For example, using a dose of dienogest 2 mg daily, the reduction of endometriosis-related pain was significant; however, in 95% of cases spotting was reported. A mouse model of endometriosis shows that dienogest reduces lesion size better than duphaston and Esmya, although all three were effective. Safety and tolerability of dienogest in endometriosis: pooled analysis from the European clinical study program Thomas Strowitzki,1 Thomas.
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It occurs when endometrial cells proliferate outside the uterus, for example on the ovaries or in the peritoneum. It is associated with symptoms such as chronic pelvic pain, and pain during menstruation and sexual intercourse. Drug treatments for endometriosis aim to suppress endometriosid function and include androgens e.
Dienogest is a progestogen-only hormone preparation for the treatment of endometriosis. It works by suppressing oestradiol production and preventing the growth of the endometrium. Dienogest is already available in Australia in combination with an oestradiol in some oral contraceptive pills Aust Prescr ; In an open-label, dose-finding trial of 68 women, daily dienogest 2 mg or 4 mg significantly reduced the severity of endometriosis, scored by laproscopic examination at baseline and 24 weeks later.
Rates of premenstrual pain, dysmenorrhoea and diffuse pelvic pain were also reduced. The trial concluded that dienogest 2 mg once a dienotest was the lowest effective dose.
In a week placebo-controlled trial involving women, daily dienogest 2 mg significantly reduced pelvic pain compared with placebo on a mm visual analogue scale by In a week open-label extension of this study, 87 women continued dienogest and 81 who had taken placebo started the drug. Endo,etriosis continued for up to 52 weeks. The mean pain score declined from At the end of treatment the mean score for all patients was A group of 34 women were followed up enddometriosis 24 weeks after treatment finished.
Their mean pain score increased slightly to Dienogest has been compared to the gonadotropin-releasing hormone agonist leuprolide leuprorelide in an open-label non-inferiority study of women. After 24 weeks of treatment, pelvic pain — assessed by a mm visual analogue score — had reduced from The trial concluded that dinogest was non-inferior to leuprorelide.
Dienogest Better to Treat Endometriosis than Esmya, Duphaston, Study Says
Similarly dienogest was found to be as effective as buserelin given intranasallyanother gonadotropin-releasing doenogest agonist. However, dienogest was associated with more vaginal bleeding than the comparator. As severe depression has been reported with dienogest, 4 patients with a history of depression should be monitored closely.
Changes in menstrual bleeding patterns were common in the trials, but endometriosix not usually lead to discontinuation. After 9—12 months, bleeding was normal in Dienogest is contraindicated in undiagnosed vaginal bleeding and during pregnancy and lactation.
Although ovulation is inhibited in most patients, dienogest is not a contraceptive and use of a non-hormonal method is recommended while taking dienogest. The menstrual cycle resumes within two months of stopping the drug.
Dienogest should not be given to patients with an active thromboembolic disorder or a duenogest of cardiovascular disease. The risk of cardiovascular events is associated with older age, hypertension and smoking. Diabetes and severe hepatic disease, a history of liver tumours or sex-hormone dependent malignancies are contraindications to dienogest. If cholestatic jaundice or pruritis develops, dienogest should be stopped.
It was not clear from the trials if dienogest affects bone mineral density. If treatment is continued for longer than six months, consider monitoring bone mineral density. After oral administration, dienogest is rapidly absorbed enfometriosis peak serum concentrations being reached after approximately 1. It is completely metabolised, mainly by cytochrome P CYP 3A4, ebdometriosis metabolites are rapidly excreted in the urine and faeces. Dienogest can be started on any day of the menstrual cycle.
It should be taken every day without interruption. If a tablet is missed, the next one should be taken as soon as possible and dosing continued as normal the next day. As with the contraceptive pill, vomiting and diarrhoea can reduce the efficacy of dienogest.
Dienogest reduces the pain associated with endometriosis and is comparable to gonadotropin-releasing hormone agonists. However, some women may still need analgesia for their pelvic pain. The Endomftriosis Score is explained in New drugs: At the time the comment was prepared, information about this drug was available on the website of the Therapeutic Goods Administration www.
National Center for Biotechnology InformationU. Journal List Aust Prescr v.
Dienogest in long-term treatment of endometriosis
Published online May Copyright and License information Disclaimer. Footnotes The Transparency Score is explained in New drugs: A dose-ranging study to determine the efficacy and safety of 1, 2, and 4mg of dienogest daily for endometriosis.
Int J Gynaecol Obstet ; Dienogest in the treatment of endometriosis-associated endo,etriosis pain: Reduced pelvic pain in women with endometriosis: Arch Gynecol Obstet ; Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: Hum Reprod ; Dienogest is as effective as intranasal buserelin dieongest for the relief of pain symptoms associated with endometriosis–a randomized, double-blind, multicenter, controlled trial.