Open-label study to evaluate the treatment continuation rate after a dose reduction of lubiprostone due to onset of adverse events

ABSTRACT

Objective

To investigate the continuation rate with a reduced lubiprostone dose (12 mcg twice daily, BD) after the onset of adverse events (AEs) in patients with chronic constipation (CC).

Methods

In this exploratory, open-label, multicenter study, patients with CC received lubiprostone 24 mcg BD and the dose was reduced to 12 mcg BD in subjects experiencing AEs. The primary objective was the continuation rate after dose reduction due to nausea/vomiting. Secondary objectives included the continuation rate after dose reduction due to diarrhea/any AE and efficacy, including changes in number of weekly bowel movements and Bristol Stool Form Scale.

Results

Of the 146 patients included in the study, 42 (28.8%) received lubiprostone 12 mcg BD (dose-reduced group) due to any AE. Thirty-six (85.7%) subjects in the dose-reduced group continued treatment and completed the study. 22/27 (81.5%) and 17/19 (89.5%) patients in whom the dose was reduced due to nausea/vomiting or diarrhea, respectively, continued treatment. There was no clinically relevant difference in efficacy after dose reduction.

Conclusion

These results suggest that treatment withdrawal due to AEs associated with lubiprostone 24 mcg BD could be minimized in patients with CC after dose reduction to 12 mcg BD, thus resulting in improved long-term outcomes.

Clinical trial registration

Japan Registry of Clinical Trials (https://jrct.niph.go.jp/latest-detail/jRCTs031180069)

KEYWORDS:

• Lubiprostone
• chronic constipation
• adverse events
• nausea
• vomiting

Author contributions

H Ohbayashi designed the study. H Ohbayashi, Y Sato, M Kiuchi, T Asano, A Nagazumi and T Kimura acquired data. H Ohbayashi, Y Sato and T Kimura were involved in data analysis. H Ohbayashi wrote the paper; all authors read and gave approval of the final version of the article to be published.

Acknowledgments

The authors thank Turacoz Healthcare Solutions, Gurugram, India, for writing support. Editorial assistance was also provided by David P. Figgitt PhD, ISMPP CMPP™, Content Ed Net.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

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

Additional information

Funding

This study was funded by Mylan EPD G.K. Editorial assistance was funded by Mylan EPD G.K.