Effects of structured follow-up and of more effective acid inhibitory treatment in the management of GORD patients in a Swedish primary-care setting: a randomized, open-label study.

BACKGROUND

Despite the high prevalence of gastro-oesophageal reflux disease (GORD) and the documented impact of GORD symptoms on individual health-related quality of life (HR-QOL) and on socioeconomic factors, structured management of GORD has had a low priority in Swedish routine primary health care.

OBJECTIVE

The primary objective of this study (IMPROVE) was to evaluate the effects of a structured follow-up and management regimen for primary-care GORD patients with symptomatic breakthrough despite standard proton pump inhibitor (PPI) treatment. Patients received either an increased dose of current PPI treatment or were switched to the more effective acid inhibitor esomeprazole.

METHODS

GORD patients with symptomatic breakthrough despite standard PPI treatment were identified through medical records and by a postal survey using the GERD Impact Scale (GIS) questionnaire. Patients rated the severity and frequency of GORD symptoms, general health status (EuroQol Group 5-Dimension Self-Report Questionnaire) and the impact of GORD symptoms on work productivity (Work Productivity and Activity Impairment) before and 4 weeks following randomization to open-label treatment with either increased acid suppressive therapy or an adjusted, higher dosage of the PPI previously used. The patients' valuation, in monetary terms, of the treatment they received pre-study versus the treatment given during the study was documented through willingness-to-pay (WTP) questions.

RESULTS

Following more effective acid suppression, 66.3% of the study population experienced complete relief of heartburn, with no difference between the groups; HR-QOL was restored to a level comparable to that of a normal Swedish population and ability to work efficiently was significantly improved. Access to a better acid suppressive treatment was highly valuable to the patients in terms of WTP.

CONCLUSION

An improved GORD management strategy including structured follow-up of treatment given and initiation of more effective acid inhibitor therapy when symptoms persist will be of great benefit to GORD patients. [ClinicalTrials.gov Identifier: NCT00272701].