Gaviscon® vs. Omeprazole in Symptomatic Treatment of Moderate Gastroesophageal Reflux

A Direct Comparative Randomised Trial

Denis Pouchain; Marc-André Bigard; François Liard; Marc Childs; Annick Decaudin; Donna McVey

Disclosures

BMC Gastroenterol. 2012;12(18) 

In This Article

Discussion

The GOOD trial is the first randomised controlled double-blind, double-dummy trial to directly compare efficacy between an alginate and a PPI with heartburn as the clinical primary endpoint. It showed that Gaviscon® (4 × 10 mL/day) was not inferior to omeprazole 20 mg/day in achieving onset of the first 24-h heartburn-free period after initial dosing in patients with moderate GERD (heartburn at least once a week). Mean times to onset of the first 24-h heartburn-free period after initial dosing were 2 ± 2.2 days for Gaviscon® and 2 ± 2.3 days for omeprazole (p = 0.93). In both groups, 9 out of 10 patients had a heartburn-free period of at least 24 h.

The mean number of heartburn-free days by D7 was significantly (p = 0.02) greater with omeprazole, due to a higher rate of symptom recurrence in the Gaviscon® group. The weekly absolute difference was 0.6 days.

There was no significant difference between groups in clinically relevant reduction in pain intensity, although overall qualitative pain relief was slightly (p = 0.049) in favour of omeprazole.

Results of the GOOD trial also showed that Gaviscon® and omeprazole 20 mg could be used both safely.

This trial, performed in a general practice setting, included patients with symptoms highly suggestive of GERD (heartburn, regurgitation) and with a very low estimated risk of ulcerative esophagitis. The same primary outcome was used in a trial comparing rabeprazole vs. placebo in GERD patients without erosive or ulcerated esophagitis on endoscopy.[13] In the rabeprazole 20 mg/day group, the median time to a 24-h heartburn-free period was 4.5 days, vs. 21.5 with placebo. A trial comparing pantoprazole 20 mg/day and esomeprazole 20 mg/day in GERD without esophagitis found a median 2 days to the beginning of heartburn relief in both groups.[14]

Alginates showed proven efficacy against GERD symptoms in randomised trials vs. placebo.[5–9] As the medications in both arms of the GOOD trial had proven short-term symptomatic efficacy in GERD vs. placebo, no placebo arm was deemed necessary.

The limitation of the GOOD trial was the treatment period, which was only 14 days, with the primary outcome set during the first 7 days of treatment. The objective was to determine whether Gaviscon® could be a relevant alternative to omeprazole 20 mg in patients suffering from mild-to-moderate episodic GERD in primary care, not requiring prolonged continuous treatment. These patients represent 74% of those consulting a primary care physician with a GERD complaint,[2] and require short-term treatment only. As the primary outcome was the time to onset of the first 24-h heartburn-free period, each day was divided into four periods so as to have four symptom assessments per day. As the treatment was symptomatic, this endpoint was relevant clinically and from the patient's point of view. Patients in the GOOD trial had moderate GERD, and therefore probably belonged to the population of patients able to use over-the-counter PPIs, which in France are packaged for a 14-day course of treatment.

The comparison was between two drugs with different pharmacokinetic and pharmacodynamic properties. Omeprazole 20 mg is somewhat pharmacologically effective as of D1, inhibiting 70% of proton pumps, with efficacy increasing up to D3.[15] Alginates display immediate action, forming a raft floating over the stomach contents, eliminating or displacing the postprandial "acid pocket", so that, in case of reflux, the raft is regurgitated first into the lower oesophagus, reducing acid contact, especially when the subject is standing.[16–21] The raft may remain in the stomach for several hours[18] but is then evacuated, so that 3 or 4 doses per day are required for optimal efficacy.

The trial used a simple, relevant and pragmatic primary clinical endpoint rather than a composite score such as symptom frequency plus intensity. On the secondary endpoints, the results were marginally (P = 0.049) in favour of better efficacy for omeprazole 20 mg on overall qualitatively perceived pain relief (but not on pain intensity) and mean number of heartburn-free days between D0 and D7, were in agreement with many literature reports of omeprazole 20 mg's efficacy on reflux symptoms with or without esophagitis.[20]

In the last 15 years, several guidelines have been published,[22–28] but mainly focused on GERD requiring a medical opinion from a gastroenterologist (disabling and/or continuous symptoms, esophagitis on endoscopy, extra-digestive manifestations, and treatment failure). In these patients, alginates and antacids were often restricted to self-medication. The GOOD trial demonstrated a role for Gaviscon® in the management of moderate GERD with occasional recurrence, alongside on-demand PPIs in patients showing rapid response to the latter.[29] This is a relevant and useful alternative and an effective non-systemic approach that should help reduce excessive use of curative or preventive prescriptions of PPIs.[30] PPIs are a well-tolerated pharmacologic class, but concomitant prescription of omeprazole with clopidogrel should be managed carefully after coronary stenting.[31–33] Some authors suggested that prolonged PPI therapy could increase Clostridium difficile infection,[34] community-acquired pneumopathy[35] and risk of hip fracture,[36,37] so that this pharmacologic class should be prescribed in moderation if other safe rapid-relief solutions are available.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....