Switching to aripiprazole in outpatients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues with risperidone: a randomized, multicentre, open-label study.
BACKGROUND
This study evaluated the safety/tolerability and effectiveness of aripiprazole titrated-dose versus fixed-dose switching strategies from risperidone in patients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues.


METHODS
Patients were randomized to an aripiprazole titrated-dose (starting dose 5 mg/day) or fixed-dose (dose 15 mg/day) switching strategy with risperidone down-tapering. Primary endpoint was rate of discontinuation due to adverse events (AEs) during the 12-week study. Secondary endpoints included positive and negative syndrome scale (PANSS), clinical global impressions - improvement of illness scale (CGI-I), preference of medication (POM), subjective well-being under neuroleptics (SWN-K) and GEOPTE (Grupo Español para la Optimización del Tratamiento de la Esquizofrenia) scales.


RESULTS
Rates of discontinuations due to AEs were similar between titrated-dose and fixed-dose strategies (3.5% vs. 5.0%; p=0.448). Improvements in mean PANSS total scores were similar between aripiprazole titrated-dose and fixed-dose strategies (-14.8 vs. -17.2; LOCF), as were mean CGI-I scores (2.9 vs. 2.8; p=0.425; LOCF) and SWN-K scores (+8.6 vs.+10.3; OC,+7.8 vs.+9.8; LOCF).


CONCLUSIONS
Switching can be effectively and safely achieved through a titrated-dose or fixed-dose switching strategy for aripiprazole, with down-titration of risperidone.
Ryckmans
V
V
Cabinet de Consultations, Avenue Vanhaelen 25, Brussels 1160, Belgium. vincent.ryckmans@yahoo.fr
Kahn
J P
JP
Modell
S
S
Werner
C
C
McQuade
R D
RD
Kerselaers
W
W
Lissens
J
J
Sanchez
R
R
D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D000068180:Aripiprazole; D003071:Cognition; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D017060:Patient Satisfaction; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects*; D011388:Prolactin / Q000097:blood; D011788:Quality of Life; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects*; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects*; D012559:Schizophrenia / Q000188:drug therapy*; D019529:Sexuality; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole; D011388:Prolactin; D018967:Risperidone