Effectiveness of 1-year treatment with long-acting formulation of aripiprazole, haloperidol, or paliperidone in patients with schizophrenia: retrospective study in a real-world clinical setting

Figures & data

Table 1 Sociodemographic and clinical characteristics of our sample

Characteristics	PP-OM (n=114)	Hal-D (n=55)	Apr-OM (n=48)	Total (n=217)	Test: probability
Sex, n (%)
Male	67 (58.8%)	32 (58.2%)	25 (52%)	124 (57.1%)	χ^2: NS
Female	47 (41.2%)	23 (41.8%)	23 (48%)	93 (42.9%)
Nationality, n (%)
Italian	92 (80.7%)	38 (69.1%)	41 (85.4%)	171 (78.8%)	χ^2: NS
European	9 (7.9%)	4 (7.3%)	0	13 (6%)
Not European	13 (11.4%)	13 (23.6%)	7 (14.6%)	33 (15.2%)
Age, mean ± SD
Years	42.7±14.3	46.3±12.5	41.4±10.8	43.32±13.23	t-test: NS
Employment status, n (%)
Unemployed	43 (37.72%)	24 (43.64%)	22 (45.83%)	89 (41%)	χ^2: NS
Employed	27 (23.68%)	8 (14.55%)	10 (20.83%)	45 (20.74%)
Retired (age)	15 (13.16%)	8 (14.55%)	6 (12.5%)	29 (13.36%)
Retired (disability)	26 (22.9%)	15 (27.26%)	10 (20.84%)	51 (23.52%)
Student	3 (2.63%)	0	0	3 (1.38%)
Living environment, n (%)
Parental family	59 (51.75%)	22 (40%)	20 (41.7%)	101 (46.54%)	χ^2: NS
Alone	13 (11.4%)	12 (21.8%)	7 (14.6%)	32 (14.77%)
Marital family	30 (26.32%)	17 (30.9%)	16 (33.4%)	63 (29.03%)
Protected facilities	9 (7.9%)	3 (5.5%)	4 (8.3%)	16 (7.36%)
Homeless	3 (2.63%)	1 (1.8%)	1 (2%)	5 (2.3%)
Socioeconomic condition, n (%)
Insufficient	35 (30.7%)	38 (69.1%)	25 (52%)	98 (45.16%)	Pearson’s χ^2=24.96: P<0.001
Sufficient	79 (69.3%)	17 (30.9%)	23 (48%)	119 (54.84%)
Psychiatric diagnosis (ICD9-CM), n (%)
Paranoid schizophrenia	46 (40.35%)	12 (21.83%)	8 (16.67%)	66 (30.41%)	Pearson’s χ^2=32.78: P<0.01
Disorganized schizophrenia	4 (3.5%)	0	0	4 (1.84%)
Undifferentiated schizophrenia	13 (11.4%)	5 (9.09%)	0	18 (8.29%)
Schizoaffective disorder	14 (12.28%)	10 (18.18%)	17 (35.41%)	41 (18.91%)
Simple type schizophrenia	7 (6.14%)	5 (9.09%)	2 (4.17%)	14 (6.45%)
Schizophreniform disorder	7 (6.14%)	6 (10.9%)	6 (12.5%)	19 (8.75%)
Delusional disorder	11 (9.65%)	10 (18.18%)	7 (14.58%)	28 (12.91%)
Other types of schizophrenia	12 (10.53%)	7 (12.73%)	8 (16.67%)	27 (12.44%)
Substance and/or alcohol abuse, n (%)
Absent	88 (77.2%)	41 (74.5%)	31 (64.58%)	160 (73.73%)	χ^2: NS
Present	26 (22.8%)	14 (25.5%)	17 (35.42%)	57 (26.27%)
Organic comorbidity, n (%)
Absent	73 (64%)	30 (54.5%)	35 (72.9%)	138 (63.6%)	χ^2: NS
Present	41 (36%)	25 (45.5%)	13 (27.1%)	79 (36.4%)
Previous psychiatric hospitalizations, n (%)
0–3	80 (70.17%)	36 (65.45%)	28 (58.33%)	144 (66.37%)	χ^2: NS
4–10	25 (21.93%)	14 (25.45%)	15 (31.25%)	54 (24.88%)
>10	9 (7.9%)	5 (9.1%)	5 (10.42%)	19 (8.75%)
Period of illness, mean ± SD
Years	11.70±8.19	14.35±9.39	11.13±6.80	12.24±8.29	ANOVA t-test: NS

Abbreviations: Apr, aripiprazole; Hal-D, haloperidol decanoate; NS, not significant; OM, once monthly; PP, paliperidone palmitate.

