Change in Clinical Status and Side Effects of Patients Treated with Either Olanzapine or Risperidone: 6 -month Results from

the 3-year
Intercontinental Schizophrenia Outpatient Health Outcomes (IC-SOHO) Observational Study
PR Gargoloff,1 RA O’Halloran,2 JM Boland,2 E Brunner,3 M Dossenbach,4 L Levitt,2 A Valencia,5 E Landa,6 C González 7

1 Clínica City Bell, La Plata, Argentina; 2 Eli Lilly Australia Pty Limited; 3 Eli Lilly de Mexico, S.A. de C.V.; 4 Eli Lilly Ges.m.b.H (Austria); 5 Hospital de Policía, Bogotá, Colombia;
6 Hospital San Juán de Dios, Zapopan, Jalisco, México; 7 Hospital Universitario Carácas, Venezuela

IC-SOHO STUDY DESIGN (cont.) ADVERSE EVENTS RELATED TO SEXUAL FUNCTION CHANGE IN WEIGHT AND BODY MASS INDEX (BMI)
ABSTRACT MEAN CHANGE IN CGI -S AT 6 MONTHS
• Sample size Loss of libido Impotence/sexual dysfunction
Objective : To compare the 6 -month change in clinical status and incidence of –7655 patients enrolled from 27 countries within 4 regions; * * 6
Overall Positive Negative Depressive Cognitive Olanzapine
side effects in patients who initiated or changed to either olanzapine or • 35% Latin America (11 countries; n =2671), 50 50 *

Mean weight change (kg)

*
• 29% Central and Eastern Europe (8 countries; n=2252), 0 Risperidone
risperidone antipsychotic treatment at baseline. 46 46

Patients (%)
42 41 4
Method: This is a 3 -year, prospective intercontinental observational study of the • 19% Africa and Middle East Region (5 countries; n=1476),
34 33 33 31
health outcomes associated with antipsychotic therapy in outpati ents with • 16% Asia Region (3 countries; n=1256). 25 29 25 30 * p=.0001
22

Mean Change
schizophrenia. Patients were enrolled if, at the discretion of the treating • Aim of presentation 20 * p=.0041
2
psychiatrist, they initiated or changed antipsychotic medication. There are two –To compare the efficacy, safety, and quality of life aspects of olanzapine and
principle cohorts: initiated or changed to olanzapine treatment (1), initiated or risperidone as antipsychotic treatments. 0 0
-1
changed to non-olanzapine treatment (2). Here we report how patients that were Baseline 3 months 6 months Baseline 3 months 6 months
–Cohorts defined based on the drug prescribed at baseline. 0
prescribed either olanzapine or risperidone at baseline have progressed after • Measures
6 months of treatment. –Demographics, * Amenorrhea Galactorrhea
*
Results: A total of 7655 patients across 27 countries in the intercontinental * 40 * * 6 Baseline BMI (kg/m2 )
–Clinical status (Clinical Global Impressions-Severity of Illness [CGI- S] rating * -2
region were included in this study. Overall, 51% of patients were prescribed scale 1 –7), * * Olanzapine 35
* Underweight Normal Overweight Obese
34

