Cost-Effectiveness of Diagnostic Strategies for H. pylori Infection in a High Prevalence Population

Abstract

Background and Aims: Ulcerative colitis (UC) is a chronic inflammatory disease of the colon that, when active, can substantially decrease patients' health-related quality of life (HRQoL). If the disease is kept in remission, however, it is possible that patients may achieve and sustain HRQoL comparable to that of the general population. In the current study we assessed the baseline level and long-term maintenance of HRQoL in patients with quiescent UC who received one year of MMX® mesalamine (Shire Pharmaceuticals Inc., Wayne, PA, USA; MMX, Cosmo Technologies Ltd, Wicklow, Ireland) treatment. Methods: This analysis examined the twelve-month maintenance phase of a two-phase, multicenter, open-label study, during which patients with quiescent UC received MMX mesalamine 2.4g/day, once daily. HRQoL was measured at baseline, six month, and twelve month visits using the SF12v2. The SF-12v2 is a 12-item patient-reported survey with a four week recall period that measures 8 domains of generic HRQoL (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) as well as summary scores for both physical (PCS) and mental (MCS) health outcomes. Disease burden was examined using one-way analysis of variance (ANOVA) models to test for sample differences in SF-12v2 scale and summary scores between study patients' and a gender and age-matched United States (US) general population normative sample. Changes in patients' SF-12v2 scale and summary scores across the three visits were assessed using repeatedmeasures ANOVA models. Results: Data were collected from 204 patients at baseline, 144 patients at Month 6, and 157 patients at Month 12/early withdrawal (endpoint). All baseline SF-12v2 scale and summary scores were significantly higher for trial patients than for the US general population normative sample (all p 0.05). The stability of HRQoL across the one-year trial was also indicated by the finding that changes from baseline to endpoint did not exceed one point for any SF-12v2 scale or summary score. Conclusion: While previous research has documented a substantial burden of active UC on HRQoL, this was not the case for quiescent UC patients in the current trial, who indicated above-average levels on all measured domains of HRQoL. Further, this higher level of HRQoL was maintained over the course of a year during which these patients received daily treatment with MMX mesalamine 2.4g/day. These findings indicate that long-term MMX mesalamine treatment has lasting benefits on HRQoL for patients with quiescent UC.