Plecanatide reduced abdominal pain and increased stool frequency in U.S.-based adults with irritable bowel syndrome with constipation.
Richard Krause, MD, of Chattanooga, Tenn.-based WR-ClinSearch, and colleagues conducted a phase III, randomized, double blind trial of 1,456 adult patients between 18 years and 85 years. Participants were given either a once-daily placebo, 3 mg of plecanatide or 6 mg of plecanatide.
Researchers measured the percentage of respondents who had their abdominal pain decrease by more than 30 percent and who had stool frequency increase beyond the baseline. Secondary outcomes included safety and tolerability.
Here's what they found:
1. Plecanatide patients decreased their abdominal pain over placebo patients. Approximately 25.7 percent of the 3 mg group and 26.6 percent of the 6 mg group decreased their pain.
2. Plecanatide patients also increased stool frequency. Around 40.9 percent of the 3 mg and 41.9 percent of the 6 mg group experienced increased frequency.
3. Patients reported that plecanatide significantly improved stool consistency and straining severity.
4. Adverse event rates were similar between the groups.
Researchers concluded, "The hallmark symptoms of IBS-C, abdominal pain and reduced stool frequency, as well as secondary symptoms, were significantly improved with 12 weeks of once-daily plecanatide treatment compared with placebo. … Plecanatide offers a promising new treatment option for patients with IBS-C."