Daily plecanatide boosts bowel movement in chronic idiopathic constipation, IBS-C
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CHARLOTTE, N.C. — Once daily plecanatide effectively relieved symptoms in patients of varying age with chronic idiopathic constipation and irritable bowel syndrome-constipation, according to a poster at the ACG Annual Scientific Meeting.
“This analysis was conducted to further assess the potential impact of age on the efficacy and safety of plecanatide in an analysis of adults with [chronic idiopathic constipation] or IBS-C,” Kyle Staller, MD, director of the Gastrointestinal Motility Laboratory at Massachusetts General and assistant professor of medicine at Harvard Medical School, told Healio.
In a post-hoc analysis of trial data, Staller and colleagues evaluated outcomes of 1,762 patients with chronic idiopathic constipation (CIC) and 1,453 patients with IBS-C.
Primary protocol-defined efficacy endpoints for the CIC trials included durable overall complete spontaneous bowel movement (CSBM) response, weekly response defined as three or more CSBMs per week and an increase from baseline of at least one CSBM for the same week, in addition to weekly response for at least 9 weeks and weekly response for at least three of the final 4 weeks of treatment.
For the IBS-C trials, the primary protocol-defined efficacy endpoints included the percentage of patients with overall response, which was defined as at least 30% reduction from baseline in “worst” abdominal pain and an increase from baseline of one or more CSBMs per week in the same week for at least 6 weeks.
Among patients in the CIC group, 36.2% were aged younger than 40 years, 44.4% were aged 40 to 59 years and 19.4% were aged 60 years or older. Compared with placebo, a greater percentage of patients treated with plecanatide achieved a durable overall response in CSBM across all age groups (14% vs. 7.9%, 23.9% vs. 13.6% and 26.3% vs. 13.5%, respectively). Researchers noted that treatment with plecanatide was well-tolerated with low discontinuation rated across age groups.
Among patients in the IBS-C group, 40.1% were aged younger than 40 years, 45.4% were aged 40 to 59 years and 14.6% were aged 60 years or older. Researchers reported a “statistically significant greater” percentage of plecanatide responders compared with placebo in the youngest (24.1% vs. 15.2%) and middle (27.1% vs. 17.3%) age groups. Response among those aged 60 years or older also favored plecanatide over placebo (25% vs. 14.4%), although small sample size may have affected results.
Moreover, plecanatide was well-tolerated among patients in the IBS-C group across all ages, with lower discontinuation rates compared with the CIC group.
“Given CIC and IBS-C are common disorders, and being that constipation is associated with increasing age, research should continue to add to our body of knowledge to help the growing senior population,” Staller and colleagues said. “We should continue to assess efficacy and safety of approved treatments of adults with CIC/IBS-C.”
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Staller K, et al. Poster D0269: Plecanatide improves symptoms of chronic idiopathic constipation and irritable bowel syndrome with constipation across age subgroups: An analysis of four phase 3 trials. Presented at: ACG Annual Scientific Meeting; Oct. 21-26, 2022; Charlotte, N.C. (hybrid meeting).
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