Assessment of the Safety and Efficacy of a Raft-Forming Alginate Reflux Suppressant (Liquid Gaviscon) for the Treatment of Heartburn during Pregnancy

Vicki Strugala,Edward C. M. Thomas,Peter W. Dettmar,Julian Bassin,Valerie S. Swales,Stephen W. Lindow

doi:10.5402/2012/481870

Abstract

Gastro-oesophageal reflux (GER) and the symptoms of heartburn and regurgitation are common in pregnancy. These symptoms are transient and mostly resolve postpartum but have a negative impact on quality of life. Here, we present a prospective clinical evaluation of the safety and efficacy of an alginate raft-forming oral suspension that is licensed for use in pregnancy. The study was a multicentre, prospective, open-label, and baseline-controlled study of Liquid Gaviscon (LG) in the treatment of heartburn in pregnant women with current symptoms of heartburn and/or reflux requiring treatment (recruited 144). The efficacy of the study medication was rated by the investigator (primary endpoint) and patient. Treatment was deemed to be a success in 91% of patients as judged by the investigator (95% CI 85.0–95.3) and 90% (95% CI 84.1–94.8) when assessed by the patient themselves. Very few adverse events or serious adverse events were reported that were considered to be related to the study medication, and these were consistent with the normal population incidences. Serum sodium levels remained unchanged. This prospective open-label study in a large number of pregnant women has shown that LG is both safe and highly efficacious in the treatment of heartburn and GER symptoms in pregnancy.

Highlights

The symptoms of gastro-oesophageal reflux (GER), heartburn and regurgitation, are common in pregnancy with 40– 80% suffering at some time during the pregnancy [1,2,3,4], and these symptoms can have a marked impact upon quality of life [2]
The prevalence of GER increases with advancing gestation time, a recent study has shown that the incidence of frequent GER is consistent across the three trimesters
The study assessment visit was attended by 131 patients (91%), and postpartum data was available for 130 patients (90%)

Summary

Introduction

The symptoms of gastro-oesophageal reflux (GER), heartburn and regurgitation, are common in pregnancy with 40– 80% suffering at some time during the pregnancy [1,2,3,4], and these symptoms can have a marked impact upon quality of life [2]. Alginate-based reflux suppressants such as Liquid Gaviscon and Gaviscon Advance (Reckitt Benckiser Healthcare (UK) Ltd) are licensed for use by pregnant women to combat the frequent symptoms of heartburn and regurgitation. Lindow et al [6] performed a formal safety and efficacy study using double strength product Gaviscon Advance (open label and uncontrolled) to treat symptoms of heartburn and regurgitation in pregnant women (n = 146). A few older studies with small numbers have shown efficacy and safety of Gaviscon in the treatment of GER in pregnancy. Due to the large number of pregnant users of the alginate-based reflux suppressant Liquid Gaviscon, there is a need for a robust safety and efficacy study of this product in pregnancy using the UK manufactured formulation that is marketed worldwide. We present clinical data from a multicentre open-label study in pregnant women who took the medication for at least 4 weeks with the impact of the medication followed up until delivery of the baby

Methods

Results

Conclusion