The effectiveness and safety of amisulpride in Chinese patients with schizophrenia who switch from risperidone or olanzapine: a subgroup analysis of the ESCAPE study

Figures & data

Figure 1 Patient flow chart.

Table 1 Demographics and baseline characteristics

Variablesa	Switch from risperidone (n=68)	Switch from olanzapine (n=41)	Treatment-naïve (n=59)
Age, years	33.9 (10.9)	31.7 (11.8)	31.5 (12.0)
Male, n (%)	36 (52.9)	18 (43.9)	28 (47.5)
BMI, kg/m^2	23.8 (4.1)	23.2 (3.0)	21.9 (4.1)
Baseline PANSS Total score	89.5 (11.8)	89.1 (15.7)	90.7 (14.1)
Baseline PANSS Positive score	23.9 (4.9)	24.0 (6.4)	25.1 (5.7)
Baseline PANSS Negative score	22.9 (7.1)	25.0 (9.1)	22.9 (8.2)
Baseline excitement score	13.8 (4.3)	13.5 (5.3)	14.8 (5.4)
Baseline CGI-S score	5.4 (0.8)	5.3 (0.7)	5.5 (0.8)

Note:

a Variables are summarized as mean (SD) unless otherwise specified.

Abbreviations: BMI, body mass index; CGI-S, Clinical Global Impression-Severity of Illness scale; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation.

Table 2 Summary of amisulpride exposure and concomitant medication use

Variable	Switch from risperidone (n=68)	Switch from olanzapine (n=41)	Treatment-naïve (n=59)	P-valuea
Week 1 mean dose of amisulpride, mg/day (SD)	413.5 (148.7)	412.2 (134.0)	410.3 (170.4)	0.993
Mean dose of amisulpride in first 2 weeks, mg/day (SD)	543.7 (171.5)	549.3 (159.0)	511.1 (204.5)	0.494
Week 8 mean dose of amisulpride, mg/day (SD)	747.8 (223.7)	822.7 (211.5)	700.0 (253.0)	0.066b
Use of any concomitant medication, n (%)	51 (75.0)	22 (53.7)	26 (44.1)	–
Concomitant medication by indication, n (%)c,d				–
Anxiety and agitation (benzodiazepines)	18 (26.5)	9 (22.0)	11 (18.6)	–
Extrapyramidal side effects (trihexyphenidyl, promethazine, and diphenhydramine)	29 (42.6)	11 (26.8)	18 (30.5)	–
Insomnia (zolpidem, zopiclone, and zaleplon)	14 (20.6)	9 (22.0)	7 (11.9)	–

Notes:

a Intergroup P-value for chi-square test,

b switch from risperidone vs switch from olanzapine, P=0.280; switch from risperidone vs treatment-naïve, P=0.534; switch from olanzapine vs treatment-naïve, P=0.052,

c concomitant medications as approved in the protocol,

d patients may have initiated concomitant medications before the beginning of the trial.

Abbreviation: SD, standard deviation.

Figure 2 Efficacy of amisulpride in Chinese patients with schizophrenia who switched from risperidone or olanzapine.

Note: P-values are for a chi-square test comparing intergroup differences.
Abbreviation: PANSS, Positive and Negative Syndrome Scale.

Figure 3 Effectiveness of amisulpride from Baseline to Week 8 in patients who switched from olanzapine or risperidone evaluated by (A) PANSS Total score, (B) PANSS Positive score, (C) PANSS Negative score, and (D) CGI-S score.

Abbreviations: CGI-S, Clinical Global Impression-Severity of Illness scale; PANSS, Positive and Negative Syndrome Scale.

Table 3 Baseline variables for responders (≥50% decrease in PANSS Total score from Baseline to Week 8) and nonresponders to amisulpride who switched from risperidone or olanzapine

