Long-term Treatment Of Endometriosis Research Articles

Long-term treatment for endometriosis with dienogest: efficacy, side effects and tolerability

Background Dienogest (DNG) improves endometriosis-associated pain (EAP) and patients’ quality of life; however, the modern cornerstone of the management of endometriosis is the long-term adherence of the patient to medical treatment. Objective To evaluate DNG as a long-term treatment of endometriosis, focusing on patients’ compliance and side effects, also correlating with different phenotypes of endometriosis. Methods This was a cohort study on a group of patients with endometriosis (n = 114) undergoing long-term treatment with DNG. During the follow up visits (12, 24, and 36 months) patients were interviewed: an assessment of EAP was performed by using a visual analogue scale (VAS) and side effects were evaluated by using a specific questionnaire of 15 items. Results At 12 months, 81% were continuing the DNG treatment, with a significant reduction of dysmenorrhea, dyspareunia, dyschezia, dysuria and chronic pelvic pain. Of the 19% that discontinued the treatment: 62% was due to spotting, reduced sexual drive, vaginal dryness, and mood disorders. The improvement of EAP was significant for all endometriosis phenotypes, especially in patients with the deep infiltrating type. At 36 months, 73% of patients were continuing the treatment, showing a significant reduction of EAP through the follow up, along with an increase of amenorrhea (from 77% at 12 months to 93% at 36 months). In a subgroup of 18 patients with gastrointestinal disorders, DNG was administered vaginally at the same dosage, showing similar results in terms of efficacy and tolerability. Conclusions DNG was an effective long-term treatment for all endometriosis phenotypes, with few side effects that caused the discontinuation of the treatment mainly during the first year. Thus, the course of 1-year treatment is a predictive indicator for long-term treatment adherence.

Long-term treatment of endometriosis with dienogest: Real-world results from the VIPOS study

Introduction: The Visanne Post-approval Observational Study (VIPOS) was designed to assess the safety of dienogest 2 mg (DNG, Visanne) compared to other hormonal endometriosis treatments. Methods: Large, prospective, non-interventional, active surveillance study in six European countries (Germany, Poland, Russia, Hungary, Switzerland, and Ukraine). Women with a new hormonal therapy for endometriosis were enrolled by gynecologists and specialized centers between 2010 and 2016 and observed for up to 7 years. Self-administered questionnaires during study entry and follow-up collected information on baseline characteristics, health status and endometriosis treatment. Self-reported clinical outcomes of interest were validated by health care professionals. Results: Among the >27,000 enrolled participants, 3262 women started DNG use either at study entry or during follow-up. A total of 798 study participants used DNG during follow-up continuously for 15 months or longer (DNG long-term users). When comparing the occurrence of serious adverse events (SAE) in users treated with DNG, no safety signal emerged for long-term users; the SAE incidence rate per 10,000 women-years was 367.7 (95% CI: 274.1–481.9) in DNG long-term users and 416.4 (349.1–492.5) in short-term users (treated with DNG for less than 15 months). Conclusions: Previous data on DNG long-term safety were derived from studies with relatively low numbers of patients and limited follow-up time. VIPOS provided valuable real-world data on the long-term use of DNG 2 mg in around 800 women treated in Europe and observed no safety signal regarding serious adverse events.

Safety and Efficacy of Dinogest in Long Term Treatment of Endometriosis

Safety and Efficacy of Dinogest in Long Term Treatment of Endometriosis

Long term treatment of endometriosis associated pain (EAP) with linzagolix: efficacy and safety after 12 months of treatment

Long term treatment of endometriosis associated pain (EAP) with linzagolix: efficacy and safety after 12 months of treatment

Long-term treatment of endometriosis with dienogest for up to five years

Purpose of Investigation: Dienogest is marketed in Japan as the first time in the world for novel treatment of endometriosis. This paper details the retrospective investigation how effective long-term use of dienogest is for the treatment of endometriosis. Materials and Methods: Data on 21 patients of diagnosed as endometriosis/adenomyosis and treated with dienogest for more than 12 months (ten patients with 60-month period) were collected. Results: Dienogest was effective in reducing pain and size of ovarian endometrioma, while the size of adenomyosis remained the same size as before treatment. The most frequent adverse effects were irregular bleeding. There was no reduction in bone mineral density after 60 months while plasma estradiol was maintained at a slightly lower level. Clinical parameters for did not change during a 60-month period. Conclusions: These results show that dienogest is safe to use for at least five years and is an effective treatment for endometriosis for long periods.

Long-term treatment of endometriosis with dienogest: retrospective analysis of efficacy and safety in clinical practice.

