Alginate antacid (Gaviscon DA) chewable tablets reduce esophageal acid exposure in Chinese patients with gastroesophageal reflux disease and heartburn symptoms.
OBJECTIVE
To assess the efficacy of Gaviscon Double Action (DA) alginate antacid chewable tablets for reducing esophageal acid exposure in Chinese patients with gastroesophageal reflux disease (GERD).


METHODS
Altogether 44 patients reporting moderate to severe heartburn symptoms underwent two pH monitoring visits. The treatment sequence was randomized to patients received DA alginate antacid or placebo at one visit and the alternate treatment 7 days later. After a standardized reflux-provoking meal, patients took four tablets of DA alginate antacid or placebo. Esophageal pH was measured for 4 h post-dosing using an electrode positioned 5 cm above the lower esophageal sphincter. The primary end-point was the percentage of 4-h post-dosing period with pH <4. Secondary end-points were number of acid reflux episodes (pH <4), longest reflux time and DeMeester scores.


RESULTS
All 44 patients completed the study and provided data for analysis. With DA alginate antacid, the mean percentage time with pH <4 was 5.1%, significantly less (P = 0.0003) than with placebo (14.8%). DA alginate antacid was statistically significantly superior (P = 0.0290) to placebo (from at least twofold to threefold better) for all other end-points. Two patients reported two mild adverse events (AEs) that resolved within a month of completing the study. No patients had serious and/or severe AEs and none withdrew due to AEs.


CONCLUSIONS
DA alginate antacid was statistically significantly superior to placebo in reducing post-prandial acid exposure without serious clinically relevant health risks. These findings suggest DA alginate antacid tablets are appropriate for treating acid reflux in Chinese GERD patients with heartburn symptoms.
Department of Gastroenterology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Yao Zong
YZ
Yuan
Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai, China.
Jing Yuan
JY
Fang
Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
Duo Wu
DW
Zou
Reckitt Benckiser, Hull, United Kingdom.
Nigel
N
Levinson
Reckitt Benckiser, Hull, United Kingdom.
Bartosz
B
Jenner
Reckitt Benckiser, Hull, United Kingdom.
Joanne
J
Wilkinson
D000284:Administration, Oral; D000328:Adult; D000464:Alginates / Q000008:administration & dosage*; D000536:Aluminum Hydroxide / Q000008:administration & dosage*; D000863:Antacids / Q000008:administration & dosage*; D044466:Asian People; D018592:Cross-Over Studies; D004338:Drug Combinations; D050782:Esophageal pH Monitoring; D005260:Female; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000188:drug therapy*; D006356:Heartburn / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008365:Manometry; D008875:Middle Aged; D012824:Silicic Acid / Q000008:administration & dosage*; D017693:Sodium Bicarbonate / Q000008:administration & dosage*; D013607:Tablets
D000464:Alginates; D000863:Antacids; D004338:Drug Combinations; D013607:Tablets; D012824:Silicic Acid; D000536:Aluminum Hydroxide; C007829:alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination; D017693:Sodium Bicarbonate
esophageal pH monitoring; esophagitis; gastroesophageal reflux disease; heartburn; sodium alginate