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 Win-win strategies for climate and food security
02.10.2017 | International Institute for Applied Systems Analysis (IIASA)

nachricht The personality factor: How to foster the sharing of research data
06.09.2017 | ZBW – Leibniz-Informationszentrum Wirtschaft

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: Neutron star merger directly observed for the first time

University of Maryland researchers contribute to historic detection of gravitational waves and light created by event

On August 17, 2017, at 12:41:04 UTC, scientists made the first direct observation of a merger between two neutron stars--the dense, collapsed cores that remain...

Im Focus: Breaking: the first light from two neutron stars merging

Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.

Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....

Im Focus: Smart sensors for efficient processes

Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).

When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...

Im Focus: Cold molecules on collision course

Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.

How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...

Im Focus: Shrinking the proton again!

Scientists from the Max Planck Institute of Quantum Optics, using high precision laser spectroscopy of atomic hydrogen, confirm the surprisingly small value of the proton radius determined from muonic hydrogen.

It was one of the breakthroughs of the year 2010: Laser spectroscopy of muonic hydrogen resulted in a value for the proton charge radius that was significantly...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

ASEAN Member States discuss the future role of renewable energy

17.10.2017 | Event News

World Health Summit 2017: International experts set the course for the future of Global Health

10.10.2017 | Event News

Climate Engineering Conference 2017 Opens in Berlin

10.10.2017 | Event News

 
Latest News

Researchers release the brakes on the immune system

18.10.2017 | Health and Medicine

Separating methane and CO2 will become more efficient

18.10.2017 | Life Sciences

Ocean atmosphere rife with microbes

17.10.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>