Baseline variablesa	Switch from risperidone (n=68)			Switch from olanzapine (n=41)
	Responderb (n=53)	Nonresponderc (n=15)	P-value	Responderb (n=23)	Nonresponderc (n=18)	P-value
Age, years	33.7 (10.1)	34.7 (14.2)	0.8882	32.5 (11.0)	30.8 (13.0)	0.2631
BMI, kg/m^2	23.5 (4.1)	24.8 (3.9)	0.2437	23.1 (2.6)	23.2 (3.5)	0.8664
Height, m	167.1 (7.8)	168.3 (8.0)	0.5846	166.5 (6.2)	165.7 (6.3)	0.6828
PANSS Total score	90.8 (12.4)	84.9 (8.03)	0.0833	87.7 (13.2)	91.0 (18.7)	0.5053
PANSS Positive score	24.7 (4.6)	21.2 (5.1)	0.0143	23.6 (7.1)	24.5 (5.6)	0.8952
PANSS Negative score	22.7 (7.3)	23.8 (6.2)	0.5854	24.3 (8.5)	25.9 (10.0)	0.5949
Excitement score	14.4 (4.2)	11.7 (3.8)	0.0292	12.9 (4.9)	14.4 (5.8)	0.3691
CGI-S score	5.5 (0.8)	5.1 (0.7)	0.0369	5.2 (0.7)	5.4 (0.7)	0.1702
Week 1 amisulpride dose, mg/day	414.6 (156.7)	409.7 (120.8)	0.8068	421.7 (112.8)	400.0 (159.6)	0.2157
Week 2 amisulpride dose, mg/day	543.5 (183.7)	544.4 (124.4)	0.9857	563.2 (124.3)	531.5 (197.2)	0.4382

Notes:

a All values are mean (SD);

b patients achieving ≥50% decrease in PANSS Total score from Baseline to Week 8;

c patients not achieving ≥50% decrease in PANSS Total score from Baseline to Week 8.

Abbreviations: BMI, body mass index; CGI-S, Clinical Global Impression-Severity of Illness scale; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation.

Table 4 Summary of safety of amisulpride in patients who switched from risperidone or olanzapine

Event, n (%)	Switch from risperidone (n=68)	Switch from olanzapine (n=41)	Treatment-naïve (n=59)
≥1 AE	48 (70.6)	27 (65.9)	36 (61.0)
Nervous system	28 (41.2)	13 (31.7)	22 (37.3)
Extrapyramidal side effects	22 (32.4)	6 (14.6)	15 (25.4)
Akathisia	4 (5.9)	3 (7.3)	4 (6.8)
Tremors	2 (2.9)	0 (0)	0 (0)
Lethargy	1 (1.5)	0 (0)	1 (1.7)
Hypersomnia	1 (1.5)	0 (0)	1 (1.7)
Dizziness	1 (1.5)	0 (0)	1 (1.7)
Dystonia	0 (0)	4 (9.8)	2 (3.4)
Somnolence	0 (0)	0 (0)	1 (1.7)
Laboratory abnormalities and ECG	24 (35.3)	20 (48.8)	27 (45.8)
Prolactin increase (>25 ng/mL)a	22 (32.4)	16 (39.0)	23 (39.0)
Increase in body weight (<7% increase from Baseline)	3 (4.4)	5 (12.2)	3 (5.1)
ECG T-wave abnormalities	3 (4.4)	0 (0)	0 (0)
Alanine aminotransferase increase	1 (1.5)	0 (0)	4 (6.8)
ECG abnormality	1 (1.5)	0 (0)	0 (0)
Elevated transaminase	1 (1.5)	0 (0)	1 (1.7)
Long QT syndrome	0 (0)	1 (2.4)	2 (3.4)
Elevated blood lipid level	0 (0)	0 (0)	1 (1.7)
Endocrine system	9 (13.2)	0 (0)	3 (5.1)
Hyperprolactinemiaa	9 (13.2)	0 (0)	3 (5.1)
Psychiatric disorders	5 (7.4)	1 (2.4)	2 (3.4)
Sleep disorders	3 (4.4)	0 (0)	0 (0)
Insomnia	1 (1.5)	0 (0)	0 (0)
Sleep abnormalities	1 (1.5)	0 (0)	0 (0)
Agitation	0 (0)	1 (2.4)	0 (0)
Apathy	0 (0)	0 (0)	1 (1.7)
Decreased activity	0 (0)	0 (0)	1 (1.7)
Gastrointestinal disorders	3 (4.4)	0 (0)	3 (5.1)
Cardiovascular system	3 (4.4)	2 (4.9)	2 (3.4)
Sinus bradycardia	3 (4.4)	1 (2.4)	1 (1.7)
Sinus arrhythmia	0 (0)	1 (2.4)	1 (1.7)
Reproductive system	3 (4.4)	0 (0)	1 (1.7)

Note:

a Blood prolactin increase with clinical symptoms.

Abbreviations: AE, adverse event; ECG, electrocardiogram.