# Tegaserod even more effective on retreatment of IBS constipation



## Jeffrey Roberts (Apr 15, 1987)

http://www.medicalnewstoday.com/medicalnew...p?newsid=32504#Tegaserod even more effective on retreatment of IBS constipation24 Oct 2005 Copenhagen, Denmark - Tegaserod may be even more effective at the second course of treatment than it is at the first course in patients with constipation predominant irritable bowel syndrome (IBS-C). This was the view of Professor Michael A Kamm, Department of Gastroenterology, St Mark's Hospital, London, UK. He was speaking at a satellite symposium during the 13th United European Gastroenterology Week (UEGW), Copenhagen, Denmark. Professor Kamm was reviewing the four pivotal Phase III randomized, placebo-controlled trials of the promotility serotonergic agent tegaserod in patients with IBS-C. One of these studies, recently published online (Tack et al 2005), investigated the efficacy of repeated treatment with the drug and is known as the ZENSAA study (Zelnorm in Europe, North and South America and Africa). In this study, tegaserod was investigated in 2,660 patients and 1,191 patients randomized, respectively, to a four-week course of treatment and (after being treatment-free for 2-12 weeks) a repeated treatment period of four weeks. Tegaserod was significantly superior to placebo during both initial and retreatment phases, providing relief from global and multiple dysmotility, and sensory symptoms associated with IBS-C. Professor Kamm illustrated these findings with the data on abdominal pain from the study. In the first treatment course of 4 weeks, the difference between the treatment group and the placebo group was 9.7% in favour of the group receiving tegaserod. Not only was that difference at least maintained it was increased on retreatment. The difference on retreatment was 12.4% in favour of those retreated. Similarly with the results of repeated treatment on bloating intensity. At first treatment the difference between placebo and treatment group was 10.5%, while with the repeated treatment the difference was 13.2%. Professor Kamm said â€˜If anything the therapeutic response is even greater than during the first treatment phase.' Concluding his summary of the four pivotal trials of tegaserod, Professor Kamm said â€˜Clinical trial data demonstrate that tegaserod rapidly and effectively relieves overall IBS-constipation symptoms as well as individual symptoms of abdominal pain discomfort, bloating and constipation. These effects are maintained for the duration of treatment and during repeated treatment.' Serotonergic treatments and the subtypes of IBSSerotonergic agents target the underlying pathophysiology of IBS and can relieve multiple symptoms. IBS is a global issue with high prevalence rates described in all continents. In Europe and North American, the prevalence lies between 10-15% among adults (Muller-Lissner et al, 2001). It is most prevalent in women. IBS results in frequent and disabling symptoms that impact on many dimensions of a patient's life and lifestyle. In the UK it has been estimated that direct healthcare costs related to IBS are more than 50% greater than for the general population (Akehurst, 2002). It was stressed in the symposium that tegaserod is for patients with constipation predominant IBS. Those with diarrhea predominant IBS require other serotonergic treatment. Professor Jan Tack, Professor and Head of Clinic, Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium, said that serotonin plays a central role in gastrointestinal motor and sensory function, and alterations in serotonin signalling are implicated in the pathogenesis of IBS. Therefore, serotonergic agents, such as tegaserod, alosetron, cilansetron, and renzapride have the potential to treat multiple dysmotility and sensory symptoms associated with the different subtypes of IBS. Tegaserod is a 5-HT4 receptor selective agonist and produces reduced abdominal pain/discomfort and bloating, softer stools, and increased stool frequency. It is appropriate for patients with IBS-C. Tegaserod has been in use clinically for some time in the USA, but is not yet licensed for use in Europe. Alosetron and cilansetron are 5-HT3 receptor antagonists. They slow gastrointestinal transit and decrease discomfort during distension of the colon. Both agents are under trial to treat patients with IBS with diarrhoea (IBS-D). However, alosetron may be association with ischaemic colitis (Chey et al, 2005). Its use in the USA has been restricted to women with severe IBS unresponsive to other treatments. Two randomized controlled trials have reported cilansetron to relieve abdominal pain/discomfort and diarrhoea (Bradetta et al, 2004; Coremans et al 2004). Renzapride, a dual 5-HT3 antagonist /5-HT4 agonist, is currently in development for the treatment of IBS-C and IBS with alternating constipation and diarrhoea (IBS-A). Data from Phase IIb randomized controlled trials indicate that renzapride may be associated with improvements in bowel frequency and stool consistency. (Meyers et al, 2004; Henderson et al 2004). ReferencesAkehurst RL. Pharmacoeconomics 2002; 20: 455-62Bradetta M et al. Gastroenterology 2004;126:A-42Chey W et al. Gastroenterol Clin Biol 2005;128:T1139Coremans G et al. Gastroenterology 2004;126:A-640Henderson JC et al. Gastroenterology 2004;126 (Suppl.2):A-915Meyers N et al. Gastroenterology 2004;126:A-640Muller-Lissner SA et al. Digestion 2001;64:200-4Tack J et al. Gut. Published online 14 July 2005Conference reporting from Cormack News at the 13th United European Gastroenterology Week (UEGW), Copenhagen, Denmark For further reports from this meeting contact roddy###roddycormack.com


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## 2btrue (Jul 22, 2003)

Has a toll been taken on the BB to determine the effectiveness of Zelnorm?The studies are done on relatively few participants who have had to fit into a very specific criteria set by the drug company. How many people have actually found this drug effective and been able to tolerate the side effects?


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## Tiss (Aug 22, 2000)

I have been on it for 2 1/2 years and really, it's changed my life--for the better.


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## 2btrue (Jul 22, 2003)

Tiss,It is so good to hear good news. Did you find it helped with both pain and constipation (I'm not sure if pain was your problem though)Do you not have any side effects?


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## Tiss (Aug 22, 2000)

I really didn't have much pain. My main problems were infrequent BMs (every 7 to 10 days) and bloating and gas. Zelnorm has just about eliminated all that.


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