Comparative utility of aripiprazole and haloperidol in schizophrenia

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Appl Health Econ Health Policy 2009; 7 (2): 109-119 1175-5652/09/0002-0109/$49.95/0

ª 2009 Adis Data Information BV. All rights reserved.

Comparative Utility of Aripiprazole and Haloperidol in Schizophrenia

Post Hoc Analysis of Two 52-Week, Randomized, Controlled Trials John M. Kane,1 Edward Kim,2 Hong J. Kan,3 Zhenchao Guo,3 John A. Bates,2 Richard Whitehead4 and Andrei Pikalov4 1 2 3 4

The Zucker Hillside Hospital, Glen Oaks, New York, USA Bristol-Myers Squibb, Plainsboro, New Jersey, USA Bristol-Myers Squibb, Wallingford, Connecticut, USA Otsuka America Pharmaceutical, Inc., Rockville, Maryland, USA

Abstract

Background: Since their introduction, second-generation antipsychotics (SGAs) have become the drugs of choice for the treatment of schizophrenia. However, recent findings have questioned the benefits of SGAs over first-generation antipsychotics (FGAs). Objective: This post hoc analysis sought to compare the utility of the SGA aripiprazole with the FGA haloperidol in patients with early-phase schizophrenia (ES) or chronic schizophrenia (CS). Method: Data were pooled from two identical 52-week, randomized, active comparator trials (31-98-217 and 31-98-304) of aripiprazole 20–30 mg/day versus haloperidol 7–10 mg/day. Patients in the efficacy sample were classified as having ES if they were £40 years of age with a duration of illness £5 years. All other patients were classified as having CS. Health-state utilities were derived from the Positive and Negative Syndrome Scale and adverse events, using the last observation carried forward method. Results: Of 1294 patients in the efficacy sample, 362 met criteria for ES (aripiprazole, n = 239; haloperidol, n = 123) and 932 met criteria for CS (aripiprazole, n = 622; haloperidol, n = 310). Baseline patient characteristics were similar between treatment arms. At week 52, patients treated with aripiprazole in the total and ES populations had significantly greater total utility than those treated with haloperidol, although there were no statistically significant differences in total utility for the CS population at week 52. For the total population, patients treated with aripiprazole had significantly higher quality-adjusted life days (QALDs)/year than haloperidol recipients (+6.48 QALDs/ year, p = 0.02). Significantly higher QALDs/year were also seen for aripiprazoletreated patients with ES (+10.65 QALDs/year, p = 0.04) but not for patients with CS (+4.92 QALDs/year, p = 0.14), compared with haloperidol-treated patients. Conclusions: Aripiprazole demonstrates greater utility than haloperidol over 52 weeks of treatment. This difference was driven by superiority of aripiprazole over haloperidol in patients with ES, which was not observed in patients with CS.

Kane et al.

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Background Antipsychotic medication represents the cornerstone of treatment for schizophrenia. The secondgeneration antipsychotics (SGAs or atypical agents) were introduced in the 1990s with the expectation of better efficacy and tolerability than first-generation antipsychotics (FGAs or typic