fibromyalgia patients often have complaints about cloudy thinking, morning
stiffness and overall inability to function in their everyday lives.
Additional Study Highlights
-- At six months, patients taking duloxetine 60mg or 120mg maintained
reduced BPI scores and patients taking 120mg had improved PGI-I scores
compared with those taking placebo.
-- At the end of the six-month trial, more patients treated with both 60mg
or 120mg of duloxetine showed a response to treatment, defined as a 50
percent reduction of baseline BPI scores (32.6 percent and 35.9 percent
of patients, respectively), compared with patients taking placebo (21.6
-- Discontinuation rates over six months were similar among the groups
(45.3 percent and 46.3 percent for duloxetine 60mg and 120mg patients,
compared with 50 percent for placebo).
* Adverse event-related discontinuation was significantly higher in
patients taking 120mg (26.5 percent) but not in the 60mg (15.3
percent) group as compared with placebo (13.2 percent).
Discontinuations due to lack of efficacy were not statistically
different among treatment groups.
* Adverse events were similar to those seen in prior duloxetine
studies. In this study, the most common adverse events (occurred at
a rate of greater than or equal to 5 percent and at least twice the
rate of placebo) included nausea, dry mouth, constipation,
somnolence (sleepiness), fatigue, insomnia, decreased appetite,
hyperhydrosis, cough, tremor, rash and weight increase.
Fibromyalgia sNDA Submitted to FDA
Eli Lilly and Company (NYSE:
Page: 1 2 3 4 5 Related medicine technology :1
|SOURCE Eli Lilly and Company|
Copyright©2007 PR Newswire.
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