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Consumer surveys have identified an over-the-counter (OTC) medication that provides complete and long-lasting relief of frequent heartburn as an unmet consumer need. The purpose of the two identical studies reported in this paper was to evaluate the safety and effectiveness of 10·3 and 20·6 mg omeprazole magnesium, referred to as Ome-Mg 10 and Ome-Mg 20, respectively (equivalent to 10 and 20 mg omeprazole) for the treatment of frequent heartburn administered as a novel 14-day OTC regimen.Subjects with frequent heartburn (heartburn two or more days per week) took Ome-Mg 10, Ome-Mg 20, or placebo for 14 consecutive mornings. Statistical analyses compared percentage of subjects with no heartburn 24 h after the first dose, after the last dose (day 14), and percentage of days that subjects were heartburn-free. Nocturnal heartburn and heartburn rated no more than mild were also assessed.Twenty-four hours following the first dose, nearly 50% of subjects receiving Ome-Mg 20 reported no heartburn, and more than 80% receiving Ome-Mg 20 had no more than mild heartburn. Both doses were significantly more effective than placebo on days 1 and 14 for percentage of subjects heartburn-free for 24 h (P ≤ 0·003), and across all 14 days for percentage of heartburn-free days (P < 0·001). Ome-Mg 20 was significantly more effective than placebo in preventing nocturnal heartburn across all 14 days (P < 0·001). Ome-Mg was well tolerated.These trials demonstrated the safety and effectiveness of a novel 14-day regimen of Ome-Mg 20 in completely preventing heartburn for 24 h establishing it as an excellent self-care treatment for frequent heartburn and supporting the approval of Prilosec OTCTM. [ABSTRACT FROM AUTHOR]

Presentations by international experts from old and new worlds bordering the Atlantic Ocean revealed surprising similarities with respect to the diagnosis and management of patients with upper gastrointestinal disorders. It was agreed that Helicobacter pylori infection continues to play a key role in gastroduodenal disease and has a great impact on clinical management. However, testing and treatment strategies vary in patients affected by functional dyspepsia and those receiving nonsteroidal anti-inflammatory drug (NSAID) therapy including aspirin. Among patients with gastro-oesophageal reflux disease (GERD), it was clear that we need to re-evaluate the validity of the classical concept of GERD as a progressive spectrum and instead focus on the pathophysiologic mechanisms responsible for producing the common symptom of heartburn and complications that occur in the three principle subsets of GERD patients: those with endoscopic negative reflux disease, erosive oesophagitis and Barrett's oesophagus. In addition, we need to be increasingly aware of the concept of extra-oesophageal manifestations of gastro-oesophageal reflux and the fact that GERD in adults often originates in childhood. In all these gastrointestinal disorders, proton pump inhibitor therapy has become the common thread either as a diagnostic tool or an effective short-term or long-term management strategy. [ABSTRACT FROM AUTHOR]

The aims of this study were to investigate the effects of H. pylori eradication on gastric myoelectrical activity and dyspeptic symptoms. Sixty-two subjects with H. pylori infection and no active peptic ulcer participated in this study, which involved three sessions. Anti-H. pylori therapy consisting of clarithromycin and omeprazole was given for two weeks. Gastric myoelectrical activity was measured using surface electrogastrography and dyspeptic symptoms were scored at each session. A [14C] urea breath test was performed at baseline and one month after treatment. In comparison with baseline, the percentage of normal slow waves was significantly increased and the mean total symptom score was significantly reduced one and three months after therapy (P < 0.05). Approximately 40% of patients with nonulcer dyspepsia' symptoms and H. pylori infection have abnormal gastric myoelectrical activity, which may be normalized following the eradication of H. pylori infection. The normalization of gastric myoelectrical activity may be one explanation for the significant symptom improvement in this subset of the dyspepsia population after H. pylori eradication. [ABSTRACT FROM AUTHOR]

