A Practical Guide to Irritable Bowel Syndrome—Alosetron HCI (Lotronex)—Risk–Benefit Considerations and Proper Patient Selection
A Practical Guide to Irritable Bowel Syndrome—Alosetron HCI (Lotronex)—Risk–Benefit Considerations and Proper Patient Selection
Citation: US Gastroenterology & Hepatology Review, 2009;5:62-67
Published: November 2009
Published: November 2009
Abstract
Irritable bowel syndrome (IBS) is a common gastrointestinal condition that is associated with patient discomfort, embarrassment, impaired quality of life, and substantial healthcare costs. Alosetron is the only 5-hydroxytryptamine-3 (5-HT3) receptor antagonist approved by the US Food and Drug Administration (FDA) for the treatment of diarrhea-predominant IBS (IBS-D) in women. In clinical studies, alosetron has been more effective than placebo in alleviating abdominal pain, urgency, global IBS symptoms, and diarrhea. Constipation is the most common side effect associated with alosetron, and rare instances of ischemic colitis and complications of constipation have been reported. A prescribing program for alosetron treatment provides patient education and assists physicians in the proper selection of patients. This practical guide reviews the efficacy and safety of alosetron, outlines treatment and management strategies, and describes the prescribing program for women with severe IBS-D who receive alosetron.
Keywords
Irritable bowel syndrome, alosetron, 5-HT3 antagonist, abdominal pain, fecal urgency, diarrhea, ischemic colitis, serious complications of constipation, prescribing program
Disclosure:In the last two years, Brian E Lacy, PhD, MD, has received investigator-initiated, unrestricted educational grants for research studies from AstraZeneca and Takeda, has served on scientific advisory boards for Ironwood and Salix, and is on the speaker’s bureau for Takeda and Prometheus.
Acknowledgement: The author would like to thank John Simmons, MD, for his assistance in the preparation of this manuscript.
Received: July 22, 2009 Accepted: July 31, 2009
Correspondence: Brian E Lacy, PhD, MD, Associate Professor of Medicine, Section of Gastroenterology & Hepatology, Area 4C, Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive, Lebanon, NH 03756. E: Brian.E.Lacy@Hitchcock.org
Support: This practical guide was supported by Prometheus Laboratories, Inc.
Irritable bowel syndrome (IBS) is a highly prevalent disorder characterized by abdominal pain associated with altered bowel habits.1 It is associated with decreased quality of life and substantial treatment costs.2 To establish a practical guide for the use of alosetron hydrochloride (Lotronex) in women with IBS and diarrhea, we reviewed the medical literature for current data on the epidemiology, pathophysiology, and treatment of IBS.The emphasis of this practical guide is on describing the indications for, and use of, alosetron in women with diarrhea-predominant IBS (IBS-D). Efficacy and safety data, as well as clinical strategies for appropriately prescribing alosetron, are also discussed.
Epidemiology and Pathophysiology of Irritable Bowel Syndrome
IBS is a common condition, with an estimated annual incidence of 1.5%.3 US prevalence rates range from 10 to 15%, although some studies report rates as low as 3% and as high as 20%.4 The latest Rome III diagnostic criteria define IBS as a chronic disordercharacterized by abdominal pain or discomfort associated with disordered defecation—either constipation (IBS-C), diarrhea (IBS-D), or mixed/alternating symptoms of constipation and diarrhea (IBS-M).1 Subtype definitions are outlined in Table 1.1 Rome III criteriastipulate that symptom onset generally occurs at least six months before patients first present for formal evaluation. Abdominal pain or discomfort should be present at least three days per month for three months and should be associated with two or more of the following: improvement with defecation,onset associated with a change in stool frequency, and onset associated with a change in stool form.1 Whereas past reviews have described the subtypes as equally divided among patients with IBS, their true prevalence in North America is unclear because the IBS definitions, studymethodologies, and levels of care differ with investigations and even in individual patients.5 Additionally, subtype group switching commonly occurs.5 Overall, it appears that IBS-D and IBS-M are more common than IBS-C.
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Keywords:
Irritable bowel syndrome, alosetron, 5-HT3 antagonist, abdominal pain, fecal urgency, diarrhea, ischemic colitis, serious complications of constipation, inflammatory bowel disease, irritable bowel syndrome, bowel cancer symptoms, colon cancer, colitis, 5 ht3 receptor antagonist, receptor binding, 5 ht antagonist, ischemic colitis,
Irritable bowel syndrome, alosetron, 5-HT3 antagonist, abdominal pain, fecal urgency, diarrhea, ischemic colitis, serious complications of constipation, inflammatory bowel disease, irritable bowel syndrome, bowel cancer symptoms, colon cancer, colitis, 5 ht3 receptor antagonist, receptor binding, 5 ht antagonist, ischemic colitis,
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