Dienogest Versus Leuprolide Acetate for Recurrent Pelvic Pain Following Laparoscopic Treatment of Endometriosis (original) (raw)
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International Journal of Gynecology & Obstetrics, 2012
To analyze the secondary efficacy and safety outcomes from a recent trial comparing dienogest (DNG) with leuprolide acetate (LA) in women with endometriosis. Methods: A 24-week, open-label, randomized, multicenter study of DNG versus LA in women with endometriosis-related pain was assessed for outcomes such as responder rates (using predefined thresholds of pain relief), changes in single symptoms/ signs and sum scores from the Biberoglu and Behrman (B&B) scale, clinical laboratory parameters, and measures of quality of life. Results: Dienogest was non-inferior to LA for treatment response using all predefined thresholds of pain relief and provided equivalent improvements in B&B symptoms and signs. No clinically relevant changes in laboratory parameters were observed during DNG treatment, whereas estrogen levels decreased in the LA group. Compared with LA, DNG was associated with pronounced improvements in specific quality-of-life measures. Conclusion: The analyses provide supportive evidence that the efficacy of DNG is equivalent to that of LA for treating endometriosis symptoms, with specific quality-of-life benefits and a favorable safety profile.
Acta obstetricia et gynecologica Scandinavica, 2015
To evaluate the efficacy of dienogest + estradiol valerate (E2V) and gonadotrophin-releasing hormone analogue (GnRH-a) in reducing recurrence of pain in patients with chronic pelvic pain due to laparoscopically diagnosed and treated endometriosis. Multi-center, prospective, randomized study. Three university departments of obstetrics and gynecology in Italy. Seventy-eight women who underwent laparoscopic surgery for endometriosis combined with chronic pelvic pain. Post-operative administration of dienogest + E2V for 9 months (group 1) or GnRH-a monthly for 6 months (group 2). A visual analogue scale was used to test intensity of pain before laparoscopic surgery at 3, 6 and 9 months of follow up. A questionnaire to investigate quality of life was administered before surgery and at 9 months of follow up. The visual analogue scale score did not show any significant differences between the two groups (p = 0.417). The questionnaire showed an increase of scores for all women compared with...
2021
Background: Endometriosis is an estrogen-dependent disease that adversely affects women’s quality of life (QOL). We aimed to compare the effect of dienogest and oral contraceptive pills (OCPs) on pain and QOL in women with endometriosis. Methods: This randomized double-blind trial was conducted at Rasoul-e-Akram hospital, affiliated to Iran University of Medical Sciences, Tehran, Iran, from March 2018 to March 2020, on women with severe endometriosis confirmed by laparoscopic surgery. Ninety patients were randomly given either dienogest (Vissane 2 mg tablet; n = 30), or OCPs (LD; n = 30), or placebo (n = 30) daily for 12 weeks. The primary objective of this study was to evaluate the patient’s pain including dyspareunia, dysuria, dyschezia, and pelvic pain. The secondary outcome was considered as a change in patients’ QOL score. Results: The mean age of population was 32.99 ± 7.1 years. There was no significant difference in the three groups regarding baseline characteristics. Pelvic...
Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment
Archives of Gynecology and Obstetrics, 2012
Purpose To investigate the eYcacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after treatment discontinuation. The study included women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an open-label extension study for up to 53 weeks. Thereafter, a patient subgroup was evaluated in a 24-week follow-up after treatment discontinuation. Methods A multicenter study performed in Germany, Italy and Ukraine. Women with endometriosis were enrolled at completion of the placebo-controlled study (n = 168). All women received dienogest (2 mg once daily, orally) and changes in pelvic pain (on a visual analog scale), bleeding pattern, adverse events and laboratory parameters were evaluated during and after treatment. Results The completion rate among women who entered the open-label extension study was 90.5% (n = 152). A sig-niWcant decrease in pelvic pain was shown during continued dienogest treatment (P < 0.001). The mean frequency and intensity of bleeding progressively decreased. Adverse events, rated generally mild or moderate, led to withdrawal in four patients (2.4%). No clinically relevant changes in laboratory parameters were observed. During treatmentfree follow-up (n = 34), the reduction in pelvic pain persisted, while bleeding frequency and intensity returned to normal patterns. Conclusions Long-term dienogest showed a favorable eYcacy and safety proWle, with progressive decreases in pain and bleeding irregularities during continued treatment; the decrease of pelvic pain persisted for at least 24 weeks after treatment cessation.
