Severity in irritable bowel syndrome: a Rome Foundation Working Team report.

Objectives: The concept of severity in irritable bowel syndrome (IBS) is clinically recognized and operative in diagnostic decision making and treatment planning. Yet, there is no consensus on its definition, and there are limited data on the prevalence of severity subgroups, its medical and psychosocial determinants, and its association with other health status measures. The aims of the Rome Foundation Working Team Committee were to summarize current research, to develop a consensus of understanding on this concept, and to make recommendations for its use in research and clinical care.

Alosetron: ischemic colitis and serious complications of constipation.

Drugs such as alosetron that modulate serotonin effects by stimulating or blocking its receptors may play an important role in the treatment of some patients with irritable bowel system. In the case of alosetron, a 5HT-3 antagonist, an analysis of data from randomized clinical trials and postmarketing experiences have demonstrated a causal relationship between this drug and ischemic colitis and serious complications of constipation. Because the mechanism(s) of drug-induced ischemic colitis and possibly other forms of intestinal ischemia associated with alosetron have not been elucidated, there is need to further assess risk with regard to patient susceptibility and other factors.

The basis for the decreased response to proton pump inhibitors in gastro-oesophageal reflux disease patients without erosive oesophagitis.

Background: The reason why heartburn in gastro-oesophageal reflux disease subjects without oesophagitis is less responsive to proton pump inhibitors than heartburn in those with erosive oesophagitis is not known.

Methods: Gastric and oesophageal pH were determined in 26 subjects with gastro-oesophageal reflux disease at baseline and on days 1, 2 and 8 of treatment with 20 mg omeprazole or 20 mg rabeprazole in a randomized, two-way cross-over fashion. The presence or absence of erosive oesophagitis at baseline was documented by upper gastrointestinal endoscopy.

Postmarketing reports of QT prolongation and ventricular arrhythmia in association with cisapride and Food and Drug Administration regulatory actions.

Objective: To describe the postmarketing safety data used in the risk assessment of cisapride and to summarize the regulatory actions of the Food and Drug Administration (FDA).

Methods: The FDA analyzed reports of patients who developed QT prolongation, torsades de pointes, and ventricular arrhythmia in association with the use of cisapride to assess probable etiology and risk factors.

Results: While cisapride was being marketed from 1993-1999, the FDA received reports of the following patients: 117 who developed QT prolongation; 107, torsades de pointes; 16, polymorphic ventricular tachycardia; 18, ventricular fibrillation; 27, ventricular tachycardia; 25, cardiac arrest; 16, serious (unspecified) arrhythmia; and 15, sudden death; for a total of 341 individual patients affected, following use of cisapride.