Table 2.

Safety/tolerability differences emerging in three longer-term studies (28–44 weeks) comparing ziprasidone to olanzapine or to risperidone

	Safety/tolerability results that favored ziprasidone (40−80 mg bid) over:
	Olanzapine 5−15 mg bid	Olanzapine 10−20 mg bid	Risperidone 3−5 mg bid
	6-month, blinded extension for completers of a 6-week, randomized, double-blind study (Simpson et al 2002a)	28-week, randomized, double-blind study (Kane et al 2003)	44-week, blinded extension for completers of 8-week, randomized, double-blind study (Addington et al 2003b)
Overall rates of laboratory abnormalities	(no significant differences)	NR	Zip 57% Risp 96% Group difference p < 0.001
Weight	Zip = −3 lbs p < 0.001 Olanz = +10 lbs p < 0.001 Group difference p < 0.001	Zip −2.5 lbs (p not given) Olanz +6.7 lbs (p not given) Group difference p < 0.001	Zip = +1 lb Risp = +8 lbs (p not given)
Body mass index change	Zip no change ns Olanz mean gain p < 0.001 Group difference p < 0.001	NR	NR
Insulin	Zip +1 μ/mL ns Olanz +2 μ/mL p < 0.01 Group difference ns	NR	NR
Glucose	Zip +2 mg/dL ns Olanz +5 mg/dL p < 0.05 Group difference ns	Zip 0 mg/dL ns Olanz +5 mg/dL (p not given) Group difference p < 0.001	NR
Prolactin	NR	(no significant differences)	Zip −8 ng/mL Risp +26 ng/mL (p not given)
Total cholesterol	Zip −1 mg/dL ns Olanz +13 mg/dL p < 0.05 Group difference ns	Zip −12 mg/dL (p not given) Olanz +3 mg/dL (p not given) Group difference p < 0.001	NR
HDL cholesterol	NR	Zip +1 mg/dL (p not given) Olanz −3 mg/dL (p not given) Group difference p < 0.001	NR
LDL cholesterol	Zip +9 mg/dL ns Olanz +17 mg/dL p < 0.05 Group difference ns	Zip −10 mg/dL (p not given) Olanz +2 mg/dL (p not given) Group difference: p < 0.01	NR
Triglycerides	NR	Zip −20 mg/dL (p not given) Olanz +32 mg/dL (p not given) Group difference p < 0.001	NR
Hepatic enzymes	Zip no change in AST level Olanz increased AST p < 0.001 Group difference p < 0.05 Zip no change in ALT level Olanz increased ALT p < 0.01 Group difference p < 0.01	NR	NR
Rates of specific adverse effects	Zip vs olanz: Weight gain 0% vs 17% p < 0.01	Zip vs olanz: Weight gain 2% vs 13% p < 0.001 Increased appetite 3% vs 7% p < 0.05	Zip < risp: Increased salivation (= 5 times lower) Akathisia (= 3 times lower)(actual rates and p not given)
Abnormal movements	Baseline to end point: Zip AIMS −0.3 (p not given) Olanz AIMS −0.8 (p not given) Group difference p < 0.05 (no significant group differences on BAS or ESRS scores)	Largest changes from baseline Zip: AIMS +0.5 (p not given) Olanz: AIMS +0.2 (p not given) Group difference p = 0.01 Zip: BAS +0.3 (p not given) Olanz: BAS +0.2 (p not given) Group difference p < 0.05 Zip: SAS +0.6 (p not given) Olanz: SAS −0.0 (p not given) Group difference p < 0.001	(No significant group differences on AIMS, BAS, MDBS, or SAS)
Rates of specific adverse effects	Zip vs olanz: EPS 11% vs 4% p < 0.05 Tremor 8% vs 3% p < 0.05	Zip vs olanz: Insomnia 22% vs 7% p < 0.001 Vomiting 9% vs 4% p < 0.05 Anorexia 3% vs 0% p < 0.05 Dystonia 0% vs 2% p < 0.05 Hypotension 0% vs 2% p < 0.05 Aggravated psychosisc 4% vs 1% p < 0.05	Zip > risp: Insomnia (≈ 3 times higher)(actual rates and p not given)

^aChanges from start of 6-week phase (Simpson et al 2001) to end of extension phase (last observation carried forward, unless otherwise stated).

^bChanges from start of 8-week phase (Addington et al 2002) to end of extension phase (last observation carried forward, unless otherwise stated).

^cCases of aggravated psychosis that led to discontinuation of treatment.

Abbreviations: AIMS, Abnormal Involuntery Movements Scale; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BAS, Barnes Akathisia Scale; EPS, extrapyramidal symptoms; ESRS, Extrapyramidal Symptom Rating Scale; HDL, high-density lipoprotein; LDL, low-density lipoprotein; MDBS, Movement Disorder Burden Scale; NR, not reported; ns, not significant; olanz, olanzapine; risp, risperidone; SAS, Simpson-Angus Scale; zip, ziprasidone.