alginate--aluminium-hydroxide--magnesium-trisilicate--sodium-bicarbonate-drug-combination and Heartburn

Topics: Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Drug Therapy, Combination; Gastric Acid; Gastroesophageal Reflux; Heartburn; Humans; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Alginate-based raft-forming formulations have been marketed word-wide for over 30 years under various brand names, including Gaviscon. They are used for the symptomatic treatment of heartburn and oesophagitis, and appear to act by a unique mechanism which differs from that of traditional antacids. In the presence of gastric acid, alginates precipitate, forming a gel. Alginate-based raft-forming formulations usually contain sodium or potassium bicarbonate; in the presence of gastric acid, the bicarbonate is converted to carbon dioxide which becomes entrapped within the gel precipitate, converting it into a foam which floats on the surface of the gastric contents, much like a raft on water. Both in vitro and in vivo studies have demonstrated that alginate-based rafts can entrap carbon dioxide, as well as antacid components contained in some formulations, thus providing a relatively pH-neutral barrier. Several studies have demonstrated that the alginate raft can preferentially move into the oesophagus in place, or ahead, of acidic gastric contents during episodes of gastro-oesophageal reflux; some studies further suggest that the raft can act as a physical barrier to reduce reflux episodes. Although some alginate-based formulations also contain antacid components which can provide significant acid neutralization capacity, the efficacy of these formulations to reduce heartburn symptoms does not appear to be totally dependent on the neutralization of bulk gastric contents. The strength of the alginate raft is dependant on several factors, including the amount of carbon dioxide generated and entrapped in the raft, the molecular properties of the alginate, and the presence of aluminium or calcium in the antacid components of the formulation. Raft formation occurs rapidly, often within a few seconds of dosing; hence alginate-containing antacids are comparable to traditional antacids for speed of onset of relief. Since the raft can be retained in the stomach for several hours, alginate-based raft-forming formulations can additionally provide longer-lasting relief than that of traditional antacids. Indeed, clinical studies have shown Gaviscon is superior to placebo, and equal to or significantly better than traditional antacids for relieving heartburn symptoms. Alginate-based, raft-forming formulations have been used to treat reflux symptoms in infants and children, and in the management of heartburn and reflux during pregnancy. While Gaviscon is effective when use

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Carbon Dioxide; Child; Cost-Benefit Analysis; Drug Combinations; Female; Gastric Acid; Gastroesophageal Reflux; Heartburn; Humans; Infant; Infant, Newborn; Male; Pregnancy; Pregnancy Complications; Proton Pumps; Silicic Acid; Sodium Bicarbonate

The alginate-antacid Gaviscon Double Action (Gaviscon DA) has a combined acid-neutralizing and reflux-suppressing action. Response to treatment in a symptomatic gastro-oesophageal reflux disease (GERD) population has not yet been tested in a large-scale clinical study.. The aim of this study was to assess the efficacy and safety of Gaviscon DA compared with matched placebo tablets in the reduction of upper gastrointestinal symptoms in patients with GERD.. In this multicentre, randomized, double-blind, placebo-controlled study, adults with GERD symptoms (N=424) received Gaviscon DA or placebo tablets for 7 days. The primary endpoint was a clinically important reduction of at least 1.5 points in the Reflux Disease Questionnaire (RDQ) GERD dimension (combined heartburn/regurgitation) between baseline and the end of the treatment. Secondary endpoints included the change in RDQ score from baseline for individual RDQ dimensions and Overall Treatment Evaluation.. A significantly greater proportion of patients treated with Gaviscon DA met the primary endpoint compared with placebo (47.8 vs. 33.2%, respectively, P=0.0031; odds ratio: 1.85, 95% confidence interval: 1.23-2.78). A significant treatment effect was also observed for heartburn, regurgitation and dyspepsia individually. Patients in the Gaviscon DA group rated their overall treatment response greater than patients in the placebo group [mean Overall Treatment Evaluation (SD): 3.2 (3.08) vs. 2.2 (3.34); P<0.001]. No notable differences in the incidence of adverse events were observed between treatments.. The alginate-antacid combination, Gaviscon DA, is an effective and well-tolerated treatment to reduce reflux symptoms and associated dyspepsia in symptomatic GERD patients.

