What is Yentreve?
Yentreve is a medicine that contains the active substance duloxetine. It is available as blue (20 mg) or orange (40 mg) capsules.
What is Yentreve used for?
Yentreve is used to treat moderate and severe stress urinary incontinence (SUI) in women. This disorder causes involuntary losses of urine during physical exertion or following coughing, laughter, sneezing, lifting or physical exercises). The medicine can only be obtained with a prescription.
How is Yentreve used?
The recommended dosage of Yentreve is 40 mg twice a day. For some patients it may be beneficial to start treatment at a dose of 20 mg twice a day for two weeks before changing to a dose of 40 mg twice a day to reduce nausea and dizziness. The benefit of the treatment must be re-evaluated at regular time intervals.
The association of Yentreve with a program of exercise of the pelvic floor musculature can give further benefit.
How does Yentreve work?
The active ingredient of Yentreve is duloxetine, a combined serotonin and norepinephrine reuptake inhibitor (SNRI). Duloxetine works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrernaline from being reabsorbed by nerve cells in the brain and spinal cord. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. By blocking their reabsorption, duloxetine increases the number of neurotransmitters in the space between nerve cells, increasing the level of communication between these cells. Its modes of action in the SUI are unclear, but it is believed that by increasing the concentrations of 5-hydroxytryptamine and Norepinephrine at the nerves that control the musculature of the urethra (the channel that connects the bladder to the outside), the duloxetine causes a stronger urethral closure during urine filling. Through this mechanism Yentreve prevents the involuntary loss of urine during a physical effort such as a cough or a laugh.
What studies have been carried out on Yentreve?
Yentreve has been studied in a total of 2850 women with SUI. The four main studies involving 1, 913 patients lasted for 12 weeks and compared Yentreve (mostly administered at a dose of 40 mg twice a day) with a placebo (a dummy treatment). The main parameters of effectiveness were the frequency of incontinence episodes (IEF, ie the number of incontinence episodes per week) reported in a diary by patients and the scores totaled in a questionnaire on incontinence-specific quality of life (I -QOL).
What benefit has Yentreve shown during the studies?
In all four studies, patients treated with Yentreve had fewer episodes of incontinence after 12 weeks, about four or five fewer episodes per week than the frequency recorded before the start of the study. The IEF decreased by 52% in the group treated with Yentreve compared to the 33% decrease observed in the placebo group. The score questionnaire was improved in the group of patients treated with Yentreve compared to the placebo group. Yentreve was more effective than placebo only in patients with stress incontinence greater than 14 episodes of incontinence per week (moderate to severe SUI) at the start of the study.
What is the risk associated with Yentreve?
The most commonly reported side effects with Yentreve (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue. For the full list of all side effects reported with Yentreve, see the Package Leaflet. Yentreve should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients. Furthermore, the medicine should not be used by patients suffering from certain types of liver disease or severe kidney disease. Yentreve should not be taken together with medicines containing monoamine oxidase (a type of antidepressant), fluvoxamine (another antidepressant) and ciprofloxacin or enoxacine (antibiotics). Treatment with Yentreve should not be initiated in patients with uncontrolled hypertension due to the risk of hypertensive crisis (sudden and sometimes dangerous increase in blood pressure).
Why has Yentreve been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Yentreve's benefits are greater than its risks for the treatment of moderate to severe stress urinary incontinence. The CHMP therefore recommended that it be given marketing authorization for this medicine.
More information on Yentreve:
On 11 August 2004, the European Commission granted a marketing authorization for Yentreve, valid throughout the European Union, to Eli Lilly Nedreland BV.
For the full EPAR for Yentreve, click here.
Last update of this summary: 05-2008.
