Jay Barth

Seven‐day therapy for Helicobacter pylori in the United States

Background : The ideal duration of Helicobacter pylori treatment in the United States and whether eradication therapy is as successful in nonulcer dyspepsia as in peptic ulcer disease are controversial topics.

Rabeprazole for the prevention of pathologic and symptomatic relapse of erosive or ulcerative gastroesophageal reflux disease

Rabeprazole for the prevention of pathologic and symptomatic relapse of erosive or ulcerative gastroesophageal reflux disease

Long-term prevention of erosive or ulcerative gastro-oesophageal reflux disease relapse with rabeprazole 10 or 20 mg vs. placebo : results of a 5-year study in the United States

Background:  Erosive gastro‐oesophageal reflux disease (GERD) is a chronic condition requiring long‐term maintenance treatment. However, few trials of proton pump inhibitors in maintaining healing of erosive or ulcerative GERD are conducted for longer than 1 year.

Integrated acidity and rabeprazole pharmacology.

Integrated gastric and oesophageal acidity can be calculated from measurements of gastric and oesophageal pH and used to quantify gastric and oesophageal acidity over time. Rabeprazole is a new proton pump inhibitor that is effective in treating gastro‐oesophageal reflux disease (GERD).

Rabeprazole for the prevention of pathologic and symptomatic relapse of erosive or ulcerative gastroesophageal reflux disease. Rebeprazole Study Group.

OBJECTIVE:We evaluated the effectiveness and safety profile of 10 and 20 mg of rabeprazole, a new proton pump inhibitor, once daily versus placebo in preventing endoscopic and symptomatic relapse for up to 1 yr among patients with healed erosive or ulcerative gastroesophageal reflux disease (GERD).METHODS:The 52-wk trial used a multicenter, randomized, double-blind, parallel-group design in which 209 men and women were assigned to 10 or 20 mg of rabeprazole once daily in the morning or placebo.RESULTS:Both rabeprazole doses were significantly superior to placebo in preventing endoscopic relapse (p < 0.001), and 20 mg was significantly more effective than 10 mg (p < 0.04). Both doses were also significantly superior to placebo in reducing the frequency and severity of heartburn relapse (p < 0.001). When adjusted for differences in exposure to study medication, no significant differences were found in the incidence of adverse events. No clinically significant changes were found regarding clinical laboratory parameters, vital signs, electrocardiograms, ophthalmological evaluations, body weight, serum gastrin, and enterochromaffin-like cell histology.CONCLUSIONS:Once-daily therapy with 10 or 20 mg of rabeprazole effectively prevents pathological and symptomatic GERD relapse. The 20-mg dose is significantly more effective than the 10-mg dose in preventing endoscopic recurrence. Treatment was well tolerated, and no clinically significant safety findings emerged. Our findings support rabeprazoles efficacy in preventing GERD recurrence with excellent tolerability and a short-term favorable safety profile.

Rabeprazole is superior to omeprazole for the inhibition of peptone meal-stimulated gastric acid secretion in Helicobacter pylori-negative subjects.

Background: Peptone meal‐stimulated gastric acid output is considered to be a reliable means to evaluate drug‐mediated inhibition of stimulated gastric acid output, an important measure of the efficacy of the agents — such as proton pump inhibitors — used to treat acid‐related disorders.

The benefit/risk profile of rabeprazole, a new proton-pump inhibitor.

Acid-related diseases such as gastro-oesophageal reflux disease (GORD) and peptic ulcer are a common cause of morbidity and if inadequately treated can lead to serious complications. The proton-pump inhibitor rabeprazole has been extensively evaluated in well-controlled trials in North America and Europe for the acute treatment of erosive or ulcerative GORD and gastric and duodenal ulcers and for the long-term maintenance of GORD healing. The results show that rabeprazole has a favourable benefit/risk profile for each indication. Rabeprazole 10 and 20 mg given once daily in the morning was highly effective in producing and maintaining healing, providing symptom relief, and improving overall well-being. Healing rates for rabeprazole were equivalent to omeprazole in all indications, and superior (GORD healing and duodenal ulcer healing) or equivalent (gastric ulcer healing) to the histamine 2-receptor antagonist ranitidine. Symptom relief provided by rabeprazole was equivalent or superior to comparator drugs. Rabeprazole was well tolerated in both short- and long-term studies. The incidence of treatment-emergent signs and symptoms related to rabeprazole was low, and these were generally mild or moderate in severity. The overall rate of discontinuations due to adverse events was approximately 3%. There were no deaths related to rabeprazole therapy. These findings indicate a favourable benefit/risk profile for each intended use.

Rabeprazole improves and maintains overall well being in gastroesophageal reflux disease (GERD) over 5 years

Purpose: To compare the impact on overall physical well being of rabepmzole 20 rag, rabeprazole 10 mg, and placebo over 5 years of mainter~ance therapy in GERD patients. Methods: 497 patients, previously diagnosed with erosive/ulcerative GERD healed in an acute efficacy trial, entered a multicenter, double-blind, placebo-controlled, parallel-arm, 1year maintenance study. All patients completing 1 year without GERD relapse were eligible to participate for 4 more years in an extension phase. Efficacy variables of the combined 5 years (260 weeks) of study included: overall physical well-being score (scale, 0 = very good; 4 = very poor), relapse of seventy/frequency of daytime and nighttime heartburn, and antacid use. Results: At endpoint (260 weeks), both rabeprazole groups had significantly higher ratings in overall well being versus placebo (p 2; p-<0.008). Rabeprazole 20 mg also produced a significantly lower relapse rate than rabeprazole 10 mg for weeks 4-65 (p~0.038). These results in overall well being corresponded with significantly lower relapse rates with rabeprazole versus placebo in heartburn frequency and severity seen over 5 years (p-<0.02). Mean daily antacid dose consumed by the rabeprazole 20 mg group (0.17) was less than in the rabeprazole 10 mg (0.24) or placebo groups (0.24) at endpoint. For weeks 4-104 and week 143, there were significant differences in change in daily antacid use from baseline favoring both rabeprazole groups versus the placebo group (p-<0.05). Conclusions: 5-year maintenance therapy with rabeprazole improves overall well being compared with placebo. Research supported by Eisai Inc., Teaneck, NJ and Janssen Pharmaceutica Inc., Titusville, NJ.

REVIEW: Efficacy of Rabeprazole Once Daily for Acid-Related Disorders

Proton-pump inhibitors (PPIs) have revolutionized the treatment of gastroesophageal reflux disease (GERD) and peptic ulcer. To evaluate the efficacy of the new PPI rabeprazole, 12 controlled clinical trials were conducted worldwide—three for each indication (erosive or ulcerative GERD healing, long-term GERD healing maintenance, duodenal ulcer healing, and gastric ulcer healing). Rabeprazole was compared to placebo, the H2-receptor antagonist ranitidine, and the PPI omeprazole. Treatment duration ranged from ≤4 weeks for duodenal ulcer to ≤6 weeks for gastric ulcer, ≤8 weeks for GERD healing, and 1 year for maintenance of GERD healing. Rabeprazole was as effective as omeprazole for each indication and significantly more effective than ranitidine for healing of GERD (87% vs 66%) and duodenal ulcer (83% vs 73%). Rabeprazole was also superior to ranitidine in providing symptom relief, particularly in GERD.

Rabeprazole results in global improvement in symptoms of nonerosive gastroesophageal reflux disease

Rabeprazole results in global improvement in symptoms of nonerosive gastroesophageal reflux disease