Interim analysis of 2-years non-interventional trial (LARA) shows tendency towards higher treatment adherence with less compliant schizophrenia patients under long-acting injectable risperidone (LAIR) compared to an oral atypicals (OA) treatment cohort

Objectives: To investigate adherence and tolerability under long-acting injectable risperidone (LAIR) and OA in 400 patients with recently diagnosed schizophrenia under naturalistic conditions. Methods: Planned interim-analysis with 179 patients. Adherence was defined as continuous treatment with the initial antipsychotic as monotherapy at least one year. Analysis included PANSS, CGI and EPS ratings. Results: 89 patients initiated treatment with LAIR, 90 with one of six OA (olanzapine 11, quetiapine 16, amisulpride 11, ziprasidone 16, aripiprazole 18, oral risperidone 18). Mean age was 32.7(LAIR) and 34.6(OA) and mean duration of schizophrenia 2.7 years (both). Baseline differences occurring between non-randomized cohorts (LAIR vs. OA) were most prominent with regard to reasons for treatment initiation (non-compliance 56% vs. 18%) and higher EPS baseline scores in the LAIR cohort. There was a tendency towards higher retention rates and mean treatment duration with LAIR (56% vs. 47%, p=0.23; 395±216 vs. 342±204 days) whereas PANSS and EPS scores improved significantly in both cohorts (p<0.01). Overall, disease-related AEs (psychosis 14%; agitation 9.5%) were most common, followed by weight gain (9.5%) and fatigue (9%). Conclusion: Interim analysis of a 2-years-running non-interventional trial showed comparable significant improvement of psychopathology and EPS under LAIR and OA and a tendency towards higher adherence with LAIR in patients with prior non-compliance.