PMID- 28343051
OWN - NLM
STAT- MEDLINE
DCOM- 20170619
LR  - 20181202
IS  - 1573-2517 (Electronic)
IS  - 0165-0327 (Linking)
VI  - 215
DP  - 2017 Jun
TI  - Tolerability of cariprazine in the treatment of acute bipolar I mania: A pooled 
      post hoc analysis of 3 phase II/III studies.
PG  - 205-212
LID - S0165-0327(16)32163-2 [pii]
LID - 10.1016/j.jad.2017.03.032 [doi]
AB  - BACKGROUND: Atypical antipsychotics have broad-spectrum efficacy against core 
      symptoms of acute mania/mixed states in bipolar disorder; however, they are 
      associated with clinically significant adverse effects (AEs). METHODS: This post 
      hoc analysis evaluated the safety and tolerability of the atypical antipsychotic 
      cariprazine in the treatment of adult patients with acute manic/mixed episodes of 
      bipolar I disorder. Data were taken from three 3-week randomized, double-blind, 
      placebo-controlled, flexible-dose trials of cariprazine 3-12mg/d. Patient 
      subgroups categorized by modal daily dose (3-6mg/d; 9-12mg/d) were used to assess 
      dose response. RESULTS: The pooled safety population comprised 1065 patients 
      (placebo=442; cariprazine 3-6mg/d=263; cariprazine 9-12mg/d=360). More 
      cariprazine- than placebo-treated patients reported double-blind 
      treatment-emergent AEs; the overall AE incidence was similar among 
      cariprazine-dose groups. AEs reported in >/=5% of cariprazine patients overall with 
      at least twice the incidence of placebo were akathisia, extrapyramidal symptoms, 
      restlessness, and vomiting. The incidence of SAEs was low and similar between the 
      placebo- and cariprazine-treatment groups. Metabolic parameter changes were small 
      and generally similar between cariprazine and placebo groups; mean increases in 
      fasting glucose levels were greater with cariprazine (3-6mg/d=6.6mg/dL; 
      9-12mg/d=7.2mg/dL) than placebo (1.7mg/dL). Mean weight change was 0.54kg and 
      0.17kg for cariprazine and placebo, respectively; weight increase >/=7% was <3% in 
      all treatment groups. Cariprazine was not associated with clinically meaningful 
      changes in electrocardiogram parameters. LIMITATIONS: Post hoc analysis, 
      flexible-dose design, short trial duration. CONCLUSION: Cariprazine was generally 
      safe and well-tolerated in patients with manic/mixed episodes associated with 
      bipolar I disorder.
CI  - Copyright (c) 2017 The Authors. Published by Elsevier B.V. All rights reserved.
FAU - Earley, Willie
AU  - Earley W
AD  - Allergan, Jersey City, NJ, USA. Electronic address: Willie.Earley@Allergan.com.
FAU - Durgam, Suresh
AU  - Durgam S
AD  - Allergan, Jersey City, NJ, USA.
FAU - Lu, Kaifeng
AU  - Lu K
AD  - Allergan, Jersey City, NJ, USA.
FAU - Debelle, Marc
AU  - Debelle M
AD  - Gedeon Richter PLC, Budapest, Hungary.
FAU - Laszlovszky, Istvan
AU  - Laszlovszky I
AD  - Gedeon Richter PLC, Budapest, Hungary.
FAU - Vieta, Eduard
AU  - Vieta E
AD  - Bipolar Disorder Unit, Institute of Neuroscience, Hospital Clinic, University of 
      Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.
FAU - Yatham, Lakshmi N
AU  - Yatham LN
AD  - University of British Columbia, Vancouver, BC, Canada.
LA  - eng
PT  - Journal Article
DEP - 20170309
PL  - Netherlands
TA  - J Affect Disord
JT  - Journal of affective disorders
JID - 7906073
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Piperazines)
RN  - F6RJL8B278 (cariprazine)
SB  - IM
MH  - Adult
MH  - Akathisia, Drug-Induced/etiology
MH  - Antipsychotic Agents/adverse effects/*therapeutic use
MH  - Bipolar Disorder/*drug therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Piperazines/adverse effects/*therapeutic use
MH  - Randomized Controlled Trials as Topic
EDAT- 2017/03/28 06:00
MHDA- 2017/06/20 06:00
CRDT- 2017/03/27 06:00
PHST- 2016/11/18 00:00 [received]
PHST- 2017/02/02 00:00 [revised]
PHST- 2017/03/08 00:00 [accepted]
PHST- 2017/03/28 06:00 [pubmed]
PHST- 2017/06/20 06:00 [medline]
PHST- 2017/03/27 06:00 [entrez]
AID - S0165-0327(16)32163-2 [pii]
AID - 10.1016/j.jad.2017.03.032 [doi]
PST - ppublish
SO  - J Affect Disord. 2017 Jun;215:205-212. doi: 10.1016/j.jad.2017.03.032. Epub 2017 
      Mar 9.