Topics: Administration, Oral; Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Double-Blind Method; Drug Combinations; Europe; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Mastication; Middle Aged; Patient Satisfaction; Remission Induction; Silicic Acid; Sodium Bicarbonate; Surveys and Questionnaires; Tablets; Time Factors; Treatment Outcome

Symptomatic breakthrough in proton pump inhibitor (PPI)-treated gastro-oesophageal reflux disease (GERD) patients is a common problem with a range of underlying causes. The nonsystemic, raft-forming action of alginates may help resolve symptoms.. To assess alginate-antacid (Gaviscon Double Action, RB, Slough, UK) as add-on therapy to once-daily PPI for suppression of breakthrough reflux symptoms.. In two randomised, double-blind studies (exploratory, n=52; confirmatory, n=262), patients taking standard-dose PPI who had breakthrough symptoms, assessed by Heartburn Reflux Dyspepsia Questionnaire (HRDQ), were randomised to add-on Gaviscon or placebo (20 mL after meals and bedtime). The exploratory study endpoint was change in HRDQ score during treatment vs run-in. The confirmatory study endpoint was "response" defined as ≥3 days reduction in the number of "bad" days (HRDQ [heartburn/regurgitation] >0.70) during treatment vs run-in.. In the exploratory study, significantly greater reductions in HRDQ scores (heartburn/regurgitation) were observed in the Gaviscon vs placebo (least squares mean difference [95% CI] -2.10 [-3.71 to -0.48]; P=.012). Post hoc "responder" analysis of the exploratory study also revealed significantly more Gaviscon patients (75%) achieved ≥3 days reduction in "bad" days vs placebo patients (36%), P=.005. In the confirmatory study, symptomatic improvement was observed with add-on Gaviscon (51%) but there was no significant difference in response vs placebo (48%) (OR (95% CI) 1.15 (0.69-1.91), P=.5939).. Adding Gaviscon to PPI reduced breakthrough GERD symptoms but a nearly equal response was observed for placebo. Response to intervention may vary according to whether symptoms are functional in origin.

Topics: Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Anti-Ulcer Agents; Breakthrough Pain; Double-Blind Method; Drug Combinations; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Proton Pump Inhibitors; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression.. To assess the efficacy of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI.. This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using the Heartburn Reflux Dyspepsia Questionnaire (HRDQ). Based on symptom score during run-in, eligible patients were randomised to Gaviscon Advance 10 mL four times a day or placebo in addition to a once daily PPI. The primary endpoint was change in HRDQ score post-treatment compared to baseline.. One hundred and thirty-six patients were randomised. Change in HRDQ reflux score was significantly greater for Gaviscon Advance (mean: -5.0, s.d.: 4.7) than for placebo (mean: -3.5, s.d.: 5.5) with an LS mean difference of 1.6 [95% CI -3.1 to -0.1], P = 0.03. A decrease in the mean (s.d.) number of nights with symptoms was observed from 3.6 (2.8) to 3.0 (3.0) in the placebo group and from 3.9 (2.8) to 2.2 (2.7) for the Gaviscon Advance group. This reduction was significantly greater in the Gaviscon Advance group than in the placebo group [LS mean difference = -0.9, 95% CI (-1.6 to -0.2), P < 0.01].. In patients with residual reflux symptoms despite PPI treatment, adding an alginate offers additional decrease in the burden of reflux symptoms (EudraCT/IND Number: 2011-005486-21).

Topics: Adult; Aged; Alginates; Aluminum Hydroxide; Double-Blind Method; Drug Combinations; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Proton Pump Inhibitors; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

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).. 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.. 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.. 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.

Topics: Administration, Oral; Adult; Alginates; Aluminum Hydroxide; Antacids; Asian People; Cross-Over Studies; Drug Combinations; Esophageal pH Monitoring; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Manometry; Middle Aged; Silicic Acid; Sodium Bicarbonate; Tablets

There is a paucity of large-scale studies evaluating the clinical benefit of the Gaviscon Double Action (DA) alginate-antacid formulation for treating gastroesophageal reflux disease (GERD) symptoms.. Randomised double-blind placebo-controlled parallel-group study to evaluate efficacy and safety of Gaviscon DA in reducing heartburn, regurgitation and dyspepsia symptoms in individuals with mild-to-moderate GERD in China.. Participants with symptomatic GERD (n = 1107) were randomised to receive Gaviscon DA or placebo (two tablets four times daily) for seven consecutive days. The primary endpoint compared the change in Reflux Disease Questionnaire (RDQ) score for the GERD (heartburn + regurgitation) dimension between Gaviscon DA and placebo. Secondary endpoints compared the change in RDQ scores for individual heartburn, regurgitation and dyspepsia dimensions, overall treatment evaluation (OTE) scores and incidence of adverse events (AEs).. Mean RDQ GERD scores: 2.51 for Gaviscon DA and 2.50 for placebo at baseline; 1.25 for Gaviscon DA and 1.46 for placebo post treatment. Gaviscon DA was statistically superior to placebo in reducing GERD and dyspepsia RDQ scores [least-squares mean (LSM) difference: GERD -0.21, P < 0.0001; dyspepsia -0.18, P = 0.0004], despite a substantial placebo response. The Gaviscon DA group reported more favourable overall treatment responses than the placebo group across all OTE categories (P < 0.0001). Superior relief of GERD symptoms was observed both in those with non-erosive and those with erosive reflux disease (LSM difference -0.14 [P = 0.038] and -0.29 [P < 0.0001] respectively). Incidence of AEs was similar in both groups.. Gaviscon DA tablets provide effective and safe reduction in acid reflux and dyspepsia symptoms in Chinese individuals with mild-to-moderate GERD. ClinicalTrials.gov: NCT01869491.

