- Fecal Incontinence
|The Impact of Stool Consistency on Bowel Movement Satisfaction in Patients With IBS-C or CIC Treated With Linaclotide or Other Medications: Real-World Evidence From the CONTOR Study
Taylor DCA1, Abel JL2, Doshi JA3, Martin C4, Goolsby Hunter A4, Essoi B4, Korrer S4, Reasner DS1, Carson RT2, Chey WD5. J Clin Gastroenterol. 2019 Jul 29. doi: 10.1097/MCG.0000000000001245. [Epub ahead of print]
1 Ironwood Pharmaceuticals Inc., Cambridge, MA.
2 Allergan plc, Madison, NJ.
3Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
4 Optum, Eden Prairie, MN.
5 Division of Gastroenterology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI.
GOALS: This study aimed to characterize the impact of stool consistency on patient-reported bowel movement (BM) satisfaction in patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation, with a focus on linaclotide.
BACKGROUND: As new medications for constipation become available, understanding patients' perceptions of treatment effects may help clinicians manage patient expectations and inform clinical decision-making.
MATERIALS AND METHODS: Data were derived from the Chronic Constipation and IBS-C Treatment and Outcomes Real-world Research Platform (CONTOR) study from 2 patient-reported 7-day daily BM diaries to create a dataset of 2922 diaries representing 26,524 BMs for 1806 participants. Binary variables were created for: medication(s) used in the past 24 hours and categorization of BMs as loose or watery stools (LoWS), hard or lumpy stools (HoLS), or intermediate (neither LoWS nor HoLS). The relationship between stool consistency, medication use, and BM satisfaction was analyzed using logistic regression with SEs corrected for repeated observations.
RESULTS: BMs characterized as intermediate stools and LoWS were satisfactory more often (61.2% and 51.2%, respectively) than HoLS (19.4%). Participants who reported taking linaclotide rated a similar proportion of BMs as satisfactory when described as LoWS (65.6%) or intermediate (64.1%). Linaclotide use was associated with higher odds of BMs being reported as satisfactory compared with nonlinaclotide use (odds ratio: 1.23, P<0.05).
CONCLUSIONS: Overall, CONTOR participants were more likely to report BMs classified as LoWS or intermediate as satisfactory, versus HoLS. Participants taking linaclotide were more likely to be satisfied, particularly those reporting LoWS, versus those not taking linaclotide.