A double-blind, randomized comparative study of aripiprazole and olanzapine in patients with schizophrenia.
BACKGROUND
Few studies have directly compared the efficacy and tolerability of atypical agents.


METHODS
This multicenter, randomized, double-blind study compared the efficacy and tolerability of aripiprazole (n = 355) with olanzapine (n = 348) in patients with schizophrenia experiencing acute relapse. After a 6-week acute treatment phase, patients with Clinical Global Impression-Improvement = 1-3 or > or = 20% reduction in the Positive and Negative Symptom Scale (PANSS) Total score could progress to the 46-week outpatient extension phase. Co-primary study objectives were to compare efficacy at Week 6 and weight gain liability from baseline to Week 26.


RESULTS
The mean olanzapine dose was 15.4 mg/day compared with a mean aripiprazole dose of 23.0 mg/day. More patients treated with olanzapine (47%) completed the 52-week study than those treated with aripiprazole (39%); time to discontinuation was significantly in favor of olanzapine (p < .05). At Week 6, mean change in PANSS Total score (olanzapine, -29.5; aripiprazole, -24.6 [random regression model]) showed a treatment difference of 4.9 points. As the pre-specified non-inferiority margin (6 points) was within the 95% confidence interval (2.2-7.6) for treatment difference, olanzapine proved to be superior to aripiprazole on this measure. More patients experienced significant weight gain at Week 26 with olanzapine (40%) than with aripiprazole (21%; p < .05 [weighted generalized estimating equation analysis]), with significant differences observed from Week 3. Mean weight gain at Week 26 was significantly greater with olanzapine than with aripiprazole (+4.30 kg vs. +.13 kg, respectively).


CONCLUSIONS
Olanzapine had a statistically significant efficacy advantage over aripiprazole, whereas aripiprazole was associated with significantly less weight gain.
Fleischhacker
W Wolfgang
WW
Department of Biological Psychiatry, Medical University of Innsbruck, Austria. wolfgang.fleischhacker@i-med.ac.at
McQuade
Robert D
RD
Marcus
Ronald N
RN
Archibald
Donald
D
Swanink
René
R
Carson
William H
WH
D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D001835:Body Weight / Q000187:drug effects; D004311:Double-Blind Method; D004562:Electrocardiography / Q000187:drug effects; D005260:Female; D005947:Glucose / Q000378:metabolism; D006801:Humans; D050356:Lipid Metabolism; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011388:Prolactin / Q000097:blood; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D001569:Benzodiazepines; D000068180:Aripiprazole; D011388:Prolactin; D005947:Glucose; D000077152:Olanzapine