Journal of Gastroenterology

, Volume 51, Issue 9, pp 874–882 | Cite as

Effect of ramosetron in female patients with irritable bowel syndrome with diarrhea: a phase III long-term study

  • Shin Fukudo
  • Yoshikazu Kinoshita
  • Toshikatsu Okumura
  • Motoko Ida
  • Kenta Hayashi
  • Hiraku Akiho
  • Yoshihiro Nakashima
  • Ken Haruma
Original Article—Alimentary Tract

Abstract

Background

The long-term safety of administration of ramosetron in female patients with irritable bowel syndrome with diarrhea (IBS-D) is unknown. The aim of this study was to assess the long-term safety, tolerability, and outcomes with the use of ramosetron in female patients with IBS-D.

Methods

This was a phase III, open-label, uncontrolled, long-term safety trial of the treatment of female Japanese patients with IBS-D, diagnosed according to the Rome III criteria. A total of 151 patients were given 2.5 μg of ramosetron for 4 weeks, and responders continued the same dose for another 48 weeks. Non-responders at 4 weeks were given 5 μg of ramosetron for 48 weeks. At the end of week 52, 106 patients receiving 2.5 μg and 17 patients receiving 5 μg had completed the study. Safety and efficacy including symptoms and quality of life (QOL) were evaluated.

Results

Concerning safety, no serious adverse event related to ramosetron, specifically ischemic colitis, was observed in patients with either dose of ramosetron. However, constipation occurred in 19.7 % of patients given 2.5 μg and 10.5 % of patients given 5 μg of ramosetron. Ramosetron-treated patients showed high rates of global improvement. Stool consistency, abdominal pain and discomfort, and IBS-QOL were also improved at the last evaluation point.

Conclusions

The results provide evidence of the long-term safety and efficacy of treatment with 2.5 and 5 μg of ramosetron in female patients with IBS-D. Clinicians should be aware that one-fifth of women with IBS-D receiving ramosetron may suffer from constipation during treatment (ClinicalTrials.gov ID: NCT01736423).

Keywords

5-Hydroxytryptamine Abdominal pain Abdominal discomfort Global improvement 

Abbreviations

BSFS

Bristol Stool Form Scale

95 % CI

95 % confidence interval

FDA

Food and Drug Administration

HR-QOL

Health-related quality of life

5-HT

5-Hydroxytryptamine

5-HT3

5-Hydroxytryptamine 3 receptor

IBS

Irritable bowel syndrome

IBS-C

Irritable bowel syndrome with constipation

IBS-D

Irritable bowel syndrome with diarrhea

IBS-M

Mixed irritable bowel syndrome

IBS-U

Unsubtyped irritable bowel syndrome

IBS-QOL

Irritable bowel syndrome-quality of life

MCID

Minimum clinically important difference

NNT

Number needed to treat

RR

Relative risk

SD

Standard deviation

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Copyright information

© Japanese Society of Gastroenterology 2016

Authors and Affiliations

  • Shin Fukudo
    • 1
  • Yoshikazu Kinoshita
    • 2
  • Toshikatsu Okumura
    • 3
  • Motoko Ida
    • 4
  • Kenta Hayashi
    • 5
  • Hiraku Akiho
    • 5
  • Yoshihiro Nakashima
    • 6
  • Ken Haruma
    • 7
  1. 1.Department of Behavioral MedicineTohoku University Graduate School of MedicineSendaiJapan
  2. 2.Department of Gastroenterology, Faculty of MedicineShimane UniversityIzumoJapan
  3. 3.Department of General MedicineAsahikawa Medical UniversityAsahikawaJapan
  4. 4.Development Planning and AdministrationAstellas Pharma Inc.TokyoJapan
  5. 5.Japan/Asia Clinical Development 2Astellas Pharma Inc.TokyoJapan
  6. 6.Data ScienceAstellas Pharma Inc.TokyoJapan
  7. 7.Department of GastroenterologyKawasaki Medical SchoolKurashikiJapan

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