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| |  Ditropan XL (Oxybutynin Chloride) Effective In Reducing Urge Incontinence And Urinary Frequency MOUNTAIN VIEW, CA -- April 10, 2001 -- ALZA Corporation announced the results and publication of a head-to-head, Phase IV clinical study, "Overactive Bladder: Judging Effective Control and Treatment" (OBJECT), evaluating the two leading medications for the treatment of overactive bladder. Published in this month's Mayo Clinic Proceedings, OBJECT is the first study to directly compare the tolerability and efficacy of Ditropan XL® (extended-release oxybutynin chloride) and Detrol® (tolterodine tartrate). "This landmark study, which was designed and directed by some of the nation's pre-eminent thoughtleaders in overactive bladder, provides additional confirmation to physicians that Ditropan XL is well-tolerated and efficacious. Ditropan XL has been demonstrated to be effective and well tolerated by the millions of patients who have been treated for their symptoms of overactive bladder," said Rodney Appell, M.D., F. Brantley Scott Professor of Urology, Baylor College of Medicine, the study's author and principle investigator. "To physicians who have been prescribing either one of these two pharmacologic agents, we now have for the first time, objective results directly comparing their abilities to treat the primary symptoms of overactive bladder -- urge incontinence, total incontinence and frequency." In an accompanying editorial, Daniel S. Elliott, M.D., et al, of the Mayo Clinic, commented that "Prior to the study by Appell, et al in this issue of Proceedings, no direct comparison of the two most commonly prescribed medications, tolterodine and (extended-release) oxybutynin, had been done. These results are encouraging and demonstrate progress toward lessening the problem of bladder dysfunction." Final results from this Phase IV clinical study showed that patients treated with Ditropan XL experienced significantly fewer episodes of urge incontinence and urinary frequency. Specifically, Ditropan XL patients experienced 19.5 fewer weekly episodes of urge incontinence or wetting accidents. Patients treated with Detrol experienced 16.3 fewer weekly episodes of urge incontinence (p=.03). Urinary frequency decreased by 24.7 episodes per week in patients treated with Ditropan XL, whereas patients treated with Detrol experienced 20.1 fewer weekly episodes of urinary frequency (p=.02). Dry mouth, the most commonly reported side effect with medications used to treat overactive bladder, was experienced by 28 percent of patients treated with Ditropan XL, versus 33 percent of patients treated with tolterodine. All other adverse events experienced by patients in both treatment groups occurred at low rates and with similar frequency. The double-blind, double-dummy clinical trial was conducted across 37 study sites in the United States. Participants were randomized into two parallel treatment arms and treated with total daily doses of either 10 mg (qd) Ditropan XL or 4 mg (2 mg bid) Detrol for a period of 12 weeks. To enhance the integrity of the study design, neither physicians nor patients could determine which product was being administered. "When ALZA decided to go ahead with OBJECT, we knew that certain risks were involved in sponsoring a double-blind, double-dummy, randomized trial against the leading overactive bladder product, marketed by one of the major pharmaceutical companies in the world. It is now clear that our confidence in Ditropan XL was well placed, and we are very pleased to be announcing the publication of the OBJECT data in a prestigious peer-reviewed journal," stated Sam Saks, M.D., group vice president of ALZA Pharmaceuticals. "In addition to compelling efficacy and tolerability results, the low discontinuation rate due to adverse events in OBJECT was completely in line with previous studies evaluating Ditropan XL." Overactive bladder is a common, treatable and chronic condition characterized by symptoms of urge incontinence (sudden and involuntary loss of bladder control resulting in wetting accidents), urgency (the urgent need to empty the bladder) and frequency (frequent urination). An estimated 17 million Americans suffer from overactive bladder -- a condition most prevalent among women and older adults. At present, overactive bladder is widely under-diagnosed and under-treated -- in part because of embarrassment and the misconception that overactive bladder is a normal part of aging. Overactive bladder can have a profound impact on patients and disrupt daily routines and activities. Some patients may become socially isolated or even housebound because they fear the embarrassment of having urinary accidents in public. Ditropan XL is a once-daily extended-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Ditropan XL should not be used by patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions, or those who have demonstrated hypersensitivity to the same substance or other components of the product.
SOURCE: ALZA Corporation
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