PATIENT ASSESSED QUALITY OF LIFE VS. CLINICIAN ASSESSMENT IN A TRIAL OF ARIPIPRAZOLE IN PEDIATRIC PATIENTS WITH BIPOLAR DISORDER

Author(s)

Yonghua Jing, PhD, Manager1, Richard Whitehead, BS, Senior Specialist2, Chien-Feng Chen, PhD, Director3, Edward Kim, MD, PhD, Associate Director1, William H. Carson, MD, Vice President3, Taro Iwamoto, PhD, President3, Suja Mathew, BS, Senior Manager2, Andrei Pikalov, MD, PhD, Senior Director21Bristol-Myers Squibb, Plainsboro, NJ, USA; 2 Otsuka America Pharmaceutical, Inc, Rockville, MD, USA; 3 Otsuka Pharmaceutical Development and Commercialization, Inc, Princeton, NJ, USA

OBJECTIVES The pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) is made up of 14 items that assess aspects of quality of life (Total) and a 1-item overall assessment (Overall). Quality of Life measures yield information independent of symptom measures. This post-hoc analysis investigated correlation between patient's QoL assessment and objective clinical assessment (YMRS, CGI-BP). METHODS A total 296 children (age 10-17) with bipolar disorder participated in a 4-week double-blind trial of aripiprazole (10 or 30 mg/day, fixed doses) vs. placebo (PBO). Completers entered a 26 week extension. Primary outcome was mean change on YMRS Total Score. Secondary measures included mean changes on CGI-BP Overall, PQ-LES-Q Total (T) and the Overall item (O). RESULTS YMRS Total and CGI-BP Overall improved vs. PBO with both doses of aripiprazole at week 4 and week 30 (p<0.05 and p<0.01 respectively, LOCF). Both aripiprazole arms improved on PQ-LES-Q(T) and (O); however they did not reach statistical significance. Observed Cases analysis (OC) demonstrated a correlation at week 4 and week 30 between % change in PQ-LES-Q(T) and % change in YMRS (r =-0.18 and -0.29, respectively; p<0.03). When 4 week YMRS Total improvement was put into categories (<20%; 20-30%; 30-50%; >50% reduction), % change in mean PQ-LES-Q(T) was 1.7, 2.3, 12.5, & 10.4 per category (trend analysis p=0.007; regression p=0.01; OC). At 30 weeks % change in mean PQ-LES-Q(T) was 3.3, NA, -2.6, 16.6 (p=0.02; Linear regression p=0.02; OC). When CGI-BP Overall was put into 4 categories (=0; -1; -2; ≤-3 point change) at 4 weeks, % change in mean PQ-LES-Q(O) was 0.02, 0.15, 0.27, 0.43 per category (trend analysis p<0.05; OC) and at 30 weeks, % change in mean PQ-LES-Q(O) was -1, 0, 0.63, 0.64 (p=0.02; OC). CONCLUSIONS In this trial of pediatric patients with BP there was positive correlation between patient-assessed QoL measures and clinician-based assessment.

Conference/Value in Health Info

2009-05, ISPOR 2009, Orlando, FL, USA

Value in Health, Vol. 12, No. 3 (May 2009)

Code

PMH7

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Mental Health

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