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Ramosetron Reduces Symptoms of Irritable Bowel Syndrome and Improves Quality of Life in Women

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What's This?

Ramosetron Reduces Symptoms of Irritable Bowel Syndrome and Improves Quality of Life in Women

Background Information

Irritable bowel syndrome (IBS) is a common disorder of the gastrointestinal system. It is classified into for types like IBS with diarrhea (IBS-D), IBS with constipation, mixed-type IBS, and unsubtyped IBS.

Many agents like 5-hydroxytryptaminereceptor 3 (5-HT3) antagonists were developed for treating IBS-D. Alosetron has been approved for the treatment of IBS-D only in women and ramosetron has been approved for the treatment of men. This study performed a randomized, placebo-controlled phase 3 study to determine whether ramosetron reduces symptoms of IBS-D in women.

Objective of the Study

The primary objective of the study was to determine whether ramosetron reduces the symptoms of IBS-D in women and improves the quality of life.

Methods and Materials

Study Design

The study design was based on the previous studies. This randomized, double-blind, placebo-controlled clinical study comprised a provisional registration period, a 1-week baseline period, and a 12-week treatment period. The study protocol was designed in accordance with the declaration of Helsinki and was approved by the institutional review board at all sites. The patients were provided written informed consent before participating in study-related procedures.

Sample Size

A total of 580 patients were selected for the study.

Statistical Analysis

Chi-Square with a 2-sided significance level of 0.005 was used for the statistical analysis. Bristol stool form scale (BSFS) change in stool frequency was evaluated using the t test. To compare the ramosetron group with the placebo group, analysis of covariance was performed with the treatment. Adverse events were evaluated using the Fisher exact test.

Study criteria

Inclusion Criteria

Female patients of age 20-64 years and diagnosed with IBS-D were included in the study.

Exclusion Criteria

Female patients with colon, carcinoid, and medullary thyroid cancers, bowel obstructions, intestinal malrotation, ovarian cancer were excluded from the study.

Study Procedure

The study was comprised of a week baseline period and a 12-week treatment period. After the baseline period, eligible patients were assigned randomly to 12 weeks of oral treatment with placebo and ramosetron hydrochloride before breakfast. The visits were scheduled for at weeks 2, 4, 8, and 12 to assess the treatment efficacy, occurrence of adverse events, and drug compliance. Statistical analysis plans were finalized, and all data had been locked.

Results

Evaluation of the Primary End Point

Global Improvement of IBS symptoms

The patients who were treated with ramosetron showed significantly higher rates for global improvement of overall IBS symptoms at the last evaluation point than the placebo-treated patients.

Improvement in Stool Consistency

The patients who were treated with ramosetron showed significant improvement in the stool consistency than the placebo-treated patients.

Evaluation of Secondary End Points

Improvement of Abdominal Pain and Discomfort

The monthly responder rate for abdominal pain/discomfort was significantly higher in ramosetron group than that in the placebo group.

Improvement in Abnormal Bowel Habits

The monthly responder rate for abdominal bowel habits was significantly higher in ramosetron group than that in the placebo group.

Efficacy Evaluation of Improvement of Abdominal Pain/Discomfort, Stool Consistency, and Composite

The responder rate for the abdominal pain/discomfort intensity, Stool consistency, and Composite (abdominal pain/discomfort and stool consistency) was significantly higher in ramosetron group than that in the placebo group.

Conclusion

The overall study proved that ramosetron was effective in treating a female patient with IBS-D and also improves the quality of life. This 5-HT3 antagonist was likely to be beneficial not only for men but also for women. Based on this study and previous study, ramosetron had been used for treating patients with IBS-D regardless to sex.

Reference

Fukudo.S et al. Ramosetron Reduces Symptoms of Irritable Bowel Syndrome with Diarrhea and Improves Quality of Life in Women. Gastroenterology. 2016 Feb; 150(2):358-66

Available at: http://www.ncbi.nlm.nih.gov/pubmed/26551550/

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