EFFECT OF RABEPRAZOLE ON HEALTH-RELATED QUALITY OF LIFE (HRQOL) IN PATIENTS REPORTING INEFFECTIVE RELIEF WITH PRIOR OMEPRAZOLE OR LANSOPRAZOLE THERAPY
Author(s)
Girts TK, Siddique RM, Jokubaitis LA , Janssen Pharmaceutica Inc., Titusville, NJ, USA
OBJECTIVES: The purpose of this study is to evaluate the effect of rabeprazole (RAB) 20mg daily on HRQoL among patients that participated in the Future of Acid Suppression Therapy (F.A.S.T.) trial. The F.A.S.T. trial was an open-label, multicenter, 8-week study measuring the effectiveness of RAB in 2579 patients with erosive gastroesophageal reflux disease (GERD). The two subpopulations in this analysis were patients reporting prior ineffective relief with omeprazole (OME) (n=290) or lansoprazole (LAN) (n=212) within 3 months of study entry. METHODS: The SF-36 health survey was used to measure HRQoL in patients at baseline and after 8 weeks of treatment with RAB. The SF-36 includes eight scales: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE) and Mental Health (MH). Two summary measures, Physical Health Component Summary (PCS) and Mental Health Component Summary (MCS), are produced from aggregating the most highly related scales. This study used paired t-tests to compare baseline to 8-week scores for significant changes in HRQoL. RESULTS: There were 248 OME and 180 LAN patients that completed a SF-36 survey at baseline and 8-weeks. All scales and summary scores in both groups had a statistically significant (p<0.05) mean increase after 8 weeks of treatment on RAB except for PF in patients having prior ineffective OME therapy. For both groups, the following scales had a increase in score of greater than five points from baseline to 8-weeks which is considered clinically significant: RP, BP, VT, SF, and RE. In addition the group of patients having prior ineffective OME therapy also had a clinically significant increase in MH. CONCLUSIONS: Overall, RAB showed significant improvements in HRQoL among patients with erosive GERD who reported ineffective relief with prior OME or LAN therapy.
Conference/Value in Health Info
2002-05, ISPOR 2002, Arlington, VA, USA
Value in Health, Vol. 5, No. 3 (May/June 2002)
Code
PGI11
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Gastrointestinal Disorders