Randomised clinical trial: addition of alginate-antacid (Gaviscon Double Action) to proton pump inhibitor therapy in patients with breakthrough symptoms

C. Coyle*, G. Crawford, J. Wilkinson, S. J. Thomas, P. Bytzer

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftArtikelForskningpeer review

Abstrakt

Background: Symptomatic breakthrough in proton pump inhibitor (PPI)-treated gastro-oesophageal reflux disease (GERD) patients is a common problem with a range of underlying causes. The nonsystemic, raft-forming action of alginates may help resolve symptoms. Aim: To assess alginate-antacid (Gaviscon Double Action, RB, Slough, UK) as add-on therapy to once-daily PPI for suppression of breakthrough reflux symptoms. Methods: In two randomised, double-blind studies (exploratory, n=52; confirmatory, n=262), patients taking standard-dose PPI who had breakthrough symptoms, assessed by Heartburn Reflux Dyspepsia Questionnaire (HRDQ), were randomised to add-on Gaviscon or placebo (20 mL after meals and bedtime). The exploratory study endpoint was change in HRDQ score during treatment vs run-in. The confirmatory study endpoint was “response” defined as ≥3 days reduction in the number of “bad” days (HRDQ [heartburn/regurgitation] >0.70) during treatment vs run-in. Results: In the exploratory study, significantly greater reductions in HRDQ scores (heartburn/regurgitation) were observed in the Gaviscon vs placebo (least squares mean difference [95% CI] −2.10 [−3.71 to −0.48]; P=.012). Post hoc “responder” analysis of the exploratory study also revealed significantly more Gaviscon patients (75%) achieved ≥3 days reduction in “bad” days vs placebo patients (36%), P=.005. In the confirmatory study, symptomatic improvement was observed with add-on Gaviscon (51%) but there was no significant difference in response vs placebo (48%) (OR (95% CI) 1.15 (0.69-1.91), P=.5939). Conclusions: Adding Gaviscon to PPI reduced breakthrough GERD symptoms but a nearly equal response was observed for placebo. Response to intervention may vary according to whether symptoms are functional in origin.

OriginalsprogEngelsk
Sider (fra-til)1524-1533
Antal sider10
TidsskriftAlimentary Pharmacology and Therapeutics
Vol/bind45
Udgave nummer12
DOI
StatusUdgivet - jun. 2017

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