Schizophrenia Outpatient Health Outcomes study: twelve-month findings

Figures & data

Table 1 Demographic and clinical characteristics at baseline assessment by treatment cohort

Characteristica	Olanzapine	Risperidone	Quetiapine	Amisulpride	Clozapine	Oral typical	Depot typical
Number (%)	5,204 (54)	1,863 (19)	760 (8)	319 (3)	316 (3)	676 (7)	470 (5)
Gender (% female)	41	42	47	44	36	49	41
Age, years	40 (13)	40 (13)	41 (13)	39 (13)	37 (10)	41 (13)	42 (12)
Age at first treatment contact for schizophrenia, years	29 (11)	29 (10)	28 (10)	30 (12)	24 (7)	29 (10)	29 (10)
CGIb overall severity	3.42 (1.00)	3.36 (0.97)	3.36 (1.02)	3.33 (0.99)	3.76 (1.00)	3.35 (1.09)	3.41 (0.99)
CGI-SCH positive symptoms	2.76 (1.44)	2.80 (1.39)	2.62 (1.50)	2.54 (1.40)	3.39 (1.41)	2.93 (1.47)	3.05 (1.41)
CGI-SCH negative symptoms	3.08 (1.28)	3.00 (1.24)	3.10 (1.29)	3.17 (1.29)	3.13 (1.31)	2.82 (1.36)	2.97 (1.25)
CGI-SCH depressive symptoms	2.48 (1.33)	2.37 (1.31)	2.50 (1.31)	2.44 (1.40)	2.48 (1.32)	2.37 (1.30)	2.21 (1.33)
CGI-SCH cognitive symptoms	2.75 (1.33)	2.71 (1.29)	2.76 (1.30)	2.87 (1.34)	2.91 (1.32)	2.74 (1.32)	2.73 (1.30)
EQ-5D VASc rating	45.71 (21.11)	46.91 (20.50)	47.59 (21.04)	45.57 (23.06)	41.98 (21.67)	47.43 (22.04)	48.76 (21.15)
Socially actived (%)	3,414 (66)	1,276 (70)	505 (67)	222 (71)	203 (65)	466 (70)	310 (66)
Paid employment (%)	1075 (21)	372 (20)	120 (16)	73 (23)	48 (15)	127 (19)	68 (15)

Notes:

a Values are means (SD) unless otherwise indicated;

b CGI-SCH: scale 0 (normal, not ill at all) to 6 (among the most severely ill);

c VAS: 0 (worst) to 100 (best);

d any social contact in the 4 weeks prior to assessment; percentages may not add up to 100 due to rounding.

Abbreviations: SD, standard deviation; CGI-SCH, Clinical Global Impression-Schizophrenia; EQ-5D, EuroQol-5 Dimensions; VAS, visual analog scale.

Table 2 Pharmacological treatment patterns by treatment cohort

	Olanzapine	Risperidone	Quetiapine	Amisulpride	Clozapine	Oral typical	Depot typical
Treated with only one antipsychotic after the baseline visit, %	82	85	76	82	84	71	76
Patients on monotherapy
Mean (SD) dose at baseline, mg	10.7 (5.2)	4.4 (2.4)	251.7 (172.6)	360.3 (244.9)	156.2 (125.9)	19.8 (65.3)	50.1 (53.1)
Mean (SD) dose at 12 months, mg	12.0 (5.9)	4.9 (2.7)	388.4 (214.7)	415.2 (261.8)	244.8 (133.0)	33.6 (150.5)	52.5 (54.7)
Patients on combination therapy
Mean (SD) dose at baseline, mg	10.4 (5.3)	3.9 (2.3)	222.4 (190.9)	296.5 (180.0)	116.8 (114.0)	43.9 (109.9)	48.9 (47.6)
Mean (SD) dose at 12 months, mg	13.9 (6.5)	5.6 (3.4)	445.7 (263.6)	522.5 (253.7)	267.6 (186.8)	25.9 (50.9)	63.4 (54.8)

Notes: All doses are converted into chlorpromazine equivalent doses; percentages may not add up to 100 due to rounding.

Abbreviation: SD, standard deviation.

Figure 1 CGI-SCH scores over 12 months, by treatment cohort.

Abbreviations: CGI, Clinical Global Impression; CGI-SCH, Clinical Global Impression-Severity for Schizophrenia.

