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ABSTRACT: Introduction
Chronic idiopathic constipation (CIC) is a common condition that affects some patient groups more often. Demographic/clinical characteristics can differ in presentation and therapeutic response. The impact of these characteristics on plecanatide efficacy/safety was examined.Methods
Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed. Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender. Endpoints included durable overall complete spontaneous bowel movement (CSBM) responder rate, weekly CSBMs and spontaneous bowel movements (SBMs), and adverse events.Results
Overall (N = 2,639; 3 mg of plecanatide [n = 877];
SUBMITTER: Rao SSC
PROVIDER: S-EPMC10371318 | biostudies-literature | 2023 Jul
REPOSITORIES: biostudies-literature