P0191 - Comparative efficacy and tolerability of intramuscular/oral ziprasidone versus haloperidol: Clinical findings in Asian and foreign patients with acute schizophrenia

Abstract

Background and Aims:

Second-generation antipsychotics (SGAs) have emerged as front-line treatment for many psychotic conditions due to reduced risk in extrapyramidal side effects (EPS) and related movement disorders. Available randomized, efficacy and tolerability data comparing conventional and SGA agents in Asian patients with acute exacerbation of schizophrenia are, however, limited.

Methods:

Our objective was to compare IM/oral ziprasidone (N=130) versus haloperidol (N=122) in a 6-week, randomized study of acute schizophrenia, conducted in 6 Asian countries/districts (Hong Kong, Malaysia, Philippines, Singapore, Taiwan, and Thailand). This study replicated an identically designed randomized trial conducted in Europe and South America (79% Caucasian, (N=600) (1).

Results:

At the end of IM treatment (<= 3 days), mean change in BPRS total score was -7.7 in the ziprasidone group compared with -5.8 in the haloperidol (p=0.066), and the magnitude of treatment difference (LS mean -1.9; 95%CI [-3.9, 0.1]) was similar to that observed in (1) (LS mean -2; 95%CI [-3.3, -0.8]). At endpoint, between-group differences in BPRS total score, CGI-S and COVI scores were not significant (p>0.74). Ziprasidone was significantly superior to haloperidol in movement disorder related measures (ESRS and Barnes Akathisia Scales) and EPS adverse event rates (4.6% vs. 22%, respectively, in the IM phase; 20% vs. 61%, respectively, in the IM and oral phases).

Conclusions:

These findings demonstrate consistent efficacy and tolerability advantages of ziprasidone over haloperidol in different ethnic groups, and support the use of bridging evidence from foreign studies for Asian patients with schizophrenia.