Abstract
Background and Objective: Research on the negative impact of gastro-oesophageal reflux disease (GORD) on the health-related quality of life (HR-QOL) and resource utilization of patients with persistent and intense GORD symptoms despite proton pump inhibitor (PPI) therapy is lacking. The aim of this study was to describe the population of patients with GORD with persistent moderate-to-severe symptoms despite ongoing PPI therapy, and to compare their HR-QOL and healthcare resource use with patients with low GORD symptom load during ongoing PPI therapy.
Methods: In this post hoc analysis of the 2007 National Health and Wellness Survey (NHWS), PPI-compliant (≥22 days with PPI use in the past month) European (France, Germany and the UK) and US respondents with physician-diagnosed GORD were stratified into those with persistent and intense GORD symptoms, those with low symptom load, or an intermediate group.
Results: 5672 PPI-compliant respondents were identified (persistent and intense symptoms, n= 1741; low symptom load, n= 1805; intermediate group, n = 2126). Respondents with persistent and intense symptoms had poorer HR-QOL than patients with a low symptom load, but none of the differences were statistically significant. Respondents with persistent and intense symptoms also reported lower work productivity (all countries; significant difference [p<0.01] only in the US), greater activity impairment (all countries; significant difference [p<0.01] only in the US) and more hours missed from work due to health problems (US, UK and Germany; significant difference [p < 0.01] only in the US). In the UK and US, respondents with persistent and intense symptoms reported significantly more visits to both primary-care physicians and specialists than respondents with a low symptom load (all p < 0.01). Additionally, US respondents with persistent and intense symptoms reported significantly more emergency room visits (p<0.01).
Conclusion: The 2007 NHWS gives support to the hypothesis that persistent and intense GORD symptoms despite PPI therapy have a significant and negative impact on both HR-QOL and healthcare resource utilization. These findings outline the need for new treatment options for symptomatic GORD patients taking PPI therapy.
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References
Vakil N, van Zanten SV, Kahrilas P, et al. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol 2006 Aug; 101(8): 1900–20
Dent J, El-Serag HB, Wallander MA, et al. Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut 2005 May; 54(5): 710–7
El-Dika S, Guyatt GH, Armstrong D, et al. The impact of illness in patients with moderate to severe gastroesophageal reflux disease. BMC Gastroenterol 2005; 5: 23
Ujszaszy L, Kulich RK, Toth GT, et al. Burden of illness in patients with reflux disease: evidence from a recent comparative methodological study in Hungary. Orv Hetil 2004 Mar 28; 145(13 Suppl. 2): 717–22, 33–8
Wiklund I, Carlsson J, Vakil N. Gastroesophageal reflux symptoms and well-being in a random sample of the general population of a Swedish community. Am J Gastroenterol 2006 Jan; 101(1): 18–28
Wahlqvist P, Karlsson M, Johnson D, et al. Relationship between symptom load of gastro-oesophageal reflux disease and health-related quality of life, work productivity, resource utilization and concomitant diseases: survey of a US cohort. Aliment Pharmacol Ther 2008 May; 27(10): 960–70
Wahlqvist P. Symptoms of gastroesophageal reflux disease, perceived productivity, and health-related quality of life. Am J Gastroenterol 2001 Aug; 96(8 Suppl.): S57–61
Wahlqvist P, Brook RA, Campbell SM, et al. Objective measurement of work absence and on-the-job productivity: a case-control study of US employees with and without gastroesophageal reflux disease. J Occup Environ Med 2008 Jan; 50(1): 25–31
Wahlqvist P, Guyatt GH, Armstrong D, et al. The Work Productivity and Activity Impairment Questionnaire for Patients with Gastroesophageal Reflux Disease (WPAI-GERD): responsiveness to change and English language validation. Pharmacoeconomics 2007; 25(5): 385–96
Brook RA, Wahlqvist P, Kleinman NL, et al. Cost of gastrooesophageal reflux disease to the employer: a perspective from the United States. Aliment Pharmacol Ther 2007 Sep 15; 26(6): 889–98
Kahrilas PJ, Shaheen NJ, Vaezi MF, et al. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology 2008 Oct; 135(4): 1383–91
