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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
6 days ago
Older women with longer endogenous oestrogen exposure and hormone therapy use are at much higher odds of having favourable cognitive status in late life, a recent study suggests.
4 days ago
In patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), rivaroxaban monotherapy is noninferior to combination treatment with an antiplatelet therapy in terms of cutting the risk of cardiovascular events and mortality, according to data from the AFIRE trial.
Elvira Manzano, 5 days ago
Supplementation with omega-3 fatty acids or vitamin D3 for up to 5 years has no effect on kidney function in adults with type 2 diabetes (T2D), the VITAL-DKD* ancillary study has shown.
Jairia Dela Cruz, 2 days ago
Many patients with nonvalvular atrial fibrillation (NVAF) in Thailand use anticoagulants, but the uptake of nonvitamin-K oral anticoagulants remains suboptimal despite showing an upward trend, according to data from the COOL-AF registry presented at the European Society of Cardioloy (ESC) Asia Congress 2019 with APSC and AFC.