A study presented at Digestive Disease Week 2017 examined plecanatide's safety and efficacy for irritable bowel syndrome with constipation.
Ronald Fogel, MD, of the Chesterfield-based Clinical Research Institute of Michigan, and colleagues conducted two phase III, double-blind, placebo-controlled trials to evaluate plecanatide 3mg and 6mg in IBS-C patients.
The patients had a two week pretreatment period followed by a 12-week treatment period and a two-week post treatment period. Patients took plecanatide once daily.
Researchers assigned 351 patients to the 3mg treatment, 350 patients to the 6mg treatment and 354 patients received a placebo in study one. For study two, 377 received the 3mg treatment, 379 received the 6mg treatment and 379 received a placebo.
Here's what they found.
1. Both the 3mg and 6mg treatment met the primary endpoint and responded to the treatment, with a significant difference over the placebo group.
In study one, the 3mg group reduced their abdominal pain by 30.2 percent, the 6mg group reduced their pain by 29.5 percent and the placebo group reduced their pain by 17.8 percent.
In study two, the 3mg group reduced their pain by 21.5 percent, the 6mg group reduced its pain by 24 percent and the placebo group experienced a 14.2 percent reduction.
2. The most common adverse event was diarrhea.
3. Eleven patients in study one and six patients in study two had a serious treatment-emergent adverse event that was not GI-related with no indication of dehydration.
4. Withdrawal rates were low in both groups.
Researchers concluded, "These clinical studies indicate plecanatide may offer a promising new treatment for patients with IBS-C."
Digestive Disease Week 2017 was May 6 through May 9 in Chicago.
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