title: Treatment patterns, symptom reduction, quality of life, and resource use associated with lubiprostone in irritable bowel syndrome constipation subtype.
abstract: Objectives Real-world patient outcomes data is scarce concerning the high disease burden of IBS-C. The aim of this study was to compare patient-reported symptom control, health-related quality of life (HRQoL), resource utilization, and treatment satisfaction of lubiprostone vs non-lubiprostone treatment for irritable bowel syndrome-constipation (IBS-C). Research design and methods An observational, retrospective US chart review and computer-assisted telephone patient survey was conducted March to August 2013 recruiting women over 18 years old with physician-confirmed IBS-C who had initiated new treatment from inadequate relief of previous treatments and who had been on the new treatment ≥3 months. Multiple IBS-C treatments were permitted. IBS-C severity, time since diagnosis, age, and race were controlled using inverse probability of treatment weighting. Weighted outcomes were compared using t-tests (continuous outcomes) and chi-squared tests (categorical outcomes). Main outcomes measures Instruments included Patient Assessment of Constipation Symptoms (PAC-SYM) and IBS quality of life (IBS-QoL). A single item assessed current treatment satisfaction. Results Of 162 patients (mean age 45.9 [SD 15.3] years old, 71% white, 61.1% with moderate IBS-C), 76 switched to lubiprostone and 86 to non-lubiprostone. Groups were similar in clinical and demographic characteristics and previous 30 day IBS-C treatment. After weighting, all PAC-SYM scores were lower for lubiprostone (P < 0.05). All IBS-QoL subscales were higher for lubiprostone including overall, dysphoria, social reaction, sexual, and relationship scores (P < 0.05.) More lubiprostone patients reported positive treatment satisfaction (92.3% vs 71.0%, P < 0.001). Conclusions In IBS-C patients with inadequate response to previous therapies, lubiprostone improved patient-reported symptom control, treatment satisfaction, and HRQoL. Key limitations include lack of measurement of patient-reported outcomes at treatment start and potential data gaps in chart documentation.
authors.affiliation: a Pharmerit International , Bethesda , MD , USA ;
authors.forename: Caitlyn T
authors.initials: CT
authors.lastname: Solem
authors.affiliation: b Takeda Pharmaceuticals International Inc. , Deerfield , IL , USA ;
authors.forename: Haridarshan
authors.initials: H
authors.lastname: Patel
authors.affiliation: a Pharmerit International , Bethesda , MD , USA ;
authors.forename: Sonam
authors.initials: S
authors.lastname: Mehta
authors.affiliation: b Takeda Pharmaceuticals International Inc. , Deerfield , IL , USA ;
authors.forename: Reema
authors.initials: R
authors.lastname: Mody
authors.affiliation: c Medical Data Analytics , Parsippany , NJ , USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Macahilig
authors.affiliation: a Pharmerit International , Bethesda , MD , USA ;
authors.forename: Xin
authors.initials: X
authors.lastname: Gao
mesh_terms: D000328:Adult; D065101:Chloride Channel Agonists / Q000627:therapeutic use*; D003248:Constipation / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006295:Health Resources; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications* / Q000188:drug therapy*; D000068238:Lubiprostone / Q000627:therapeutic use*; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D065101:Chloride Channel Agonists; D000068238:Lubiprostone
keywords: Chart review; Health-related quality of life (HRQoL); Irritable bowel syndrome–constipation (IBS-C); Lubiprostone; Patient-reported outcomes