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aIMS Health data.

aIMS Health data.

resulting in abdominal pain, abdominal distention, and disturbed defecation, and is associated with significant disability and healthcare costs. IBS accounts for up to 50% of referrals to gastroenterology clinics; symptoms vary over the years, often overlapping with other functional disorders such as dyspepsia. Ten percent of the patients turn to their physicians, and the illness has a large economic impact on the healthcare system overall, on absenteeism, and on lost productivity. The annual direct cost for IBS is around $41 billion in the eight most industrialized countries,12 although most individuals with IBS do not consult a physician, and the disease is therefore underestimated. IBS sufferers report substantially lower quality of life scores as compared with healthy individuals.11

A meta-analysis evaluating 213 studies related to the efficacy of pharmacological agents for IBS treatment that included smooth muscle relaxants, bulking agents, prokinetic agents, psychotropic agents, and loperamide13 showed that only 70 of the 213 studies met the inclusion criteria for methodology, but the strongest evidence for efficacy was shown for smooth muscle relaxants in patients with abdominal pain as the predominant symptom. In contrast, the meta-analysis found that the efficacy of bulking agents has not been established, loperamide is only effective for diarrhea, and the evidence for the use of psychotropic agents is inconclusive. Among the smooth muscle relaxants, calcium channel inhibitors selective for the GI tract (e.g., pinaverium and otilonium bromide) are effective for pain relief; they are marketed in Europe, but not in the USA, where the available spasmolytics are n-butyl scopolammonium bromide or hyoscine butylbromide, and dicyclomine, whose efficacy in IBS has yet to be demonstrated.14 For these reasons, the market for this class of pharmaceuticals is not as large as expected (Table 2; antispasmodics and anticholinergics).

New therapeutic opportunities for IBS are emerging from serotonin (5HT) receptor antagonists or agonists that have been described as potential modulators of the visceral sensitivity and gut motility.15 The selective 5HT3 antagonist alosetron was effective in diarrhoic women, a subset of the IBS population, but was associated with several cases of ischemic colitis and death, and was initially withdrawn and then reapproved by the US Food and Drugs Administration with warning restrictions. A similar compound, cilansetron, with efficacy in diarrhea-predominant IBS patients of both sexes, is under development.16 Tegaserod, a 5HT4 receptor partial agonist, is effective and safe in treating patients with IBS with constipation, and, in the absence of other competitors, is expanding in the world market of IBS (Table 2; gastrointestinal sensorimotor modulators). Apart from the limitation of the IBS patient population that can be treated (only one-third of the total) by tegaserod, some doubts regarding its efficacy exist, the therapeutic advantage over placebo being between 5% and 20% in different trials. Furthermore, tegaserod is not very efficient in reducing pain and discomfort.17 New safer and more effective drugs are now awaited to treat this chronic and important disease.

Ulcerative colitis (UC) and Crohn's disease (CD) are idiopathic inflammatory disorders of unknown etiology, and are collectively termed IBD (see 6.28 Inflammatory Bowel Disease). A typical presentation is that of prolonged diarrhea often associated with rectal bleeding in UC, and abdominal pain as a key symptom in CD. The mucosa of the colon is inflamed, with erythema, edema, ulceration, and bleeding in UC, or with focal irregular deeper ulceration in CD. Although endoscopic

Table 3 Sales of the leading therapy classes for the treatment of nonulcer dyspepsia and emesis in 2004s

Audited world therapy class

2004 sales ($ millions)

Growth (year over year) (%)

Gastroprokinetics

Constipation Prescription

Constipation Prescription

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