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Safety, tolerability and satisfaction with tegaserod therapy in Asia-Pacific patients with irritable bowel syndrome with constipation.
J Gastroenterol Hepatol 2007; 22(8):1190-8JG

Abstract

BACKGROUND AND AIM

The 5-HT(4) receptor agonist tegaserod (6 mg b.i.d.) provides significantly better overall multiple symptom relief compared with placebo in patients with irritable bowel syndrome with constipation (IBS-C). The clinical benefit and safety of tegaserod in IBS-C patients has been demonstrated worldwide in several studies. The aim of this study was to obtain further safety and tolerability data in patients with IBS in the Asia-Pacific region, and to assess patients' satisfaction and compliance with treatment and willingness to re-use tegaserod in a post-marketing setting.

METHODS

A multicenter, single-arm, open-label trial was conducted at 869 outpatient centers in 10 countries. Men and women with IBS, whose predominant bowel symptom was not diarrhea (non-D-IBS), received tegaserod for 4-12 weeks. Safety and tolerability were assessed by recording adverse events (AE). Patients were questioned about compliance, satisfaction with treatment and willingness to use tegaserod in future.

RESULTS

Data were available from 14 537 patients (18% men, 82% women). Four percent of patients reported at least one AE. The most common AE were diarrhea (2%) and abdominal pain (1%), and most treatment-related AE occurred in the first week of treatment. Serious AE (SAE) were observed in eight patients, and no deaths were reported. Most patients (79%) reported to be satisfied or very satisfied with treatment, and 76% stated they would use tegaserod in the future. Compliance was 97%.

CONCLUSIONS

Tegaserod has a favorable safety and tolerability profile for treating non-D-IBS and IBS-C in men and women in the Asia-Pacific region. Satisfaction with tegaserod treatment can be expected in the majority of patients.

Authors+Show Affiliations

Changi General Hospital, Singapore, Singapore.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17524039

Citation

Fock, Kwong M., et al. "Safety, Tolerability and Satisfaction With Tegaserod Therapy in Asia-Pacific Patients With Irritable Bowel Syndrome With Constipation." Journal of Gastroenterology and Hepatology, vol. 22, no. 8, 2007, pp. 1190-8.
Fock KM, Wagner A, Asia Pacific Gastroenterology Group. Safety, tolerability and satisfaction with tegaserod therapy in Asia-Pacific patients with irritable bowel syndrome with constipation. J Gastroenterol Hepatol. 2007;22(8):1190-8.
Fock, K. M., & Wagner, A. (2007). Safety, tolerability and satisfaction with tegaserod therapy in Asia-Pacific patients with irritable bowel syndrome with constipation. Journal of Gastroenterology and Hepatology, 22(8), pp. 1190-8.
Fock KM, Wagner A, Asia Pacific Gastroenterology Group. Safety, Tolerability and Satisfaction With Tegaserod Therapy in Asia-Pacific Patients With Irritable Bowel Syndrome With Constipation. J Gastroenterol Hepatol. 2007;22(8):1190-8. PubMed PMID: 17524039.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety, tolerability and satisfaction with tegaserod therapy in Asia-Pacific patients with irritable bowel syndrome with constipation. AU - Fock,Kwong M, AU - Wagner,Amy, AU - ,, Y1 - 2007/05/24/ PY - 2007/5/26/pubmed PY - 2007/10/17/medline PY - 2007/5/26/entrez SP - 1190 EP - 8 JF - Journal of gastroenterology and hepatology JO - J. Gastroenterol. Hepatol. VL - 22 IS - 8 N2 - BACKGROUND AND AIM: The 5-HT(4) receptor agonist tegaserod (6 mg b.i.d.) provides significantly better overall multiple symptom relief compared with placebo in patients with irritable bowel syndrome with constipation (IBS-C). The clinical benefit and safety of tegaserod in IBS-C patients has been demonstrated worldwide in several studies. The aim of this study was to obtain further safety and tolerability data in patients with IBS in the Asia-Pacific region, and to assess patients' satisfaction and compliance with treatment and willingness to re-use tegaserod in a post-marketing setting. METHODS: A multicenter, single-arm, open-label trial was conducted at 869 outpatient centers in 10 countries. Men and women with IBS, whose predominant bowel symptom was not diarrhea (non-D-IBS), received tegaserod for 4-12 weeks. Safety and tolerability were assessed by recording adverse events (AE). Patients were questioned about compliance, satisfaction with treatment and willingness to use tegaserod in future. RESULTS: Data were available from 14 537 patients (18% men, 82% women). Four percent of patients reported at least one AE. The most common AE were diarrhea (2%) and abdominal pain (1%), and most treatment-related AE occurred in the first week of treatment. Serious AE (SAE) were observed in eight patients, and no deaths were reported. Most patients (79%) reported to be satisfied or very satisfied with treatment, and 76% stated they would use tegaserod in the future. Compliance was 97%. CONCLUSIONS: Tegaserod has a favorable safety and tolerability profile for treating non-D-IBS and IBS-C in men and women in the Asia-Pacific region. Satisfaction with tegaserod treatment can be expected in the majority of patients. SN - 0815-9319 UR - https://www.unboundmedicine.com/medline/citation/17524039/Safety_tolerability_and_satisfaction_with_tegaserod_therapy_in_Asia_Pacific_patients_with_irritable_bowel_syndrome_with_constipation_ L2 - https://doi.org/10.1111/j.1440-1746.2007.04955.x DB - PRIME DP - Unbound Medicine ER -