapine monotherapy for bipolar mania were somnolence, dizziness, extrapyramidal symptoms (EPS, other than akathisia) and increased bodyweight, which were similar in nature to those occurring during longer-term monotherapy with asenapine. EPS did not worsen in severity during longer-term asenapine monotherapy. Asenapine had minimal effects on plasma glucose, lipid and prolactin levels over both short- and longer-term treatment periods, and had little pro-arrhythmogenic potential. Further active comparator trials and longer-term tolerability and safety data are required. In the meantime, asenapine is a further option for the management of manic and/or mixed symptoms in patients with bipolar I disorder and may be of particular value for patients who are at high risk for metabolic abnormalities.

Authors+Show Affiliations

Adis, a Wolters Kluwer Business, Auckland, New Zealand. demail@adis.co.nzNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Review

Language

eng

PubMed ID

21323396

Citation

Chwieduk, Claudine M., and Lesley J. Scott. "Asenapine: a Review of Its Use in the Management of Mania in Adults With Bipolar I Disorder." CNS Drugs, vol. 25, no. 3, 2011, pp. 251-67.
Chwieduk CM, Scott LJ. Asenapine: a review of its use in the management of mania in adults with bipolar I disorder. CNS Drugs. 2011;25(3):251-67.
Chwieduk, C. M., & Scott, L. J. (2011). Asenapine: a review of its use in the management of mania in adults with bipolar I disorder. CNS Drugs, 25(3), 251-67. https://doi.org/10.2165/11206700-000000000-00000
Chwieduk CM, Scott LJ. Asenapine: a Review of Its Use in the Management of Mania in Adults With Bipolar I Disorder. CNS Drugs. 2011;25(3):251-67. PubMed PMID: 21323396.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Asenapine: a review of its use in the management of mania in adults with bipolar I disorder. AU - Chwieduk,Claudine M, AU - Scott,Lesley J, PY - 2011/2/18/entrez PY - 2011/2/18/pubmed PY - 2011/6/3/medline SP - 251 EP - 67 JF - CNS drugs JO - CNS Drugs VL - 25 IS - 3 N2 - Asenapine is an atypical antipsychotic agent available in sublingual formulations (5 or 10 mg) and indicated in the US (Saphris) for the acute treatment, as monotherapy or adjunctive therapy, of manic and mixed episodes and in the EU (Sycrest) for the treatment of moderate to severe manic episodes, in adult patients with bipolar I disorder. In two large (both n = 480), well designed, 3-week trials in adult patients with bipolar I disorder, asenapine monotherapy was significantly more effective than placebo at improving mania symptoms, as assessed using the Young Mania Rating Scale total score (YMRS; primary endpoint), with significant differences between the asenapine and placebo groups occurring after 2 days of treatment. In both trials, Clinical Global Impression for Bipolar Disorder (CGI-BP) scale mania severity scores exceeded those of placebo. In one trial, response and remission rates exceeded those of placebo. In a 9-week extension study that recruited completers from the monotherapy trials, there were no significant differences between asenapine and olanzapine groups in terms in Montgomery-Åsberg Depression Rating Scale (MADRS) scores, CGI-BP mania severity scores, YMRS response rates or YMRS remission rates during the extension phase. In the extension study, the efficacy of asenapine monotherapy appeared to be maintained over 40 weeks (total treatment duration of 52 weeks). In a 12-week trial of asenapine as adjunctive therapy to lithium or valproate, asenapine was more effective than placebo in improving manic symptoms, based on the difference between groups in the YMRS total score at week 3 (primary endpoint). Most adverse events associated with asenapine were of mild to moderate severity, with <7% of asenapine recipients experiencing serious adverse events (vs 7% with placebo). In a pooled analysis of the monotherapy trials, the most common adverse events (occurring in ≥ 5% of patients and at twice the incidence of placebo) reported during acute phase asenapine monotherapy for bipolar mania were somnolence, dizziness, extrapyramidal symptoms (EPS, other than akathisia) and increased bodyweight, which were similar in nature to those occurring during longer-term monotherapy with asenapine. EPS did not worsen in severity during longer-term asenapine monotherapy. Asenapine had minimal effects on plasma glucose, lipid and prolactin levels over both short- and longer-term treatment periods, and had little pro-arrhythmogenic potential. Further active comparator trials and longer-term tolerability and safety data are required. In the meantime, asenapine is a further option for the management of manic and/or mixed symptoms in patients with bipolar I disorder and may be of particular value for patients who are at high risk for metabolic abnormalities. SN - 1179-1934 UR - https://www.unboundmedicine.com/medline/citation/21323396/Asenapine:_a_review_of_its_use_in_the_management_of_mania_in_adults_with_bipolar_I_disorder_ L2 - https://dx.doi.org/10.2165/11206700-000000000-00000 DB - PRIME DP - Unbound Medicine ER -