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

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

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.

Figures

Figure 1
Figure 1
Frequency distribution for the ITT population of impression of treatment of heartburn in pregnancy by Liquid Gaviscon at study assessment visit.
Figure 2
Figure 2
Severity of daytime and nocturnal heartburn experienced by pregnant women at baseline and after prn treatment with Liquid Gaviscon for 4 weeks. (ITT).

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