Archives of Gynecology and Obstetrics, 2017
Purpose Dienogest has recently been marketed as a medical treatment for endometriosis. Given the recent introduction on the market of Dienogest, little data are available regarding its effectiveness in routine clinical practice. Methods The study is an observational, single-center, cohort study. Eligible was women with a surgical diagnosis of endometriosis dating back \24 months or a clinical/instrumental diagnosis of endometriosis and endometriosisassociated pelvic pain score of at least 40 mm on a 100-mm visual analog scale (VAS) at start of treatment and who had been taking Dienogest 2 mg once daily treatment at the time of study entry for no more than 30 days, consecutively observed between September 2013 to September 2014. In accordance with routine practice, women came back for clinical assessment and evaluation of pain after 1 (V1), 3 (V2), and 12 (V3) months. Results A total of 132 women were enrolled in the study. A total of 21 of the enrolled patients were released from the study during follow-up due to adverse effects. The mean pelvic pain VAS score at baseline was 8.9 (SD 1.3). The corresponding values were 6.7 (SD 3.2) and 5.7 (SD 3.7) for dyspareunia and dyschezia. The mean VAS scores progressively and significantly decreased to 0.9 (SD 1.6) for pelvic pain, 1.4 (SD 2.1) for dyspareunia and 0.2 (SD 0.9) for dyschezia, respectively, 12 months after start of treatment. Conclusion This study confirms that in routine clinical practice, Dienogest 2 mg is an effective and well-tolerated treatment for endometriosis-related pain in women with endometriosis.
European Archives of Medical Research, 2021
Endometriosis is a common disease that affects 5%-15% of women of reproductive age. This study aimed to evaluate the effect of dienogest (DNG) on improving pain scores of patients with endometriosis. Methods: Data of 77 women who were admitted to the endometriosis clinic from March 1, 2015, to March 1, 2017, were evaluated. Patients were divided into 2 groups: DNG group (n=46) or group that denied use of any medication (expectant management group, n=31). The main presenting symptoms were graded using the visual analog scale (VAS). Age, parity, gravidity, body mass index (BMI), VAS scores, and further surgery requirement of the study groups were compared. Results: The most common presenting symptom was dysmenorrhea (79.2%), and the least common was dysuria (7.8%). No statistically significant difference was found between the study groups in terms of age, parity, gravidity, BMI, and further surgery requirement. A significant difference was found in the reduction of dysmenorrhea, dyspareunia, dyschezia, and pelvic pain VAS scores between the study groups, and more reduction was observed in the DNG group after 6 months of follow-up (p<0.001, p=0.04, p=0.009, and p=0.01, respectively). Conclusion: DNG might be an alternative treatment for reducing pain symptoms related to endometriosis.
