Abstract
Background
Disease burden and associated costs are not well understood among patients with gastroesophageal reflux disease (GERD) who have persistent symptoms despite optimized proton pump inhibitor (PPI) therapy. The aim of this study was to investigate disease burden and costs of GERD in partial responders to PPI therapy.
Methods
The Partial Response to PPI treatment: the Cost to Society and the Burden to the Patient in the US (REMAIN US) study was a 12-month, multicenter, noninterventional, observational study of 552 partial PPI responders in the USA. Participating sites were comprised of family practice (n = 30), internal medicine (n = 8), and specialist (gastroenterologist) centers (n = 15). GERD symptoms, health-related quality of life (HRQL), and impact on productivity were evaluated from patient-reported outcome instruments. Resource utilization data were also collected.
Results
Patients had a high symptom burden, impaired HRQL, and reduced productivity while at work and in daily activities, despite optimized PPI therapy. Mean annual GERD-related costs were US$9944 per patient, comprising total direct costs and mean productivity loss costs of US$4068 and US$5876 per patient, respectively.
Conclusion
Patients with GERD and a partial response to PPI therapy have considerable direct and indirect costs, along with substantial impairments in HRQL and productivity.
Supplementary material
Table S1 Unit cost data for medical consultations, hospitalizations, tests, procedures, and surgeries
Authors’ contributions
Study planning and interpretation of data: Brennan M Spiegel. Study planning, monitoring of conduct, and interpretation of data: Helena Granstedt Löfman, Peter Wahlqvist, and Nils-Olov Stålhammar. Monitoring of study conduct and interpretation of data: Maria Karlsson. Study planning and interpretation of data: Jørgen Næsdal. Study planning, conduct, and interpretation of data: M Todd Nelson and Nicolas Despiégel. All authors contributed to drafting and critical revision of the manuscript, and approved the final version for submission.
Disclosure
This study was supported by AstraZeneca R&D, Mölndal, Sweden. Medical writing services from Melanie Gatt and Steve Winter of inScience Communications, Springer Healthcare were funded by AstraZeneca. Brennan M Spiegel has received grant support from Shire-Movetis and Ironwood, and has received consultancy fees from Ironwood, Prometheus, and Shire-Movetis. Helena Granstedt Löfman, Maria Karlsson, Peter Wahlqvist, Jørgen Næsdal, and Nils-Olov Stålhammar are current, former, or retired employees of AstraZeneca. M Todd Nelson and Nicolas Despiégel are employees of OptumInsight, who conducted the study with funding from AstraZeneca. The authors report no other conflicts of interest in this work.