Study finds novel drug effective for functional constipation



Novel Drug Eases Chronic Constipation

New drug appears to be safe and effective.

By Nancy Walsh, MedPage Today

Medically Reviewed byZalman S Agus, MD

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ORLANDO — WEDNESDAY, May 22, 2013 —Plecanatide, a novel agent that mimics the effects of a gastrointestinal fluid-regulating peptide, was effective on objective measures and patient-rated outcomes in adults with chronic idiopathic constipation, a multicenter randomized trial found.

Among 951 patients included in the study, 21.5 percent of those receiving 3 mg per day of plecanatide responded to the treatment during at least 9 of 12 weeks, compared with 11.5 percent of those receiving placebo, according to Philip B. Miner, MD, of the Oklahoma Foundation for Digestive Research in Oklahoma City.

In addition, the durable responder rate, meaning favorable response during 3 of the last 4 weeks of treatment, was 19 percent of patients in the treatment group versus 10.7 percent of those in the placebo group, Miner reported in a late-breaking abstract session at the annual Digestive Disease Week here.

Plecanatide is a guanylate-cyclase C (GC-C) receptor agonist with effects similar to those of the natriuretic peptide uroguanylin in that it can induce the secretion of fluid into the gastrointestinal tract lumen and thereby increase motility.

"This is one of several drugs in development that provide a new way of managing a common chronic gastrointestinal problem. It's a new receptor and a new mechanism of action, and while there are a lot of unknowns, it looks like this will have a very positive effect on patient care," Miner toldMedPage Today.

In this phase II trial, patients were required to meet the modified Rome III criteria for chronic idiopathic constipation, with features such as straining and sensations of incomplete evacuation, and to have fewer than three complete spontaneous bowel movements per week at enrollment.

Participants were assigned to receive placebo or plecanatide in doses of 0.3 mg, 1 mg, or 3 mg per day for 3 months. Response was defined as three or more spontaneous complete bowel movements per week and an increase of at least one from baseline.

Participants' mean age was 47, and 87 percent were women.

A total of 738 patients completed the trial. Reasons for withdrawal included adverse events in 4.9 percent, lack of efficacy in 5.4 percent, and administrative difficulties in 10 percent.

The percent of responders for at least 9 of the 12 weeks was lower in the 0.3-mg and 1-mg groups (19 percent and 17.2 percent), but the lowest dose still was significant compared with placebo.

Patients in the 3-mg group also reported significant changes in straining scores compared with placebo.

Similarly, patient-rated symptom scores decreased significantly in the 3-mg group (-1.05 versus -0.80) as did the impact of symptoms on patient-reported quality of life.

Diarrhea was reported in 1.3 percent of the placebo group and in 5.5 percent, 8.4 percent, and 9.7 percent of the 0.3 mg, 1 mg, and 3 mg plecanatide groups, respectively.

Withdrawals because of diarrhea were seen in 0.4 percent of the placebo group and in 0.8 percent, 3.4 percent, and 3 percent of the plecanatide groups.

Serious adverse events such as exacerbations of hypertension and chest pain were reported in fewer than 1 percent of the plecanatide group, and were considered unrelated to treatment.

This was a dose-ranging study, Miner pointed out. "The phase III trial will focus more on clinical response and patient-reported outcomes and less on dose response," he said in an interview. "It also may provide us with a better understanding of the patient population this will be used for."

The drug is also being assessed for use in patients with constipation-prominent irritable bowel syndrome, he noted.






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Date: 06.01.2019, 01:15 / Views: 51585