Tegaserod: long-term treatment for irritable bowel syndrome patients with constipation in primary care.
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.


OBJECTIVE
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 Previous successful treatment with the withdrawn drug, cisapride, was noted.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.
Layer
Peter
P
Israelitisches Krankenhaus, Hamburg University, Hamburg, Deutschland. layer@ik-h.de
Keller
Jutta
J
Mueller-Lissner
Stefan
S
Rüegg
Peter
P
Loeffler
Helena
H
D003248:Constipation / Q000150:complications / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000627:therapeutic use*; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D007211:Indoles; C105050:tegaserod