Risk for adverse events and discontinuation due to adverse events of ziprasidone
monotherapy relative to placebo in the acute treatment of bipolar depression,
mania, and schizophrenia.
Author(s): Gao K(1), Pappadopulos E, Karayal ON, Kolluri S, Calabrese JR.
Affiliation(s): Author information:
(1)Mood and Anxiety Clinic in the Mood Disorders Program of the Department of
Psychiatry, University Hospitals Case Medical Center, Case Western Reserve
University, Cleveland, OH 44106, USA. keming.gao@uhhospitals.org
Publication date & source: 2013, J Clin Psychopharmacol. , 33(3):425-31
OBJECTIVE: This study aimed to examine the risk difference (RD) in the
discontinuation due to adverse events, akathisia, overall extrapyramidal symptoms
(EPS), reported-somnolence, and 7% or greater weight gain between ziprasidone
monotherapy and placebo in the acute treatment of bipolar depression (BPD),
bipolar mania (BPM), and schizophrenia.
METHODS: Pooled data from 9 randomized, double-blind, placebo-controlled, acute
studies of ziprasidone in BPD, BPM, and schizophrenia were used. The number
needed to treat to harm (NNTH) of ziprasidone relative to placebo was estimated
when an RD was statistically significant.
RESULTS: The RD in discontinuation due to adverse events or 7% or greater weight
gain between ziprasidone and placebo was not significant in all 3 psychiatric
conditions. The risk for akathisia with ziprasidone was significantly higher in
BPD with an RD of 2.3% (NNTH = 44) and in BPM with an RD of 8.4% (NNTH = 12).
Risk for overall EPS with ziprasidone was significantly higher in BPM with an RD
of 8.7% (NNTH = 12) and schizophrenia with an RD of 3.3% (NNTH = 30). Risk of
reported-somnolence with ziprasidone was also significantly higher in BPD with an
RD of 11.8% (NNTH = 8), BPM with an RD of 14.3% (NNTH = 7), and schizophrenia
with an RD of 7% (NNTH = 14). Dose-dependent increase in the risk for reported
somnolence with ziprasidone was observed in BPD and schizophrenia.
CONCLUSIONS: Ziprasidone was associated with significant differential adverse
effects relative to placebo in BPM, BPD, and schizophrenia with no significant
difference in weight gain in all 3 groups. Self-reported somnolence was increased
across the 3 conditions. Subjects with BPM were more vulnerable to EPS than those
with BPD or schizophrenia.
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