[Alginate on demand as add-on for patients with gastro-oesophageal reflux disease and insufficient PPI effect].

BACKGROUND

Chronic reflux patients with long-term PPI therapy frequently have persistent symptoms. A critical source of the persistent acid reflux is the acid pocket, which can be treated effectively by the non-systemic reflux suppressing action of alginates.

METHODS

GERD patients with at least one year of PPI long-term therapy, who were dissatisfied with their therapy, were treated over a period of 14 days with alginate as add-on and when required (up to 4 times daily) in a prospective, multi-centre, non-randomised, non-interventional and uncontrolled study in GP practices. The frequency of symptoms in the week before treatment was recorded, as well as in the second week of the study phase and the consumption of alginate. The validated GERD Q score was also applied. The patients assessed satisfaction with the therapy on a five-point Likert scale (very unhappy - happy) before the beginning and at the end of the study. The primary endpoint of the study was improvement in satisfaction with the therapy by ≥ 1 point.

RESULTS

155 patients (54 % women, median age 57 (18 - 85) years) entered the study. Six patients had to be excluded from the final efficacy analysis (no intake of study drug, lost to follow-up). The median duration of GORD was 8 (1 - 50) years and the median time on PPI therapy was 6 years. On average the patients took 3 sachets of alginate per day. The alginate therapy led to an improvement by at least 1 point on the Likert scale in 72 % of patients (1 step n = 45, 2 steps n = 41, 3 steps n = 16, 4 steps n = 5). Patients with a Gerd Q score > 8 showed a higher response rate at 81 %. There was improvement in all typical reflux symptoms and sleep disorders. The treatment was generally well-tolerated.

CONCLUSIONS

A reflux blocking alginate taken on demand is an effective and safe option for the treatment of breakthrough symptoms in GERD patients on PPI.