# Zelnorm longer term study



## Kathleen M. (Nov 16, 1999)

Digestion. 2005 Jul 12;71(4):238-244 [Epub ahead of print] Tegaserod: Long-Term Treatment for Irritable Bowel Syndrome Patients with Constipation in Primary Care.Layer P, Keller J, Mueller-Lissner S, Ruegg P, Loeffler H.Israelitisches Krankenhaus, Hamburg, Deutschland.Background: Tegaserod, a prokinetic 5-HT(4) 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 Previous successful treatment with the withdrawn drug, cisapride, was noted.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. Copyright © 2005 S. Karger AG, Basel.


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