This study assessed treatment compliance, effectiveness, tolerability and safety of oral second generation antipsychotics (oSGA) versus long-acting injectable risperidone (RLAI).

Non-interventional, 24-month study (RIS-SCH-4057) in schizophrenic patients (ICD-10 F20.x; CGI≤5) with monotherapy of oSGA (amisulpride, aripiprazole, olanzapine, quetiapine, ziprasidone, or risperidone) or RLAI.

Interim analysis after 12 months including 300 RLAI and 159 oSGA patients (ITT; m/f 48%/52%; age 42.1±11.5 years; mean disease duration 8.8±8.1 years). PANSS, CGI-C and SWN-K significantly improved in both groups (p< 0.001; no between-group differences). Compliance to study medication was 75-100% in >70% of both groups. In RLAI vs. oSGA patients retention rates were higher (54.0% vs. 43.3%; p=0.0542), retention time was 277±11 vs. 254±13 days (p=0.0995), relapse rate/patient/year was 0.15 vs. 0.21 and time to first relapse was 309±7 vs. 290±10 days (p=0.0485). Adverse events (AEs) were reported in 69.0% RLAI vs. 76.1% oSGA patients, serious AEs in 19.7% vs. 19.5%. One RLAI patient died with no causal relationship to study medication. Most common AEs at least possibly related to the study medication in RLAI vs. oSGA patients were fatigue (12.7% vs. 16.4%), disturbance in attention (12.7% vs. 13.8%), dry mouth (13.0% vs. 13.2%), weight increase (11.0% vs. 10.1%), and EPS (3.0% vs. 2.5%). 6.0% RLAI and 6.9% oSGA patients had serious AEs at least possibly related to the study medication.

The trend of these data towards lower relapse rates and longer retention with RLAI vs. oSGA indicates that RLAI therapy may help patients effectively to achieve better long-term outcomes.