Feel the Flow: IBS With Constipation? Lubiprostone May Help!

I'll tell you one thing, constipation isn't a problem here at Digestive Disease Week 2007, which is by the way the largest annual international meeting of digestive disease specialists. Whoa, That's a lot of Gastros and their groupies (like me) in one place!

And yes, a steady, sometimes quick stream of news and information is flowing like you wouldn't believe. No bowel obstructions of any kind.
And this perfect regularity has nothing to do with my taste-testing Benefiber down at the Novartis booth. Way better tasting than Metamucil (and no lumpy, choke-hold swallowing problems getting this stuff down, either). Suzanne, the kind demo-lady was taking her Benefiber in a cup of Cappuccino. Oh, la, la. Is this the beginning of it's hip, cool and wow to get your fiber on along with your foam? I bet we'll soon see girlie girls ordering grande-decaf-non-fat-extra-hot-fiber-filled-sugar-free vanilla lattes! Just remember, you heard it here first!

Anway, when I asked Suzanne for a sample of a fiber-filled cappuccino, she laughingly said, "OH, no you better wait until tomorrow." She was looking out for Gastro soundness since I already guzzled the Benefiber in a nice cup of Spring Water. Nothing's moved yet, in case you're wondering.

Anyway, back to the reason for the post. Oh, yea, the new study that shows the active ingredient in AMITIZA® (lubiprostone), given 8 mcg twice a day, may improve symptom relief rates in adults with irritable bowel syndrome with constipation (IBS-C).

"In this study, patients receiving lubiprostone were nearly twice as likely to achieve an overall response from symptoms of IBS-C compared to those receiving placebo," said Douglas A. Drossman, M.D., primary investigator, UNC Center for Functional GI and Motility Disorders, University of North Carolina, and the Chair of the Rome Committee. "As a result, lubiprostone may represent an important treatment for IBS-C sufferers."

In case you didn't know, IBS affects about 58 million Americans and accounts for 25-50 percent of referrals to gastroenterologists. IBS-C symptoms include abdominal pain or discomfort associated with defecation or a change in bowel habits with features of disordered defecation. Not fun!


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Lubiprostone is marketed in the U.S. as AMITIZA, a 24-mcg gelcap that was approved for use for chronic idiopathic constipation in adults on January 31, 2006.

Sucampo Pharmaceuticals expects to submit a supplemental New Drug Application for IBS-C to the U.S. Food and Drug Administration by July 2007.

The following is from the DDW 2007 press release (wanted you to have this info quickly so I've posted it here:)About the Study for IBS-C (lubiprostone 8 mcg)

"In two phase III, multi-center, double-blind, randomized, placebo-controlled trials, 1,171 adults diagnosed with IBS-C (Rome II Criteria) were enrolled and received lubiprostone 8 mcg taken twice daily (783 adults) or placebo (388 adults) over a 12-week period.

Primary efficacy was determined by a unique question: "How would you rate your relief of IBS symptoms (abdominal discomfort/pain, bowel habits and other IBS symptoms) over the past week compared to how you felt before you entered the study"" A 7-point balanced scale with a strict evaluation using the two highest scale points to qualify as a responder was used. Patients were considered monthly responders if they reported at least moderate relief four out of four weeks or significant relief two out of four weeks. To qualify as an overall responder (the measure used in the primary endpoint), patients had to be a monthly responder for at least two out of three months. During the evaluation period, patients discontinuing for any reason or reporting an increase in rescue medication use, lack of efficacy or moderately or significantly worse relief were deemed non-responders. These responder rates may not be comparable to those in other studies since the new scale was more restrictive than those used in previous reports.

The findings demonstrated that patients receiving lubiprostone 8 mcg twice daily were nearly twice as likely to achieve overall response compared to those receiving placebo (lubiprostone 17.9 percent vs. placebo 10.1 percent, P=0.001). There was a similar incidence of serious adverse events (1 percent in each group) and related adverse events (lubiprostone 22 percent vs. placebo 21 percent) compared to placebo. The most common treatment-related adverse events (>5% of patients) were nausea (8 percent vs. 4 percent, respectively), diarrhea (6 percent vs. 4 percent, respectively) and abdominal pain (4 percent vs. 5 percent, respectively)."