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.

Keywords:

• Chart review
• Health-related quality of life (HRQoL)
• Irritable bowel syndrome–constipation (IBS-C)
• Lubiprostone
• Patient-reported outcomes

Declaration of funding

This study and manuscript preparation was sponsored by Takeda Pharmaceuticals International Inc., Deerfield, IL, USA.

Author contributions: C.T.S., H.P., S.M., R.M., C.M. and X.G. participated in the design and conception of the study. C.M. carried out the data collection. C.S. and S.M. performed the statistical analysis. C.T.S., H.P., S.M., R.M., C.M. and X.G. contributed to the review and interpretation of the results. C.T.S. and S.M. drafted the manuscript. C.T.S., H.P., S.M., R.M., C.M. and X.G. read, revised and approved the final manuscript.

Declaration of financial/other relationships

R.M. and H.P. have disclosed that they are employees of Takeda Pharmaceuticals International Inc. S.M., C.T.S., and X.G. have disclosed that they are employees of Pharmerit International, a company that was paid by Takeda to help in the development and execution of this study and preparation of the manuscript. C.M. has disclosed that she is an employee of Medical Data Analytics and was a paid consultant to Takeda in the development and execution of this study.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgment

The authors would like to thank all sites that contributed patients to this study. We would also like to acknowledge the project management and operations support from Scott Merrill, Peter Wolthoff and Cheryl Yendrick.