Patients (%)
olanzapine, 20% risperidone. Olanzapine-treated patients improved significantly -2 30 5
–Safety (adverse events), Risperidone 29
4 4 BMI<18.5 at BMI≥18.5/<25 BMI≥25/<30 BMI≥30 at
(p<.0001) with respect to overall, positive, negative, depressive, and cognitive 20
21 3 4
–Concomitant medications, 19 baseline at baseline at baseline baseline
symptoms (Table 1). Olanzapine-treated patients had a significantly greater improvement compare d with
–Quality of life (EuroQol [EQ-5D], Visual Analogue Scale, social and work 2
status). risperidone-treated patients across all symptom domains at both 3 and 6 month s. 1
Table 1. Mean change from baseline following 6 months of treatment (CGI)* 0 0 This figure illustrates mean change in weight (kg) with associated upper and lower
• Statistical significance Baseline 3 months 6 months Baseline 3 months 6 months 95% confidence limits at 6 months.
Clinical status (CGI)* Olanzapine Risperidone p Value** *p≤.0001 (two-sample t test), olanzapine versus risperidone.
Overall symptoms - baseline 4.35 (1.08) 4.21 (1.04) –Due to multiple comparisons, the cut-off level of significance for all analyses Olanzapine Risperidone
Olanzapine Risperidone
- change - 1.51 (1.27) -1.20 (1.17) <.0001 was determined, a priori, to be .001. Measure 6 months 6 months p Value
Positive symptoms - baseline 3.89 (1.43) 3.84 (1.39) *p≤.0001 (Chi-square test), olanzapine versus risperidone. Mean weight change 3.0 (5.4) 1.8 (4.8) <.0001*
(kg± SD)
- change - 1.47 (1.50) -1.28 (1.46) .0001
BASELINE PATIENT DEMOGRAPHICS Patients (%) with 29 20 <.0001†
Negative symptoms - baseline 3.96 (1.33) 3.84 (1.27) ADVERSE EVENTS —EPS AND TD weight gain >7%
- change - 1.26 (1.36) -0.99 (1.21) <.0001 Patient Characteristic Olanzapine Risperidone CONCOMITANT MEDICATIONS
Concomitant Olanzapine Risperidone Mean BMI change 1.0 (2.3) 0.6 (1.9) <.0001*
Depressive - baseline 3.31 (1.40) 3.21 (1.33)
symptoms - change - 1.09 (1.41) -0.82 (1.31) <.0001
Patient distribution, n (%) 3940 (51) 1497 (20) EPS medication (% patients) (% patients) p Value* (kg/m2 ±SD)

Cognitive symptoms - baseline 3.70 (1.36) 3.60 (1.33) Mean age ( ±SD) 35.1 (12.0) 36.3 (11.9)
50 Anticholinergics *Two-sample t test. † Chi-square test.
Baseline 18 35 <.0001
- change - 1.16 (1.33) -0.89 (1.23) <.0001 Gender (% Women) 44 48 3 months 13 33 <.0001
*CGI – Clinical Global Impressions severity rating scale (1-7); mean (SD); **Two sample t test
Married/Partner (%)* 35 39 * 6 months 11 29 <.0001
*

Patients (%)
† Antidepressants
Patients prescribed olanzapine had a greater improvement in the severity of Mean BMI (kg/m2 ±SD) 25.0 (4.2) 25.0 (4.2) 40 39 Baseline 15 17 .04 FINDINGS
tardive dyskinesia ( p=.0445) and a significantly greater improvement in the Neuroleptic Naïve (%) * 16 15 3 months 16 17 .29
severity of extrapyramidal symptoms ( p<.0001) compared to risperidone- treated • Substantial improvements from baseline were observed for patients in both the
25 29 6 months 15 16 .38
patients. Furthermore, at 6 months risperidone-treated patients were prescribed Diagnosed with Schizophrenia olanzapine and risperidone treatment groups for all measures tested.
25 Anxiolytics/hypnotics
anticholinergic medications significantly ( p<.0001) more frequently than those ≤1 year (%) 27.5 25.8 • CGI-S scores improved significantly more for olanzapine- treated patients across
Baseline 34 38 .007
prescribed olanzapine (32% v 10%). Weight changes observed were significantly >1 year (%) 72.5 74.2 all symptom domains at both 3 and 6 months compared with risperidone- treated
3 months 29 33 .009
higher in the olanzapine group. Clinical Status (CGI-S),‡ mean ( ±SD) 14 6 months 26 30 .010 patients. Furthermore, there was a significantly greater propor tion of responders
Conclusions: Olanzapine provided greater efficacy and fewer side effects when Overall symptoms 4.35 (1.08) 4.21 (1.04) 10 Mood stabilizers on olanzapine compared with risperidone .
compared with risperidone after 6 months of treatment. These patients will Positive symptoms 3.89 (1.43) 3.84 (1.39) 0 Baseline 9 10 .63 • The prevalence of neurological adverse events (EPS and TD) decreased over time
3.96 (1.33) 3.84 (1.27) Baseline 3 months 6 months
continue to be evaluated prospectively throughout the remainder of this 3 -year Negative symptoms 3 months 10 9 .30 for both patient groups. These adverse events were present significantly less
study. Depressive symptoms 3.31 (1.40) 3.21 (1.33) 6 months 10 9 .47 frequently in olanzapine compared with risperidone-treated patients at 3, and at 6
Olanzapine Risperidone
Cognitive symptoms 3.70 (1.36) 3.60 (1.33) months.
*Chi-square test, olanzapine versus risperidone.
*
Clinical Global Impressions-Severity of Illness rating scale 1-7. • Compared with risperidone, patients receiving olanzapine developed significantly
fewer new incidences of EPS and TD during the 6 -month time interval.
TD QUALITY OF LIFE IMPROVEMENTS *
INTRODUCTION RESPONDERS* AND NON-RESPONDERS • Olanzapine-treated patients were co-prescribed anticholinergics less frequently
EuroQol† Health Status‡ compared with those receiving risperidone.
To compare the 3 - and 6 -month efficacy and safety results among patients Olanzapine Risperidone
10
prescribed either olanzapine or risperidone upon entry into the IC-SOHO
† § p=.0001 § p<.0001 § p=.0002 § p<.0001 • Adverse events associated with sexual function were significantly lower for
†
p<.0001 olanzapine- compared with risperidone- treated patients.
Patients (%)