Endometriosis is a debilitating disease with high recurrence rates requiring long-term management. Progestins such as dienogest are used empirically when first symptoms occur and post-surgery to reduce recurrence. This retrospective, practice-based study assessed the efficacy and safety of dienogest in women with endometriosis treated for at least 60months. 37 women (age 39 ± 8years) with laparoscopically diagnosed endometriosis received dienogest 2mg orally once daily. Endometriosis-associated pelvic pain (EAPP) was measured on a 0-100mm visual analog scale at baseline and every 12months. Laboratory measures of lipid and liver metabolism, hemostatic and hormonal parameters were investigated in a subgroup of 15 women. Adverse events including bleeding disturbances and depressive symptoms were recorded. In 22 women, dienogest was begun after laparoscopy; median EAPP score was 70mm pre-surgery and 10, 10, 20, 20, and 20mm, respectively, after 12, 24, 36, 48, and 60months of dienogest treatment. Another 15 women began dienogest without prior surgery; median EAPP score was 80mm pretreatment and 20, 20, 30, 30, and 30mm, respectively, after 12, 24, 36, 48, and 60months. All laboratory parameters remained within the normal range. Mean serum estradiol was 28 ± 12pg/ml after 60months. Seven women experienced spotting episodes and four women presented with phases of depressed mood, which could all be clinically managed. Long-term (60-month) treatment with dienogest 2mg once-daily in women with endometriosis effectively reduced EAPP and avoided pain recurrence post-surgery. Dienogest was well tolerated and adverse effects were clinically managed.

Dienogest in long-term treatment of endometriosis

Endometriosis is a chronic disease primarily affecting women of childbearing age, in which endometriotic lesions form outside the uterus, typically leading to painful symptoms, fatigue, and infertility. The symptoms of endometriosis may cause significant impairment in quality of life and represent a substantial economic burden to patients, families, and society. There is no cure for endometriosis; management consists of alleviating pain and other symptoms, reducing endometriotic lesions, and improving quality of life. Recurrence after surgical intervention is common, while the clinical evidence to support the efficacy and safety of many medications currently used in endometriosis is limited. Dienogest is an oral progestin that has been investigated extensively in the treatment of endometriosis in two clinical programs performed in Europe and Japan, including dose-ranging, placebo-controlled, active comparator-controlled, and long-term (up to 65 weeks) studies. These studies demonstrated that dienogest 2 mg daily effectively alleviates the painful symptoms of endometriosis, reduces endometriotic lesions, and improves indices of quality of life. Dienogest showed a favorable safety and tolerability profile in these studies, with predictable adverse effects, high rates of patient compliance, and low withdrawal rates. This review article describes the clinical trial evidence that characterizes the efficacy and safety of dienogest in endometriosis, including two studies characterizing dienogest in long-term use. The relevance of these findings to the management of endometriosis in clinical practice is discussed.

Safety of dienogest in the long-term treatment of endometriosis: a one-year, open-label, follow-up study

Safety of dienogest in the long-term treatment of endometriosis: a one-year, open-label, follow-up study

TxB2 generation by platelets during long-term treatment of endometriosis with the gonadotropin releasing hormone (GnRH) analogue decapeptyl: [formula omitted], ∗V. Bruni, ∗D. Rosati, R. Paniccia, R. Abbate. Clinica Medica I, ∗ Clinica Ostetrica e Ginecologica I, University of Florence, Italy

TxB2 generation by platelets during long-term treatment of endometriosis with the gonadotropin releasing hormone (GnRH) analogue decapeptyl: [formula omitted], ∗V. Bruni, ∗D. Rosati, R. Paniccia, R. Abbate. Clinica Medica I, ∗ Clinica Ostetrica e Ginecologica I, University of Florence, Italy

Circulating lipid and lipoprotein concentrations during danazol and high-dose medroxyprogesterone acetate therapy of endometriosis

In a study on endometriosis, ten patients were treated with danazol (200 mg three times a day) and ten patients with high-dose medroxyprogesterone acetate (MPA) (100 mg a day) for 6 months. The circulating high-density lipoprotein-cholesterol concentration decreased significantly in the danazol (53%) and in the MPA groups (26%); the change in the danazol group was significantly higher than that in the MPA group. Danazol also significantly increased the low-density lipoprotein-cholesterol levels (37%), whereas MPA had no significant effect. Danazol (29%) and MPA (12%) decreased the apolipoprotein A-1 levels significantly. The decrease caused by danazol was significantly greater. Danazol also significantly decreased the apolipoprotein A-2 levels (12%) and significantly increased the apolipoprotein B levels (17%), whereas MPA had no significant effects on them. Three months after the end of medication, all values were at the pretreatment levels. The circulating cholesterol, triglyceride, and very low-density lipoprotein concentrations remained unchanged during both treatments. Danazol and high-dose MPA induced a similar significant regression of peritoneal endometriotic implants in relation to placebo. Our present results, showing that danazol, to a greater extent than high-dose MPA, is associated with changes in lipoprotein metabolism that expose the individual to an increased risk of cardiovascular diseases, suggest that high-dose MPA is preferable to danazol in the long-term treatment of endometriosis.