Amitiza just got FDA approval for IBS with constipation :):)

[Guest guest]

Good new for people like me who have IBS with constipation.

I have been told this is good to use also does help.I will ask my

Doctors about it, see what they say. Heidi

Many patients may soon find relief from the bloating, cramping,

abdominal pain and constipation associated with irritable bowel

syndrome, or IBS.

Lubiprostone, known by the brand name AMITIZA®, was just approved by

the U.S. Food and Drug Administration for use in women with IBS plus

constipation, thanks in part to University of Michigan Health System

research that demonstrated the safety and efficacy of the drug for

treatment of IBS-C.

Led by U-M gastroenterologist D. Chey, M.D., the studies show

that lubiprostone significantly improves all of the symptoms

associated with IBS-C in many women.

Results from these studies will be presented on May 18 and May 19 at

Digestive Diseases Week in San Diego.

" We found that individuals who were treated with AMITIZA were nearly

twice as likely to experience improvement in their IBS symptoms

compared to individuals who were treated with placebo, " says Chey,

director of the Gastrointestinal Physiology Laboratory and professor

of internal medicine at the U-M Medical School. " Right now, it is the

only FDA-approved treatment available that addresses the entire

clinical spectrum of symptoms related to IBS-C. "

IBS, an often painful disorder of the lower intestine, affects

between 10 to 15 percent of the U.S. population.

While IBS is the second-leading cause of work absenteeism behind the

common cold, Chey says fewer than half of patients with IBS seek

medical treatment. And, he says, most over-the-counter medicines

commonly used to treat symptoms -- fiber, laxatives and stool

stimulants -- don't address the bloating and pain associated with IBS.

Most patients with IBS tend to fall into two categories: IBS-C or IBS

with diarrhea. IBS-C is more common among older adults, while IBS-D

tends to be seen more in younger patients.

Since the majority of patients with IBS are women, studies involving

IBS tend to be made up of predominately female participants -- more

than 80 percent in most cases, Chey estimates.

" Although AMITIZA is only approved for use in women with IBS-C, it

doesn't mean that the drug doesn't work for men. Unfortunately, we

just haven't had enough men represented in these studies to make a

firm decision on treatment using this drug, " notes Chey.

The supplemental New Drug Application for AMITIZA -- which also is

approved by the FDA for treatment of chronic idiopathic constipation -

- was based on two phase III, multi-center trials involving 1,154

participants. These trials compared lubiprostone versus a placebo

during the course of 12 weeks. Each participant kept an electronic

diary to report weekly outcomes of IBS-C symptoms.

After one week, 20 percent of the lubiprostone participants reported

moderate to significant relief of symptoms. By week four, 32 percent

said they experienced relief of global IBS-C symptoms -- abdominal

pain, bloating, constipation severity and straining during bowel

movements. Lubiprostone also improved stool consistency.

Additionally, Chey will present findings at DDW from a follow-on

study related to the two phase III trials. This 48-week study looked

at the efficacy and safety of lubiprostone. Many of its 476

participants also took part in the phase III trials. For this study,

however, participants all received lubiprostone; no placebos were

given.

The study found that lubiprostone is effective and well tolerated in

adults with IBS-C for up to one year. The spectrum of symptoms that

constitute IBS-C, including abdominal pain and discomfort, bloating

and constipation-related complaints, significantly improved during

the 48-week treatment period. The most common treatment-related

adverse events among the study groups were nausea and diarrh