PMID- 27550371
OWN - NLM
STAT- MEDLINE
DCOM- 20180108
LR  - 20181202
IS  - 1179-1934 (Electronic)
IS  - 1172-7047 (Linking)
VI  - 30
IP  - 11
DP  - 2016 Nov
TI  - Tolerability and Safety Profile of Cariprazine in Treating Psychotic Disorders, 
      Bipolar Disorder and Major Depressive Disorder: A Systematic Review with 
      Meta-Analysis of Randomized Controlled Trials.
PG  - 1043-1054
AB  - BACKGROUND: Cariprazine is a novel antipsychotic agent recently approved for 
      treating schizophrenia and bipolar mania in the USA. The sample sizes of 
      published randomized controlled trials (RCTs) of the drug are small; previous 
      meta-analyses included few RCTs and did not specifically investigate the 
      tolerability/safety profile of cariprazine. OBJECTIVE: Our objective was to 
      conduct a meta-analysis of published RCTs to systematically review the 
      tolerability and safety of cariprazine versus placebo. METHODS: We searched the 
      clinical trial registers (the metaRegister of controlled trials, 
      ClinicalTrials.gov and the World Health Organization International Clinical 
      Trials Registry Platform) and electronic databases (PubMed, Embase, PsycINFO and 
      Cochrane library) up to June 2016 to identify phase II/III RCTs of cariprazine in 
      patients with schizophrenia, bipolar disorder or major depressive disorder. We 
      conducted a meta-analysis to investigate outcomes, including risks of 
      discontinuation due to adverse events (AEs), extrapyramidal side effects (EPS) or 
      related events, metabolic syndrome and cardiovascular-related events. RESULTS: We 
      included nine RCTs, with a total of 4324 subjects. The risk of discontinuation 
      due to AEs for cariprazine was similar to that for placebo (risk ratio [RR] 1.13, 
      95 % confidence interval [CI] 0.77-1.66). Cariprazine was associated with higher 
      risks of EPS-related events than was placebo, including risk of akathisia (RR 
      3.92, 95 % CI 2.83-5.43), tremor (RR 2.41, 95 % CI 1.53-3.79) and restlessness 
      (RR 2.17, 95 % CI 1.38-3.40). The cariprazine treatment group was more likely to 
      have clinically significant weight gain (RR 1.68, 95 % CI 1.12-2.52). No 
      statistically significant differences in results were found in other metabolic 
      parameters or cardiovascular-related events. CONCLUSION: There was a 
      statistically significant higher risk of EPS-related AEs and a slight increase in 
      mean body weight with cariprazine. There were no statistically significant 
      effects on prolactin level or cardiovascular parameters. EPSs were the main 
      short-term adverse reactions reported in the limited number of patients studied. 
      Further clinical and post-marketing pharmacovigilance studies are needed to 
      investigate the long-term safety of cariprazine.
FAU - Lao, Kim S J
AU  - Lao KS
AD  - Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, Centre 
      for Safe Medication Practice and Research, The University of Hong Kong, 2/F 
      Laboratory Block FMB, 21 Sassoon Road, Hong Kong SAR, China.
FAU - He, Ying
AU  - He Y
AD  - Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, Centre 
      for Safe Medication Practice and Research, The University of Hong Kong, 2/F 
      Laboratory Block FMB, 21 Sassoon Road, Hong Kong SAR, China.
FAU - Wong, Ian C K
AU  - Wong IC
AD  - Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, Centre 
      for Safe Medication Practice and Research, The University of Hong Kong, 2/F 
      Laboratory Block FMB, 21 Sassoon Road, Hong Kong SAR, China.
AD  - Research Department of Practice and Policy, UCL, School of Pharmacy, London, UK.
FAU - Besag, Frank M C
AU  - Besag FM
AD  - Research Department of Practice and Policy, UCL, School of Pharmacy, London, UK.
AD  - East London NHS Foundation Trust, Bedfordshire, London, UK.
AD  - Institute of Psychiatry, Psychology and Neuroscience, London, UK.
FAU - Chan, Esther W
AU  - Chan EW
AD  - Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, Centre 
      for Safe Medication Practice and Research, The University of Hong Kong, 2/F 
      Laboratory Block FMB, 21 Sassoon Road, Hong Kong SAR, China. ewchan@hku.hk.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
PL  - New Zealand
TA  - CNS Drugs
JT  - CNS drugs
JID - 9431220
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Piperazines)
RN  - F6RJL8B278 (cariprazine)
SB  - IM
MH  - Antipsychotic Agents/*adverse effects/*therapeutic use
MH  - Bipolar Disorder/*drug therapy
MH  - Clinical Trials, Phase II as Topic
MH  - Clinical Trials, Phase III as Topic
MH  - Depressive Disorder, Major/*drug therapy
MH  - Humans
MH  - Piperazines/*adverse effects/*therapeutic use
MH  - Psychotic Disorders/*drug therapy
MH  - Schizophrenia
EDAT- 2016/10/26 06:00
MHDA- 2018/01/09 06:00
CRDT- 2016/08/24 06:00
PHST- 2016/10/26 06:00 [pubmed]
PHST- 2018/01/09 06:00 [medline]
PHST- 2016/08/24 06:00 [entrez]
AID - 10.1007/s40263-016-0382-z [pii]
AID - 10.1007/s40263-016-0382-z [doi]
PST - ppublish
SO  - CNS Drugs. 2016 Nov;30(11):1043-1054. doi: 10.1007/s40263-016-0382-z.