A 6-year open-label study of the efficacy and safety of olanzapine long-acting injection in patients with schizophrenia: a post hoc analysis based on the European label recommendation

Figures & data

Table 1 Patient demographics and baseline characteristics

Characteristic	Olanzapine LAI patients (N=669)
Age, years, mean (SD)	39.4 (11.8)
Sex (male), n (%)	442 (66.1)
Race, n (%)
Caucasian	453 (67.7)
Hispanic	108 (16.1)
African	60 (9.0)
East Asian	29 (4.3)
West Asian	17 (2.5)
Native American	2 (0.3)
Number of previous episodes or exacerbations of schizophrenia in the last 24 months, n (%)
0	179 (26.8)
1	209 (31.2)
2	167 (25.0)
3	47 (7.0)
4	27 (4.0)
≥5	40 (6.0)
Age of onset of first episode of schizophrenia (years), mean (SD)	25.63 (8.81)
Length of most recent episode of schizophrenia (days), mean (SD)	784.59 (1,644.17)
PANSS total score, mean (SD)	52.87 (16.43)
CGI-S, mean (SD)	2.84 (1.01)

Abbreviations: CGI-S, Clinical Global Impression-Severity; LAI, long-acting injection; N, total number of patients; n, number of affected patients; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation.

Table 2 Patient disposition

Reason for discontinuation	Olanzapine LAI patients (N=669), n (%)
Completed	298 (44.5)
Patient decision	194 (29.0)
Adverse event	47 (7.0)
Lost to follow-up	45 (6.7)
Physician decision	25 (3.7)
Sponsor decision	25 (3.7)
Protocol violation	14 (2.1)
Lack of efficacy	13 (1.9)
Death	8 (1.2)

Abbreviations: LAI, long-acting injection; N, total number of patients; n, number of affected patients.

Figure 1 Kaplan–Meier time to discontinuation (N=669).

Abbreviation: N, total number of patients.

Figure 2 Positive and Negative Syndrome Scale total and subscale scores, change from baseline to endpoint (mixed model repeated measures analysis).

Note: A quarter equals 3 months.
Abbreviations: N, number of patients; SE, standard error.

Figure 3 Maintenance of treatment effect. The CGI-S visit-wise mean score for all 669 patients (mean baseline =2.84, mean endpoint =2.62).

Note: Mean improvements from baseline to endpoint (last observation carried forward) were significant (P≤0.02) for all measured time points starting at visit four.
Abbreviation: CGI-S, Clinical Global Impression-Severity.

Figure 4 Categorical analysis of the Patient Satisfaction with Medication Questionnaire-Modified at endpoint (N=620).

Note: “Depot” refers to olanzapine long-acting injectable.
Abbreviation: N, number of patients.

Table 3 Treatment-emergent adverse events in ≥5% of patients

	Olanzapine LAI patients (N=669), n (%)
Patients with ≥ 1 TEAEs	445 (66.5)
Weight increased	84 (12.6)
Somnolence	61 (9.1)
Anxiety	57 (8.5)
Insomnia	50 (7.5)
Nasopharyngitis	43 (6.4)
Headache	36 (5.4)

Abbreviations: LAI, long-acting injection; N, total number of patients; n, number of affected patients; TEAEs, treatment-emergent adverse events.

Table 4 Mean changes in laboratory results and weight

	N	Baseline mean (SD)	Mean change (SD)	P-value
Glucose, fasting (mmol/L)	627	5.43 (1.35)	0.30 (1.59)	<0.001
Total fasting cholesterol (mmol/L)	629	5.12 (1.09)	0.07 (0.96)	0.073
HDL fasting cholesterol (mmol/L)	628	1.14 (0.33)	0.04 (0.27)	<0.001
LDL fasting cholesterol (mmol/L)	623	3.12 (0.96)	0.03 (0.85)	0.427
Triglycerides, fasting (mmol/L)	629	1.94 (1.25)	−0.01 (1.32)	0.810
Prolactin, fasting (pmol/L)	410	905.21 (1,367.82)	14.35 (1,163.04)	0.804
Total bilirubin (μmol/L)	657	7.96 (4.59)	0.18 (3.83)	0.220
Alkaline phosphatase (μkat/L)	657	1.43 (0.46)	−0.06 (0.34)	<0.001
AST/SGOT (μkat/L)	657	0.41 (0.21)	−0.01 (0.20)	0.293
ALT/SGPT (μkat/L)	657	0.48 (0.39)	−0.01 (0.35)	0.314
Weight (kg)	659	79.65 (17.64)	2.19 (8.00)	<0.001

Abbreviations: ALT/SGPT, alanine transaminase/serum glutamic pyruvic transaminase; AST/SGOT, aspartate aminotransferase/serum glutamic-oxaloacetic transaminase; HDL, high-density lipoprotein; LDL, low-density lipoprotein; N, total number of patients; SD, standard deviation.