The search for an efficient drug for constipation in IBS seems to have ended with Linaclotide , an experimental peptide. Here is an explanation.

Team@CMHF

Linaclotide appears to increase spontaneous bowel movements and relieves other symptoms of chronic constipation compared with placebo, researchers found.

Over 12 weeks, significantly more patients on two different doses of linaclotide had at least three complete spontaneous bowel movements per week than did those on a sham treatment (P<0.01), Anthony Lembo, MD, of Harvard, and colleagues reported in the New England Journal of Medicine.

“Linaclotide has the potential to offer multi-symptom relief to patients with chronic constipation,” they wrote.

So to test its safety and efficacy in patients with chronic constipation, they conducted two phase-III trials — named Trial 303 and Trial 01 — at 204 centers in the U.S. and eight centers in Canada totaling 1,276 patients.

Both were randomized, double-blind, parallel-group, placebo-controlled, dual-dose trials conducted over 12 weeks.
Patients received either placebo or one of two doses of linaclotide on a daily basis: 145 mcg or 290 mcg.

The primary efficacy endpoint was three or more complete spontaneous bowel movements per week and an increase of one or more such bowel movements from baseline for at least nine weeks of the trial.

They also found that improvements in all secondary endpoints were significantly greater in both linaclotide groups than for those on placebo.

These included changes in bowel symptoms (the number of bowel movements, stool consistency, and straining severity), abdominal symptoms (discomfort and bloating) and constipation severity.

Improvement in bowel function is likely due to increased luminal fluid that accelerates intestinal transit, Lembo and colleagues said, but additional mechanisms “may contribute to improvements in abdominal symptoms.”

They added that long-term trials are needed to assess the safety of long-term treatment with linaclotide.

Ref: http://www.medpagetoday.com/Gastroenterology/GeneralGastroenterology/27992?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=ET&userid=333280