In the treatment of Helicobacter pylori-associated peptic ulcer disease, the complexity (ie, frequency and duration) of drug administration, the presence or development of bacterial antibiotic resistance, and the occurrence of side effects influence patient compliance and eradication rates, which consequently affect the costs of treatment regimens. The National Institutes of Health Consensus Conference and 1997 Digestive Health Initiative Update Conference have recommended that all patients with gastric or duodenal ulcer and H. pylori infection, whether on first presentation or recurrence, be treated with antimicrobials. However, H. pylori resistance to antimicrobials, specifically to nitroimidazole compounds, has resulted in varied and decreasing success rates of treatment regimens. Comparing the efficacy, safety, and costs of current treatment strategies for the eradication of H. pylori, a combination triple therapy with a proton pump inhibitor, amoxicillin, and clarithromycin is recommended as an effective alternative to standard bismuth-based triple therapy. When compared with other therapies, these offer more rapid symptomatic relief, improved tolerability, increased compliance and efficacy, and moderate costs. [ABSTRACT FROM AUTHOR]

The gastroduodenal mucus layer is considered the primary mucosal protective barrier, especially important in the maintenance of a mucosal pH gradient. Thus, the measurement of the mucus layer thickness in various disease states could advance our understanding of gastroduodenal pathophysiology. We present a novel method for measuring the mucus layer in endoscopic biopsy material and compare layer thickness in Helicobacter pylori (HP)-negative and HP-positive specimens. Endoscopic biopsies were obtained from 17 patients with gastroduodenal mucosa harboring IIP and from 15 patients without current HP colonization. The thickness of the mucus layer was measured in fresh specimens by the phase-contrast dark-field microscopy technique. In patients with confirmed IIP infection, the thickness of the mucus layer (mean ± SD) was 0.093 ± 0.033 mm in duodenal, 0.085 ± 0.027 mm in antral, and 0.105 ± 0.033 mm in corporal mucosa. In patients without concomitant HP colonization, the thickness of the mucus gel was 0.162 ± 0.045 mm, 0.175 ± 0.067 mm, and 0.161 ± 0.064 mm in duodenum, antrum, and corpus, respectively. The differences between the means were statistically significant (77 < 0.001 for the duodenal, p < 0.001 for antral, and p < 0.01 for corporal mucosa). This study suggests that colonization of the gastroduodenal mucosa by HP impairs the mucus layer covering the surface epithelium. This mucus layer impairment may lead to mucosal injury with subsequent development of inflammation and, possibly, peptic ulcer disease. [ABSTRACT FROM AUTHOR]

Presents a case study on running-associated proximal hemorrhagic colitis. Association of intestinal ischemia with intestinal bleeding; Appearance of the midascending colon and the cecum and ileocecal valve in a patient with gastrointestinal bleeding.

Background: Drug exposure and corresponding antisecretory effects increase over the first 4-5 days of esomeprazole treatment. To date, this effect has not been correlated with symptomatic improvement. Therefore, the efficacy of esomeprazole was evaluated on days 1-4 and 5-14 using pooled data from two identical randomised, double-blind, placebo-controlled studies conducted in subjects with frequent heartburn who are likely to self-treat with over-the-counter medications., Methods: Adults without confirmed diagnoses of gastro-oesophageal reflux disease experiencing heartburn 2 or more days per week in the past 4 weeks were randomly assigned to treatment with esomeprazole 20 mg or placebo once daily for 14 days following a 1-week placebo run-in period (esomeprazole: n=330; placebo: n=321). Heartburn episodes were documented in daily diaries. The current analyses evaluated the change in baseline percentage of heartburn-free days across days 1-4 and 5-14., Results: Change in the percentage of heartburn-free days from the run-in was significantly greater with esomeprazole compared with placebo (p<0.001) starting on days 1-4. The greatest treatment benefit was observed during days 5-14. During this period, esomeprazole-treated subjects increased their heartburn-free time over the run-in period by 32.5% compared with 14.3% with placebo (p<0.001)., Conclusions: Frequent heartburn sufferers treated with esomeprazole 20 mg had significantly more heartburn-free days relative to placebo throughout the studies. Maximal clinical benefits coincided with the estimated timing of maximal pharmacokinetic and pharmacodynamic effects and duration of acid control on days 5-14., Trial Registration Number: NCT01370525; NCT01370538., Competing Interests: Competing interests: DP reports personal fees from Takeda and Horizon outside the submitted work and has served as a consultant for AstraZeneca, Pfizer, Takeda and Horizon. ALM, HW and CP are former employees of Pfizer Consumer Healthcare.