Table 3 Clinical and social outcomes at 12 months

Outcomesa	Olanzapine	Risperidone	Quetiapine	Amisulpride	Clozapine	Oral typical	Depot typical
CGI-SCH overall at 12 months, mean (SD)	2.0 (1.1)	2.1 (1.1)	2.3 (1.2)	2.1 (1.2)	2.0 (1.2)	2.2 (1.2)	2.4 (1.2)
Responseb at any time in CGI-SCH overall symptoms	64	55	46	45	64	47	48
EQ-5D VAS rating, mean (SD)	65.9 (19.3)	63.5 (18.4)	63.1 (19.6)	59.9 (21.3)	63.4 (19.9)	60.9 (20.3)	63.1 (18.5)
Responseb in CGI-SCH positive symptoms	67	62	52	53	65	55	53
Responseb in CGI-SCH negative symptoms	61	52	47	44	60	44	42
Responseb in CGI-SCH cognitive symptoms	61	54	47	43	59	43	40
Responseb in CGI-SCH depressive symptoms	67	58	55	52	66	48	50
Symptom remission	39	34	24	25	40	30	26
Socially active	70	66	52	53	67	54	60
Paid employment, number (%)	20	17	11	15	15	13	11
Any hospitalization during follow-up	13	14	20	24	16	16	18

Notes:

a Outcomes values are % unless otherwise indicated;

b response defined as a decrease of 2 points from a baseline of 4–6 points or a decrease of 1 point from a baseline of 1–3 points.

Abbreviations: CGI-SCH, Clinical Global Impression-Schizophrenia; SD, standard deviation; EQ-5D, EuroQol-5 Dimensions; VAS, visual analog scale.

Table 4 Social and clinical outcomes at 12 months: odds ratios from multivariate analysis comparing olanzapine with the other treatment cohorts

Outcomesa	Olanzapine	Risperidone	Quetiapine	Amisulpride	Clozapine	Oral typical	Depot typical
Change in CGI-overall from baseline, difference (SE)	0	0.16 (0.03)c	0.28 (0.04)c	0.16 (0.06)	–0.06 (0.05)	0.26 (0.04)c	0.26 (0.05)c
Response in CGI-overall	1	0.68	0.47	0.51	1.00	0.48	0.55
		0.60; 0.76c	0.40; 0.56c	0.39; 0.65c	0.78; 1.28	0.40; 0.57c	0.45; 0.68c
Difference in EQ-5D VAS from baseline (95% CI)	0	−2.66	−2.84	−4.51	0.13	−4.42	−4.11
		−3.52; −1.79c	−4.14; −1.55c	−6.52; −2.50c	−1.67; 1.93	−5.76; −3.08c	−5.63; −2.59c
Response in CGI-SCH positive symptoms	1	0.81 (0.71; 0.92)b	0.53 (0.44; 0.63)c	0.64 (0.49; 0.83)b	0.85 (0.66; 1.11)	0.59 (0.50; 0.71)c	0.55 (0.45; 0.68)c
Response in CGI-SCH negative symptoms	1	0.70 (0.62; 0.78)c	0.54 (0.45; 0.64)c	0.57 (0.44; 0.74)c	0.89 (0.69; 1.14)	0.48 (0.40; 0.57)c	0.49 (0.40; 0.60)c
Response in CGI-SCH cognitive symptoms	1	0.75 (0.66; 0.84)c	0.55 (0.46; 0.65)c	0.51 (0.39; 0.66)c	0.90 (0.70; 1.17)	0.46 (0.38; 0.55)c	0.45 (0.36; 0.56)c
Symptom remission	1	0.71 (0.63; 0.81)c	0.45 (0.37; 0.55)c	0.57 (0.42; 0.77)b	1.36 (1.05; 1.77)	0.58 (0.48; 0.71)c	0.56 (0.44; 0.70)c
Socially active	1	0.73 (0.53; 0.99)	0.50 (0.32; 0.78)	0.57 (0.29; 1.13)	0.69 (0.37; 1.28)	0.49 (0.31; 0.78)	0.54 (0.32; 0.91)
Response in CGI-SCH depressive symptoms	1	0.67 (0.59; 0.76)c	0.62 (0.52; 0.74)c	0.56 (0.43; 0.74)c	0.95 (0.73; 1.25)	0.46 (0.39; 0.56)c	0.53 (0.42; 0.66)c
Any hospitalization during follow-up	1	1.18 (0.98; 1.41)	1.77 (1.40; 2.24)c	1.81 (1.30; 2.51)b	1.04 (0.72; 1.48)	1.54 (1.20; 1.98)b	1.52 (1.15; 2.00)

Notes:

a Values are odds ratios (95% CI) unless otherwise indicated. Odds ratio >1 indicates a lower response compared with olanzapine cohort; adjusted difference >0 indicates better outcome compared with the olanzapine cohort;

b P < 0.001;

c P < 0.0001.