Topics: Adolescent; Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Anti-Ulcer Agents; China; Double-Blind Method; Drug Combinations; Dyspepsia; Female; Gastroesophageal Reflux; Heartburn; Humans; Laryngopharyngeal Reflux; Male; Middle Aged; Placebos; Silicic Acid; Sodium Bicarbonate; Surveys and Questionnaires; Treatment Outcome; Upper Gastrointestinal Tract; Young Adult

The alginate-antacid, Gaviscon Double Action (Gaviscon DA; Reckitt Benckiser, Slough, UK) suppresses reflux after meals by creating a gel-like barrier that caps and displaces the acid pocket distal to the oesophago-gastric junction. The effect of Gaviscon DA on reflux and dyspepsia symptoms has not yet been demonstrated with a modern trial design.. A pilot study to assess the efficacy and safety of Gaviscon DA compared with matched placebo for decreasing upper gastrointestinal symptoms in symptomatic gastro-oesophageal reflux disease (GERD) patients.. A randomised, double-blind, parallel group study was performed in 110 patients with symptoms of GERD. Patients received Gaviscon DA or placebo tablets for 7 consecutive days. The primary endpoint compared the change in overall Reflux Disease Questionnaire (RDQ) symptom score (combined heartburn/regurgitation/dyspepsia). Secondary endpoints assessed individual dimensions, GERD dimension (heartburn and regurgitation) and overall treatment evaluation (OTE).. There was a greater decrease in overall RDQ symptom score in the Gaviscon DA group compared with the placebo group (Least Squares Mean difference -0.55; P = 0.0033), and for each of the dimensions independently. Patients in the Gaviscon DA group evaluated their overall treatment response higher than patients in the placebo group [mean (standard deviation) OTE 4.1 (2.44) vs. 1.9 (3.34); P = 0.0005]. No differences in the incidence of adverse events were observed between treatment groups.. Gaviscon DA decreases reflux and dyspeptic symptoms in GERD patients compared with matched placebo and has a favourable benefit-risk balance. Larger scale clinical investigations of medications targeting the acid pocket are warranted. (EudraCT, 2012-002188-84).

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Double-Blind Method; Drug Combinations; Dyspepsia; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Pilot Projects; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Was conducted a muIticenter study VIA APIA, in which the impact of gaviscon forte (suspension) on symptoms, general state and quality of life of 148 patients (male 53, female 95, age 42.9 +/- 15.6) with gastroesophageal reflux disease (GERD) were investigated. The patients had undergone clinical evaluation of dynamics of GERD symptoms (Likert scale), general state (Visual Analogue Scale, questionnaire SAN) and quality of life (SF-36). It was shown that 14-days treatment with gaviscon forte provided symptoms relief in 84.5% patients and conducted improvement of general state and quality of life. Gaviscon forte recommended as drug of choice in initial treatment for the first time visited patient with heartburn before endoscopy and for pathogenetic treatment of typical reflux syndrome.

