Adding linaclotide to PEG did not improve bowel prep quality in high-risk colonoscopy patients undergoing screening procedures
This multicenter, randomized, double-blind trial evaluated the efficacy of adding linaclotide to polyethylene glycol for bowel preparation in patients at increased risk of inadequate cleansing. The study included 672 patients in the modified intention-to-treat analysis and 574 in the per-protocol analysis. Participants received either a two-day regimen of linaclotide with polyethylene glycol or placebo with polyethylene glycol before their colonoscopy procedures.
results showed no statistically significant difference between the two groups regarding the rate of adequate bowel preparation. The odds ratios favored the linaclotide group but confidence intervals crossed unity, indicating non-significance. Similarly, the mean number of adenomas detected per colonoscopy did not differ significantly between the treatment and control arms across both analysis populations.
Despite the lack of improvement in primary outcomes, the study observed a significant increase in the mean number of polyps found in the right colon among patients receiving linaclotide and polyethylene glycol. This finding was consistent across the overall population and specifically noted in patients aged 70 years and older. Safety data were not reported in the provided abstract, though the study design suggests a focus on tolerability.