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| |  ACOG MEETING: Ditropan XL Reduces Incontinence Episodes By 81% PHILADELPHIA, PA -- May 19, 1999 -- Data from a pivotal phase III clinical study of Alza’s Ditropan(R) XL (oxybutynin chloride) extended-release tablets showed that patients receiving the drug experienced an 81 percent reduction in urinary incontinence episodes, reducing the number of episodes from 18.6 per week to 2.9 per week. By comparison, patients receiving the immediate-release formulation of oxybutynin reported a 75 percent reduction in urinary incontinence episodes. Results of the clinical study were reported in a poster which was presented today at the American College of Obstetricians and Gynecologists' (ACOG) 47th annual clinical meeting. In the phase III clinical study, 46 percent of patients receiving Ditropan XL reported symptoms of dry mouth, compared with 54 percent of patients receiving comparable doses of immediate-release oxybutynin. Among these patients, 17 percent receiving Ditropan XL reported moderate-to-severe dry mouth, compared with 26 percent receiving immediate-release formulation of oxybutynin. "These clinical results help demonstrate the value of Ditropan XL as an important new treatment option for patients with symptoms of overactive bladder," said Eboo Versi, M.D., Ph.D., chief of urogynecology at Brigham and Women's Hospital, who presented the data at the meeting. Ditropan XL is the first and only once-a-day treatment for overactive bladder in the United States. Overactive bladder is a common and chronic condition that affects an estimated 17 million Americans. It is characterised by urge urinary incontinence (sudden and involuntary loss of bladder control resulting in wetting accidents), urgency (the urgent need to empty the bladder) and frequency (frequent urination). In the randomised, double-blind, dose-adjustable trial, a total of 226 patients with urge incontinence (201 women and 25 men) were first given placebo tablets and asked to complete urinary diaries for one week (baseline). Patients were then randomised to receive either immediate-release oxybutynin or Ditropan XL. Both groups began at 5 mg/day and were allowed to titrate up to achieve optimal efficacy and tolerability; dose titration stopped when patients experienced no urge incontinence episodes for two days or reached their maximum tolerated dose. The maximum dose used in the study was 20 mg/day. In clinical trials, Ditropan XL was demonstrated to be generally well-tolerated by patients. The most common adverse events observed with Ditropan XL were those expected with anticholinergic agents, including dose-dependent dry mouth (61 percent overall; only one percent of patients discontinued the clinical trials due to dry mouth), constipation (13 percent), drowsiness (12 percent), diarrhea (nine percent), blurred vision (eight percent), dry eyes (six percent), dizziness (six percent) and runny nose (six percent). In controlled trials, seven percent of patients treated with Ditropan XL discontinued because of adverse events.
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