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| |  ACG: Aciphex (Rabeprazole Sodium) Provides Gastroesophageal Reflux Disease Relief After One Day NEW YORK, NY -- October 16, 2000 -- In data presented here at the American College of Gastroenterology (ACG) meeting, most patients with erosive gastroesophageal reflux disease (GERD) who were taking Aciphex® (rabeprazole sodium) once daily reported significant symptom relief for both daytime and nighttime heartburn after the first day of treatment. Results of the eight-week, open-label, multicenter trial were presented in an abstract on behalf of participating sites by Malcolm Robinson, M.D., chairman of the study steering committee and founder and a medical director of the Oklahoma Foundation for Digestive Research at the University of Oklahoma. The trial involved more than 2,500 patients with endoscopically confirmed erosive gastroesophageal reflux disease. According to the abstract, patients were diagnosed and treated by 420 community-based gastroenterologists. The study assessed the change in severity of erosive GERD symptoms, such as heartburn and regurgitation, during the first seven days of therapy and again at week four. Patients' symptom severity was rated on a four-point scale that ranged from zero (indicating no symptoms) to three (severe symptoms). Satisfactory symptom relief was defined as a zero or one rating (no symptoms or mild symptoms) on the scale. Based on data from a preliminary analysis, approximately 80 percent of patients with moderate to severe symptoms taking Aciphex reported satisfactory symptom relief on day one for both daytime and nighttime heartburn. By day seven, 91.2 percent of patients reported satisfactory symptom relief for daytime heartburn, and 91.7 percent reported satisfactory symptom relief for nighttime heartburn. "Patients with erosive GERD taking Aciphex reported significant symptom relief for both daytime and nighttime heartburn, which is very important because this disease can disrupt a wide range of daily activities and nighttime sleep," said Dr. Robinson. Within 36 hours of the first dose, patients began reporting the severity of their symptoms via an interactive telephone response system. Patients responded to a series of voice prompts and had the option to report their symptoms to a representative who recorded the information. "By using a voice-activated telephone response system, we captured patients' symptomatic response to therapy in real time," said Dr. Robinson. "Because patients could call in on a daily basis and rate the severity of the symptoms they were experiencing, the timeliness and accuracy of the symptom reporting increased over that associated with traditional paper diaries." This research was sponsored by Janssen Pharmaceutica, Inc., Titusville, NJ, and Eisai Inc., Teaneck, NJ. Aciphex is indicated for healing of erosive gastroesophageal reflux disease (GERD), maintenance of healed erosive GERD, healing of duodenal ulcers and treatment of related symptoms of these conditions. Aciphex also has been approved for the treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Aciphex product labeling recommends once-daily dosing for most indications. In clinical trials, Aciphex demonstrated a favorable side-effect profile. Headache was the most common side effect assessed as possibly related to Aciphex (2.4 percent vs. 1.6 percent for placebo). Aciphex is contraindicated in patients with known sensitivity to rabeprazole, substituted benzimidazoles or any component of the formulation. As is the case for other proton pump inhibitors, symptomatic response to therapy with Aciphex does not preclude the presence of gastric malignancy. Proton pump inhibitors, however, constitute an established class of drugs that has been shown to be effective and well tolerated.
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