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Prospective Studies; Quality of Life; Severity of Illness Index; Silicic Acid; Sodium Bicarbonate; Surveys and Questionnaires; Suspensions; Treatment Outcome

We conducted a crossover study, in which the efficacy and the onset of action of a single dose of Gaviscon (suspension) and Gaviscon forte (suspension) in 52 patients with heartburn of moderate intensity and gastroesophageal reflux disease (GERD) have been investigated. The average age of the patients was 44.0 +/- 17.3-years-old. The patients have undergone clinical evaluation of intensity of GERD symptoms and psychological assessment (questionnaires SF-36, SMOL, LOBI). Alginates' effects and qualities were evaluated using stopwatch technique, clinical examination, and organoleptic assessment. Primary sensation of a cooling (soothing) effect after use of a single dose of Gaviscon has been reported in 65.7 seconds (on average), and Gaviscon forte--in 66.1 seconds. Fourty three (82.7%) patients with heartburn have described the effects of both medications as "instant" cooling effects. Heartburn was relieved in 3.3 minutes in all patients after a single dose of Gaviscon, and in 3.6 minutes in 51 (98.1%) patients who have received a single dose of Gaviscon forte. Organoleptic qualities averaged at 3.6 points (on a scale of 1-5) for Gaviscon, and at 3.5 points for Gaviscon forte. Assessment of mental status of the patients suggested that a "delayed" effect of the medications in relieving heartburn in some patients may have occurred due to possible physical disadaptation.

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Cross-Over Studies; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Combinations; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Quality of Life; Silicic Acid; Sodium Bicarbonate; Taste; Time Factors; Treatment Outcome

This study investigated the efficacy and safety of a novel reflux suppressant, Gaviscon Advance, in the treatment of heartburn during pregnancy. The study was an open-label, multicentre, phase IV study in general practice and antenatal clinics in the UK and Republic of South Africa. Pregnant women (< or = 38 weeks gestation; n=150) aged 18-40 years suffering from heartburn were instructed to take Gaviscon Advance 5-10 ml, as required, to relieve symptoms. The main outcome measures were the efficacy rating of the study medication by the investigator and women after four weeks using a five-point efficacy scale. After four weeks the investigators' and women's rating of efficacy was 'very good' or 'good' in 88% and 90% of women, respectively. Most women (57%, n=83) reported symptom relief within 10 minutes. Thus Gaviscon Advance effectively and rapidly treats heartburn during pregnancy. Its use during pregnancy presents no known significant safety concerns for mother or child.

Topics: Adolescent; Adult; Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Female; Gastroesophageal Reflux; Heartburn; Humans; Patient Satisfaction; Pregnancy; Pregnancy Complications; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Forty-four patients with symptoms of gastro-oesophageal reflux were randomly assigned in a crossover trial to treatment for 15-day periods with Liquid Gaviscon (a reflux suppressant) or an antacid gel containing magnesium and aluminium hydroxide. Good relief of symptoms was reported by 84% of patients during therapy with Liquid Gaviscon compared to only 23% during antacid therapy. Relief of symptoms was obtained within 15 minutes by 68% of patients during therapy with Liquid Gaviscon compared to only 9% during antacid treatment. The beneficial effect lasted for more than 4 hours in 75% of patients during treatment with Liquid Gaviscom compared to only 23% of patients obtaining long-term relief during antacid therapy.

Topics: Abdomen; Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Drug Combinations; Female; Heartburn; Humans; Magnesium; Magnesium Hydroxide; Male; Middle Aged; Pain; Silicic Acid; Silicon Dioxide; Sodium Bicarbonate

Recently, an 'acid pocket' has been described in the proximal stomach, particularly evident postprandially in GERD patients, when heartburn is common. By creating a low density gel 'raft' that floats on top of gastric contents, alginate-antacid formulations may neutralise the 'acid pocket'.. To assess the ability of a commercial high-concentration alginate-antacid formulation to neutralize and/or displace the acid pocket in GERD patients.. The 'acid pocket' was studied in ten symptomatic GERD patients. Measurements were made using concurrent stepwise pH pull-throughs, high resolution manometry and fluoroscopy in a semi-recumbent posture. Each subject was studied in three conditions: fasted, 20 min after consuming a high-fat meal and 20 min later after a 20 mL oral dose of an alginate-antacid formulation (Gaviscon Double Action Liquid, Reckitt Benckiser Healthcare, Hull, UK). The relative position of pH transition points (pH >4) to the EGJ high-pressure zone was analysed.. Most patients (8/10) exhibited an acidified segment extending from the proximal stomach into the EGJ when fasted that persisted postprandially. Gaviscon neutralised the acidified segment in six of the eight subjects shifting the pH transition point significantly away from the EGJ. The length and pressure of the EGJ high-pressure zone were minimally affected.. Gaviscon can eliminate or displace the 'acid pocket' in GERD patients. Considering that EGJ length was unchanged throughout, this effect was likely attributable to the alginate 'raft' displacing gastric contents away from the EGJ. These findings suggest the alginate-antacid formulation to be an appropriately targeted postprandial GERD therapy.

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Manometry; Middle Aged; Silicic Acid; Sodium Bicarbonate; Treatment Outcome