Ironwood Pharmaceuticals Inc., Cambridge, MA.
Allergan plc, Madison, NJ.
J Clin Gastroenterol. 2019 Nov/Dec;53(10):737-743. doi: 10.1097/MCG.0000000000001245.
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.
As new medications for constipation become available, understanding patients' perceptions of treatment effects may help clinicians manage patient expectations and inform clinical decision-making.
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.
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).
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.
本研究旨在描述粪便稠度对肠易激综合征便秘型(IBS-C)或慢性特发性便秘患者报告的排便(BM)满意度的影响,重点关注利那洛肽。
随着新的便秘治疗药物的出现,了解患者对治疗效果的看法可能有助于临床医生管理患者的期望并为临床决策提供信息。
数据来自慢性便秘和 IBS-C 治疗及结局真实世界研究平台(CONTOR)研究,该研究使用患者报告的 2 个为期 7 天的每日 BM 日记,创建了一个包含 1806 名参与者的 2922 个 BM 日记的数据集,共 26524 个 BM。创建了两个二项变量:过去 24 小时使用的药物和粪便分类为稀便(LoWS)或水样便(HoLS)、硬便或块状便(HoLS)或中间便(既非 LoWS 也非 HoLS)。使用具有重复观察校正的 SE 的逻辑回归分析粪便稠度、药物使用与 BM 满意度之间的关系。
描述为中间便和 LoWS 的 BM 更常被认为是满意的(分别为 61.2%和 51.2%),而 HoLS 仅为 19.4%。报告服用利那洛肽的参与者将 LoWS(65.6%)或中间便(64.1%)描述为满意的 BM 比例相似。与非利那洛肽使用者相比,利那洛肽使用者报告的 BM 更有可能被认为是满意的(比值比:1.23,P<0.05)。
总体而言,CONTOR 参与者更有可能报告 LoWS 或中间便分类的 BM 为满意,而不是 HoLS。服用利那洛肽的参与者更有可能感到满意,特别是报告 LoWS 的参与者,而不是未服用利那洛肽的参与者。