Safety and effectiveness of lurasidone in the treatment of Chinese schizophrenia patients: An interim analysis of post-marketing surveillance

Table 1 Baseline demographics and clinical characteristics (n = 965)

Background factor	Category	n (%)
Sex	Male	378 (39.2%)
	Female	587 (60.8%)
Age	mean ± SD	35.4 ± 14.27
	< 18 yr	72 (7.5%)
	18 yr	892 (92.5%)
Height (cm)	mean ± SD	166.1 ± 7.97
Weight (kg)	mean ± SD	66.0 ± 13.86
Months since onset of first episode	mean ± SD	92.6 ± 113.95
Months since onset of current episode	mean ± SD	5.8 ± 55.52
Baseline BPRS score	mean ± SD	43.6 ± 15.28
Comorbidity of mental disorder besides schizophrenia	Yes	958 (99.3%)
Comorbidity besides mental disorder	Yes	848 (88.1%)
Antipsychotic medication within 1 mo prior to baseline	Yes	532 (55.3%)

BPRS: Brief psychiatric rating scale.

Table 2 Concomitant therapy (n = 949¹)

Category	n	%
All	544	57.3
Pharmacological therapy	520	54.8
Oral antipsychotic drugs	434	45.7
Injectable antipsychotics	12	1.3
Sedative-hypnotics/EPS drugs	112	11.8
Mood stabilizers/antiepileptic drugs	39	4
Antidepressants/anxiolytics	61	6.4
Other categories	105	11.0
Non-pharmacological therapy	156	16.4
ECT	12	1.3
rTMS	14	1.5
Other categories	142	15

¹n = 949, number of patients in the full analysis set with concomitant therapy data documentation.

EPS: Extrapyramidal symptoms; ECT: Electroconvulsive shock therapy; rTMS: Repetitive transcranial magnetic stimulation.

Table 3 Summary of adverse events and adverse drug reactions (n = 894)

Category	n	%
Any AE	101	11.3%
Any ADR	78	8.7%
AE leading to discontinuation	14	1.6%
ADR leading to discontinuation	12	1.3%
EPS AE	29	3.1%
EPS ADR	25	2.7%
EPS AE leading to discontinuation	3	0.3%
EPS ADR leading to discontinuation	3	0.3%
Serious AE	1	0.1%
Serious ADR	1	0.1%

AE: Adverse event; ADR: Adverse drug reactions; EPS: Extrapyramidal symptoms.

Table 4 Percentage of participants with extrapyramidal symptom adverse drug reactions (n = 894)

Category	n	%
All	25	2.8%
Acute dystonia	7	0.8%
Akathisia	20	2.2%
Parkinsonism	2	0.2%
Tardive dystonia	0	0.0%
Other EPS ADR	0	0.0%

EPS: Extrapyramidal symptoms; ADR: Adverse drug reactions.

Table 5 Summary of weight gain (n = 894)

	Total
Baseline (mean ± SD)	66.21 ± 14.01
12 weeks (mean ± SD)	66.21 ± 13.70
Change in body weight (mean ± SD)	0.20 ± 2.361
Weight gain from baseline ≥ 7%, n (%)	7 (0.8%)

¹P < 0.05.

Table 6 Changes in laboratory values from baseline to week 12

Measure	n	Mean	SD
GPT (U/L)
Baseline	376	25.14	21.548
Week 12	109	27.33	20.624
Mean change	93	5.381	21.705
GOT (U/L)
Baseline	363	22.19	12.715
Week 12	108	24.39	12.565
Mean change	92	0.96	16.625
Serum creatinine (μmol/L)
Baseline	370	65.86	16.383
Week 12	106	69.26	14.695
Mean change	90	1.21	10.854
Fasting blood glucose (mmol/L)
Baseline	368	5.478	1.536
Week 12	101	5.451	1.5486
Mean change	84	-0.162	1.4467
Total cholesterol (mmol/L)
Baseline	363	4.501	1.0389
Week 12	101	4.551	1.0888
Mean change	83	-0.079	1.1075
Triglycerides (mmol/L)
Baseline	362	1.589	1.3002
Week 12	101	1.655	0.8413
Mean change	82	-0.207	1.3234
HDL cholesterol (mmol/L)
Baseline	359	1.287	0.365
Week 12	99	1.308	0.3959
Mean change	82	0.073	0.415
LDL cholesterol (mmol/L)
Baseline	344	2.694	0.8467
Week 12	90	2.746	0.7907
Mean change	73	-0.086	0.7312
QTc interval (ms)
Baseline	280	415.6	93.41
Week 12	71	402	29.32
Mean change	57	-0.2	35.76

¹P < 0.05.

GPT: Glutamic pyruvic transaminase; GOT: Glutamic oxaloacetic transaminase; HbA1c: Glycosylated hemoglobin; LDL: Low-density lipoprotein; HDL: High density lipoprotein.

Table 7 Change from baseline to week 12 (last-observation-carried forward) in the total brief psychiatric rating scale score and 5-factor model score

BPRS (mean ± SD)	Baseline (n = 959)	2/4 wk (n = 959)	6/8 wk (n = 959)	12 wk ± 14 d (n = 959)
Total score	43.6 ± 15.28	34.7 ± 12.22	30.1 ± 10.68	26.8 ± 9.58
Change in total score	-	-8.9 ± 9.761	-13.5 ± 12.291	-16.8 ± 13.971
Anxiety-depression	9.3 ± 4.00	7.6 ± 3.20	6.7 ± 2.75	6.0 ± 2.45
Change in anxiety-depression score	-	-1.6 ± 2.401	-2.6 ± 2.941	-3.3 ± 3.421
Anergia	8.9 ± 3.55	7.5 ± 3.01	6.7 ± 2.75	6.2 ± 2.47
Change in anergia score	-	-1.4 ± 2.281	-2.2 ± 2.691	-2.8 ± 3.001
Thought disturbance	10.7 ± 4.40	8.3 ± 3.49	7.1 ± 3.07	6.2 ± 2.79
Change in thought disturbance score	-	-2.4 ± 3.031	-3.7 ± 3.771	-4.5 ± 4.151
Activation	5.9 ± 3.10	4.7 ± 2.35	4.2 ± 1.86	3.8 ± 1.58
Change in activation score	-	-1.2 ± 2.011	-1.7 ± 2.411	-2.1 ± 2.701
Hostility-suspiciousness	8.8 ± 3.93	6.5 ± 2.85	5.4 ± 2.47	4.6 ± 2.17
Change in hostility-suspiciousness score	-	-2.3 ± 2.811	-3.4 ± 3.421	-4.1 ± 3.771

¹P < 0.001(paired t-test).

n = 959: Number of patients in the full analysis set with brief psychiatric rating scale data.