Table 2 Modality of LAI-APD implementation in our sample

Pharmacological variables	PP-OM (n=114)	Hal-D (n=55)	Apr-OM (n=48)	Total (n=217)	Test: probability
Clinical motivation, n (%)
Inefficacy of previous therapies	23 (20.17%)	11 (20%)	5 (10.42%)	39 (17.97%)	Pearson’s χ^2=43.28: P<0.001
Intolerance of previous therapies	14 (12.28%)	7 (12.73%)	16 (33.33%)	37 (17.06%)
Lack of therapeutic adherence	48 (42.1%)	37 (67.27%)	27 (56.25%)	112 (51.61%)
Patient choice	29 (25.45%)	0	0	29 (13.46%)
Switch from oral or LAI therapies, n (%)
From LAI-APDs	71 (62.28%)	18 (32.73%)	16 (33.33%)	105 (48.39%)	Pearson’s χ^2=18.57: P=0.001
From oral antipsychotics	43 (37.72%)	37 (67.27%)	32 (66.67%)	112 (51.61%)
Previous antipsychotic drugs, n (%)
Risperidone LAI	50 (43.87%)	5 (9.09%)	3 (6.25%)	58 (26.73%)	Pearson’s χ^2=92.98: P<0.001
Hal-D	17 (14.91%)	0	3 (6.25%)	21 (9.68%)
Fluphenazine decanoate	4 (3.5%)	6 (10.9%)	3 (6.25%)	12 (5.53%)
Other oral antipsychotics	43 (37.72%)	37 (67.27%)	32 (66.67%)	112 (51.61%)
PP	0	6 (10.9%)	7 (14.58%)	13 (5.99%)
Apr-OM	0	1 (1.82%)	0	1 (0.46%)

Abbreviations: APD, antipsychotic drug; Apr, aripiprazole; Hal-D, haloperidol decanoate; LAI, long-acting injectable; OM, once monthly; PP, paliperidone palmitate.

Figure 1 Relapses (urgent consultations and psychiatric hospitalizations) in patients treated with PP-OM: mirror analysis at months 6 and 12.

Notes: *Versus urgent consultations in 6 months before PP-OM (t=3.74, P<0.001); **vs urgent consultations in 12 months before PP-OM (t=5.17, P<0.001); ^§vs psychiatric hospitalizations in 6 months before PP-OM (t=4.35, P<0.001); ^§§vs psychiatric hospitalizations in 12 months before PP-OM (t=4.09, P<0.001).
Abbreviations: OM, once monthly; PP, paliperidone palmitate.

Figure 2 Relapses (psychiatric hospitalizations and urgent consultations) in patients treated with Hal-D: mirror analysis at months 6 and 12.

Notes: *Versus urgent consultations in 6 months before Hal-D (t=3.94, P<0.001); **vs urgent consultations in 12 months before Hal-D (t=4.8, P<0.001); ^§vs psychiatric hospitalizations in 6 months before Hal-D (t=5.4, P<0.001); ^§§vs psychiatric hospitalizations in 12 months before Hal-D (t=6.02, P<0.001).
Abbreviation: Hal-D, haloperidol decanoate.

Figure 3 Relapses (psychiatric hospitalizations and urgent consultations) in patients treated with Apr-OM: mirror analysis at months 6 and 12.

Notes: *Versus urgent consultations in 6 months before Apr-OM (t=4.96, P<0.001); **vs urgent consultations in 12 months before Apr-OM (t=4.27, P<0.001); ^§vs psychiatric hospitalizations in 6 months before Apr-OM (t=5.99, P<0.001) ^§§vs psychiatric hospitalizations in 12 months before Apr-OM (t=4.05, P<0.001).
Abbreviations: Apr, aripiprazole; OM, once monthly.

Figure 4 Hospitalization days before and after LAI implementation: mirror analysis at month 12.