observational study. 100 100

8 8 • A significantly greater proportion of olanzapine-treated patients had quality of life

Improvement (% patients)
† 88 83 89 83 86 86
p<.0001 81 80 improvements during the first 6 months of treatment, particularly i n t e r m s o f
100 5 6 6 50 50 EuroQol and health and social status.
60 44 71 56
IC-SOHO STUDY DESIGN • Beneficial shifts in body weight were observed for patients considered underweight
80 4
Patients (%)

• Description 3 0 0 at baseline (BMI<18.5 kg/m 2) in both olanzapine and risperidone treatment

–Three-year prospective observational study of health outcomes associated with 60 3 months 6 months 3 months 6 months groups.
antipsychotic medication therapy in outpatients treated for schizophrenia. 56 0
• Non-interventional study 40 44 Baseline 3 months 6 months Social Status Work Status
§ p<.0001
40 § p<.0001
§ p=.017
–All patient care is at the discretion of the participating psychiatrists. 80 60 § p=.055
CONCLUSION
20 29 Olanzapine Risperidone
• Patient selection criteria
67 47
–Diagnosis of schizophrenia (DSM- IV or ICD-10), 0 60 58 41 42 Substantial improvements from baseline status were observed for patients in both
At 6 months, both EPS and TD were significantly lower for olanzapine- compared with 40 52 30 37
–Treatment in the outpatient, community, or ambulatory setting, treatment cohorts at 3 and at 6 months. Improvements were signi ficantly more
3 months 6 months 3 months 6 months risperidone-treated patients.
–18 years of age or older, pronounced for olanzapine- compared with risperidone-treated patients.
–Initiating or changing antipsychotic treatment (decision made prior to Non- Olanzapine Risperidone *p≤.0001, † p=.0002 (two-sample t test), olanzapine versus risperidone. 0 0
enrollment). responder responder responder EPS = extrapyramidal symptoms; TD = tardive dyskinesia. 3 months 6 months 3 months 6 months
• Two patient cohorts (approximately 50% in each group)
*Patients were defined as responders if their overall CGI-S score at baseline was 4 or Olanzapine Risperidone
–Initiated or changed to olanzapine antipsychotic treatment (Group 1 ) , more and decreased by 2 or more, or, their overall CGI-S score at baseline was 3 or LIMITATIONS
–Initiated or changed to non-olanzapine antipsychotic treatment (Group 2). less and decreased by 1 or more. Analyses do not account for baseline differences among treatment cohorts.
*Improved or maintained baseline status; † EuroQol total score; ‡ Visual Analogue
• Data collection †
Chi-square test, olanzapine versus risperidone. Scale; § Chi-square test, olanzapine versus risperidone. Findings require confirmation using multivariate analyses.
–Assessments at baseline, 3 months, 6 months, and every 6 months thereafter.