TY - JOUR
T1 - Post hoc analyses of asenapine treatment in pediatric patients with bipolar i disorder
T2 - Efficacy related to mixed or manic episode, stage of illness, and body weight
AU - Findling, Robert L.
AU - Earley, Willie
AU - Suppes, Trisha
AU - Patel, Mehul
AU - Wu, Xiao
AU - Chang, Cheng Tao
AU - McIntyre, Roger S.
N1 - Funding Information:
Writing assistance and editorial support were provided by Krystina Neuman, PhD, of Prescott Medical Communications Group (Chicago, IL), a contractor of Allergan. The study was sponsored by Merck & Co., Inc. This manuscript was supported by funding from Allergan (Madison, NJ).
Publisher Copyright:
© 2018 Findling et al.
PY - 2018
Y1 - 2018
N2 - Background: Patient characteristics and disease progression may affect response to pharmacologic intervention in bipolar I disorder. Asenapine is approved for acute treatment of manic/mixed episodes of bipolar I disorder in patients 10–17 years old. Post hoc analyses assessed asenapine efficacy in pediatric patients by current manic or mixed episode, number of lifetime episodes, and baseline body mass index (BMI). Patients and methods: Data were obtained from a 3-week, randomized, double-blind, placebo-controlled, parallel-group trial of asenapine 2.5, 5.0, or 10.0 mg twice daily (BID) in male or female patients (10–17 years) with bipolar I disorder (NCT01244815). Patients were stratified by current episode type (Diagnostic and Statistical Manual of Mental Disorders, fourth edition – defined mixed/manic), number of lifetime episodes (<3, 3–5, >5), and baseline BMI tertile. Changes from baseline to day 21 in Young Mania Rating Scale (YMRS) total score and Clinical Global Impressions Scale for use in Bipolar Illness (CGI-BP) were assessed in asenapine subgroups vs placebo. Results: In patients with mixed episodes, differences in YMRS and CGI-BP scores were statistically significant for each asenapine dose vs placebo (P<0.001) at day 21; in patients with manic episodes, significant differences vs placebo were seen in all groups (P<0.05) except 2.5 mg BID on the YMRS. In patients with <3 previous mixed/manic episodes, significant differences in YMRS and CGI-BP scores were observed for all asenapine doses vs placebo (P<0.05). In patients with 3–5 or >5 previous episodes, asenapine 10 mg BID was significantly different than placebo (P<0.05) on both scales; differences vs placebo varied for lower doses. Baseline body weight or BMI did not appear to influence the efficacy of asenapine. Conclusion: Asenapine was effective in the treatment of pediatric patients with bipolar I disorder. Efficacy did not appear to be influenced by the type of current episode, stage of disease progression, or baseline body weight/BMI.
AB - Background: Patient characteristics and disease progression may affect response to pharmacologic intervention in bipolar I disorder. Asenapine is approved for acute treatment of manic/mixed episodes of bipolar I disorder in patients 10–17 years old. Post hoc analyses assessed asenapine efficacy in pediatric patients by current manic or mixed episode, number of lifetime episodes, and baseline body mass index (BMI). Patients and methods: Data were obtained from a 3-week, randomized, double-blind, placebo-controlled, parallel-group trial of asenapine 2.5, 5.0, or 10.0 mg twice daily (BID) in male or female patients (10–17 years) with bipolar I disorder (NCT01244815). Patients were stratified by current episode type (Diagnostic and Statistical Manual of Mental Disorders, fourth edition – defined mixed/manic), number of lifetime episodes (<3, 3–5, >5), and baseline BMI tertile. Changes from baseline to day 21 in Young Mania Rating Scale (YMRS) total score and Clinical Global Impressions Scale for use in Bipolar Illness (CGI-BP) were assessed in asenapine subgroups vs placebo. Results: In patients with mixed episodes, differences in YMRS and CGI-BP scores were statistically significant for each asenapine dose vs placebo (P<0.001) at day 21; in patients with manic episodes, significant differences vs placebo were seen in all groups (P<0.05) except 2.5 mg BID on the YMRS. In patients with <3 previous mixed/manic episodes, significant differences in YMRS and CGI-BP scores were observed for all asenapine doses vs placebo (P<0.05). In patients with 3–5 or >5 previous episodes, asenapine 10 mg BID was significantly different than placebo (P<0.05) on both scales; differences vs placebo varied for lower doses. Baseline body weight or BMI did not appear to influence the efficacy of asenapine. Conclusion: Asenapine was effective in the treatment of pediatric patients with bipolar I disorder. Efficacy did not appear to be influenced by the type of current episode, stage of disease progression, or baseline body weight/BMI.
KW - Adolescent
KW - Asenapine
KW - Atypical antipsychotic
KW - Bipolar disorder
KW - Child
KW - Second-generation antipsychotic
UR - http://www.scopus.com/inward/record.url?scp=85057520600&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85057520600&partnerID=8YFLogxK
U2 - 10.2147/NDT.S165743
DO - 10.2147/NDT.S165743
M3 - Article
C2 - 30122926
AN - SCOPUS:85057520600
SN - 1176-6328
VL - 14
SP - 1941
EP - 1952
JO - Neuropsychiatric Disease and Treatment
JF - Neuropsychiatric Disease and Treatment
ER -