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Asenapine safely prevents recurrence of mood events in bipolar I disorder

29 Jan 2018

Long-term treatment with asenapine is well-tolerated and effective in preventing recurrence of mood events in adults with bipolar I disorder compared with placebo, according to a recent study.

Of the 549 patients in the open-label period, 253 were enrolled in the double-blind randomized withdrawal period (127 in the placebo group and 126 in the asenapine group).

Patients treated with asenapine had statistically significantly longer time to recurrence of any mood episode than those treated with placebo. Posthoc analyses showed significant differences in time to recurrence of manic and depressive episodes in favour of asenapine over placebo.

Somnolence (10.0 percent), akathisia (7.7 percent) and sedation (7.7 percent) were the most common treatment-emergent adverse events in the open label period, and mania (11.9 percent of the placebo groups vs 4.0 percent of the asenapine group) and bipolar I disorder (6.3 percent vs 1.6 percent) in the double-blind period.

Researchers enrolled adults with an acute manic or mixed episode per DSM-IV-TR criteria in this randomized, placebo-controlled trial consisting of an initial 12‒16-week open-label period and a 26-week double-blind randomized withdrawal period.

The target asenapine dosage in the open-label period was 10 mg b.i.d., but it could be titrated down to 5 mg b.i.d. After completing the open-label period, those who met the stabilization/stable-responder criteria were randomly assigned to asenapine or placebo treatment in the double-blind period.

Time to recurrence of any mood event during the double-blind period was the primary efficacy endpoint. Researchers performed Kaplan-Meier estimation and determined 95 percent confidence intervals. They also assessed the safety of the study drug.

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Most Read Articles
4 days ago
The consumption of red and processed meats does not seem to affect the likelihood of symptom relapse among Crohn’s disease (CD) patients in relapse, reports a recent study.
Roshini Claire Anthony, 10 Jul 2019

Women who receive a single dose of amoxicillin and clavulanic acid within 6 hours of operative vaginal delivery could significantly reduce their postpartum infection risk, according to the UK-based ANODE* trial.

Pearl Toh, 2 days ago
In addition to the known evils of maternal smoking during pregnancy on the son’s semen quality, prenatal exposure to paternal smoking can also be harmful, according to data from a large Danish National Birth Cohort (DNBC) presented at the ESHRE 2019 Meeting.
4 days ago
Treatment with metformin may improve whole-body and peripheral insulin resistance (IR) in youth who are overweight/obese with type 1 diabetes (T1D), according to a study.