Long-term adherence and health outcomes study with risperdal consta and oral atypicals in the treatment of schizophrenia patients (interim-analysis RIS-SCH-4023)

Abstract

Objectives

Two-years naturalistic study investigating adherence to therapy, tolerability, functionality and quality of life (QoL) of 400 patients with early schizophrenia under treatment with the only available atypical depot (CONSTA) and other oral atypicals (OATYP).

Methods

Planned interim-analysis comprised 179 patients (ITT population; baseline to endpoint). Thereof, 89 patients started treatment with CONSTA, 90 patients with one of six OATYP (11 Olanzapin, 16 Quetiapine, 11 Amisulpride, 16 Ziprasidone, 18 Aripiprazole, 18 Risperidone). Mean age was 32.7 for CONSTA and 34.6 years for OATYP cohort. Mean duration of schizophrenia (82%: F20.0) was 2.7 years (SD 1.6) for both groups.

Results

There were baseline differences between CONSTA and OATYP cohort with regard to reasons for starting treatment (non-compliance 56% vs 18%; lack of tolerability 22% vs 31%, respectively) and severity of illness (PANSS total 94 vs 87). With regard to change of therapy, there was a tendency towards higher retention rates and mean study duration in the CONSTA cohort (56% vs 47%, p=0.23; 395 vs 342 days). PANSS scores improved significantly for both cohorts (CONSTA -17.2 vs OATYP -16.3). EPS score improved with no significant differences between cohorts. Overall, reported AEs related to schizophrenia (psychosis 14%; agitation 9.5%) were most common, followed by weight gain (9.5%) and fatigue (9%).

Conclusion

In this prospective, non-randomized study, interim-analysis from 45% of 400 planned patients with initial CONSTA or OATYP treatment shows comparable improvement of psychopathology and EPS and a tendency towards higher treatment adherence with CONSTA, considering initially more non-compliant patients in this group.