Brian E Lacy1, Elizabeth P Shea2, Machelle Manuel3, Jessica L Abel4, Hancheng Jiang3, Douglas C A Taylor5. 1. Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL, United States of America. 2. Medical Writing and Publications, Ironwood Pharmaceuticals, Inc., Boston, MA, United States of America. 3. Ironwood Pharmaceuticals, Inc., Boston, MA, United States of America. 4. Global Health Economics & Outcomes Research, AbbVie Inc., Madison, NJ, United States of America. 5. Health Economics & Outcomes Research, Ironwood Pharmaceuticals, Inc., Boston, MA, United States of America.
Abstract
INTRODUCTION: Chronic idiopathic constipation (CIC) is a prevalent functional gastrointestinal disorder diagnosed based on patient-reported symptoms and the absence of structural gastrointestinal abnormalities. Individuals with CIC typically institute dietary changes and use stool softeners or over-the-counter (OTC) laxatives, possibly at the direction of a healthcare provider, before prescription medications for CIC are initiated. Although highly prevalent, there is limited information regarding CIC patient experiences with OTC medications. METHODS: This post-hoc analysis used patient-reported data from a questionnaire administered during patient screening for a prospective linaclotide Phase 3b clinical trial in patients with CIC (N = 1482 screened). The questionnaire asked patients to report their experiences with OTC CIC medications over the preceding 6 months. RESULTS: Among patients with screening responses (N = 1423), most were female (85%) and white (66%), with a mean age of 48.9 years. A high proportion of patients had used one or more OTC medications (70% had ≥1 OTC; 19% had ≥3 OTCs), with the majority being bisacodyl (33%) and polyethylene glycol (30%). The most commonly cited reason for stopping an OTC medication was insufficient symptom relief (17-40%). The majority of patients taking OTC medications reported no or little satisfaction with the medication's effect on their constipation (62%) and CIC-specific abdominal symptoms (78%). Many patients had little to no confidence in bowel movement (BM) frequency after taking OTC medications and their confidence in their ability to predict BM timing was also low (49-81% not at all confident). CONCLUSIONS: Treatment effects on individual CIC symptoms, predictability of bowel habits, and satisfaction with treatment are all important factors for healthcare providers and patients to consider when establishing an effective treatment regimen for CIC. TRIAL REGISTRATION NUMBER: NCT01642914.
INTRODUCTION:Chronic idiopathic constipation (CIC) is a prevalent functional gastrointestinal disorder diagnosed based on patient-reported symptoms and the absence of structural gastrointestinal abnormalities. Individuals with CIC typically institute dietary changes and use stool softeners or over-the-counter (OTC) laxatives, possibly at the direction of a healthcare provider, before prescription medications for CIC are initiated. Although highly prevalent, there is limited information regarding CIC patient experiences with OTC medications. METHODS: This post-hoc analysis used patient-reported data from a questionnaire administered during patient screening for a prospective linaclotide Phase 3b clinical trial in patients with CIC (N = 1482 screened). The questionnaire asked patients to report their experiences with OTC CIC medications over the preceding 6 months. RESULTS: Among patients with screening responses (N = 1423), most were female (85%) and white (66%), with a mean age of 48.9 years. A high proportion of patients had used one or more OTC medications (70% had ≥1 OTC; 19% had ≥3 OTCs), with the majority being bisacodyl (33%) and polyethylene glycol (30%). The most commonly cited reason for stopping an OTC medication was insufficient symptom relief (17-40%). The majority of patients taking OTC medications reported no or little satisfaction with the medication's effect on their constipation (62%) and CIC-specific abdominal symptoms (78%). Many patients had little to no confidence in bowel movement (BM) frequency after taking OTC medications and their confidence in their ability to predict BM timing was also low (49-81% not at all confident). CONCLUSIONS: Treatment effects on individual CIC symptoms, predictability of bowel habits, and satisfaction with treatment are all important factors for healthcare providers and patients to consider when establishing an effective treatment regimen for CIC. TRIAL REGISTRATION NUMBER: NCT01642914.
Authors: Alexander C Ford; Paul Moayyedi; Brian E Lacy; Anthony J Lembo; Yuri A Saito; Lawrence R Schiller; Edy E Soffer; Brennan M R Spiegel; Eamonn M M Quigley Journal: Am J Gastroenterol Date: 2014-08 Impact factor: 10.864
Authors: Claire M Ervin; Sheri E Fehnel; Mollie J Baird; Robyn T Carson; Jeffrey M Johnston; Steven J Shiff; Caroline B Kurtz; Allen W Mangel Journal: Clin Exp Gastroenterol Date: 2014-06-03
Authors: L Chang; A J Lembo; B J Lavins; S J Shiff; X Hao; J G Chickering; X D Jia; M G Currie; C B Kurtz; J M Johnston Journal: Aliment Pharmacol Ther Date: 2014-10-13 Impact factor: 8.171