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| |  DDW: Lotronex Appears Promising As Treatment For IBS ORLANDO, FL -- May 18, 1999 -- Two new groundbreaking studies show that Glaxo Wellcome Inc.’s investigational drug Lotronex(TM) (alosetron), compared to placebo, provides significantly greater relief from the pain and discomfort resulting from irritable bowel syndrome (IBS) in female diarrhea predominant IBS patients. Data from the studies also suggest that those patients who received Lotronex experienced significantly greater improvements in bowel function compared to those in the placebo group. The studies mark the first reported data from large phase III clinical trials -- involving one of a new generation of compounds being studied for IBS -- which were designed specifically to evaluate a drug's impact on multiple symptoms of IBS. The studies were presented at the annual Digestive Disease Week meeting in Orlando. "Proven therapeutic options for IBS are currently limited and the medications available are usually directed at treating isolated symptoms -- for example, antidiarrheals for diarrhea, or laxatives for constipation," said Lin Chang, MD, co-director of the Neuroenteric Disease Program at the University of California at Los Angeles School of Medicine. "These data suggest a potential new approach to addressing multiple symptoms associated with this condition." Irritable bowel syndrome may affect as many as one in five Americans, with female sufferers outnumbering male sufferers by an estimated three to one. IBS is the most common diagnosis among gastroenterology practices and is the seventh-leading diagnosis in the U.S. among all physicians. IBS is characterised by chronic, or recurrent, abdominal pain and discomfort and irregular bowel movements such as diarrhea, constipation or sometimes both. The studies presented today were identical in design and involved 1,273 non-constipated female IBS patients (647 in one study; 626 in another) who were recruited from more than 200 clinical sites in the United States. After a two-week screening period to verify a required threshold of IBS associated pain and stool consistency, patients were randomly assigned to receive 12 weeks of treatment with either Lotronex (1 mg twice daily) or placebo and then were followed for four weeks after treatment discontinuation. Patients recorded symptoms of pain and bowel function every day and also recorded on a weekly basis whether or not they had obtained adequate relief of their IBS pain and discomfort during the previous seven days. Adequate relief of pain and discomfort was the primary endpoint for the studies as pain has been reported by patients to be the most bothersome symptom associated with IBS. In both studies, clinical and statistical significance was achieved between weeks one and four of treatment against the primary endpoint of adequate relief of pain and discomfort. Once the treatment benefit was achieved, it persisted throughout the remainder of the 12-week study period. Data from the studies also showed that by one week of treatment, patients receiving Lotronex experienced important changes in bowel function, including decreased urgency (the sudden feeling of having to go to the bathroom) and stool frequency and improved stool consistency, than did patients in the placebo group. These changes in bowel function also persisted throughout the 12-week study period. By one week following discontinuation of Lotronex, symptoms were comparable between the group which had received Lotronex and the placebo group. "It appears that Lotronex may work by blocking serotonin 5-HT3 receptors that are found in the gastrointestinal tract and central nervous system and which may mediate pain perception as well as gastrointestinal motility," Dr. Chang said. “These data would suggest that Lotronex may not only provide relief of IBS associated pain in diarrhea predominant female sufferers, but may improve bowel function as well." The most commonly reported side effects in these two studies of Lotronex included constipation (28 percent with Lotronex; five percent with placebo), headache (nine percent with Lotronex; 12 percent with placebo), nausea (seven percent with Lotronex; six percent with placebo) and abdominal pain and discomfort (five percent with Lotronex; three percent with placebo).
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