Product Information / Press Release

Cymbalta is a new antidepressant manufactured by Eli Lilly and Company, the approval of which Has finally been granted by the U.S. Food and Drug Administration.  This happens on the heals of one suicide of a 19 year-old, in perfect health, no mental disorder, hanging herself at the Eli Lilly complex, after taking Cymbalta. This is approved when pressure is being put on all of the pharmaceutical firs to fully disclose their clinical trials.

Did the FDA feel a little pressure from the Bush Administration? If you have an adverse event or commit suicide while taking Cymbalta, odds are the Bush Administration will pay for and support Eli Lilly to beat you in court. Bush admits this.

The Phase III data are consistent with previously published Phase II data and provide further support for duloxetine as a pharmacological agent for the treatment of SUI.

"These data are important for physicians and sufferers as there are currently no pharmaceutical options for the millions of women affected by SUI. A pharmaceutical option would be a welcomed choice," said Roger Dmochowski, MD, Professor of Urology in the Department of Urology at Vanderbilt University, Nashville, TN, and a principal investigator in this study.

Study Results

-- The results showed that duloxetine 80 mg, taken as 40 mg twice daily, significantly reduced the frequency of incontinence episodes by 50 percent versus 27 percent for placebo in women with SUI. Reduction of incontinent episodes is the medically recognized measurement of treatment efficacy.

-- Furthermore, 51 percent of all women taking duloxetine experienced a 50 percent to 100 percent reduction in frequency of incontinence episodes.

-- The improvements with duloxetine were not a result of more frequent voiding by the patients, in that the average time between voids (emptying of the bladder) was not decreased, but even increased overall by 20 minutes in the duloxetine group compared with 2 minutes in the placebo group

-- In addition, the significant duloxetine treatment response was unaffected by baseline incontinence severity (based on the number of incontinence episodes at the start of the study). Women experiencing 14 or more leakage episodes per week at baseline experienced a similar percentage reduction in their leakages as women experiencing fewer than 14 episodes per week at baseline.

-- The most commonly reported side effects with duloxetine in this study (incidence of greater than or equal to 10.0 percent and at least twice placebo) were: nausea, fatigue, dry mouth, insomnia, constipation and dizziness. After the first month of therapy, the incidence of these adverse events did not differ significantly between duloxetine- and placebo-treated patients.

Quality of Life Results

Of particular interest to many women, patients on duloxetine in this study also reported improvements on incontinence-specific scales used to measure effects on their quality of life. Patients taking duloxetine had significantly better improvements in their quality of life scores compared with patients taking placebo using a validated incontinence quality of life question survey. Based on the Patient Global Impression of Improvement (PGI-I) Scale, 62.0 percent of duloxetine-treated subjects rated their condition improved compared with 39.6 percent of placebo-treated women.

Study methodology

The Phase III double-blind placebo-controlled study performed in the United States and Canada enrolled a total of 683 women aged 22-84 years. All women had predominant SUI symptoms and experienced at least seven episodes of incontinence per week. Incontinence symptoms had to be present for a minimum of three months for a woman to be eligible for the study. The trial lasted 12 weeks. One primary measure of efficacy used by researchers was the incontinence episode frequency recorded by patients on real-time diaries. A second primary measure was the total score from the validated Incontinence Quality of Life (I-QOL) questionnaire. Additional measures included voluntary voiding frequency, the Patient Global Impression of Improvement (PGI-I) Scale and three I-QOL subscale scores.