New data shows underdiagnosis of Irritable Bowel Syndrome (IBS) burdens patients and healthcare systems worldwide
Novartis announced today results of an international study, "Truth In IBS", that found IBS affects up to 12% of the population, and that under-diagnosis and lack of effective treatment create a considerable burden on patients and healthcare systems. Additional data from a multicentre study reinforced that Zelmac® (tegaserod) is safe and well-tolerated in relieving the multiple symptoms of IBS (abdominal pain/discomfort, bloating, and constipation). Both studies were presented today at the 9th annual United European gastroenterology Week (UEGW) meeting in Amsterdam.
"Truth In IBS" study To assess the global prevalence and impact of IBS, the "Truth In IBS" study was conducted in nine countries: the UK, Germany, Belgium, the Netherlands, Switzerland, Spain, Italy, France and the US. "This large, international study provides compelling new evidence that IBS is a debilitating condition for which there is no single effective treatment," said Professor Jan Tack, study author and staff member at the Department of Gastroenterology and Principal Researcher, Centre for Gastroenterological Research at the University Leuven, Belgium.
The study found that the prevalence of IBS in Europe ranges from 6% in the Netherlands to 12% in Italy, including patients who have been formally diagnosed for the condition and those who have not. Women were predominantly affected, averaging between 63% and 74% of identified IBS sufferers in the nine countries. Diagnosed and undiagnosed sufferers were all ages, with an average of 43 years. Significantly, researchers also found that more than 90% of IBS cases in Europe have not been diagnosed.1
The study was conducted in two phases, the first consisting of 5 000 screening calls in each country to identify diagnosed and undiagnosed IBS sufferers. Undiagnosed patients were identified using Manning, Rome I and Rome II diagnostic criteria captured through questionnaires concerning each patient's experience with abdominal pain, bowel function and bloating.2-4 In the second phase of the study, follow-up phone interviews with identified sufferers collected further information about the impact of IBS on their lives.
Interviews determined that 89% of IBS sufferers experienced bloating, 85% constipation, and 76% abdominal pain. A majority said that IBS affected their diet (69%), concentration (60%) and physical appearance (54%), and said the symptoms have reduced their productivity at work (60%). A majority of IBS sufferers had been to healthcare professionals (90% to a primary care physician) regarding their symptoms with 17% going to a hospital at least once relating to their condition. The study also revealed IBS patients find currently available treatments to be largely ineffective against bloating (89%), constipation (85%) and abdominal pain (76%).
Multicentre dose-titration study Also at the UEGW meeting, data was presented from a long-term safety and tolerability study5 which found 62% of IBS patients reported considerable relief of symptoms at 12 months when treated with Zelmac. The multicentre, dose-titration study evaluated 579 patients to reinforce past studies that established the safety of Zelmac. As in previous studies, Zelmac was found to be safe and well-tolerated with mild side effects, the most common being transient diarrhoea (10%) and headache (8%). Patients treated with Zelmac showed no haematological or biochemical abnormalities. Blood pressure and pulse rate remained normal, as did the results of urinalysis.
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