Tegaserod does not alter fasting or meal-induced biliary tract motility

Area of Science:

• Gastroenterology
• Pharmacology
• Digestive Physiology

Background:

• Irritable Bowel Syndrome with Constipation (IBS-C) is a chronic functional gastrointestinal disorder.
• IBS-C is associated with increased abdominal surgeries, including cholecystectomy.
• The effects of tegaserod, a 5-HT(4) receptor agonist, on non-gut digestive organs like the gallbladder have not been studied.

Purpose of the Study:

• To evaluate the effects of tegaserod on gallbladder contractility.
• To assess tegaserod's impact on sphincter of Oddi function.
• To investigate these effects in both healthy female subjects and female patients with IBS-C during digestive and interdigestive periods.

Main Methods:

• A 6-week, double-blind, placebo-controlled crossover study was conducted.
• Real-time ultrasonography quantified gallbladder contractility and common bile duct (CBD) and common hepatic duct (CHD) diameters.
• Measurements were taken before and after a liquid meal in healthy women (n=13), IBS-C patients (n=20) on standard tegaserod dose, and IBS-C patients (n=20) on double dose.

Main Results:

• Tegaserod treatment (6 mg b.i.d. or 12 mg b.i.d.) showed no significant changes in gallbladder contractility variables compared to placebo.
• No significant alterations in CHD or CBD diameters, indicative of sphincter of Oddi function, were observed with tegaserod.
• Plasma cholecystokinin (CCK) concentrations and adverse events were not significantly affected by tegaserod.

Conclusions:

• Tegaserod demonstrated no significant pharmacodynamic effects on gallbladder contractility.
• The study found no significant impact of tegaserod on sphincter of Oddi function, assessed via CBD and CHD diameters.
• These findings apply to both fasting and postprandial states in healthy women and IBS-C patients.