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New Study Demonstrates that Amitizia (Lubiprostone) May Help Improve Symptoms of Irritable Bowel Syndrome with Constipation

LOS ANGELES, C.A. -- May 21, 2006 -- A new study found that Amitizia(TM) (lubiprostone) may help relieve the symptoms associated with constipation-predominant irritable bowel syndrome (IBS-C). IBS is a condition that affects nearly 30 million people in North America and accounts for 25-50 percent of referrals to gastroenterologists. The study was presented today at Digestive Disease Week, the largest annual meeting of digestive disease specialists.

"The results of this study suggest that Amitizia may help improve several of the most frequently reported symptoms of IBS-C, including abdominal pain, bloating and discomfort," said John Johanson, MD, primary investigator and clinical associate professor, University of Illinois College of Medicine. "There are several additional studies underway that further explore the uses of Amitizia in this patient population and we look forward to learning the findings."

Amitizia is a novel selective chloride channel activator that has been shown to be effective and well-tolerated in a number of well-controlled clinical trials in patients with chronic idiopathic constipation. Amitizia was approved for use for chronic idiopathic constipation in adults on January 31, 2006. This is the first time Amitizia has been tested exclusively in the IBS-C population.

About the Study
In a double-blind, placebo-controlled, dose-ranging study, approximately 200 patients with diagnosed IBS-C (per the Rome II criteria) were randomized to receive placebo or Amitizia (8, 16 or 24 mcg) twice-daily for 12 weeks. In an electronic diary, patients recorded data related to dosing, side effects and IBS-C symptoms including bloating, abdominal pain/discomfort, frequency of and straining during bowel movements, stool consistency and rescue medication use.

Significant improvements versus placebo were observed for at least two of the three months for abdominal pain/discomfort, abdominal bloating, frequency of spontaneous bowel movements (SBM), stool consistency, bowel straining and assessments of constipation severity. Comparisons between the groups revealed that during the first and second months, the improvements in abdominal discomfort/pain and SBM frequency rates were more than doubled in all Amitizia groups.

Overall, the improvements were typically highest in the highest Amitizia dose group (48 mcg/day). Dose-dependent trends were also seen for adverse events, with incidence and drop-out rates rising with the dose of Amitizia.

About Irritable Bowel Syndrome (IBS)
Irritable bowel syndrome (IBS) is a chronic disorder characterized by multiple symptoms of abdominal pain and discomfort, bloating, and changes of bowel habits such as constipation and/or diarrhea. The condition can significantly interfere with daily activities and reduce patients' quality of life, resulting in absences from school, missed work and reduced productivity.

Three main types of IBS exist: constipation-predominant (IBS-C), diarrhea- predominant (IBS-D) and alternating constipation and diarrhea (IBS-A). In IBS-C, symptoms are present for at least 12 weeks (these do not need to be consecutive) over a 12-month period. Although people with IBS-C report suffering from many of the same symptoms associated with constipation, the presence of pain and discomfort is what differentiates IBS-C from chronic constipation. The condition is approximately 2 to 2.5 times more prevalent in women than men, and women are more likely to report a history of constipation, whereas men are more likely to report diarrhea.

About Amitizia
Amitizia, approved by the U.S. Food and Drug Administration (FDA) in January 2006 for the treatment of chronic idiopathic constipation in adults, is an oral treatment that works by increasing fluid secretion in the small intestine by activating ClC-2 chloride channels, and thereby increasing the passage of the stool and improving symptoms associated with chronic idiopathic constipation.

Amitizia is indicated for the treatment of chronic idiopathic constipation in the adult population. Amitizia should not be used in patients with a known hypersensitivity to any components of the formulation and in patients with a history of mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be evaluated prior to initiating Amitizia treatment.

The safety of Amitizia in pregnancy has not been evaluated in humans. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. Amitizia should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with Amitizia and should be capable of complying with effective contraceptive measures.

Amitizia should not be administered to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. If the diarrhea becomes severe, patients should consult their health professional.

In clinical trials, the most common adverse event was nausea (31%). Other adverse events (greater than or equal to 5% of patients) included diarrhea (13%), headache (13%), abdominal distention (7%), abdominal pain (7%), flatulence (6%), sinusitis (5%) and vomiting (5%).


Amitizia is a trademark of Sucampo Pharmaceuticals, Inc.


SOURCE: Takeda Pharmaceuticals North America, Inc.; Sucampo Pharmaceuticals

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