Abbreviations: CGI, clinical global impression; SE, standard error; EQ-5D, EuroQol-5 Dimensions; VAS, visual analog scale; CI, confidence intervals.

Figure 2 Time to discontinuation over 12 months, by treatment cohort.

Figure 3 Time to discontinuation over 12 months, by treatment cohort: sensitivity analysis (patients not participating in a visit were considered to have discontinued).

Table 5 Appearance of adverse events during the 12 months of follow-up

Adverse event	Olanzapine	Risperidone	Quetiapine	Amisulpride	Clozapine	Oral typical	Depot typical
EPS
Patients experiencing new event, %	8	20	11	18	12	21	31
Odds ratio	1	2.27	1.20	1.51	0.95	2.39	4.12
95% CI	–	1.99; 2.59c	0.98; 1.47	1.12; 2.04a	0.69; 1.29	1.97; 2.88c	3.33; 5.11c
TD
Patients experiencing new event, %	1.9	3.5	2.5	3.5	3.3	6.0	6.1
Odds ratio	1	1.29	1.08	1.42	1.22	1.69	1.79
95% CI	–	1.03; 1.63a	0.78; 1.51	0.92; 2.21	0.75; 1.99	1.25; 2.29b	1.29; 2.50b
Loss of libido
Patients experiencing new event, %	23	29	21	30	17	29	28
Odds ratio	1	1.33	1.13	1.17	1.17	1.55	1.36
95% CI	–	1.18; 1.51c	0.95; 1.35	0.90; 1.53	0.91; 1.52	1.29; 1.86c	1.10; 1.68a
Impotence/sexual dysfunction
Patients experiencing new event, %	16	20	12	22	18	22	19
Odds ratio	1	1.44	1.06	1.43	1.34	1.49	1.35
95% CI	–	1.27; 1.64c	0.88; 1.28	1.10; 1.88a	1.02; 1.76a	1.23; 1.79c	1.08; 1.68a
Gynecomastia
Patients experiencing new event, %	2	2	2	5	2	3	3
Odds ratio	1	1.08	1.47	0.98	1.62	1.30	1.20
95% CI	–	0.78; 1.49	0.98; 2.21	0.53; 1.81	0.93; 2.83	0.84; 2.02	0.72; 1.98
Galactorrhea
Patients experiencing new event, %	1	2	1	4	1	2	2
Odds ratio	1	1.77	1.16	1.89	0.82	1.35	1.51
95% CI	–	1.18; 2.65a	0.60; 2.24	0.87; 4.14	0.25; 2.67	0.72; 2.54	0.74; 3.09
Amenorrhea
Patients experiencing new event, % female patients	4	7	5	10	4	5	6
Odds ratio	1	2.01	1.18	2.23	1.30	1.11	1.71
95% CI	–	1.64; 2.46c	0.88; 1.59	1.47; 3.38a	0.83; 2.06	0.82; 1.51	1.21; 2.41a
Weight
Change to 12 months (kg) mean (SD)	3.2 (8.5)	1.8 (6.6)	0.6 (6.1)	1.1 (9.7)	2.1 (7.9)	1.4 (7.5)	1.5 (8.0)
Adjusted differences in weight change	0	−0.83	−1.14	−1.38	−0.42	−1.24	−1.18
95% CI	–	−1.22; −0.43c	−1.73; −0.56a	−2.29; −0.47	−1.24; 0.39	−1.85; −0.63c	−1.87; −0.49a
Clinically significant weight gain
Patients experiencing event, %	28	18	15	19	20	19	20
Adjusted odds ratio	1	0.56	0.46	0.71	0.60	0.57	0.67
95% CI	–	(0.48–0.65)c	0.36; 0.58c	0.51; 0.99a	0.44; 0.82a	0.46; 0.72c	0.52; 0.87

Notes: Percentages may not add up to 100 due to rounding.

a P < 0.05;

b P < 0.001;

c P < 0.0001.

Abbreviations: EPS, extrapyramidal symptoms; CI, confidence interval; TD, tardive dyskinesia; SD, standard deviation.