(RxWiki News) Irritable bowel syndrome (IBS) can be a literal pain in the gut. IBS symptoms such as diarrhea, tummy aches and cramps can negatively impact quality of life.
Current treatment options for diarrhea associated with irritable bowel syndrome are limited, but a recent study says eluxadoline — a new drug undergoing clinical trials — is safe and effective for the treatment of diarrhea caused by irritable bowel syndrome.
According to the study, patients given eluxadoline showed significant improvement in their symptoms. The patients had less constipation and experienced a better quality of life that increased with the length of treatment.
"Ask your doctor about new treatments for irritable bowel syndrome."
The study was conducted by Leonard S. Dove, PhD, at Furiex Pharmaceuticals, along with colleagues from several institutions in the US.
The aim of this study was to look at the safety and effectiveness of eluxadoline for irritable bowel syndrome.
Irritable bowel syndrome (IBS) is a functional bowel disorder of unknown cause that affects the intestine. The disorder occurs more commonly in women than men and is also more common in patients who are younger than 45 years of age.
Common symptoms of the disorder include abdominal pain, cramping and alternations in bowel movements — such as diarrhea or constipation. In a certain form of irritable bowel syndrome, which the study researchers focused on, diarrhea is the predominant symptom.
Eluxadoline is a new drug currently being studied to counter this type of irritable bowel syndrome.
The researchers looked at 807 patients and randomly assigned them to two groups. Patients in the treatment group received 5, 25, 100 or 200 milligrams of eluxadoline orally twice a day for 12 weeks. Patients in the placebo group received a blank pill with no drug twice a day for 12 weeks.
Upon analysis of the results, the researchers found that more patients receiving eluxadoline responded to treatment than those who took placebos.
Patients who took 100 milligrams (28 percent of these patients) or 200 milligrams (28.5 percent of these patients) of eluxadoline were more likely to meet a treatment goal recommended by the FDA when compared to patients who only took a placebo (13.8 percent).
The FDA-recommended goal was based on improvement in abdominal pain, stool consistency and bowel characteristics.
The rate of constipation was low among patients taking eluxadoline, and the drug was well tolerated. Both relief of symptoms as well as quality of life improved with longer duration of treatment.
"There is a critical need for a safe and effective treatment for IBS-D, a disorder affecting approximately 10 to 15 percent of the population in Western counties," said Anthony Lembo, study co-author from Harvard Medical School, Center for Clinical and Translational Research in Gastrointestinal Motility, Beth Israel Deaconess Medical Center, Division of Gastroenterology, Boston, MA.
"The results of our study confirm the effectiveness of eluxadoline to decrease abdominal pain and improve stool consistency, without significant risk of constipation, for patients with IBS-D," Lembo said.
Eluxadoline, which is still undergoing clinical trials, has not yet been approved by the FDA or launched in the market.
According to Maxwell Chait, MD, FACP, a gastroenterologist at ColumbiaDoctors Medical Group, “The results of eluxadoline clinical trials so far have shown that the drug decreases abdominal pain and improves stool consistency without a significant development of constipation.
“There is a scarcity of drug options available in treating patients with irritable bowel syndrome. But further study is necessary to determine certain characteristics in patients that could predict the clinical response to the drug and possible adverse reactions that caused the withdrawal of previous agents for irritable bowel syndrome from the market,” said Dr. Chait.
The results of the study were published August 12 in Gastroenterology.
The study was funded by Furiex Pharmaceuticals, the company that makes eluxadoline.