Partial response to proton pump inhibitor therapy for GERD: observational study of patient characteristics, burden of disease, and costs in the USA

Nils-Olov St lhammar,1 Brennan M Spiegel,2,3 Helena Granstedt L fman,1 Maria Karlsson,1 Peter Wahlqvist,1 J rgen N sdal,4 M Todd Nelson,5 Nicolas Despiégel61Payer Evidence, AstraZeneca R&D, M lndal, Sweden; 2Department of Gastroenterology, VA Greater Los Angeles Healthcare System, 3David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 4Medical Department, AstraZeneca R&D, M lndal, Sweden; 5Late Phase, Life Sciences, OptumInsight, Raleigh, NC, USA; 6HEOR, OptumInsight, Nanterre, FranceBackground: 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.Keywords: gastroesophageal reflux disease, GERD, proton pump inhibitors, partial response