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Exploring the long-term safety of asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study

Authors Durgam S, Landbloom RP, Mackle M, Wu X, Mathews M, Nasrallah HA

Received 14 December 2016

Accepted for publication 23 March 2017

Published 31 July 2017 Volume 2017:13 Pages 2021—2035

DOI https://doi.org/10.2147/NDT.S130211

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Prof. Dr. Roumen Kirov

Peer reviewer comments 3

Editor who approved publication: Dr Roger Pinder


Suresh Durgam,1 Ronald P Landbloom,2 Mary Mackle,2 Xiao Wu,1 Maju Mathews,3 Henry A Nasrallah4

1Allergan Inc, Jersey City, 2Merck, Whitehouse Station, 3Forest Research Institute (now Allergan), Jersey City, NJ, 4Saint Louis University School of Medicine, St Louis, MO, USA

Purpose: The primary objective of this study was to assess long-term safety with sublingual asenapine 2.5 or 5 mg twice daily (BID) in patients with schizophrenia.
Patients and methods: Actively treated patients on asenapine 2.5 mg BID, asenapine 5 mg BID, or olanzapine 15 mg once daily (QD) who completed a 6-week randomized, double-blind, placebo- and olanzapine-controlled study continued lead-in treatment in this 26-week, multicenter, double-blind, double-dummy, olanzapine-controlled Phase IIIB extension study; placebo patients were assigned to asenapine 2.5 mg BID treatment. Safety analyses were based on the all treated set (patients who received one or more doses of extension trial medication); change from baseline analyses used the acute study baseline. Treatment-emergent adverse events (TEAEs) and changes in laboratory parameters were monitored; weight change for asenapine versus olanzapine was the key secondary objective. Descriptive statistics were used; weight change was analyzed using a mixed-model repeated-measure approach.
Results: Of the 120 patients in the all-treated set, 60% completed treatment (asenapine 2.5 mg BID 66.1% overall, asenapine 5 mg BID 52.4%, olanzapine 15 mg QD 56.3%). The incidence of TEAEs was higher for placebo patients from the lead-in study who switched to asenapine 2.5 mg BID for extension treatment (71.0%) versus patients continuing asenapine 2.5 mg BID (38.7%), asenapine 5 mg BID (38.1%), or olanzapine 15 mg QD (25.0%). The most common TEAE (≥5% in every group) was worsening of schizophrenia. Least squares mean change in body weight from the acute study baseline to week 26 was +0.6 kg for overall asenapine 2.5 mg BID, +0.8 kg for asenapine 5 mg BID, and +1.2 kg for olanzapine 15 mg QD. There were no clinically relevant changes in metabolic parameters; values were generally similar across treatment groups.
Conclusion: Asenapine 2.5 mg BID and 5 mg BID were generally well tolerated in long-term treatment. Weight gain was less for overall asenapine 2.5 mg BID and 5 mg BID than for olanzapine 15 mg QD.

Keywords: asenapine, schizophrenia, long-term, safety, weight, olanzapine

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