REHOSPITALIZATION AFTER DISCONTINUATION OF PALIPERIDONE ER IN PATIENTS WITH SCHIZOPHRENIA
Author(s)
Seina Park Lee, PharmD, MS, Outcomes Research Fellow(Ortho-McNeil Janssen Scientific Affairs, LLC)1, Jasmanda H. Wu, PhD, MPH, Associate Director2, Lian Mao, PhD, Associate Director2, Ja. Pesa, MSEd, PhD, MPH, Associate Director31Jefferson Medical College, Philadelphia, PA, USA; 2 Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3 Ortho-McNeil Janssen Scientific Affairs, LLC, Superior, CO, USA
Objective: One way to evaluate effectiveness of antipsychotics is to measure frequency of symptomatic relapses in patients with schizophrenia. The occurrence and duration of hospitalizations are important markers of potential relapses. This study assessed differences in days hospitalized among schizophrenic patients receiving paliperidone extended-release tablets (paliperidone ER) during the 52-week open-label extension (OLE) phases of three double-blind (DB) trials as compared to treatment as usual (TAU) in the six months following the OLE phases of these trials. Methods: Data on resource use was collected through retrospective chart review. Average number of hospital days during OLE and TAU phases was calculated including the use of bootstrap resampling methods to assess statistical significance of differences. Total person years were calculated for OLE and TAU phases to account for different lengths of observation. Antipsychotic use during TAU phase was also evaluated. Paliperidone ER was not commercially available during TAU phase. Results: In this analysis, patients (n=71) were from the US (31.0%), Canada (21.1%) and Malaysia (47.9%). Mean (±SD) patient age was 37.9 (±10.5) years; and the majority were male (70.4%). During the OLE, the mean paliperidone ER treatment duration (±SD) was 212.9 (±141.2) days, and the mean dose was 11.4 (±2.1) mg. Patients experienced an average of 5.0 and 15.3 hospital days per person year in OLE and TAU phases, respectively, indicating that a mean increase of 10.3 days of hospitalization was observed during TAU phase (95%CI 2.3,19.2, P=0.006). During TAU phase, the treatments received were second-generation antipsychotics (SGAs) (52.1%), first-generation antipsychotics (FGAs) (9.9%), or both FGAs and SGAs (14.1%). Conclusion: Patients discontinuing paliperidone ER after the OLE phases experienced more hospital days compared to the OLE phases where they received paliperidone ER. Whether this increase in hospital days is associated with a greater frequency or severity of relapses remains to be tested.
Conference/Value in Health Info
2008-05, ISPOR 2008, Toronto, Ontario, Canada
Value in Health, Vol. 11, No. 3 (May/June 2008)
Code
PMH5
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Mental Health