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| |  ICS MEETING: Ditropan XL Effective In The Treatment Of Overactive Bladder DENVER, CO -- Aug. 25, 1999 -- A majority of patients receiving once-a-day ALZA Corp.’s Ditropan(R) XL, an extended-release formulation of oxybutynin for the treatment of overactive bladder, remained on therapy for a period of six months or more, according to interim results of a community-use study. The findings were presented today at the 29th annual meeting of the International Continence Society in Denver. In the study, 62 percent of patients continued to take Ditropan XL for a period of six months or more. Of the patients who discontinued therapy, the majority did so within the first month or two of treatment. "Long-term use of conventional therapies for overactive bladder is generally believed to be poor, with reported use as low as 18 percent after six months," said Richard Labasky, M.D., professor of surgery at the University of Utah at Salt Lake City, who presented the data at the meeting. "This study evaluates the continuation rate of Ditropan XL as the first once-daily medication offered for this condition and also looks at reasons for discontinuation with therapy. These factors are especially important to urologists, who must balance patient compliance with therapy and tolerability." The open-label, non-randomised study enrolled 1,070 adults with symptoms of urge incontinence at 99 sites U.S.- wide. Patients, who were typically seen in a community-based urology practice, were started with a 5 mg/day dose of Ditropan XL and adjusted their dose to a balance of symptom reduction and tolerability, up to 30 mg/day. Adverse events were reported by telephone and at office visits every two to three months. The ongoing study will follow patients for a period of 12 months. According to results of the six-month interim analysis, the primary reasons for discontinuation with therapy were lack of effectiveness (8.2 percent), dry mouth (seven percent), indigestion (1.6 percent), constipation (1.5 percent), diarrhea (1.2 percent), dizziness (1.1 percent), personal (three percent), non-compliance (2.6 percent) and lost to follow-up (1.5 percent). During the course of the study, 645 patients reported on the bothersomeness of their overactive bladder symptoms, as measured by the General Health and Bothersome Scale. This scale asked patients to rate their discomfort on a scale of zero to 100, from not bothersome at all (zero) to as bothersome as I can imagine (100). The mean bothersome score at baseline was 72; this dropped to 37 after three months of treatment with Ditropan XL. An estimated 17 million Americans suffer from overactive bladder - a common, treatable and chronic condition characterised by symptoms of 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). The condition is most prevalent among women and older adults. In pivotal studies reviewed by the U.S. Food and Drug Administration, the efficacy and safety of Ditropan XL were demonstrated in 429 adult overactive bladder patients with incontinence episodes in three controlled studies and one open-label study. In a controlled study, Ditropan XL demonstrated efficacy superior to placebo in the reduction of urge incontinence episodes. Patients treated with Ditropan XL experienced a decrease in incontinence episodes from 18.6 episodes per week to 1.5 episodes per week. Patients taking a sugar pill went from 20.9 episodes per week to 10.3 episodes per week. In clinical trials, Ditropan XL was 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, 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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