Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

New study demonstrates that Lubiprostone may improve symptom relief rates in adults with IBS-C

23.05.2007
A new study demonstrated that 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). These results were presented as a late-breaker at Digestive Disease Week 2007, the largest annual international meeting of digestive disease specialists.

"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."

IBS is a condition that affects approximately 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.

Lubiprostone 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. 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.

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).

Amy Losak | EurekAlert!
Further information:
http://www.ketchum.com

More articles from Studies and Analyses:

nachricht Multi-year study finds 'hotspots' of ammonia over world's major agricultural areas
17.03.2017 | University of Maryland

nachricht Diabetes Drug May Improve Bone Fat-induced Defects of Fracture Healing
17.03.2017 | Deutsches Institut für Ernährungsforschung Potsdam-Rehbrücke

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Giant Magnetic Fields in the Universe

Astronomers from Bonn and Tautenburg in Thuringia (Germany) used the 100-m radio telescope at Effelsberg to observe several galaxy clusters. At the edges of these large accumulations of dark matter, stellar systems (galaxies), hot gas, and charged particles, they found magnetic fields that are exceptionally ordered over distances of many million light years. This makes them the most extended magnetic fields in the universe known so far.

The results will be published on March 22 in the journal „Astronomy & Astrophysics“.

Galaxy clusters are the largest gravitationally bound structures in the universe. With a typical extent of about 10 million light years, i.e. 100 times the...

Im Focus: Tracing down linear ubiquitination

Researchers at the Goethe University Frankfurt, together with partners from the University of Tübingen in Germany and Queen Mary University as well as Francis Crick Institute from London (UK) have developed a novel technology to decipher the secret ubiquitin code.

Ubiquitin is a small protein that can be linked to other cellular proteins, thereby controlling and modulating their functions. The attachment occurs in many...

Im Focus: Perovskite edges can be tuned for optoelectronic performance

Layered 2D material improves efficiency for solar cells and LEDs

In the eternal search for next generation high-efficiency solar cells and LEDs, scientists at Los Alamos National Laboratory and their partners are creating...

Im Focus: Polymer-coated silicon nanosheets as alternative to graphene: A perfect team for nanoelectronics

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are less stable. Now researchers at the Technical University of Munich (TUM) have, for the first time ever, produced a composite material combining silicon nanosheets and a polymer that is both UV-resistant and easy to process. This brings the scientists a significant step closer to industrial applications like flexible displays and photosensors.

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are...

Im Focus: Researchers Imitate Molecular Crowding in Cells

Enzymes behave differently in a test tube compared with the molecular scrum of a living cell. Chemists from the University of Basel have now been able to simulate these confined natural conditions in artificial vesicles for the first time. As reported in the academic journal Small, the results are offering better insight into the development of nanoreactors and artificial organelles.

Enzymes behave differently in a test tube compared with the molecular scrum of a living cell. Chemists from the University of Basel have now been able to...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

International Land Use Symposium ILUS 2017: Call for Abstracts and Registration open

20.03.2017 | Event News

CONNECT 2017: International congress on connective tissue

14.03.2017 | Event News

ICTM Conference: Turbine Construction between Big Data and Additive Manufacturing

07.03.2017 | Event News

 
Latest News

Argon is not the 'dope' for metallic hydrogen

24.03.2017 | Materials Sciences

Astronomers find unexpected, dust-obscured star formation in distant galaxy

24.03.2017 | Physics and Astronomy

Gravitational wave kicks monster black hole out of galactic core

24.03.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>