Notes: *Versus hospitalization days in 12 months before PP-OM (t=3.02, P=0.001); **vs hospitalization days in 12 months before Hal-D (t=4.09, P<0.001); ***vs hospitalization days in 12 months before Apr-OM (t=3.87, P<0.001).
Abbreviations: Apr, aripiprazole; Hal-D, haloperidol decanoate; LAI, long-acting injectable; OM, once monthly; PP, paliperidone palmitate.

Figure 5 Kaplan–Meier curve of treatment period in the three LAI groups.

Abbreviations: Apr, aripiprazole; Hal-D, haloperidol decanoate; LAI, long-acting injectable; OM, once monthly; PP, paliperidone palmitate.

Table 3 LAI-treatment period, dropout, and relapse

Pharmacological variables	PP-OM (n=114)	Hal-D (n=55)	Apr-OM (n=48)	Total (n=217)	Test: probability
Period of LAI treatment, mean ± SD
Days	332.50±87.06	345.82±57.01	335.79±72.52	336±77.16	t-test: NS
Dropouts, n (%)
Patients in treatment	98 (86%)	48 (87.27%)	40 (83.33%)	186 (85.72%)	χ^2: NS
Dropouts	16 (14%)	7 (12.73%)	8 (16.67%)	31 (14.28%)
Reasons for LAI dropout, n (%)
Lack of therapeutic adherence	5 (4.38%)	2 (3.64%)	2 (4.17%)	9 (4.15%)	χ^2: NS
Inefficacy	7 (6.12%)	4 (7.3%)	4 (8.33%)	15 (6.91%)
Adverse effects	4 (3.5%)	1 (1.8%)	2 (4.17%)	7 (3.22%)
Relapses, n (%)
No relapses	72 (63.18%)	31 (56.36%)	26 (54.17%)	129 (59.45%)	χ^2: NS
Urgent consultations	34 (29.82%)	19 (35.54%)	18 (37.5%)	71 (32.72%)
Psychiatric hospitalizations	8 (7%)	5 (9.1%)	4 (8.33%)	17 (7.83%)

Abbreviations: Apr, aripiprazole; Hal-D, haloperidol decanoate; LAI, long-acting injectable; NS, not significant; OM, once monthly; PP, paliperidone palmitate.

Table 4 CGI and GAF scores at T0, T6, and T12

Clinical and functioning scales	PP-OM (n=114)	Hal-D (n=55)	Apr-OM (n=48)	Total (n=217)	Test: probability
CGI, mean ± SD
CGI-S T0	4.96±0.95	5.49±0.74	5.56±0.77	5.52±0.9	ANOVA F=11.74: P<0.001
CGI-I T6	3.41±0.77	3.67±0.61	3.38±0.61	3.47±0.70	ANOVA t-test: NS
CGI-I T12	2.95±0.84	3.02±0.38	2.9±0.49	2.96±0.68	ANOVA t-test: NS
GAF, mean ± SD
GAF T0	41.80±11.86	36.27±7.15	40.94±9.03	40.21±10.47	ANOVA F=5.56: P<0.001
GAF T6	49.36±14.86	40.28±9.24	45.80±9.69	46.18±13.03	ANOVA F=9.42: P<0.01
GAF T12	52.67±14.10	42.81±10.31	49.25±9.64	49.39±12.96	ANOVA F=10.21: P<0.001

Abbreviations: Apr, aripiprazole; CGI-I, Clinical Global Impression – Improvement; CGI-S, Clinical Global Impression – Severity; GAF, Global Assessment of Functioning; Hal-D, haloperidol decanoate; NS, not significant; OM, once monthly; PP, paliperidone palmitate; T0, baseline; T6, 6 months; T12, 12 months.

Figure 6 CGI-S and CGI-I scores (±SD) at T0, T6, and T12 in the three LAI groups.

Abbreviations: Apr, aripiprazole; CGI-I, Clinical Global Impression – Improvement; CGI-S, CGI – Severity; Hal-D, haloperidol decanoate; LAI, long-acting injectable; OM, once monthly; PP, paliperidone palmitate; T0, baseline; T6, 6 months; T12, 12 months.

Figure 7 GAF scores (±SD) at T0, T6, and T12 in the three LAI groups.

Abbreviations: Apr, aripiprazole; GAF, Global Assessment of Functioning; Hal-D, haloperidol decanoate; LAI, long-acting injectable; OM, once monthly; PP, paliperidone palmitate; T0, baseline; T6, 6 months; T12, 12 months.