BMC Women's Health
Background: Dienogest has been shown to substantially improve endometriosis-associated symptoms such as debilitating chronic pelvic pain, and in turn, health-related quality of life (HRQoL). To date, there is no data on patient-reported outcomes reflecting the real-world practice in Asia where endometriosis is a relevant health, social and economic burden. This non-interventional, multi-center, prospective study aims to investigate the influence of dienogest on HRQoL. Methods: Asian women received dienogest (2 mg/daily) and were followed for 24 months. The effectiveness of dienogest to improve HRQoL and endometriosis-associated pelvic pain (EAPP) was assessed by patient-reported outcomes. HRQoL, especially the "pain" domain as primary endpoint, was evaluated with the Endometriosis Health Profile-30 (EHP-30) questionnaire. The numeric rating scale served to determine changes in the severity of EAPP. Within the presented interim analysis (data cutoff: 2017-11-27), the mean changes in EHP-30 and EAPP scores from baseline to 6 months upon availability of the data were evaluated. Treatment-emergent adverse events (TEAEs) and bleeding profiles were documented. Results: Dienogest therapy decreased EHP-30 scores in all assessed domains (score 0-100, lower scores indicate better HRQoL). Primarily, the "pain" domain was improved in 78.4% of patients. EAPP was reduced (score 0-10, lower scores reflect less pain), highlighted by a mean reduction of the pain score by − 4.5 points. Patients with a higher EAPP score at baseline had an increased response to dienogest (− 6.2 points mean change) compared to patients with low baseline EAPP severity (− 1.4 points mean change). Both surgically and clinically diagnosed patients described comparable pain reduction, as well as women with or without prior treatment. Drug-related TEAEs were documented for 31.5% of patients, with amenorrhoea (5.9%) and metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon dienogest, characterized by decreased normal bleeding (84.2 to 28.8%) and increased amenorrhea (3.2 to 42.9%) at 6 months.
European Journal of Obstetrics & Gynecology and Reproductive Biology, 2014
Objective: To evaluate patient satisfaction at 6-months dienogest (DNG) treatment in women with symptomatic rectovaginal endometriosis who had pain persistence and were unsatisfied after 6-months of norethisterone acetate (NETA) therapy. Study design: This 24-weeks pilot open-label prospective study enrolled 25 women. The main outcome was the degree of patient satisfaction measured by using a Likert scale. Secondary outcomes were to evaluate differences in endometriosis-related pain, quality of life, sexual function changes and volumetric nodules changes during DNG compared to NETA treatment. Results: Patient satisfaction improved at 3-and 6-months (p < 0.001, respectively) treatment with DNG compared with baseline treatment with NETA. Six months DNG treatment decreased the intensity of all the endometriosis-associated pain (chronic pelvic pain, dyspareunia, dyschezia) compared to baseline (p < 0.001 for all comparisons). Quality of life and quality of sexual life evaluated with the EHP-30 and FSFI, respectively, increased after 6 months treatment. The volume of the endometriotic nodules did not significantly change during treatment.
Archives of Gynecology and Obstetrics, 2023
Purpose To evaluate the efficacy and long-term safety (up to 108 months) of treatment with Dienogest in patients with endometriosis. Methods Patients with chronic pelvic pain endometriosis-related were enrolled in this observational study from June 2012 to July 2021. The patients enrolled took Dienogest 2 mg as a single daily administration. Group B of long-term therapy patients (over 15 months) were compared with group A of short-term therapy patients (0-15 months). The effects of the drug on pain variation were assessed using the VAS scale and endometriomas dimensions through ultrasonographic evaluation. Furthermore, has been valuated the appearance of side effects and the effect of the drug on bone metabolism by performing MOC every 24 months in group B. Results 157 patients were enrolled. The mean size of the major endometrioma progressively decreased from 33.2 mm (29.4-36.9) at T0 to 7 mm (0-15.8) after 108 months of treatment. We found a significant improvement in dysmenorrhea, dyspareunia, dyschezia and non-cyclic pelvic pain. As for the side effects, both groups complained menstrual alterations present in 22.9%. In 27.6% of group B, osteopenia was found. Group B had a higher percentage statistically significant of side effects such as headaches, weight gain and libido reduction compared to group A. 2 Conclusion Long-term therapy with Dienogest has proven effective in controlling the symptoms of the disease and reducing the size of endometriomas, with an increase in the positive effects related to the duration of the intake and in the absence of serious adverse events. Study approved by the "Palermo 2" Ethics Committee on July 2, 2012 No. 16.