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Antimuscarinic, Solifenacin, Appears Superior to Tolterodine ER in Treatment of Overactive Bladder ISTANBUL, TURKEY -- March 17, 2005 -- New landmark data (the STAR Study), revealed today from the European Association of Urology in Istanbul, Turkey, show that patients suffering from Overactive Bladder (OAB) syndrome will see considerably better improvements in their symptoms when being treated with the new antimuscarinic drug solifenacin, than on tolterodine ER - an antimuscarinic drug that is widely used. The data show that solifenacin is superior to tolterodine ER in treating all the aspects of incontinence, including the number of times a patient wets themselves and the urgency feeling that can lead to incontinence. The STAR study compared the flexible dosage regime of solifenacin, (5mg and 10mg) and the recommended dosage of tolterodine ER (4mg). The data show that solifenacin is 65%(1) more effective at treating urge incontinence than tolterodine ER. Urge incontinence is the symptom that bothers patients most and drives patients to seek help from their doctors. It is estimated that, in Europe, 49 million people (men and women) have this condition. 44 million of those people do not seek any help and suffer in silence. Of the five million people who do go to the doctor, only 1.5 million(2) will get any treatment. One of the most common treatments for these patients has been tolterodine ER. Mr Chris Chapple, Consultant Urologist, Royal Hallamshire Hospital, UK and Principal Investigator of the STAR study, commented: "This is a landmark study in the area of OAB syndrome, which has been well conducted in line with current recommendations from the International Consultation on Incontinence Expert Committee on Pharmacotherapy for head to head studies. The STAR study has delivered clear unequivocal results to demonstrate that solifenacin offers superior efficacy on many of the key parameters of OAB syndrome." Solifenacin Solifenacin was launched throughout most of Europe in 2004 and is available in both 5mg and 10mg formulations offering flexible once-daily dosing. The licence was granted following an extensive clinical trial programme of 3,700 patients. Data from this registration trial programme indicated that solifenacin may be superior to tolterodine 2mg twice daily. However a head-to-head study with tolterodine's newer once-daily formulation was needed to substantiate any difference, which has now been proven. STAR Study The STAR study was conducted as a double-blind, double-dummy randomised head-to-head study. The study compared the flexible dosage regime of solifenacin (5mg and 10mg) and the recommended dosage of tolterodine ER (4mg). The study was conducted in 17 countries in Europe with 117 sites involving 1355 patients. References: 1) Tolterodine ER achieved a reduction in urge incontinence per 24-hours of -0.83. Solifenacin achieved an improvement over tolterodine ER in urge incontinence of -0.538. This represents an improvement of 65% over tolterodine ER. 0.538 ----- x 100 = 65% 0.83 2) Datamonitor report, 2004 SOURCE: Yamanouchi Europe E-mail this page to a friend or colleague! To print, use this version