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Tegaserod: long-term treatment for irritable bowel syndrome patients with constipation in primary care.
Digestion 2005; 71(4):238-44D

Abstract

BACKGROUND

Tegaserod, a prokinetic 5-HT4 receptor agonist, has demonstrated efficacy and tolerability in irritable bowel syndrome (IBS) patients with constipation (IBS-C) in controlled clinical trials. Its use in primary care has not been investigated.

AIM

To determine whether tegaserod is effective and well tolerated by primary care IBS-C patients.

METHODS

Patients received tegaserod 6 mg b.i.d. for 12 weeks and were assessed for response, abdominal pain/discomfort, bloating, stool consistency/frequency and straining at weeks 4 and 12. Previous successful treatment with the withdrawn drug, cisapride, was noted. A 9-month study extension was offered to patients completing 12 weeks of tegaserod treatment.

RESULTS

212 patients entered the 12-week treatment period; 166 completed as planned. Response rates were 64.2% at week 4 and 70.3% at week 12. After 12 weeks, abdominal pain/discomfort and bloating were reduced from baseline (p < 0.0001; mean change -1.02 and -0.91 points, respectively), stool frequency increased (0.78-0.97 stools/day) and stool consistency improved (2.45-3.42; lumpy stools became softer). Tegaserod was well tolerated; the most common adverse events were headache (13.2%) and diarrhea (9.4%). One hundred and twenty patients entered the 9-month extension study, 85 completed and tegaserod continued to be well tolerated.

CONCLUSIONS

In ambulatory primary care IBS-C patients, tegaserod is an effective and well-tolerated long-term treatment.

Authors+Show Affiliations

Israelitisches Krankenhaus, Hamburg University, Hamburg, Deutschland. layer@ik-h.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16024929

Citation

Layer, Peter, et al. "Tegaserod: Long-term Treatment for Irritable Bowel Syndrome Patients With Constipation in Primary Care." Digestion, vol. 71, no. 4, 2005, pp. 238-44.
Layer P, Keller J, Mueller-Lissner S, et al. Tegaserod: long-term treatment for irritable bowel syndrome patients with constipation in primary care. Digestion. 2005;71(4):238-44.
Layer, P., Keller, J., Mueller-Lissner, S., Rüegg, P., & Loeffler, H. (2005). Tegaserod: long-term treatment for irritable bowel syndrome patients with constipation in primary care. Digestion, 71(4), pp. 238-44.
Layer P, et al. Tegaserod: Long-term Treatment for Irritable Bowel Syndrome Patients With Constipation in Primary Care. Digestion. 2005;71(4):238-44. PubMed PMID: 16024929.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tegaserod: long-term treatment for irritable bowel syndrome patients with constipation in primary care. AU - Layer,Peter, AU - Keller,Jutta, AU - Mueller-Lissner,Stefan, AU - Rüegg,Peter, AU - Loeffler,Helena, Y1 - 2005/07/12/ PY - 2004/11/16/received PY - 2005/02/02/accepted PY - 2005/7/19/pubmed PY - 2005/12/13/medline PY - 2005/7/19/entrez SP - 238 EP - 44 JF - Digestion JO - Digestion VL - 71 IS - 4 N2 - BACKGROUND: Tegaserod, a prokinetic 5-HT4 receptor agonist, has demonstrated efficacy and tolerability in irritable bowel syndrome (IBS) patients with constipation (IBS-C) in controlled clinical trials. Its use in primary care has not been investigated. AIM: To determine whether tegaserod is effective and well tolerated by primary care IBS-C patients. METHODS: Patients received tegaserod 6 mg b.i.d. for 12 weeks and were assessed for response, abdominal pain/discomfort, bloating, stool consistency/frequency and straining at weeks 4 and 12. Previous successful treatment with the withdrawn drug, cisapride, was noted. A 9-month study extension was offered to patients completing 12 weeks of tegaserod treatment. RESULTS: 212 patients entered the 12-week treatment period; 166 completed as planned. Response rates were 64.2% at week 4 and 70.3% at week 12. After 12 weeks, abdominal pain/discomfort and bloating were reduced from baseline (p < 0.0001; mean change -1.02 and -0.91 points, respectively), stool frequency increased (0.78-0.97 stools/day) and stool consistency improved (2.45-3.42; lumpy stools became softer). Tegaserod was well tolerated; the most common adverse events were headache (13.2%) and diarrhea (9.4%). One hundred and twenty patients entered the 9-month extension study, 85 completed and tegaserod continued to be well tolerated. CONCLUSIONS: In ambulatory primary care IBS-C patients, tegaserod is an effective and well-tolerated long-term treatment. SN - 0012-2823 UR - https://www.unboundmedicine.com/medline/citation/16024929/Tegaserod:_long_term_treatment_for_irritable_bowel_syndrome_patients_with_constipation_in_primary_care_ L2 - https://www.karger.com?DOI=10.1159/000087049 DB - PRIME DP - Unbound Medicine ER -