Long-term efficacy and safety of aripiprazole vs. olanzapine in schizophrenia: a 52-week, open-label extension study

Objective: To compare long-term efficacy, safety, and metabolic profile of aripiprazole with olanzapine in patients with acute relapse or chronic stable schizophrenia.

Methods: In this open-label extension trial, 214 Patients were randomized to aripiprazole (15–30mg/day, n=104) and olanzapine (10–20mg/day, n=110) for up to additional 52 weeks. Of these patients, 112 had previously completed a 26-week, randomized, double-blind, placebo-controlled trial of aripiprazole in stabilized patients with chronic schizophrenia and 102 patients had experienced a relapse after at least 2 weeks of double-blind treatment.

Results: While clinical improvement across all psychiatric scales was comparable between groups, olanzapine treatment led to significantly greater mean weight gain compared with aripiprazole (week 52 (LOCF): 2.54kg vs. 0.04kg; p<0.001). Significant differences favoring aripiprazole were also seen for the mean changes from baseline to Week 52 (LOCF) for fasting total cholesterol (aripiprazole, 1.6mg/dL; olanzapine, 17.2mg/dL; p=0.009), fasting LDL (aripiprazole, –1.5mg/dL; olanzapine, 13.9mg/dL; p=0.006) and fasting HDL (aripiprazole, +1.1mg/dL; olanzapine, –2.7mg/dL; p=0.026).

Conclusion: Symptom improvement in acutely relapsing and stable chronic patients treated for up to 52 weeks was comparable with aripiprazole and olanzapine. However, aripiprazole was consistently superior to olanzapine with regard to weight and metabolic factors.