Objectives: Esomeprazole 20 mg once daily has been shown to be effective for treating frequent heartburn over 14 days in subjects who are likely to self-treat with over-the-counter medications. These analyses were conducted to assess durability of effects and symptomatic rebound after cessation of treatment, treatment satisfaction, and rescue antacid use with esomeprazole 20 mg once daily for 14 days., Methods: Adults with frequent heartburn (≥ two days/week in the past four weeks) were randomly assigned to 14 days of double-blind treatment with esomeprazole 20 mg or placebo in two identical multicenter studies. All subjects entered a 1-week single-blind placebo follow-up period after treatment. The results of the primary efficacy endpoints were reported previously. The percentage of heartburn-free days during the 1-week follow-up, use of rescue antacids, and treatment satisfaction, measured with the Global Assessment Questions instrument, are described., Results: The percentage of heartburn-free days was maintained during the 1-week follow-up period; the proportion was 43% among esomeprazole subjects in these studies, suggesting no evidence of symptomatic rebound. Rescue antacid use generally decreased compared with the run-in period in the 14-day treatment and 1-week follow-up periods. Significantly more subjects taking esomeprazole were "very satisfied" or "satisfied" with treatment versus placebo (Study 1: 78% vs. 63%, respectively, P = 0.0038; Study 2: 81% vs. 60%, respectively, P = 0.0002)., Conclusions: Subjects who are likely to self-treat their frequent heartburn with over-the-counter medications reported satisfaction with esomeprazole 20 mg. Esomeprazole's treatment effect was maintained for ≥ one week after treatment ended, with no sign of symptomatic rebound. These trials were registered at ClinicalTrials.gov: NCT01370525; NCT01370538.

Pain affects the quality of life for millions of individuals and is a major reason for healthcare utilization. As populations age, medical personnel will need to manage more and more patients suffering from pain associated with degenerative and inflammatory musculoskeletal disorders. Nonsteroidal anti-inflammatory drugs (NSAIDs) are an effective treatment for both acute and chronic musculoskeletal pain; however, their use is associated with potentially significant gastrointestinal (GI) toxicity. Guidelines suggest various strategies to prevent problems in those at risk for NSAID-associated GI complications. In this article, we review the data supporting one such strategy - the use of histamine type-2 receptor antagonists (H2RAs) - for the prevention of GI adverse events in NSAID users. Older studies suggest that high-dose H2RAs are effective in preventing upper GI ulcers and dyspepsia. This suggestion was recently confirmed during clinical trials with a new ibuprofen/famotidine combination that reduced the risk of ulcers by 50% compared with ibuprofen alone.

Arthritis affects nearly 50 million people in the USA and, with the aging of the population, the prevalence is expected to rise. While NSAIDs are very effective in relieving pain associated with osteoarthritis (OA) and rheumatoid arthritis (RA), they are associated with side effects, including gastrointestinal (GI) toxicity, which may manifest as dyspepsia, ulcers and/or bleeding. A number of approaches have been employed in an effort to either completely avoid or reduce the risk of GI toxicities associated with NSAID use. Two new products combining an NSAID with a gastroprotective agent have recently been approved and other agents are in the pipeline. Patient adherence to prescribed gastroprotective therapy is known to be poor, often resulting in an increased risk of GI events in patients taking NSAIDs. These newer combination products may fulfill an important need for many patients who need to receive NSAIDs for the pain of OA and RA, but who are also at risk of upper GI events. This article reviews preclinical and clinical results for a new fixed-dose combination of ibuprofen and famotidine, DUEXIS(®) (HZT-501), which has recently been approved in the USA for the relief of signs and symptoms of RA and OA and to decrease the risk of developing upper GI ulcers.