Abstract

Introduction: Chronic idiopathic constipation (CIC) patients experience both, bowel and abdominal symptoms. Patients often manage symptoms through use of over-the-counter laxatives, stool softeners, as well as prescription medications. However, little is known regarding patient experience with these treatments. The objective of this study was to evaluate CIC patients' experience with treatments used for management of CIC symptoms. Methods: At screening for a Phase 3b, double-blind, randomized, controlled trial, patients meeting modified Rome II criteria for CIC and prominent abdominal bloating (≥5 on 11-pt numerical rating scale) completed a questionnaire regarding prior medication use [polyethylene glycol (PEG), psyllium (P), wheat dextrin (WD), stimulant laxative (SL), docusate (DS), or lubiprostone (Lubi)] during the prior 6 months. Questions assessed frequency and duration of use; confidence (3-pt scale) in having ≥1 bowel movement (BM) every other day while taking medication; predictability of BM timing (3-pt scale); and treatment satisfaction (5-pt scale) for relief of constipation symptoms, abdominal discomfort, and abdominal bloating. Results: Of 1423 screened patients who completed the survey, 1009 (71%) reported taking ≥1 constipation medication in the prior 6 months. Duration of single medication use ≥ 1 month ranged from 53% (WD) to 76% (SL). The percentage of patients not at all confident in having at least one BM every other day while taking the medication ranged from 30% (SL) to 64% (WD).The percentage of patients who reported unpredictable BM timing after taking medication ranged from 51% (SL) to 81% (WD). The percentage of patients who were not at all or a little satisfied with the medications' ability to: (1) relieve constipation symptoms ranged from 48% (SL) to 83% (WD), (2) relieve abdominal discomfort ranged from 59% (SL) to 81% (WD), and (3) relieve abdominal bloating ranged from 69% (SL) to 90% (BL) (Table). Conclusion: Overall, the majority of CIC patients were not at all or a little satisfied with prior medications' ability to relieve constipation and abdominal symptoms of discomfort and bloating. Approximately one half to two thirds of patients lacked confidence for having a BM at least once every other day, and for the majority, timing of their BMs was not predictable. Unmet need for management of CIC symptoms continues to exist with older, commonly used treatments.Table 1

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