Review of the safety, efficacy, and side effect profile of asenapine in the treatment of bipolar 1 disorder

Jodi M. Gonzalez, Peter M. Thompson, Troy A Moore

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Objective: Asenapine is approved for acute manic and mixed states in bipolar disorder. The objective is to review the efficacy of asenapine in bipolar disorder, with a particular focus on acceptability and adherence to treatment. Methods: Five clinical trials were conducted in bipolar disorder manic or mixed states: two 3-week trials (n = 976) comparing asenapine to placebo, a 9-week extension (n = 504), and a 40-week extension (n = 107). One trial was conducted comparing asenapine to placebo (n = 326) as adjunctive therapy for subjects with an incomplete response to lithium or valproate. All trials were conducted in the USA and internationally. Results: Asenapine was found to be efficacious for manic and mixed states in bipolar disorder compared with placebo control, and compares equally well to olanzapine on efficacy measures after 3 weeks of treatment. Asenapine was not found to be efficacious for depression symptoms. Common asenapine side effects in the 40-week extension trial were sedation, insomnia, and dizziness, and 31% reported clinically significant weight gain, compared with 55% reporting clinically significant weight gain with olanzapine. Additionally, 18% had clinically significant changes in fasting blood glucose levels compared to 22% of those on olanzapine. In terms of patient acceptability, one concern may be sublingual administration requiring no liquids or food for 10 minutes after dosing and a twice-daily regimen. Suggestions about addressing barriers to adherence and acceptability are provided. Conclusion: Asenapine is a promising new medication in bipolar disorder. Asenapine in the long-term has a more favorable weight gain profile compared to olanzapine. No benefit was seen for depression symptoms, a major patient-reported concern. Some side effects do not remit after the short-term trials in at least 10% of patients.

Original languageEnglish (US)
Pages (from-to)333-341
Number of pages9
JournalPatient Preference and Adherence
Volume5
DOIs
StatePublished - 2011

Fingerprint

Bipolar Disorder
olanzapine
Safety
Weight Gain
Therapeutics
Placebos
Sublingual Administration
Depression
Asenapine
medication
Valproic Acid
Sleep Initiation and Maintenance Disorders
Dizziness
food
Lithium
Blood Glucose
Fasting
Clinical Trials
Food

Keywords

  • Acceptability
  • Adherence
  • Antipsychotic
  • Asenapine
  • Metabolic syndrome

ASJC Scopus subject areas

  • Social Sciences (miscellaneous)
  • Medicine (miscellaneous)
  • Health Policy
  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Cite this

Review of the safety, efficacy, and side effect profile of asenapine in the treatment of bipolar 1 disorder. / Gonzalez, Jodi M.; Thompson, Peter M.; Moore, Troy A.

In: Patient Preference and Adherence, Vol. 5, 2011, p. 333-341.

Research output: Contribution to journalArticle

Gonzalez, Jodi M. ; Thompson, Peter M. ; Moore, Troy A. / Review of the safety, efficacy, and side effect profile of asenapine in the treatment of bipolar 1 disorder. In: Patient Preference and Adherence. 2011 ; Vol. 5. pp. 333-341.
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