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The effects of withdrawing tegaserod treatment in comparison with continuous treatment in irritable bowel syndrome patients with abdominal pain/discomfort, bloating and constipation: a clinical study.
Aliment Pharmacol Ther 2004; 20(2):213-22AP

Abstract

BACKGROUND

The post-withdrawal characteristics of tegaserod treatment in patients with irritable bowel syndrome with constipation remain undefined.

AIM

To evaluate the effects of continuous tegaserod treatment, versus intermittent or withdrawal of treatment in patients with irritable bowel syndrome with constipation.

METHODS

In a randomized, open-label trial, all patients initially received tegaserod 6 mg b.d. Responders were randomized to continue or withdraw from treatment for 8 weeks and symptom recurrence was assessed. Tegaserod was re-introduced in withdrawal patients who experienced symptom recurrence, allowing an assessment of intermittent treatment. Two separate analyses assessed the effects of intermittent and withdrawal of treatment on symptom recurrence.

RESULTS

Five hundred irritable bowel syndrome with constipation patients initially received tegaserod; 410 completed treatment. Time to symptom recurrence was shorter in withdrawal patients than those maintained on tegaserod. Significantly more patients maintained on tegaserod had not experienced symptom recurrence by week 8, compared with intermittent (86.5% vs. 58.1%, respectively) or withdrawal of treatment (69.2% vs. 11.3%, respectively) (P < 0.0001 for both). Significant treatment effects were observed for bloating (P < 0.01) and abdominal pain/discomfort (P < 0.02). Most adverse events were mild to moderate.

CONCLUSIONS

Irritable bowel syndrome with constipation patients who receive continuous or intermittent tegaserod are less likely to experience symptom recurrence than patients withdrawn from treatment.

Authors+Show Affiliations

District General Hospital, Rotherham, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15233702

Citation

Bardhan, K D., et al. "The Effects of Withdrawing Tegaserod Treatment in Comparison With Continuous Treatment in Irritable Bowel Syndrome Patients With Abdominal Pain/discomfort, Bloating and Constipation: a Clinical Study." Alimentary Pharmacology & Therapeutics, vol. 20, no. 2, 2004, pp. 213-22.
Bardhan KD, Forbes A, Marsden CL, et al. The effects of withdrawing tegaserod treatment in comparison with continuous treatment in irritable bowel syndrome patients with abdominal pain/discomfort, bloating and constipation: a clinical study. Aliment Pharmacol Ther. 2004;20(2):213-22.
Bardhan, K. D., Forbes, A., Marsden, C. L., Mason, T., & Short, G. (2004). The effects of withdrawing tegaserod treatment in comparison with continuous treatment in irritable bowel syndrome patients with abdominal pain/discomfort, bloating and constipation: a clinical study. Alimentary Pharmacology & Therapeutics, 20(2), pp. 213-22.
Bardhan KD, et al. The Effects of Withdrawing Tegaserod Treatment in Comparison With Continuous Treatment in Irritable Bowel Syndrome Patients With Abdominal Pain/discomfort, Bloating and Constipation: a Clinical Study. Aliment Pharmacol Ther. 2004 Jul 15;20(2):213-22. PubMed PMID: 15233702.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effects of withdrawing tegaserod treatment in comparison with continuous treatment in irritable bowel syndrome patients with abdominal pain/discomfort, bloating and constipation: a clinical study. AU - Bardhan,K D, AU - Forbes,A, AU - Marsden,C L, AU - Mason,T, AU - Short,G, PY - 2004/7/6/pubmed PY - 2004/11/2/medline PY - 2004/7/6/entrez SP - 213 EP - 22 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 20 IS - 2 N2 - BACKGROUND: The post-withdrawal characteristics of tegaserod treatment in patients with irritable bowel syndrome with constipation remain undefined. AIM: To evaluate the effects of continuous tegaserod treatment, versus intermittent or withdrawal of treatment in patients with irritable bowel syndrome with constipation. METHODS: In a randomized, open-label trial, all patients initially received tegaserod 6 mg b.d. Responders were randomized to continue or withdraw from treatment for 8 weeks and symptom recurrence was assessed. Tegaserod was re-introduced in withdrawal patients who experienced symptom recurrence, allowing an assessment of intermittent treatment. Two separate analyses assessed the effects of intermittent and withdrawal of treatment on symptom recurrence. RESULTS: Five hundred irritable bowel syndrome with constipation patients initially received tegaserod; 410 completed treatment. Time to symptom recurrence was shorter in withdrawal patients than those maintained on tegaserod. Significantly more patients maintained on tegaserod had not experienced symptom recurrence by week 8, compared with intermittent (86.5% vs. 58.1%, respectively) or withdrawal of treatment (69.2% vs. 11.3%, respectively) (P < 0.0001 for both). Significant treatment effects were observed for bloating (P < 0.01) and abdominal pain/discomfort (P < 0.02). Most adverse events were mild to moderate. CONCLUSIONS: Irritable bowel syndrome with constipation patients who receive continuous or intermittent tegaserod are less likely to experience symptom recurrence than patients withdrawn from treatment. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/15233702/The_effects_of_withdrawing_tegaserod_treatment_in_comparison_with_continuous_treatment_in_irritable_bowel_syndrome_patients_with_abdominal_pain/discomfort_bloating_and_constipation:_a_clinical_study_ L2 - https://doi.org/10.1111/j.1365-2036.2004.02032.x DB - PRIME DP - Unbound Medicine ER -