PMID- 27629292
OWN - NLM
STAT- MEDLINE
DCOM- 20170629
LR  - 20240123
IS  - 1092-8529 (Print)
IS  - 1092-8529 (Linking)
VI  - 21
IP  - 6
DP  - 2016 Dec
TI  - Once-monthly paliperidone palmitate compared with conventional and atypical daily 
      oral antipsychotic treatment in patients with schizophrenia.
PG  - 466-477
LID - 10.1017/S1092852916000444 [doi]
AB  - OBJECTIVE: This analysis of the Paliperidone Palmitate Research in Demonstrating 
      Effectiveness (PRIDE) study (NCT01157351) compared outcomes after administration 
      of once-monthly paliperidone palmitate (PP) vs conventional oral antipsychotics 
      (COAs) or atypical oral antipsychotics (AOAs). METHODS: PRIDE was a 15-month 
      study of 444 individuals with schizophrenia and a history of incarceration. They 
      were randomly assigned to PP or to 1 of 7 commonly prescribed OAs. Primary 
      endpoint was time to first treatment failure (TF). Event-free probabilities were 
      estimated using the Kaplan-Meier method; treatment group differences (PP vs COAs, 
      PP vs AOAs, and PP vs oral paliperidone/risperidone) were assessed using a 
      log-rank test. Hazard ratios (HRs) and 95% confidence intervals (CIs) were 
      estimated using Cox proportional hazards regression models. No adjustment was 
      made for multiplicity. RESULTS: Compared with PP, risk for first TF was 34% 
      higher with COAs (HR: 1.34; 95% CI: 0.80-2.25), 41% higher with AOAs (HR: 1.41; 
      95% CI: 1.06-1.88), and 39% higher with paliperidone/risperidone (HR: 1.39; 95% 
      CI: 0.97-1.99). Incidences of extrapyramidal symptom-related adverse events (AEs) 
      were 45.7%, 13.7%, and 10.6% in the COA, AOA, and oral paliperidone/risperidone 
      groups vs 23.9% in the PP group. Incidences of prolactin-related AEs were 5.7%, 
      3.8%, and 3.5% vs 23.5%, and incidences of >/=7% weight increase were 11.4%, 14.9%, 
      and 16.0% vs 32.4%. CONCLUSIONS: Results suggest a lower risk of TF but a higher 
      rate of some AEs after treatment with PP vs COAs, AOAs, and 
      paliperidone/risperidone. Deselection of specific OAs and low patient-compliance 
      rates with OAs likely biased the safety results.
FAU - Kim, Edward
AU  - Kim E
AD  - Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
FAU - Correll, Christoph U
AU  - Correll CU
AD  - Hofstra Northwell School of Medicine, Hempstead, New York, USA.
AD  - Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, New York, USA.
FAU - Mao, Lian
AU  - Mao L
AD  - Janssen Research & Development, LLC, Titusville, New Jersey, USA.
FAU - Starr, H Lynn
AU  - Starr HL
AD  - Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
FAU - Alphs, Larry
AU  - Alphs L
AD  - Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160915
PL  - United States
TA  - CNS Spectr
JT  - CNS spectrums
JID - 9702877
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 12794-10-4 (Benzodiazepines)
RN  - 2S3PL1B6UJ (Quetiapine Fumarate)
RN  - 82VFR53I78 (Aripiprazole)
RN  - FTA7XXY4EZ (Perphenazine)
RN  - J6292F8L3D (Haloperidol)
RN  - L6UH7ZF8HC (Risperidone)
RN  - N7U69T4SZR (Olanzapine)
RN  - R8P8USM8FR (Paliperidone Palmitate)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Antipsychotic Agents/*administration & dosage/therapeutic use
MH  - Aripiprazole/therapeutic use
MH  - Basal Ganglia Diseases/chemically induced
MH  - Benzodiazepines/therapeutic use
MH  - Delayed-Action Preparations
MH  - Female
MH  - Haloperidol/therapeutic use
MH  - Humans
MH  - Hyperprolactinemia/chemically induced
MH  - Injections, Intramuscular
MH  - Male
MH  - Middle Aged
MH  - Olanzapine
MH  - Paliperidone Palmitate/*administration & dosage/therapeutic use
MH  - Perphenazine/therapeutic use
MH  - Proportional Hazards Models
MH  - Quetiapine Fumarate/therapeutic use
MH  - Risperidone/therapeutic use
MH  - Schizophrenia/*drug therapy
MH  - Schizophrenic Psychology
MH  - Treatment Failure
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Long-acting injectable antipsychotic
OT  - PRIDE
OT  - oral antipsychotic
OT  - paliperidone palmitate
OT  - schizophrenia
EDAT- 2016/09/16 06:00
MHDA- 2017/07/01 06:00
CRDT- 2016/09/16 06:00
PHST- 2016/09/16 06:00 [pubmed]
PHST- 2017/07/01 06:00 [medline]
PHST- 2016/09/16 06:00 [entrez]
AID - S1092852916000444 [pii]
AID - 10.1017/S1092852916000444 [doi]
PST - ppublish
SO  - CNS Spectr. 2016 Dec;21(6):466-477. doi: 10.1017/S1092852916000444. Epub 2016 Sep 
      15.