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On demand vs continuous use of proton pump inhibitors (PPI) on symptoms burgden and quality of lifes: results of a real-world RCT in primary care patients with gastroesophageal, reflux disease (GORD)

Andreasson, A., Agreus, L., Verheij, R., Wright, E., Curcin, V., Delaney, B.D. On demand vs continuous use of proton pump inhibitors (PPI) on symptoms burgden and quality of lifes: results of a real-world RCT in primary care patients with gastroesophageal, reflux disease (GORD) Gastroenterology: 2019, 156(supp. 1) . Abstract. In: Digestive Disease Week 2019, 2-5 mei 2019, San Diego.
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Introduction
The aim in the study was to investigate if prescription of on demand vs continuous use of PPI influenced symptom burden, health related quality of life and selfrated health in primary care. Previous trials in this area have used 'willingness to continue' as a proxy outcome measure. The use of an innovative trials platform integrating the electronic record and patient outcomes via smartphone enables symptoms and quality of life profile to be captured.

Methods
36 primary care centres participated in the study: 8 in Greece, 10 in Poland, 8 in the Netherlands and 10 in UK. Eligible patients were adults 18 to 65 years of age with GORD, either current or former PPI users, and identified based on primary care electronic health records data. Patients were randomized to either on demand (when the patient experiences bothersome reflux symptoms) or continuous use of PPI. Patient reported demographics, drug use, symptom burden, quality of life and self-rated health at the first visit and the follow-up visit after 8 weeks. The trial was registered with EudraCT as nr 2014-001314-25. The effect of on demand vs continuous PPI use on PPI intake and patient reported outcomes (reflux symptom burden, assessed with RDQ; Health related quality of life, assessed with SF-12) was tested using mixed effect regression model with treatment allocation (on demand vs continuous PPI use), visit and an interaction term between treatment allocation and visit as exposure variables. Change in PPI dose was
correlated with change in patient reported outcomes using Spearman correlation.

Results
A total of 488 patients (median age 51 years, 58 % women) completed the first visit and 360 completed the follow-up visit. There was no significant difference in baseline PPI use, reflux symptom burden or QoL, or in study completion, between treatment allocation. There was no difference between continuous or on-demand advice on PPI use (b=.57, 95 %CI: -.40-1.53), however, PPI use increased between baseline and follow-up in both groups (b=1.33, 95 %CI: .65-2.01). There was no difference between continuous or on-demand on either of the patient reported outcomes. However, symptom burden (b=-.61, 95%CI:-.73- -.49) and health related quality of life (b= 3.31, 95 %CI: 2.17-4.45) improved significantly between baseline and follow up in both groups (Table 2). An increased PPI intake correlated significantly with a reduced reflux symptom score (n=347, rho= -0.12, p=.02) and an improved physical SF-12 subscale score (n=217, rho=0.16, p=0.02), while no significant association was found for SF-12 mental subscale or self-rated health.

Conclusion
Both continuous and on-demand dosing increase PPI consumption in real-world settings. Reaching a sufficient dose of PPI to reduce reflux symptom burden improves quality of life in patients with GORD.