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Tegaserod for female patients suffering from IBS with mixed bowel habits or constipation: a randomized controlled trial.
Am J Gastroenterol 2008; 103(5):1217-25AJ

Abstract

OBJECTIVES

Though the greatest proportion of irritable bowel syndrome (IBS) patients report a mixed bowel pattern (IBS-Mixed), no available therapies have been rigorously evaluated in this subgroup. This study aimed to evaluate the efficacy and safety of the 5-HT(4) agonist tegaserod in women with IBS-Mixed and IBS with constipation (IBS-C).

METHODS

This prospective, double-blind, randomized, placebo-controlled, multicenter study was conducted in 100 centers in North America, South America, and Europe. Women with IBS-Mixed or IBS-C received tegaserod 6 mg or placebo twice daily. The primary efficacy variable was the patient's assessment of satisfactory relief over the 4-wk treatment period. The proportion of patients reporting satisfactory relief for >/=3 of 4 treatment weeks (75% rule) and individual IBS symptoms were assessed.

RESULTS

In total, 661 women were randomized (IBS-Mixed 324, IBS-C 337). Baseline symptom assessments identified clear differences between the two cohorts. Tegaserod provided significant improvement in satisfactory relief of IBS symptoms over 4 wk (OR 1.75, 95% CI 1.35-2.25, P < 0.001) in both IBS-Mixed and IBS-C patients. Using the 75% rule, 52.3% of tegaserod-receiving IBS-M patients and 43.3% of IBS-C patients were responders (vs 36.3, OR 1.88, 95% CI 1.16-3.04, P < 0.010; and 28.9, OR 1.90, 95% CI 1.19-3.05, P < 0.008 for placebo, respectively). The most frequent adverse events leading to study discontinuation in tegaserod-treated patients were diarrhea (1.5%) and abdominal pain (0.9%). Overall 7% of IBS-C patients reported diarrhea compared to 12% of IBS-Mixed (placebo 2.4%, 1.8%, respectively).

CONCLUSIONS

Tegaserod is effective in treating overall IBS symptoms in patients with IBS-Mixed and IBS-C.

Authors+Show Affiliations

University of Michigan Health System, Division of Internal Medicine, Ann Arbor, Michigan, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

18477346

Citation

Chey, William D., et al. "Tegaserod for Female Patients Suffering From IBS With Mixed Bowel Habits or Constipation: a Randomized Controlled Trial." The American Journal of Gastroenterology, vol. 103, no. 5, 2008, pp. 1217-25.
Chey WD, Paré P, Viegas A, et al. Tegaserod for female patients suffering from IBS with mixed bowel habits or constipation: a randomized controlled trial. Am J Gastroenterol. 2008;103(5):1217-25.
Chey, W. D., Paré, P., Viegas, A., Ligozio, G., & Shetzline, M. A. (2008). Tegaserod for female patients suffering from IBS with mixed bowel habits or constipation: a randomized controlled trial. The American Journal of Gastroenterology, 103(5), pp. 1217-25. doi:10.1111/j.1572-0241.2008.01808.x.
Chey WD, et al. Tegaserod for Female Patients Suffering From IBS With Mixed Bowel Habits or Constipation: a Randomized Controlled Trial. Am J Gastroenterol. 2008;103(5):1217-25. PubMed PMID: 18477346.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tegaserod for female patients suffering from IBS with mixed bowel habits or constipation: a randomized controlled trial. AU - Chey,William D, AU - Paré,Pierre, AU - Viegas,Andrea, AU - Ligozio,Gregory, AU - Shetzline,Michael A, PY - 2008/5/15/pubmed PY - 2008/5/31/medline PY - 2008/5/15/entrez SP - 1217 EP - 25 JF - The American journal of gastroenterology JO - Am. J. Gastroenterol. VL - 103 IS - 5 N2 - OBJECTIVES: Though the greatest proportion of irritable bowel syndrome (IBS) patients report a mixed bowel pattern (IBS-Mixed), no available therapies have been rigorously evaluated in this subgroup. This study aimed to evaluate the efficacy and safety of the 5-HT(4) agonist tegaserod in women with IBS-Mixed and IBS with constipation (IBS-C). METHODS: This prospective, double-blind, randomized, placebo-controlled, multicenter study was conducted in 100 centers in North America, South America, and Europe. Women with IBS-Mixed or IBS-C received tegaserod 6 mg or placebo twice daily. The primary efficacy variable was the patient's assessment of satisfactory relief over the 4-wk treatment period. The proportion of patients reporting satisfactory relief for >/=3 of 4 treatment weeks (75% rule) and individual IBS symptoms were assessed. RESULTS: In total, 661 women were randomized (IBS-Mixed 324, IBS-C 337). Baseline symptom assessments identified clear differences between the two cohorts. Tegaserod provided significant improvement in satisfactory relief of IBS symptoms over 4 wk (OR 1.75, 95% CI 1.35-2.25, P < 0.001) in both IBS-Mixed and IBS-C patients. Using the 75% rule, 52.3% of tegaserod-receiving IBS-M patients and 43.3% of IBS-C patients were responders (vs 36.3, OR 1.88, 95% CI 1.16-3.04, P < 0.010; and 28.9, OR 1.90, 95% CI 1.19-3.05, P < 0.008 for placebo, respectively). The most frequent adverse events leading to study discontinuation in tegaserod-treated patients were diarrhea (1.5%) and abdominal pain (0.9%). Overall 7% of IBS-C patients reported diarrhea compared to 12% of IBS-Mixed (placebo 2.4%, 1.8%, respectively). CONCLUSIONS: Tegaserod is effective in treating overall IBS symptoms in patients with IBS-Mixed and IBS-C. SN - 1572-0241 UR - https://www.unboundmedicine.com/medline/citation/18477346/Tegaserod_for_female_patients_suffering_from_IBS_with_mixed_bowel_habits_or_constipation:_a_randomized_controlled_trial_ L2 - http://Insights.ovid.com/pubmed?pmid=18477346 DB - PRIME DP - Unbound Medicine ER -