LONG-TERM TREATMENT OF SCHIZOPHRENIA FOR RELAPSE PREVENTION (LASER)- 6-MONTH OUTCOMES IN PATIENTS STARTED ON RISPERIDONE LONG-ACTING INJECTABLE IN GERMANY - DATA FROM THE E-STAR DATABASE

Author(s)

Naber D1, Mehnert A2, Rosillon D3, Farmer D4, Schreiner A2, Jacobs A51Department of Psychiatry and Psychotherapy, Hamburg, Germany; 2 Janssen-Cilag GmbH, Neuss, Germany; 3 SGS Biopharma, Wavre, Belgium; 4 Interactive Educational Systems, Ltd, Hampton Court, Surrey, United Kingdom; 5 Janssen Pharmaceutica NV, Beerse, Belgium

OBJECTIVES: To evaluate 6-month clinical and economic outcomes following initiation of long-acting injectable risperidone (LAIR) in patients with schizophrenia/schizoaffective disorder. METHODS: Data are collected via a secured web-based system, retrospectively for 12-months and prospectively for 2-years. Patient demographics, treatment and hospitalisation history, reason for initiating new treatment, Clinical Global Impression - Severity (CGI-S), Global Assessment of Functioning (GAF) and adverse event data are collected. This interim analysis includes the first 991 patients in Germany with at least 6 months follow-up or who discontinued treatment during this 6 month period. RESULTS: Of the 991 patients, 56% were male. Mean age was 43 (±14) years, mean duration of illness at initiation of LAIR was 10 (±10) years. A total of 79% were diagnosed with schizophrenia whilst 17% had schizoaffective disorder. After 6-months, 75% of patients still received their original starting dose. Compared with the preceding 6-month period, fewer patients required full hospitalisations (34% vs 20%; p<0.001). Decreases from baseline were seen in the concomitant use of anticholinergics (13.3% to 6.1%), antidepressants (18.1% to 11.8%), mood stabilisers (9.8% to 7.1%), benzodiazepines (17.3% to 8.4%), and somatic medication (14.7% to 8.5%; all comparisons p<0.001). Compared to baseline, CGI-S ratings improved from 4.7 to 3.8, and patient functioning (GAF) increased from 46.7 to 58.0 at 6-months (both p<0.001); 13% of patients discontinued treatment with LAIR. Most frequent reason (3.5%) was patient/family choice; 1.2% discontinued due to adverse event. CONCLUSIONS: The 6-month interim data show that the majority of patients initiated on LAIR remained on stable doses. Discontinuation rates were low. Need for inpatient care was reduced, as was use of psychotropic and somatic concomitant medication. There was significant and clinically relevant improvement in illness and functioning. Longer term data with larger sample size are being accrued to further explore these outcomes over time.

Conference/Value in Health Info

2005-11, ISPOR Europe 2005, Florence, Italy

Value in Health, Vol. 8, No.6 (November/December 2005)

Code

PMH34

Topic

Study Approaches

Topic Subcategory

Registries

Disease

Mental Health

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