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Transdermal Oxybutynin Improves Treatment Persistence and Patient Outcomes: Presented at ACOG

By Bruce Sylvester

NEW ORLEANS, LA -- May 6, 2003 -- The problem of dry mouth resulting form use of oral oxybutynin (Oxytrol) therapy for overactive bladder is largely overcome in the newly-approved transdermal formulation, researchers reported here April 30^th.

This reduction in dry mouth appears to also lead to greater treatment persistence, said investigator and presenter G. Willy Davila, MD, Chairman, department of gynecology, The Cleveland Clinic, in Weston, Florida, at the 51^st Annual Meeting of the American College of Obstetricians and Gynecologists.

However, transient adverse site reactions to the Oxytrol patch have been noted, although they have a minimal effect on treatment persistence, he added.

"The subjects in this study understood that some erythema, or passing redness, at the patch site could be the trade-off for having a drug-delivery system that would not affect the liver and cause dry mouth," Dr. Davila said. "It appeared in a majority of the subjects in this study, but it went away within 48 hours and did not affect ongoing trial participation or reasons given for withdrawals."

For their randomised, multicenter, double-blind, active and placebo-controlled trial, the investigators enrolled 361 subjects in. The 121 subjects in the treatment arm used the transdermal patch, which contains 3.9 mg/day of oxybutynin, twice weekly applied to the abdomen. The 123 subjects received 4 mg/day of tolterodine capsules administered twice-daily and 117 received placebo. They also received matching patches or capsules along with the active treatment. The double blind period lasted 12-week.

Subjects were evaluated for site skin reactions to the patch at 2, 4 and 12 weeks. They used a 4-point scale -- 0=absent, 1=mild, 2=moderate, 3 =severe.

The researchers reported that 22.3% of the oxybutynin patch subjects showed absent or mild redness at the patch site. Twelve out of the 121 in this treatment arm withdrew from the study, with discontinuations being unrelated to erythematic symptoms, Dr. Davila said.

Eighty-nine percent of all study subjects who completed the double-blind phase of the trial went on to the open-label phase. As determined by the results of a voluntary questionnaire, 66% of the subjects preferred the transdermal to the other treatments for its simplicity of use and appearance.

The investigators noted that while more oxybutynin subjects had erythematic reactions than the subjects treated with tolterodine capsules. The majority of treatment-related adverse reactions on tolterodine were systemic rather than superficial.


[Study title: Oxybutynin Transdermal Administration Improves Treatment Persistence and Patient Outcomes. Poster: 57.]

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