Pharmacotherapy patterns in patients with chronic idiopathic constipation beginning treatment with linaclotide or lubiprostone in the United States

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Abstract

Background: Chronic idiopathic constipation (CIC) is a common gastrointestinal disorder in community settings. Limited information exists on its treatment with the prosecretory agents linaclotide and lubiprostone. This retrospective cohort study investigated real-world pharmacotherapy patterns of linaclotide and lubiprostone.

Methods: Patients (≥18 years) with CIC who received linaclotide or lubiprostone between January 2013 and December 2015 were identified in a United States health insurance claims database. Follow-up was from the date of the earliest claim for either drug to the end of continuous enrolment or switch to the alternative agent. Patterns of pharmacotherapy, evidence of irritable bowel syndrome (IBS), and concomitant use of selective serotonin reuptake inhibitors were examined using the International Classification of Diseases, Ninth or Tenth Revision, Clinical Modification codes and National Drug Codes.

Results: In total, 43,164 and 17,743 patients with CIC received linaclotide and lubiprostone, respectively (~80% women, mean age ~47 years). Approximately 40% of subjects (linaclotide: 40.1%; lubiprostone: 37.6%) had evidence of IBS. Over a mean follow-up of 17 months, mean (standard deviation) treatment duration in patients without IBS was 6.6 (7.9) months for linaclotide and 4.5 (6.5) months for lubiprostone. Treatment episodes >180 days were more common with linaclotide (36.1%) than with lubiprostone (23.2%). At 12 months, Kaplan–Meier estimates of switching from lubiprostone to linaclotide and from linaclotide to lubiprostone were 13.4 and 5.6%, respectively. The number of patients receiving serotonin reuptake inhibitors was unchanged with treatment (~22%).

Conclusions: Most patients with CIC receive linaclotide or lubiprostone for <6 months; few remain on therapy for >1 year. Additional research is warranted to understand the potential reason(s) for early discontinuation.

Keywords: chloride channel agonists, constipation, guanylate cyclase-c agonists, lubiprostone, practice patterns.

Citation: Nag A, Bornheimer R, Oster G. Pharmacotherapy patterns in patients with chronic idiopathic constipation beginning treatment with linaclotide or lubiprostone in the United States. Drugs in Context 2020; 9: 2020-5-10. DOI: 10.7573/dic.2020-5-10

Contributions: AN is the guarantor for the submission. All authors contributed to the conception and design of the study, analysis or interpretation of the data, preparation of the manuscript, and critical review of the manuscript. All authors have read and approved the final version of the manuscript, including the authorship list. Medical writing support was provided by Maxine Cox, BSc, of PharmaGenesis London, London, UK.

Disclosure and potential conflicts of interest: AN is an employee of Shire, a member of the Takeda group of companies, and is a stockholder of Takeda. RB and GO are employees of Policy Analysis Inc., which received financial support from Shire, a member of the Takeda group of companies, for their participation in the design of the study, the analyses of the data, and the interpretation of findings. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2020/07/dic.2020-5-10-COI.pdf

Acknowledgements: The authors wish to thank Margaret Gerbasi, a former employee of Policy Analysis Inc., for her contribution to the study. Medical writing support was provided by Maxine Cox, BSc, of PharmaGenesis London, London, UK.

Funding declaration: Funding support for this study was provided by Shire Human Genetic Therapies Inc., a member of the Takeda group of companies, Indianapolis, IN, USA. Funding for medical writing support was provided by Shire Human Genetic Therapies Inc., a member of the Takeda group of companies, Indianapolis, IN, USA.

Copyright: Copyright © 2020 Nag A, Bornheimer R, Oster G. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2020 Nag A, Bornheimer R, Oster G. https://doi.org/10.7573/dic.2020-5-10. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://www.drugsincontext.com/pharmacotherapy-patterns-in-patients-with-chronic-idiopathic-constipation-beginning-treatment-with-linaclotide-or-lubiprostone-in-the-united-states

Correspondence: Arpita Nag, Shire, a member of the Takeda group of companies, 55 Hayden Avenue, Lexington, MA 02421, USA. arpita.nag@takeda.com

Provenance: submitted; externally peer reviewed.

Submitted: 21 May 2020; Peer review comments to author: 8 June 2020; Revised manuscript received: 16 July 2020; Accepted: 20 July 2020; Publication date: 12 August 2020.

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