Jones R, Liker HR, Ducrotté P. Relationship between symptoms, subjective well-being and medication use in gastro-oesophageal reflux disease. Int J Clin Pract 2007 Aug; 61(8): 1301–7
Carlsson R, Dent J, Watts R, et al. Gastro-oesophageal reflux disease in primary care: an international study of different treatment strategies with omeprazole. International GORD Study Group. Eur J Gastroenterol Hepatol 1998 Feb; 10(2): 119–24
Inadomi JM, McIntyre L, Bernard L, et al. Step-down from multiple- to single-dose proton pump inhibitors (PPIs): a prospective study of patients with heartburn or acid regurgitation completely relieved with PPIs. Am J Gastroenterol 2003 Sep; 98(9): 1940–4
Crawley JA, Schmitt CM. How satisfied are chronic heartburn sufferers with their prescription medications? Results of the patient unmet needs survey. J Clin Outcome Manag 2000; 7(11): 29–34
CHS 2011 [online]. Available from URL: http://www.chsinternational.com/default.aspx [Accessed 2011 Jan 7]
Poh CH, Gasiorowska A, Navarro-Rodriguez T, et al. Upper GI tract findings in patients with heartburn in whom proton pump inhibitor treatment failed versus those not receiving antireflux treatment. Gastrointest Endosc 2010 Jan; 71(1): 28–34
Ware Jr J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996 Mar; 34(3): 220–33
Samsa G, Edelman D, Rothman ML, et al. Determining clinically important differences in health status measures: a general approach with illustration to the Health Utilities Index Mark II. Pharmacoeconomics 1999 Feb; 15(2): 141–55
Prasad M, Wahlqvist P, Shikiar R, et al. A review of self-report instruments measuring health-related work productivity: a patient-reported outcomes perspective. Pharmacoeconomics 2004; 22(4): 225–44
Wahlqvist P, Carlsson J, Stålhammar NO, et al. Validity of a Work Productivity and Activity Impairment questionnaire for patients with symptoms of gastro-esophageal reflux disease (WPAI-GERD): results from a cross-sectional study. Value Health 2002 Mar–Apr; 5(2): 106–13
Wahlqvist P, Reilly MC, Barkun A. Systematic review: the impact of gastro-oesophageal reflux disease on work productivity. Aliment Pharmacol Ther 2006 Jul 15; 24(2): 259–72
Dent J, Kahrilas PJ, Hatlebakk J, et al. A randomized, comparative trial of a potassium-competitive acid blocker (AZD0865) and esomeprazole for the treatment of patients with nonerosive reflux disease. Am J Gastroenterol 2008 Jan; 103(1): 20–6
Kahrilas PJ, Dent J, Lauritsen K, et al. A randomized, comparative study of three doses of AZD0865 and esomeprazole for healing of reflux esophagitis. Clin Gastroenterol Hepatol 2007 Dec; 5(12): 1385–91
Boeckxstaens GE, Beaumont H, Mertens V, et al. Effects of lesogaberan on reflux and lower esophageal sphincter function in patients with gastroesophageal reflux disease. Gastroenterology 2010 Aug; 139(2): 409–17
Boeckxstaens GE, Rydholm H, Lei A, et al. Effect of lesogaberan, a novel GABA-receptor agonist, on transient lower esophageal sphincter relaxations in male subjects. Aliment Pharmacol Ther 2010 Jun; 31: 1208–17
Boeckxstaens GE, Beaumont H, Hatlebakk JG, et al. A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial. Gut. Epub 2011 Mar 14
Acknowledgements
This study was supported by AstraZeneca R&D, Mölndal, Sweden. We thank Anna Mett and Simon Lancaster of inScience Communications, a Wolters Kluwer business, who provided medical writing support funded by AstraZeneca R&D, Mölndal, Sweden.
Samira Toghanian and Nils-Olov Stålhammar are former and current employees of AstraZeneca, respectively. David A. Johnson is a consultant to AstraZeneca, Eisai, Novartis, Proctor and Gamble, Xenoport and Takeda, and has received research/grant support from AstraZeneca and Takeda; he is also a clinical investigator for AstraZeneca, Novartis, Eisai and Takeda, and has received speaker fees from AstraZeneca and Takeda. Frank Zerbib has served as a speaker, a consultant and an advisory board member for Addex Pharma SA, Given Imaging, AstraZeneca, Janssen-Cilag, Movetis, Xenoport, Reckitt Benckiser, Abbott and Pfizer, and has received research funding from Nycomed.
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Toghanian, S., Johnson, D.A., Stålhammar, NO. et al. Burden of Gastro-Oesophageal Reflux Disease in Patients with Persistent and Intense Symptoms Despite Proton Pump Inhibitor Therapy. Clin. Drug Investig. 31, 703–715 (2011). https://doi.org/10.2165/11595480-000000000-00000
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DOI: https://doi.org/10.2165/11595480-000000000-00000